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NATIONAL NANOTECHNOLOGY INITIATIVE: 

CHARTING THE COURSE FOR REAUTHORIZATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND 

INNOVATION 

OF THE

COMMITTEE ON COMMERCE, 

SCIENCE, AND TRANSPORTATION 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

APRIL 24, 2008 

Printed for the use of the Committee on Commerce, Science, and Transportation 

( 

(II) 

SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

DANIEL K. INOUYE, Hawaii, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

JOHN F. KERRY, Massachusetts 

BYRON L. DORGAN, North Dakota 

BARBARA BOXER, California 

BILL NELSON, Florida 

MARIA CANTWELL, Washington 

FRANK R. LAUTENBERG, New Jersey 

MARK PRYOR, Arkansas 

THOMAS R. CARPER, Delaware 

CLAIRE MCCASKILL, Missouri 

AMY KLOBUCHAR, Minnesota 

TED STEVENS, Alaska, Vice Chairman 

JOHN MCCAIN, Arizona 

KAY BAILEY HUTCHISON, Texas 

OLYMPIA J. SNOWE, Maine 

GORDON H. SMITH, Oregon 

JOHN ENSIGN, Nevada 

JOHN E. SUNUNU, New Hampshire 

JIM DEMINT, South Carolina 

DAVID VITTER, Louisiana 

JOHN THUNE, South Dakota 

ROGER F. WICKER, Mississippi 

MARGARET L. CUMMISKY, Democratic Staff Director and Chief Counsel 

LILA HARPER HELMS, Democratic Deputy Staff Director and Policy Director 

CHRISTINE D. KURTH, Republican Staff Director and General Counsel 

PAUL NAGLE, Republican Chief Counsel 

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND INNOVATION 

JOHN F. KERRY, Massachusetts, Chairman 

JOHN D. ROCKEFELLER IV, West Virginia 

BYRON L. DORGAN, North Dakota 

BARBARA BOXER, California 

MARIA CANTWELL, Washington 

MARK PRYOR, Arkansas 

CLAIRE MCCASKILL, Missouri 

AMY KLOBUCHAR, Minnesota 

JOHN ENSIGN, Nevada, Ranking 

JOHN MCCAIN, Arizona 

KAY BAILEY HUTCHISON, Texas 

GORDON H. SMITH, Oregon 

JOHN E. SUNUNU, New Hampshire 

JIM DEMINT, South Carolina 

JOHN THUNE, South Dakota 

(III) 

C O N T E N T S 

Page 

Hearing held on April 24, 2008 .............................................................................. 1 

Statement of Senator Kerry .................................................................................... 1 

Statement of Senator Stevens ................................................................................ 2 

Statement of Senator Thune ................................................................................... 33 

WITNESSES

Ferguson, Ph.D., P. Lee, Assistant Professor, Department of Chemistry and 

Biochemistry, University of South Carolina ...................................................... 62 

Prepared statement .......................................................................................... 63 

Goel, M.D., Ph.D., Anita, Founder, Chairman, and Scientific Director, 

Nanobiosym, Inc. and Founder, Chairman, and CEO, Nanobiosym 

Diagnostics, Inc. ................................................................................................... 69 

Prepared statement .......................................................................................... 72 

Heath, Jim, Elizabeth W. Gilloon Professor and Professor of Chemistry; Director, NanoSystems Biology Cancer Center, California Institute of Technology .................................................................................................................... 76 

Prepared statement .......................................................................................... 78 

Nordan, Matthew M., President, Lux Research, Inc. ........................................... 38 

Prepared statement .......................................................................................... 39 

Rejeski, David, Director, Project on Emerging Nanotechnologies, Woodrow 

Wilson International Center for Scholars .......................................................... 47 

Prepared statement .......................................................................................... 50 

Robinson, Robert A., Managing Director, Natural Resources and Environment, U.S. Government Accountability Office ................................................... 18 

Prepared statement .......................................................................................... 20 

Russell, Ambassador Richard M., Associate Director and Deputy Director 

for Technology, Office of Science and Technology Policy, Executive Office 

of the President .................................................................................................... 3 

Prepared statement .......................................................................................... 5 

(1) 

NATIONAL NANOTECHNOLOGY INITIATIVE: 

CHARTING THE COURSE FOR 

REAUTHORIZATION 

THURSDAY, APRIL 24, 2008 

U.S. SENATE, 

SUBCOMMITTEE ON SCIENCE, TECHNOLOGY, AND

INNOVATION, 

COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION, 

Washington, DC. 

The Subcommittee met, pursuant to notice, at 2:49 p.m. in room 

253, Russell Senate Office Building, Hon. John Kerry, Chairman of 

the Subcommittee, presiding. 

OPENING STATEMENT OF HON. JOHN F. KERRY, 

U.S. SENATOR FROM MASSACHUSETTS 

Senator KERRY. This hearing will come to order. Thank you all 

very much. I apologize for being a little bit late. I was voting on 

the tail end there. We thank our witnesses for their patience. We’re 

going to try to roll right along here. 

This issue couldn’t be more timely as we look forward to the next 

generation of nanotechnology breakthroughs. In the 8 years since 

President Clinton first created the National Nanotechnology Initiative, it’s really become clear that our ability to manipulate, engineer, and manufacture nanoparticles provides an unlimited potential for innovation and growth throughout the economy. In 2006, an estimated $50 billion in products worldwide incorporated some form of nanotechnology and that figure has been projected by some to reach about 2.6 trillion over the next 8 years. Scientists are using this technology to create advanced materials and 

systems that will obviously improve our way of life and also revolutionize the very concepts of size and scale. 

The nanotechnology revolution is occurring across all sectors. In 

Massachusetts, my friend Dr. Robert Linares started a company in 

his garage after discovering a way to use nanotechnology to turn 

carbon powder into diamonds. I have visited one of Dr. Linares’s 

facilities and actually watched the team that has worked to build 

a diamond atom by atom. His company, Apollo Diamond, is currently working with the Defense Department to develop related 

technologies that will reduce collateral damage, protect soldiers 

and citizens, and improve the capabilities of our military aircraft. 

We also know that there’s extraordinary potential for nanotechnology and life sciences and we’ll hear later this afternoon from Dr. 

Goel who is CEO of Nanobiosym Diagnostics. Dr. Goel’s company 

2 

is creating portable nanotechnology-enabled devices that can rapidly and accurately provide patients with real-time access to medical diagnostic information. Even better, she’s working to perfect 

this technology in Medford, Massachusetts, a little parochialism. 

As visionaries and innovators, such as Dr. Linares and Dr. Goel, 

work to harness this potential, the Federal Government does have 

a critical role to play. As we look toward reauthorizing the National 

Nanotechnology Initiative at the end of this Fiscal Year, there are 

issues and questions that have to be addressed so we can stay out 

in front of our global competitors, most of whom are betting big on 

nanotechnology right now. 

We also have a responsibility to make sure we’re dedicating sufficient resources toward researching the environmental health and 

safety impacts of these particles. 

The Chairman of the Committee asked for a GAO report to assess just how much of a priority is being placed on EHS research 

across the 25 agencies that administer the National Nanotechnology Initiative. GAO’s response is troubling. 

In 2006, just 3 percent of the $1.3 billion designated for the National Nanotechnology Initiative was used to further EHS research. 

Even that statistic is a little misleading because, according to the 

Controller General, the agencies are using a faulty reporting structure and are not receiving appropriate guidance for how to apportion funding across multiple topics. 

Funding for EHS research will be a top priority as we move forward with this reauthorization process. We need to ensure a wellcoordinated, well-funded governmentwide approach to performing 

the research that will tell us whether these particles are safe to 

work around, whether they’re safe for the environment, and whether they’re safe for consumers once they reach the shelves. 

It’s obviously critical to do that research upfront so we’re not 

asking what went wrong a hundred years from now. 

I look forward to discussion with these panels and working with 

my colleagues on the Subcommittee, including Senator Pryor, with 

whom I chair the High-Tech Task Force, to draft a reauthorization 

proposal. I hope our discussion today will be instructive with respect to that. 

Senator Stevens? 

STATEMENT OF HON. TED STEVENS, 

U.S. SENATOR FROM ALASKA 

Senator STEVENS. Well, thank you very much, Mr. Chairman. I’m 

delighted you’re holding this hearing today on nanotechnology and 

the reauthorization of the National Nanotechnology Initiative. 

Nanotechnology is fascinating and revolutionary in many ways 

and it has the potential to change and improve our lives. I do think 

we all think about it from the golf course to the emergency room. 

Nanoscience is developing novel materials and devices and systems 

that open up new avenues of science and engineering and controlling matter at the size of 1,000ths of the diameter of the human 

hair creates really an interest in the public and everyone concerned 

with it. I think it is such an amazing new area, that it is, as I said, 

just plain fascinating to me. 

3 

As this nanotechnology evolves, safety becomes the topic of great 

interest and I think there appears to be very little evidence so far 

that nanotechnology is creating any serious dangers to our Nation 

or is unsafe. On the contrary, I’m told medicine has used nanoparticles for at least 25 years in therapeutic medicines. Magnetic resonance imaging tests already employ nanotechnology and they’ve 

not revealed any demonstrable negative impacts on human health. 

So in the absence of that, I hope that Congress and the Federal 

Government will not, as policymakers or administrators, overestimate our role and we will conduct ourselves in the way to support 

the research and avoid imposing additional regulatory regimes on 

this developing field of science, unless we’re convinced that additional regulations is really warranted. 

Mr. President—Mr. Chairman, I have to leave—— 

Senator KERRY. I like Mr. President. It’s OK. 

[Laughter.] 

Senator KERRY. Even if it’s very fleeting. 

Senator STEVENS. I had the privilege of being President of the 

Senate for 4 years, so I understand what you’re saying. 

Chairman of the Committee, Senator Inouye and I have an appointment, however, with the Chairman of the Foreign Affairs 

Committee of the National Peoples Congress in China, very important meeting, so I’ll have to leave soon. 

I want to give my apologies to my great friend Jim Heath who’s 

here and look forward to seeing Jim. I hope he’ll stop by the office 

before he leaves today. 

Thank you very much. 

Senator KERRY. Thanks so much, Senator Stevens, and thank 

you for your interest in this. We know that you have a huge ability 

to help make the right things happen on this. this. So we really appreciate your interest in it and participation. 

So Mr. Russell, thank you, Director, for being here. We appreciate that, and Mr. Robinson, why don’t you guys lead off? If you 

can summarize your statements in about 5 minutes, your full statements will be placed in the record as if read in full, so don’t fear 

that anything will be left out of the record, and we’ll have a little 

more chance to explore it with the panels. 

Thank you. 

STATEMENT OF AMBASSADOR RICHARD M. RUSSELL, 

ASSOCIATE DIRECTOR AND DEPUTY DIRECTOR FOR 

TECHNOLOGY, OFFICE OF SCIENCE AND TECHNOLOGY 

POLICY, EXECUTIVE OFFICE OF THE PRESIDENT 

Mr. RUSSELL. Terrific. Thank you, Chairman Kerry and Vice 

Chairman Stevens, and when the rest of the members of the Subcommittee come, thank them as well. 

I’m very pleased to appear here before you to discuss the National Nanotechnology Initiative and issues associated with its upcoming reauthorization. 

First of all, I’d like to thank the Committee on behalf of the Administration and the NNI for its bipartisan support of nanotechnology research. NNI is truly an example of the successful bipartisan 

effort to promote one of the most important areas of science and 

technology currently being sponsored by the Federal Government. 

4 

The NNI was first established during the last year of the Clinton 

Administration. With the support of Congress and the Bush Administration, the program has more than tripled in scale, a permanent coordinating office has been established and authorizing legislation passed and signed into law. The Committee deserves great 

credit for its longstanding support of the program. 

I have submitted detailed written testimony which I will summarize. 

NNI is built on the voluntary association of 25 Federal agencies 

that have activities and interests related to nanoscale science and 

technology. The Administration believes the organization, structure 

and management of the NNI is appropriate and effective and, accordingly, I urge Congress to proceed with caution in considering 

any fundamental changes to the structure. In Fiscal Year 2009, the Administration has requested $1.5 billion for the program. The NNI now represents a cumulative investment of almost $10 billion. The NNI recently released an updated 

strategic plan that outlines the following four basic goals for the 

initiative. 

Goal 1. Advanced a world class nanotechnology research and development program. 

The NNI has funded thousands of individual R&D projects since 

its inception, contributing to U.S. world leadership in nanotechnology. While identifying meaningful metrics for evaluating U.S. global leadership in nanotechnology is challenging, by many of the 

measures that we do have available, the United States continues 

to lead in both basic and applied research, nanoscale science and 

technology. While the U.S. leads in many important statistics, the 

rest of the world is hard on our heels. 

In terms of both funding and research results, Europe, Asia and 

now Russia are matching and in some cases exceeding our nanofunding and are hoping to take over the leadership role. 

Goal 2. Foster the transfer of new technologies into products for 

commercial and public benefit. 

The NNI has put in place a number of efforts targeted to enhance the transfer of research results into practical applications 

and commercialization. For example, there are over 60 interdisciplinary research centers and user facilities around the country 

which provide collaborative environments where researchers from 

academia and industry can interact, increasing the likelihood of 

technology transfer. 

Goal 3. Develop and sustain educational resources, a skilled work 

force, and support infrastructure and tools to advance nanotechnology. 

Education is among the chief objectives of the NNI-funded university research. In addition, there are numerous specific programs 

targeted at K through 12 education. 

Goal 4. Support responsible development of nanotechnology, 

something, Mr. Chairman, you were just alluding to. As potential 

environment, health and safety concerns about nanotechnology 

begin to emerge in the early years of the initiative, an interagency 

EHS working group was formed. 

In December 2004, the NNI released a strategic plan calling out 

EHS research for special attention. In September 2006, the EHS 

5 

1http://www.nano.gov/NNIlStrategiclPlanl2007.pdf. 

Research Needs Report was completed. It identified 75 research 

needs within five general categories of EHS research. Most recently, in February 2008, a comprehensive EHS strategy was released. In addition, the National Research Council is now under 

contract to assess the EHS strategy. 

The Federal Government needs to ensure that nano-EHS research is adequately addressed. To this end, the NNI has systematically: (1) identified research needs, (2) prioritized those needs, 

(3) developed an associated inventory from which a gap analysis 

can be performed, and (4) developed a strategy for addressing and 

prioritizing the needs that are not currently being addressed. 

The Administration believes this systematic approach is the right 

way to address EHS research needs. This systematic approach has 

led to EHS funding being more than doubled since Fiscal Year 

2005, from $35 million to $76 million in the Fiscal 2009 request, 

a growth rate significantly faster than the overall growth than 

NNI. 

As GAO points out in its report on NNI’s EHS research, and I 

quote, ‘‘Some environmental and industry groups have advocated 

for a more top-down and directed approach for setting and funding 

Federal nanotechnology research priorities. However, such a structure and approach is generally inconsistent with the historical approaches used to set Federal research priorities and may be difficult to implement.’’ 

We agree, and the Administration does not support establishing 

an arbitrary top-down EHS set-aside. 

In conclusion, Mr. Chairman, the NNI has been and remains a 

highly successful enterprise, due in large part to the unparalleled 

interagency coordination and collaboration which in turn has been 

effective because of a voluntary bottom-up nature in which all the 

agencies that participate benefit. 

I look forward to working with the Committee as it considers 

how to improve upon the successful program. 

[The prepared statement of Mr. Russell follows:] 

PREPARED STATEMENT OF AMBASSADOR RICHARD M. RUSSELL, ASSOCIATE DIRECTOR

AND DEPUTY DIRECTOR FOR TECHNOLOGY, OFFICE OF SCIENCE AND TECHNOLOGY

POLICY, EXECUTIVE OFFICE OF THE PRESIDENT

I. Introduction 

Chairman Kerry, Ranking Member Ensign and members of the Subcommittee, I 

am pleased to appear before you to discuss the National Nanotechnology Initiative 

(NNI) and issues associated with its upcoming reauthorization. First of all, I would 

like to thank this Committee on behalf of the Administration and the NNI for its 

bipartisan support for nanotechnology research, as well as for the good working relationship the Committee has established with our office and the representatives of 

the NNI. 

In my testimony today, I would like to provide an overview of the NNI organization, activities, and funding, and communicate the Administration’s policy priorities 

with respect to the upcoming reauthorization of the program, in the context of the 

NNI’s newly updated strategic plan.1 I also want to go into particular detail on 

nanotechnology-related environmental, health, and safety (EHS) issues. 

Established in 2000 to coordinate Federal nanotechnology research and development (R&D), the NNI is built on the voluntary association of 25 Federal agencies 

that have activities and interests related to nanoscale science and technology. The 

management of the NNI is led by the Office of Science and Technology Policy 

6 

2http://ostp.gov/galleries/PCAST/PCASTlNNAPlNNIlAssessmentl2008.pdf 

(OSTP), which oversees the National Science and Technology Council (NSTC) and 

the National Nanotechnology Coordination Office (NNCO). The participating agencies of the NSTC’s Subcommittee on Nanoscale Science, Engineering, and Technology (NSET) coordinates the NNCO. The NNCO provides technical and administrative support to the NSET Subcommittee, serves as a central point of contact for 

Federal nanotechnology R&D activities, and provides public outreach on behalf of 

the NNI. By providing a locus for communication, cooperation, and collaboration the 

NNI provides effective avenues for each individual agency to leverage the resources 

and expertise of all participating agencies. 

The NNI has become a successful model for interagency cooperation and coordination in science and technology. From the broader perspective of the U.S. Government as a whole, this cooperation and coordination creates synergy that makes the 

NNI greater than the sum of its parts. The coordination in addressing potential 

EHS implications of nanotechnology has been particularly strong, and successful: 

never before have regulatory and research agencies successfully communicated so effectively on a topic of common interest, and among such a large number of agencies. 

Through the NNI the member agencies have been working hard to understand—and 

to think strategically about—nanotechnology-related EHS issues in a systematic, coordinated fashion. 

The NNI enterprise does come with some ‘‘overhead’’ expenses. As long as those 

expenses are relatively modest, the voluntary interagency cooperation that has been 

the hallmark of the NNI will continue. But in an era when so-called ‘‘discretionary 

funding’’ accounts in the Federal budget, including R&D funding, are under extreme 

pressure, we need to be particularly careful not to increase the overhead expenses 

unduly. These expenses include not just the budget for the NNCO, but also the personnel costs at each of the agencies associated with managing a complex interagency 

coordinated effort like this. 

The Administration believes the organization, structure, and management of the 

NNI is appropriate and effective, and accordingly I urge Congress to proceed with 

caution in considering any fundamental changes in this area. 

II. Overview and Status of NNI Goals 

The NNI now represents a cumulative investment of almost $10 billion since its 

inception in Fiscal Year 2001, including the President’s requested NNI budget for 

Fiscal Year 2009. The requested investment for 2009 of $1.5 billion and the substantial growth in this investment since 2001 reflects a shared appreciation by both this 

Administration and Congress of the potential for nanoscale science and technology 

R&D. Managed under the auspices of the NNI, these investments will expand our 

fundamental knowledge of this field and make important contributions to national 

priorities such as economic competitiveness, homeland and national security, and 

public health. A summary of the FY 2009 NNI Budget request broken down by 

agency and program component area is attached in Appendix I. 

The NNI recently released an updated strategic plan that outlines the following 

four basic goals for the initiative: 

Goal 1: Advance a world-class nanotechnology research and development program. 

Toward this goal, the NNI has funded thousands of individual R&D projects since 

its inception, contributing to U.S. world leadership in nanotechnology. As indicated 

in the recently released President’s Council of Advisors on Science and Technology 

(PCAST) review of the NNI,2 identifying meaningful metrics for evaluating U.S. 

global leadership in nanotechnology is challenging. But by many of the measures 

that we do have available, the United States continues to lead in both basic and 

applied research in nanoscale science and technology. 

As shown in the PCAST report, U.S.-based researchers dominate in publication 

of nanotechnology-related papers in three of the world’s premier scientific journals, 

Science, Nature, and Proceedings of the National Academy of Sciences, rising from 

about 60 percent at the inception of the NNI in 2000 to over 70 percent in 2006. 

U.S. papers also are cited far more frequently in peer reviewed journal publications 

than are papers from any other country—another clear indicator of the ‘‘world-class’’ 

quality of U.S. nanotechnology research. This leadership in citations has also been 

sustained over the initial years of the NNI, even while other nations have also substantially increased their investments in nanotechnology R&D. 

Finally, and perhaps most significantly, U.S. inventors lead the world by far in 

nanotechnology-enabled patents, including patents filed in three or more international patent offices. This is a clear indicator of leadership in nanotechnology intellectual property, which we would expect to ultimately translate into leadership 

in commercialization of nanotechnology-based products. 

7 

These are all strong indicators that the United States is indeed advancing a 

world-class nanotechnology research and development program, in large part under 

the auspices of the NNI. However, we must not be complacent in evaluating our 

international competitiveness in nanotechnology. Also as indicated in the new 

PCAST report, Europe as a whole leads the world in nanotechnology publications 

in the Science Citation Index (SCI) data base, and China and other Asian countries 

are rapidly gaining on the United States and Europe in SCI publications. Therefore 

we must continue to sustain and increase our strategic investments in this critical 

area of science and technology. 

Goal 2: Foster the transfer of new technologies into products for commercial and 

public benefit. 

The NNI has put in place a number of efforts targeted to enhance the transfer 

of research results into practical applications and commercialization. Examples of 

successful technology transfer efforts under the NNI are included in Appendix II. 

Specific NNI activities supporting this technology transfer/commercialization goal 

include the following: 

• U.S. leadership in nanotechnology patenting, an essential step in commercialization. The U.S. Patent and Trademark Office (USPTO) is working hard to 

assure efficient and appropriate processing of nanotechnology-related patents by 

creating a nanotechnology patent cross reference collection, including patents 

and patent applications spanning the wide range of fields of science and engineering that now involve nanoscale science and technology. USPTO is also conducting training sessions for its examiners to improve their understanding of 

nanotechnology. 

• Agency-specific programs support application and use of nanotechnology (DOD, 

NASA, NIH, etc.). For example, DOD has led the way in development of electronics and sensing applications of nanotechnology, as well as in development 

and deployment of specialized coatings, e.g., to reduce wear and maintenance 

costs on moving parts in the Navy fleet. NASA has led in the development of 

nanotechnology-enabled sensors. NIH has led in funding the development of numerous biomedical applications of nanotechnology, including a number of promising novel approaches for early detection and treatment of cancer. 

• Industry liaison groups and public/private partnerships. These groups assist in 

exchanging information on NNI research activities and industry needs and in 

leveraging funds for cooperative R&D. Industry liaison groups with the electronics, forest products, and chemical industries, and with the industrial research management community, are continuing, while formation of comparable 

groups with other sectors (e.g., the construction industry) is under consideration. One successful example is the collaboration between NSF, NIST, and the 

industry-led Nanoelectronics Research Initiative (NRI), where industry and government representatives collaborate in setting long-term research priorities for 

nanoelectronics, reviewing proposals and supporting pre-competitive research. 

In another example, NIH is formulating a ‘‘NanoHealth Enterprise,’’ which is 

envisioned as a partnership with other Federal agencies, private industry, and 

international partners to address research needs for safe development of 

nanoscale materials and devices. 

• NNI support for the development of international standards for nanotechnology. 

Such standards are critical to future commercialization activities. NNCO Director Clayton Teague chairs the U.S. Technical Advisory Group (TAG) to the 

International Organization for Standardization (ISO) Technical Committee on 

Nanotechnologies (ISO TC 229). NNI agencies have provided initial financial 

support to the American National Standards Institute’s Nanotechnology Standards Panel (ANSI–NSP) and the ANSI-accredited TAG that represents the 

United States on ISO TC 229. The ANSI–NSP leads the ISO TC 229 working 

group on EHS aspects of nanotechnology. 

• Workshops facilitating technology transfer of NNI research results. Two workshops have been held to bring together representatives from state and regional 

nanotechnology commercialization initiatives to learn best practices and exchange information. Other workshops have been convened to discuss opportunities and priorities for nanotechnology research in specific sub-fields, where industry participants are invited to provide input, but also where they can learn 

about NNI-funded research that may be of interest to their companies. In particular, the NNI agencies are now organizing a series of workshops to address 

research priorities in specific areas of nanotechnology-related EHS. 

• Research on manufacturing at the nanoscale, or ‘‘nanomanufacturing.’’ Nanomanufacturing will be key to the large-scale application of nanotechnology innoVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00011 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
8 

vations for commercial and public benefit. The NNI places a special emphasis 

on nanomanufacturing research, as one of its eight program component areas 

(or PCAs). For example, NSF has established a new program dedicated to nanomanufacturing supporting individual projects and the National Nanomanufacturing Network. Several workshops have been conducted to help guide the NNI 

nanomanufacturing research agenda and coordinate it with industry; several 

more are planned for the near future. 

• Industry participation in NNI research. Another way in which technology transfer takes place is within the interdisciplinary research centers and user facilities around the country. In these collaborative environments, researchers from 

academia and industry can interact, allowing for rapid diffusion of knowledge 

and increasing the likelihood of innovation. 

Goal 3: Develop and sustain educational resources, a skilled work force, and the 

supporting infrastructure and tools to advance nanotechnology. 

One of the chief overarching achievements of the NNI is the successful development and deployment of a unique infrastructure of nanotechnology research centers 

and user facilities, one that is second to none in the world. Part of the original NNI 

plan, this extensive network of over 60 research centers, user facilities and other 

infrastructure for nanotechnology research (more than 80 if you count other related 

centers and affiliated institutions), is now largely established. This mature infrastructure serves to accelerate nanotechnology research and development and enables researchers from across various sectors to broadly leverage their interdisciplinary intellectual and technological capital. 

With respect to education and workforce development, education is among the 

chief objectives of NNI-funded university research. In addition, there are specific 

programs targeted at K–12 education, educating the public about nanotechnology, 

and improving nanotechnology curricula in our schools and universities. For example: 

• Educational impact is among the key review criteria for NSF proposals. As a 

result of the NNI, thousands of undergraduate and graduate students have received training in nanoscale science and technology, providing the pipeline for 

nanotechnology workers and researchers that industry needs to commercialize 

the results of basic research in nanoscale science and technology. NSF annually 

supports education for about 10,000 students and teachers in the field of nanotechnology. 

• The NNI has created strong incentive for interdisciplinary research at our 

major research institutions, and a new cadre of multi-disciplinary researchers, 

trained in multiple fields previously considered ‘‘diverse’’ and highly distinct, 

such as biology and solid state physics. While we retain a strong appreciation 

for the importance of building a solid foundation for our researchers of the future in the traditional disciplines of science and engineering, it is this ‘‘silo busting’’ new culture of interdisciplinary research, and the new generation of multidisciplinary researchers emerging from the NNI-funded centers, that I consider 

to be one of the greatest achievements of the NNI. It is at the intersection of 

the traditional disciplines where we are seeing some of the most interesting and 

potentially beneficial applications of nanotechnology emerge. 

• In addition to the general educational impact of the NNI discussed above, NNI 

agencies, particularly NSF, have also engaged in a number of initiatives to improve nanotechnology education, curricula, and workforce development specifically. These include the Nanotechnology Center for Learning and Teaching 

(NCLT) and the Nanoscale Informal Science Education (NISE) Network. Details 

are available in the NNI Supplement to the President’s Budget for FY 2008. 

• The NNI has recently engaged the Departments of Education and Labor, and 

the research agencies are now working with staff from those departments to develop additional initiatives aimed at education and workforce development. 

Goal 4: Support responsible development of nanotechnology. 

The activities and issues associated with this goal have received a great deal of 

attention by the NNI. The original NNI implementation plan of July 2000 included 

a substantial section on ‘‘Societal Implications of Nanotechnology,’’ and requested 

significant resources for this activity. As potential EHS concerns about nanomaterials began to emerge in the early years of the initiative, the NNI also led the way, 

holding in August 2003 the first interagency meeting on this subject, which eventually led to the establishment of the formal Nanotechnology Environmental and 

Health Implications (NEHI) interagency working group. 

9 

3http://www.nano.gov/NNIl06Budget.pdf 4http://www.nano.gov/NNIlEHSlresearchlneeds.pdf 5http://www.nano.gov/PrioritizationlEHSlResearchlNeedslEngineeredlNanoscalel 

Materials.pdf 6http://www.nano.gov/NNIlEHSlResearchlStrategy.pdf 

In December 2004, the NNI released a strategic plan calling out EHS research 

for special attention, as part of a Program Component Area (PCA) on Societal Dimensions of Nanotechnology. In early 2005, the NEHI Working Group began work 

on a cross-agency EHS research needs document, building on an earlier effort in 

2004 to inventory existing EHS research funded under the NNI. In March of 2005, 

the NNI released its Supplement to the President’s FY 2006 Budget,3 which for the 

first time reported EHS research investments separately. In the fall of 2005, NNI 

began preparation of a research needs document. The resulting document, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials,4 released in September 2006, identified 75 research needs within five general categories of EHS research. It also set out a plan for ‘‘next steps’’ for the NNI to address this issue, including further prioritization of the research needs identified in 

the report, evaluation of the existing NNI EHS research portfolio, a gap analysis 

based on a comparison of the prioritized research needs and the existing research 

portfolio, coordination of the NNI agencies’ research programs to address the priorities, and development of a process for periodic review and updating of research 

needs and priorities. 

The NEHI Working Group then proceeded to follow that ‘‘next steps’’ agenda. The 

research needs document was posted for public comment in the fall of 2006, followed 

by a public meeting to gather input on the document in January 2007. Based on 

this input, the NEHI Working Group in August 2007 released an interim document 

for public comment entitled Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials.5 That document narrowed the list 

of EHS research needs down to five in each of the categories, for a total of 25 highpriority research needs. Based on input on that interim document and extensive further analysis by the EOP and the agencies involved, in February 2008 the NEHI 

Working Group released its first comprehensive Strategy for Nanotechnology-Related 

Environmental, Health, and Safety Research.6

This strategy for the NNI’s EHS research presents a path for coordinated interagency implementation of research to address the needs identified in earlier reports. 

It is based in part on a detailed analysis of the Federal Government’s FY 2006 

nanotechnology-related EHS research portfolio, a $68 million investment in 246 

projects. Experts from the NEHI Working Group analyzed how these activities addressed the priority research needs and then proposed emphasis and sequencing for 

future research efforts. Agency-specific research and regulatory needs, public comVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00013 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE

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10 

7http://www.nano.gov/NNI Strategic Plan 2007.pdf 

ments on the prior documents, and considerations of the state of EHS research in 

the national and international nanotechnology communities all played an important 

role in shaping the strategy. It reflects a strong commitment among the NNI member agencies to the roles they will assume, consistent with their respective missions 

and responsibilities, to move the Federal efforts in nanotechnology-related EHS research forward. The comprehensive detail in the document demonstrates that the 

NNI is working hard to understand—and to think strategically about—nano EHS 

issues in a systematic, coordinated fashion. As indicated in both the initial EHS research needs document and in this new strategy document, the strategy will be updated periodically. Furthermore, as indicated in the timeline above, the National Research Council (NRC) is now under contract from the NNCO to assess the EHS 

strategy. Once the NRC assessment is complete, their recommendations will be incorporated, as appropriate, into an updated strategy. 

I think the NNI has made tremendous progress toward the goal of supporting responsible development of nanotechnology. Funding for EHS research in particular 

has more than doubled since FY 2005, from $35 million to $76 million in the FY 

2009 request. This is only counting the narrowly defined ‘‘primary purpose’’ EHS 

R&D. Beyond just increasing the funding, the NNI agencies have come up with an 

excellent strategy that all the relevant agencies support, to carry forward these investments in the most effective way possible. The increasing emphasis on EHS is 

notable and important. 

I believe the Federal Government needs to ensure that nano-EHS research needs 

are adequately addressed. To this end, the NNI has systematically: (1) identified research needs, (2) prioritized those needs, (3) developed an associated inventory from 

which a gap analysis can be performed, and (4) developed a strategy for addressing 

the prioritized needs that are not currently being addressed. The Administration believes this systematic approach is the right way to address EHS research needs. The 

Administration therefore does not support establishing an arbitrary EHS set-aside. 

IV. Summary and Conclusions 

The NNI has been and remains a highly successful enterprise, due in large part 

to the unparalleled interagency coordination and cooperation, which in turn has 

been effective because of the voluntary, ‘‘bottom up’’ nature of that cooperation, in 

which all the agencies benefit. As demonstrated above and validated by external reviews, the NNI is effectively pursuing its goals of advancing world-class nanotechnology R&D; fostering technology transfer; developing and sustaining educational 

resources, work force, and supporting infrastructure; and supporting responsible development of nanotechnology. The findings of the external reviews clearly indicate 

that the existing structure is working well, and I look forward to working with the 

Committee as it considers the future of this successful program. 

APPENDIX I 

National Nanotechnology Initiative FY 2009 Budget and Highlights 

The 2009 Budget provides $1.5 billion for the National Nanotechnology Initiative 

(NNI), reflecting steady growth in the NNI investment. This sustained major investment in nanotechnology research and development (R&D) across the Federal Government over the past nine Fiscal Years of the NNI reflects the broad support of 

the Administration and of Congress for this program, based on its potential to vastly 

improve our fundamental understanding and control of matter, ultimately leading 

to a revolution in technology and industry for the benefit of society. The NNI remains focused on fulfilling the Federal role of supporting basic research, infrastructure development, and technology transfer, in the expectation that the resulting advances and capabilities will make important contributions to national priorities, 

with applications across a wide range of industries including healthcare, electronics, 

aeronautics, and energy. Increasing investments by mission agencies in nanotechnology-related research since 2001 reflect a recognition of the potential for this research to support agency missions and responsibilities. 

Table 1 provides NNI investments in 2007–2009 for Federal agencies with budgets/investments for nanotechnology R&D. Tables 2–4 list the investments by agency 

and by program component area (PCA). Note that the program component areas 

shown in these tables are those outlined in the new NNI Strategic Plan released 

in December 2007,7 with nanotechnology-related environmental, health, and safety 

(EHS) research now reported for the first time in a separate PCA from education 

and other societal dimensions investments. 

11 

The 2009 NNI budget supports nanoscale science and engineering R&D at 13 

agencies. Agencies with the greatest investments are the Department of Defense 

(DOD—investments addressing the defense mission); the National Science Foundation (NSF—fundamental research across all disciplines of science and engineering); 

the Department of Energy (DOE—research providing a basis for new and improved 

energy technologies); the National Institutes of Health (NIH, within the Department 

of Health and Human Services, DHHS—nanotechnology-based biomedical research 

at the intersection of biology and the physical sciences); and the National Institute 

of Standards and Technology (NIST—fundamental research and development of 

tools, analytical methodologies, and metrology for nanotechnology). Other agencies 

that are investing in mission-related research are the National Aeronautics and 

Space Administration (NASA), the National Institute for Occupational Safety and 

Health (NIOSH/DHHS), the Environmental Protection Agency (EPA), and the Departments of Agriculture (USDA—Cooperative State Research, Education, and Extension Service, CSREES; and Forest Service, FS), Homeland Security (DHS), Justice (DOJ), and Transportation (DOT—Federal Highway Administration, FHWA). 

Key Points about the 2009 NNI Investments 

• The 2009 NNI budget provides increased support for research on fundamental 

nanoscale phenomena and processes, from $481 million in 2007 to $551 million 

in 2009. 

• Increases in nanotechnology R&D funding for DOE, NIST, and NSF reflect the 

President’s continuing commitment to significantly increase funding for physical 

sciences and engineering research as part of the American Competitiveness Initiative. 

• The proposed budget also reflects substantial ongoing growth in funding for instrumentation research, metrology, and standards (from $53 million in 2007 to 

$82 million in 2009) and in nanomanufacturing research (from $48 million in 

2007 to $62 million in 2009). NNI agencies are gathering input and feedback 

from industry and the research community on these growing investments 

through a series of workshops. 

• EHS R&D funding in 2009 ($76 million) is over double the level of actual funding in 2005 ($35 million)—the first year this data was collected. The steady 

growth in EHS R&D spending follows the NNI strategy of expanding the capacity to do high-quality research in this field. For tables in this document, EHS 

R&D is defined as research whose primary purpose is to understand and address potential risks to health and to the environment posed by nanotechnology. 

Therefore the proposed $76 million for 2009 does not include substantial research reported under other PCAs, e.g., on instrumentation and metrology and 

on fundamental interactions between biosystems and engineered nanoscale materials, both of which are important in the performance and interpretation of 

toxicological research. An indication of the level of funding for these broader 

categories of nanotechnology-related EHS research may be deduced from the detailed 2006 data collected and analyzed specifically for this purpose. This data 

showed that the total funding for nanotechnology-related EHS research in 2006 

was about $68 million, 80 percent higher than that reported for ‘‘primary purpose research.’’ 

• A more detailed Budget Supplement will be released when data become available on funding for nanotechnology under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) programs. 

12 

Table 1.—NNI Budget, 2007–2009 

[dollars in millions] 

2007 

Actual 

2008 

Estimate*

2009 

Proposed 

DOD 450 487 431 NSF 389 389 397 DOE** 236 251 311 DHHS (NIH) 215 226 226 DOC (NIST) 88 89 110 NASA 20 18 19 EPA 8 10 15 DHHS (NIOSH) 7 6 6 USDA (FS) 3 5 5 USDA (CSREES) 4 6 3 DOJ 2 2 2 DHS 2 1 1 DOT (FHWA) 1 1 1 

TOTAL 1,425 1,491 1,527 

*The 2008 DOD estimate exceeds the 2008 request by $112 million but includes many Congressional earmarks that are outside the NNI plan. **Funding levels for DOE include the Offices of Science, Fossil Energy, and Energy Efficiency and Renewable Energy. 

13 

Table 2.—Actual 2007 Agency Investments by Program Component Area 

[dollars in millions] 

Fundamental 

Phenomena 

and Processes 

Nanomaterials Nanoscale Devices and Systems 

Instrument 

Research, 

Metrology, 

and 

Standards 

Nanomanufacturing 

Major 

Research 

Facilities 

and Instr. 

Acquisition 

Environment, 

Health, 

and Safety 

Education 

and Societal 

Dimensions 

NNI Total 

DOD 210.1 86.0 120.0 4.3 7.5 22.3 450.2 NSF 145.2 58.4 52.4 14.9 26.6 30.0 26.9 34.4 388.8 DOE 52.6 68.5 9.7 11.3 0.5 92.9 0.5 236.0 DHHS (NIH) 45.7 25.4 125.7 5.9 0.8 7.7 4.2 215.4 DOC (NIST) 24.2 7.5 22.9 14.2 12.4 5.5 0.9 87.6 NASA 0.8 9.9 9.1 19.8 EPA 0.2 0.2 0.1 7.1 7.6 DHHS (NIOSH) 1.7 5.6 7.3 USDA (FS) 0.4 1.3 0.7 0.3 0.2 2.9 USDA (CSREES) 0.5 1.0 2.1 0.1 0.1 0.1 3.9 DOJ 0.1 1.6 1.7 DHS 2.0 2.0 DOT (FHWA) 0.9 0.9 TOTAL 480.6 258.3 344.7 52.5 48.1 152.4 48.3 39.2 1,424.1 

14 

Table 3.—Estimated 2008 Agency Investments by Program Component Area 

[dollars in millions] 

Fundamental 

Phenomena 

and Processes 

Nanomaterials Nanoscale Devices and Systems 

Instrument 

Research, 

Metrology, 

and 

Standards 

Nanomanufacturing 

Major 

Research 

Facilities 

and Instr. 

Acquisition 

Environment, 

Health, 

and Safety 

Education 

and Societal 

Dimensions 

NNI Total 

DOD 258.7 68.9 119.8 8.0 5.4 24.6 2.0 487.4 NSF 138.8 62.1 50.3 16.0 26.9 31.6 29.2 33.8 388.7 DOE 51.4 77.5 13.0 12.0 2.0 92.0 3.0 0.5 251.4 DHHS (NIH) 55.6 25.4 125.8 5.9 0.8 7.7 4.6 225.8 DOC (NIST) 22.5 7.4 21.7 16.1 14.4 5.8 0.8 88.7 NASA 1.5 9.7 6.2 0.4 0.2 18.0 EPA 0.2 0.2 0.2 9.6 10.2 DHHS (NIOSH) 6.0 6.0 USDA (FS) 1.3 1.9 1.2 0.4 0.2 5.0 USDA (CSREES) 0.7 1.6 3.1 0.5 0.1 0.1 6.1 DOJ 2.0 2.0 DHS 1.0 1.0 DOT (FHWA) 0.9 0.9 TOTAL 531.6 254.7 342.3 60.4 50.2 154.4 58.6 39.0 1,491.27 

15 

Table 4.—Planned 2008 Agency Investments by Program Component Area 

[dollars in millions] 

Fundamental 

Phenomena 

and Processes 

Nanomaterials Nanoscale Devices and Systems 

Instrument 

Research, 

Metrology, 

and 

Standards 

Nanomanufacturing 

Major 

Research 

Facilities 

and Instr. 

Acquisition 

Environment, 

Health, 

and Safety 

Education 

and Societal 

Dimensions 

NNI Total 

DOD 227.8 55.2 107.7 3.6 12.8 22.1 1.8 431.0 NSF 141.7 62.5 51.6 16.0 26.9 32.1 30.6 35.5 396.9 DOE 96.9 63.5 8.1 32.0 6.0 101.2 3.0 0.5 311.2 DHHS (NIH) 55.5 25.4 125.8 5.9 0.8 7.7 4.6 225.7 DOC (NIST) 24.5 8.5 22.7 20.9 15.3 5.7 12.8 110.4 NASA 1.2 9.8 7.7 0.2 0.1 19.0 EPA 0.2 0.2 0.2 14.3 14.9 DHHS (NIOSH) 6.0 6.0 USDA (FS) 1.7 1.3 0.7 1.1 0.2 5.0 USDA (CSREES) 0.4 0.8 1.5 0.1 0.1 0.1 3.0 DOJ 2.0 2.0 DHS 1.0 1.0 DOT (FHWA) 0.9 0.9 TOTAL 550.8 227.2 327.0 81.5 62.1 161.3 76.4 40.7 1,527.0 

16 

Highlights of Ongoing and Planned Activities 

• The extensive network of research centers, user facilities and other infrastructure for nanotechnology research, originally envisioned as a key element of the 

NNI strategy, is now largely complete. This mature infrastructure serves to accelerate nanotechnology research and development and enables researchers 

from across various sectors to broadly leverage their interdisciplinary intellectual and technological capital. NNI agencies are encouraging industrial interaction with NNI-funded research centers, and are promoting broad access to the 

NNI user facilities by all sectors, including small businesses. While emphasis 

in the near future will be on maximizing the utility and utilization of the substantial infrastructure already in place, the agencies will also consider possible 

new needs for the longer term. 

• Industry liaison and technology transfer activities are given a high priority in 

the new NNI Strategic Plan released in December 2007. NNI agencies are working with industry representatives to gather input on their nanotechnology-related activities and are funding increasing numbers of nanotechnology-related 

SBIR and STTR awards to promote technology transfer to industry. Industry liaison groups with the electronics, forest products, and chemical industries, and 

with the industrial research management community, are continuing, while formation of comparable groups with other sectors (e.g., the construction industry) 

is under consideration. One successful example is the collaboration between 

NSF, NIST, and the industry-led Nanoelectronics Research Initiative, where industry and government representatives collaborate in reviewing proposals and 

in supporting pre-competitive research. In another example, NIH is formulating 

a ‘‘NanoHealth Enterprise,’’ which is envisioned as a partnership with other 

Federal agencies, private industry, and international partners to address research needs for safe development of nanoscale materials and devices. 

• EHS research planning is a major activity for the NNI. In August 2007, the National Science and Technology Council’s Nanoscale Science, Engineering, and 

Technology (NSET) Subcommittee published a draft report for public comment 

prepared by its Nanotechnology Environmental and Health Implications (NEHI) 

Working Group entitled Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, and, in February 2008, completed a comprehensive Strategy for Nanotechnology-Related Environmental, 

Health, and Safety Research. This is the culmination of 2 years of intensive 

work, including a detailed review of individual EHS research projects funded by 

the NNI agencies in 2006, as a guide to identification of gaps in the research 

portfolio compared to the designated priority research areas. 

• As the NNI EHS research strategy evolves, ongoing activities to address the 

breadth of EHS issues proceed at an accelerating pace. A Food and Drug Administration (FDA) task force released a report in 2007 addressing scientific 

questions related to the application of its regulatory authorities to nanotechnology-enabled products. EPA issued a white paper on nanotechnology in 2007, and 

has initiated a Nanoscale Materials Stewardship Program under the Toxic Substances Control Act (TSCA) to gather and develop information from manufacturers, importers, processors and users of engineered chemical nanoscale materials. 

NIOSH continues to update its guidance document on best practices for safe 

handling of nanomaterials in the workplace, and has posted a draft document 

providing interim guidance on medical screening of workers potentially exposed 

to engineered nanoparticles. NNI agencies organized a workshop hosted by 

NIST in September 2007 entitled ‘‘Standards for Environmental, Health, and 

Safety for Engineered Nanoscale Materials.’’ On the research front, two joint 

interagency solicitations addressing potential environmental and health implications of nanotechnology continue. One (led by EPA, with NSF) addresses environmental implications, while another (led by NIH, with EPA and NIOSH) focuses on human health implications. NSF and EPA will fund a new Center for 

Environmental Implications of Nanotechnology (CEIN) in 2008. NSF plans to 

form a network around it in 2009 with collaboration from EPA and other agencies. 

• International collaborations in nanotechnology are progressing, with strong NNI 

participation. The Organisation for Economic Cooperation and Development 

(OECD) Working Party on Manufactured Nanomaterials, chaired by the United 

States, has begun its work addressing health and safety issues. A second OECD 

working party formed under the Committee for Scientific and Technological Policy is addressing broader issues such as economic impact, education and training, and public communication. With respect to standards development, the National Nanotechnology Coordination Office and several NSET member agencies 

17 

8http://www.nano.gov/NNI Strategic Plan 2007.pdf 

represent the United States on the International Organization for Standardization (ISO) Technical Committee on Nanotechnologies (ISO TC 229), and the 

United States leads the ISO TC 229 working group on EHS aspects of nanotechnology. 

APPENDIX II 

A FEW EXAMPLES OF NNI SUPPORTED TRANSFERS OF NANOTECHNOLOGY

Research Results from the Laboratory to Applications and 

Commercialization 

In addition to the examples given below, the 2007 NNI Strategic Plan 8 includes 

several examples of early NNI successes in technology transfer (pp. 14–15), as well 

as a number of high-impact application opportunities that are now emerging from 

NNI-funded laboratories (pp. 25–34). Further, the new PCAST/NNAP report includes more examples of technologies that are being transitioned from NNI-funded 

research into commercial applications. 

• One of the original motivations for the NNI was the need for more basic research in nanotechnology-enabled electronics, photonics, and magnetics research, to keep the semiconductor industry on the ‘‘Moore’s Law’’ curve of continuous improvement in cost/performance of semiconductor devices that has 

been so important to our economic prosperity in the past 50 years. While semiconductor device design rules have been in the sub–100 nanometer range for 

several years now, at the time of the NNI’s inception, leaders in the industry 

were predicting that future progress would soon be hitting a ‘‘brick wall’’ where 

continued scaling of traditional CMOS devices would be difficult or impossible 

due to current leakage, heat dissipation problems, and interference by quantum 

effects that begin to dominate device behavior in the nanoscale size range. They 

called on the Government to conduct an intensified basic research program 

under the auspices of the NNI to address these problems, including the specific 

goal of developing a completely new paradigm to replace the electronic ‘‘switch’’ 

that is at the heart of both logic and memory devices. The collaboration by NSF 

and NIST with industry in the Nanoelectronics Research Initiative referred to 

above was one of the NNI responses to this problem. As a result of this and 

other NNI investments in nano-electronics, -magnetics, and -photonics research 

and infrastructure, progress in addressing this problem has been faster than 

had been expected previously. At a meeting of the President’s Council of Advisors on Science and Technology on January 8, 2008, George Scalise, President 

of the Semiconductor Industry Association, stated that, for the roadmaps the 

semiconductor industry has laid out, their consensus is that they are 2 years 

ahead of where they thought they would be just a few years ago, thanks in part 

to the NRI and the NNI. Dr. Scalise also said that for the next generation 

switch, most of the new ideas are coming from the United States, not from 

abroad. 

• Another major thrust of the NNI that has emerged in recent years is the applications of nanotechnology related to human health—i.e., to diagnosis and treatment of disease. The budget for nanotechnology research at the National Institutes of Health (NIH) has increased dramatically, from $40 million in 2001 to 

a proposed $226 million in 2009. With this NIH has established 21 new research centers focused on nanomedicine and cancer nanotechnology R&D. The 

range of biomedical applications of nanotechnology under investigation is extremely broad, spanning almost all of the NIH institutes. Widespread clinical 

application of the results of this research is likely to take many years, given 

the careful review and approval processes needed for such applications. But we 

can cite a couple of interesting examples that are nearing fruition in the cancer 

and regenerative medicine arenas, as follows: 

» Researchers at Northwestern University have developed a diagnostic biobarcode assay based on nanotechnology that is able to detect each of the three 

markers simultaneously at concentrations multiple orders of magnitude below 

that detectable by the standard immunoassay. The biobarcode assay can simultaneously detect trace levels of multiple biomarkers (including DNA and 

proteins) associated with human cancers using oligonucleotide- and antibodycoated gold nanoparticles. Nanoparticle-tagged oligonucleotide biobarcodes 

have been developed to detect three cancer-related protein biomarkers: prosVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00021 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
18 

tate specific antigen (PSA); human chorionic gonadotrophin (HCG), a marker 

for testicular cancer; and α-fetoprotein (AFP), a liver cancer marker. The ability to detect low-levels of protein biomarkers directly in serum in a multiplexed manner will enable more powerful diagnostic methods to detect earlystage malignancy. The nanotechnology biobarcode assay is being commercially 

developed now; so far the FDA has cleared its use for two molecular diagnostic tests associated with blood disorders. 

» Another group at Northwestern has developed an engineered nanomaterial 

that can be injected into damaged spinal cords and could help prevent scars 

and encourage damaged nerve fibers to grow. The liquid material contains 

molecules that self-assemble into nanofibers, which act as a scaffold on which 

nerve fibers grow. Researchers have reported that treatment with the material 

restores function to the hind legs of paralyzed mice. A spinoff company has 

now been founded, with the objective of developing this therapy for humans. 

Initial in vitro tests have shown no apparent toxicity to human cells. The next 

step will be to make a material that meets FDA standards for clinical trials. 

This example is particularly interesting for several reasons: (1) it represents 

a collaboration between a materials scientist much of whose work was initially funded by the National Science Foundation and a stem cell biologist, 

working in a field with a strong history of NIH funding. As such it is a sterling example of both interdisciplinary collaboration and interagency collaboration that has become a hallmark of the NNI. (2) We have been hearing rumors of this work and seeing private presentations on it for several years 

now. Only in the past month were the results of this particular breakthrough 

published in the open literature. As such, we think this example is just the 

beginning of a flood of new biomedical applications of nanotechnology that are 

likely to come to light in coming years, as innovations make their way 

through the long pipeline between initial conception, early exploratory research, initial application experiments, in vitro safety testing, in vivo animal 

model safety and effectiveness testing, and finally to human clinical trials. 

Given this long timeline and the large potential payoffs of this type of research, it is understandable that researchers are careful about when they 

publish results in open literature. 

• There are numerous examples of potential applications of nanotechnology in energy production, conversion, storage, transmission, and conservation. Just one 

of these examples addressed in the recently released PCAST report concerns the 

use of nanotechnology to enhance the efficiency and lower the cost of converting 

energy in sunlight directly into electricity, known as photovoltaics. Thin-film 

photovoltaic technology has improved over the last decade to a point where it 

can now convert sunlight to electricity as efficiently as all but the most expensive silicon-based solar cells. New low-cost production methods could help make 

these thin-film cells an important contributor to the Nation’s energy needs. One 

company that has received substantial funding from NNI agencies, Nanosolar, 

Inc. is using printing presses instead of vacuum deposition equipment to make 

solar panels based on a semiconducting material called copper indium gallium 

diselenide (CIGS). The presses deposit nanostructured ink, which is then processed to create the light-absorbing nanoarchitecture at the heart of the solar 

cell. Nanosolar has recently shipped its first utility-scale panels. 

Senator KERRY. Thank you very much, Director Russell. We appreciate it. 

Director Robinson? 

STATEMENT OF ROBERT A. ROBINSON, MANAGING DIRECTOR, 

NATURAL RESOURCES AND ENVIRONMENT, 

U.S. GOVERNMENT ACCOUNTABILITY OFFICE 

Mr. ROBINSON. Thank you, Mr. Chairman, for this opportunity to 

briefly present GAO’s work on this very important aspect of Federal nanotechnology research. 

I would like to note for the record that today I am sitting in for 

Anu Mittal, who directed the work on this project but is unable to 

be here today because she is undergoing treatment for a very serious illness. 

19 

At the request of the full Committee and several other Members 

of the Congressional Nanotechnology Caucus, we examined how the 

NNI is addressing the potential environmental, health, and safety 

risks, so-called EHS risks, that may be associated with exposure to 

nanoscale materials. 

Nanotechnology has vast potential for truly transformational innovation in virtually every industry and hundreds of products common to consumers today and others that perhaps we can only 

dream of. Some of what seems to be possible can only be described 

by someone of my age as jaw-dropping. 

At the same time, the unique properties and microscale size of 

these materials raise questions about their risk to the human body 

and the environment whose answers are not fully known and 

where research is needed to fill the information gaps. In this context, the Committee asked us to examine: (a) the extent of Federal 

research on these risks in 2006 which was the latest year where 

data was available at the time of our review, (b) the reasonableness 

of Federal efforts to identify and prioritize research needs in this 

area, and (c) the effectiveness of Federal efforts to coordinate and 

collaborate on this research. 

As presented in the report that you have released today, here’s 

what we found. 

First, in 2006, Federal agencies reported devoting about 3 per- cent or about $38 million of the $1.3 billion in total Federal nanotechnology research funding to EHS risks. 

Our analysis, however, shows that this figure somewhat overstates the actual extent of EHS research. About 20 percent of the 

research that the agencies classified to us as being primarily focused on EHS actually dealt with using nanotechnology to address 

other kinds of environmental issues rather than on the risks associated with nanotechnology itself. 

This misclassification resulted mostly from agency confusion over 

how to characterize this kind of research in the existing reporting 

structure and how to apportion research funding that addressed 

multiple objectives at the same time. 

Given the relatively small size of research funding devoted to 

EHS issues and the differences of opinion about the appropriate 

percentage of nanotechnology funding that should be devoted to 

EHS risks, errors of this size are not inconsequential. 

Second, the process used by NNI and the Federal agencies to 

identify and prioritize EHS risks and the associated research needs 

appeared reasonable overall. The priorities were arrived at in a collaborative, iterative, and professional fashion, and the research actually conducted was generally consistent with agreed upon priorities. 

However, at the time of our review, the NNI had not yet completed its strategic EHS research plan. This plan, which has been 

released just a month or so ago, falls short of expectations on several levels. 

Third, coordination of EHS research, among the 25 agencies participating in NNI, has been generally effective. The agencies meet 

frequently to identify opportunities for collaboration, jointly sponsor research workshops, have detailed staff to each other, and 

share the sense that a common purpose, a stable group memberVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00023 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
20 

1GAO, Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal 

Research Focused on Environmental, Health, and Safety Risks, GAO–08–402 (Washington, D.C.: 

Mar. 31, 2008). 

ship and mutual respect for each other’s roles in an exciting mission has led to a satisfying and effective working relationship. relationship. 

While presenting a generally favorable picture of Federal nanotechnology research activities, we did make one recommendation to 

improve them. Specifically, we believe that to clearly understand 

the potential EHS risks and the gaps in ongoing research, it is essential to have consistent, accurate and complete information on 

the extent to which agency research is designed to address those 

risks. 

Transparency and credibility of the information presented is vitally important to ensure public confidence in the Government’s efforts on this very important front. 

Right now, however, the inventory of projects identified as addressing these risks is not entirely accurate. To improve the accuracy of this inventory, we recommend that the guidance provided 

to agencies on how to report the focus of their research activities 

be improved. 

Mr. Chairman, let me close my prepared remarks here and we’d 

love to get into conversation. 

[The prepared statement of Mr. Robinson follows:] 

PREPARED STATEMENT OF ROBERT A. ROBINSON, MANAGING DIRECTOR, NATURAL

RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today to participate in your hearing on the future direction of the National Nanotechnology Initiative (NNI). As you know, the NNI was 

established in 2001 as a Federal, multiagency effort intended to accelerate the discovery, development, and deployment of nanoscale science, engineering, and technology to achieve economic benefits, enhance the quality of life, and promote national security. One of the key roles of the NNI is to coordinate the nanotechnologyrelated activities of 25 Federal agencies. These agencies include both those that 

fund nanoscale research as well as those that have a stake in the outcome of this 

research, such as agencies that regulate products containing nanomaterials. While 

the NNI is designed to facilitate intergovernmental cooperation and identify goals 

and priorities for nanotechnology research, it is not a research program. It has no 

funding or authority to dictate the nanotechnology research agenda for participating 

agencies or to ensure that adequate resources are available to achieve specific goals. 

Instead, participating agencies develop and fund their own nanotechnology research 

agendas, and in Fiscal Year 2006, 13 of the 25 agencies participating in the NNI 

allocated a total of about $1.3 billion from their appropriated budgets to nanotechnology research and development activities. Of this total in Fiscal Year 2006, the 

NNI reported that $37.7 million (or about 3 percent of the total) was used to fund 

research to study the potential environmental, health, and safety (EHS) risks that 

might result from exposure during the manufacture, use, and disposal or recycle of 

nanoscale materials. As you know, while the use of nanoscale materials holds much 

promise, the small size and unique properties of these materials raise questions 

about their potential EHS risks, and research is needed to fill current gaps in scientific information about their risks. 

At the request of the full committee and Members of the Congressional Nanotechnology Caucus, we just completed a report that is being released today on the NNI’s 

and Federal agencies’ efforts to study the potential environmental, health, and safety risks of nanotechnology.1 My testimony is based on the findings of this review 

and will cover the following three areas: (1) the extent to which selected research 

and regulatory agencies conducted research in Fiscal Year 2006 that primarily was 

focused on the potential EHS risks of nanotechnology; (2) the reasonableness of the 

processes that agencies and the NNI use to identify and prioritize Federal research 

21 

on the potential EHS risks of nanotechnology; and (3) the effectiveness of the processes that agencies and the NNI use to coordinate their research. For our review, 

we collected data from five Federal agencies that provided 96 percent of Fiscal Year 

2006 funding for EHS research—the Environmental Protection Agency (EPA), the 

National Institutes of Health (NIH), the National Institute for Occupational Safety 

and Health (NIOSH), the National Institute of Standards and Technology (NIST), 

and the National Science Foundation (NSF). We also contacted three regulatory 

agencies—the U.S. Consumer Product Safety Commission (CPSC), the Food and 

Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA)—that do not have specific research budgets to determine whether they 

conducted any research on their own relative to potential EHS risks. We conducted 

this performance audit from June 2007 to February 2008 in accordance with generally accepted government auditing standards. Those standards require that we 

plan and perform the audit to obtain sufficient, appropriate evidence to provide a 

reasonable basis for our finding and conclusions based on our audit objectives. We 

believe that the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives. 

In summary we found the following: 

• About 20 percent of the over $37 million in Fiscal Year 2006 research expenditures that the NNI reported as being primarily focused on the EHS risks of 

nanotechnology cannot actually be attributed to this purpose. We found that 22 

of the 119 projects identified as EHS-related by EPA, NIH, NIOSH, NIST, and 

NSF in Fiscal Year 2006 were not primarily related to understanding the extent 

to which nanotechnology poses an EHS risk. These 22 projects, funded by NSF 

and NIOSH, accounted for about $7 million of the $37 million that the NNI reported as being primarily focused on EHS risks. The focus of many of these 

projects was to explore how nanotechnology could be used to remediate environmental damage or to detect a variety of hazards unrelated to nanotechnology. 

We determined that this mischaracterization was the result of the current reporting structure that does not allow these types of projects to be easily categorized in another more appropriate category, and also the lack of guidance for 

agencies on how to apportion research funding across multiple topics, when appropriate. To address this issue, we recommended that the Office of Science and 

Technology Policy (OSTP), in consultation with the NNI and the Office of Management and Budget (OMB), provide better guidance to agencies regarding how 

to report research that is primarily focused on understanding or addressing the 

EHS risks of nanotechnology. In commenting on this report, OSTP asserted that 

it already provides extensive guidance, but it agreed to review the manner in 

which agencies respond to the current guidance. 

• In addition to the EHS funding totals reported by the NNI, we found that Federal agencies conduct other EHS research that is not captured in the NNI totals. This research was not captured by the NNI because either the research 

was funded by an agency not generally considered to be a research agency or 

because the primary purpose of the research was not to study EHS risks. Because the agencies that conduct this research do not systematically track it as 

EHS-related research, we could not establish the exact amount of Federal funding that is being devoted to this additional EHS research. 

• Federal agencies and the NNI were, at the time of our review, in the process 

of identifying and prioritizing EHS risk research needs; overall, we believe that 

the process they were using was reasonable. For example, identification and 

prioritization of EHS research needs was being done by the agencies and the 

NNI collaboratively. The NNI was also engaged in an iterative prioritization effort through its Nanotechnology Environmental and Health Implications 

(NEHI) working group. As a result of this effort, NEHI had identified five general research categories that should be the focus of Federal research efforts and 

five specific research priorities under each general category. Our analysis of the 

97 research projects that were underway in Fiscal Year 2006 that were primarily related to studying EHS risks found that the focus of these projects was 

generally consistent with agency priorities as well as NEHI’s five general research categories. However, we did find that, while agency funded research addressed each of the five general research categories, it focused on the priority 

needs within each category to varying degrees. As our report was in production, 

NEHI released a new EHS research strategy on February 13, 2008, which is 

intended to provide a framework to help ensure that the highest priority EHS 

research needs are met. 

• Agency and NNI processes to coordinate activities related to potential EHS 

risks of nanotechnology have been generally effective. The NEHI working group 

22 

2 As of December 2007, a total of four working groups exist within the NSET subcommittee: 

(1) Global Issues in Nanotechnology; (2) Nanotechnology Environmental and Health Implications; (3) Nanomanufacturing, Industry Liaison, and Innovation; and (4) Nanotechnology Public 

Engagement and Communications. 3The 21st Century Nanotechnology Research and Development Act, Pub. L. 108–153 (2003). 

has convened frequent meetings that have helped agencies identify opportunities to collaborate on EHS risk issues, such as joint sponsorship of research and 

workshops to advance knowledge and facilitate information-sharing among the 

agencies. These types of exchanges, according to most agency officials we spoke 

with, have helped advance knowledge and facilitated information-sharing 

among the agencies. In addition, NEHI has incorporated several practices that 

we have previously identified as key to enhancing and sustaining interagency 

collaborative efforts, such as defining a common outcome and leveraging resources, but it had not, at the time of our review, completed its overarching 

strategy to help better align agencies’ EHS research efforts. Finally, all agency 

officials we spoke with expressed satisfaction with the coordination and collaboration on EHS risk research that has occurred through NEHI. They cited several factors they believe contribute to the group’s effectiveness, including the 

stability of the working group membership and the expertise and dedication of 

its members. Furthermore, according to these officials, this stability, combined 

with common research needs and general excitement about the new science, has 

resulted in a collegial, productive working environment. 

Background 

Nanotechnology encompasses a wide range of innovations based on the understanding and control of matter at the scale of nanometers—the equivalent of onebillionth of a meter. To illustrate, a sheet of paper is about 100,000 nanometers 

thick and a human hair is about 80,000 nanometers wide. At the nanoscale level, 

materials may exhibit electrical, biological, and other properties that differ significantly from the properties the same materials exhibit at a larger scale. Exploiting 

these differences in nanoscale materials has led to a range of commercial uses and 

holds the promise for innovations in virtually every industry from aerospace and energy to health care and agriculture. In 2006, an estimated $50 billion in products 

worldwide incorporated nanotechnology and this figure has been projected to grow 

to $2.6 trillion by 2014. One research institute estimates that over 500 consumer 

products already available to consumers may contain nanoscale materials. 

The National Nanotechnology Initiative (NNI) was established in 2001 as a Federal, multiagency effort intended to accelerate the discovery, development, and deployment of nanoscale science, engineering, and technology to achieve economic benefits, enhance the quality of life, and promote national security. Management of the 

NNI falls under the purview of the National Science and Technology Council 

(NSTC) that coordinates science and technology policy across the Federal Government. The NSTC is managed by the Director of the Office of Science and Technology 

Policy (OSTP), who also serves as the Science Advisor to the President. The NSTC’s 

Committee on Technology established the Nanoscale Science, Engineering, and 

Technology (NSET) subcommittee to help coordinate, plan, and implement the NNI’s 

activities across participating agencies. In 2003, the NSET subcommittee further established a Nanotechnology Environmental and Health Implications (NEHI) working group.2 The purpose of the NEHI working group, composed of representatives 

from 16 research and regulatory agencies, is to, among other things, coordinate 

agency efforts related to EHS risks of nanotechnology. Similar to the NNI, the 

NEHI working group has no authority to mandate research priorities or to ensure 

that agencies adequately fund particular research. 

In December 2003, Congress enacted legislation to establish a National Nanotechnology Program to coordinate Federal nanotechnology research and development.3

Among other things, the act directs the NSTC to establish goals and priorities for 

the program and to set up program component areas that reflect those goals and 

priorities. To implement these requirements, the NSTC has established a process to 

categorize research projects and activities undertaken by the various Federal agencies into seven areas. Six of the seven focus on the discovery, development, and deployment of nanotechnology, while the seventh relates to the societal dimensions of 

nanotechnology that include issues such as the EHS risks of nanotechnology. 

As part of the annual Federal budget process, agencies also report their research 

funding for each area to OMB. The NNI’s annual Supplement to the President’s 

Budget, prepared by the NSTC, includes EHS research figures from the agencies 

and a general description of the research conducted by the agencies in each of the 

areas. For reporting purposes, the NSET subcommittee has defined EHS research 

23 

as efforts whose primary purpose is to understand and address potential risks to 

health and to the environment posed by nanotechnology. Eight of the 13 agencies 

that funded nanotechnology research in Fiscal Year 2006 reported having devoted 

some of those resources to research that had a primary focus on potential EHS 

risks. 

Under the NNI, each agency funds research and development projects that support its own mission as well as the NNI’s goals. While agencies share information 

on their nanotechnology-related research goals with the NSET subcommittee and 

NEHI working group, each agency retains control over its decisions on the specific 

projects to fund. While the NNI was designed to facilitate intergovernmental cooperation and identify goals and priorities for nanotechnology research, it is not a 

research program. It has no funding or authority to dictate the nanotechnology research agenda for participating agencies. 

The NNI used its Fiscal Year 2000 strategic plan and its subsequent updates to 

delineate a strategy to support long-term nanoscale research and development, 

among other things. A key component of the 2000 plan was the identification of nine 

specific research and development areas—known as ‘‘grand challenges’’—that highlighted Federal research on applications of nanotechnology with the potential to realize significant economic, governmental, and societal benefits. 

In 2004, the NNI updated its strategic plan and described its goals as well as the 

investment strategy by which those goals were to be achieved. Consistent with the 

21st Century Nanotechnology Research and Development Act, the NNI reorganized 

its major subject categories of research and development investment into program 

component areas (PCA) that cut across the interests and needs of the participating 

agencies. These seven areas replaced the nine grand challenges that the agencies 

had used to categorize their nanotechnology research. Six of the areas focus on the 

discovery, development, and deployment of nanotechnology. The seventh, societal dimensions, consists of two topics—research on environmental, health, and safety; and 

education and research on ethical, legal, and other societal aspects of nanotechnology. 

PCAs are intended to provide a means by which the NSET subcommittee, OSTP, 

OMB, Congress, and others may be informed of the relative Federal investment in 

these key areas. PCAs also provide a structure by which the agencies that fund research can better direct and coordinate their activities. In response to increased concerns about the potential EHS risks of nanotechnology, the NSET subcommittee and 

the agencies agreed in Fiscal Year 2005 to separately report their research funding 

for each of the two components of the societal dimensions PCA. The December 2007 

update of the NNI’s strategic plan reaffirmed the program’s goals, identified steps 

to accomplish those goals, and formally divided the societal dimensions PCA into 

two PCAs—’’environment, health, and safety’’ and ‘‘education and societal dimensions.’’ 

Beginning with the development of the Fiscal Year 2005 Federal budget, agencies 

have worked with OMB to identify funding for nanoscale research that would be reflected in the NNI’s annual Supplement to the President’s Budget. OMB analysts 

reviewed aggregated, rather than project-level, data on research funding for each 

PCA to help ensure consistent reporting across the agencies. Agencies also relied on 

definitions of the PCAs developed by the NSET subcommittee to determine the appropriate area in which to report research funding. Neither NSET nor OMB provided guidance on whether or how to apportion funding for a single research project 

to more than one PCA, if appropriate. However, representatives from both NSET 

and OMB stressed that the agencies were not to report each research dollar more 

than once. 

Almost One-Fifth of Reported EHS Research Projects Were Not Primarily 

Focused on Studying the EHS Risks of Nanotechnology 

About 18 percent of the total research dollars reported by the agencies as being 

primarily focused on the study of nanotechnology-related EHS risks in Fiscal Year 

2006 cannot actually be attributed to this purpose. Specifically, we found that 22 

of the 119 projects funded by five Federal agencies were not primarily related to 

studying EHS risks. These 22 projects accounted for about $7 million of the total 

that the NNI reported as supporting research primarily focused on EHS risks. Almost all of these projects—20 out of 22—were funded by NSF, with the two additional projects funded by NIOSH. We found that the primary purpose of many of 

these 22 projects was to explore ways to use nanotechnology to remediate environmental damage or to identify environmental, chemical, or biological hazards not related to nanotechnology. For example, some NSF-funded research explored the use 

of nanotechnology to improve water or gaseous filtration systems. Table 1 shows our 

24 

analysis of the nanotechnology research projects reported as being primarily focused 

on EHS risks. 

Table 1.—GAO Analysis of the Number and Dollar Value of Nanotechnology Research Projects 

Reported by Selected Agencies as Being Primarily Focused on Environmental, Health, and 

Safety Risks, Fiscal Year 2006 

[Dollars in millions] 

Projects reported by agencies as being 

primarily focused on EHS 

Projects determined by 

GAO to be primarily 

focused on EHS 

Projects determined by 

GAO not to be primarily 

focused on EHS 

Agency Number Dollar Value a Number Dollar Value Number Dollar value 

EPA 10 $3.6 10 $3.6 0 $0 

NIH 18 $5.6 18 $5.6 0 $0 

NIOSH 23 $4.3 21 $4.2 2 $0.1 

NIST 2 $2.4 2 $2.4 0 $0 

NSF 66 $21.1 46 $14.7 20 $6.4 

Total 119 $37 97 $30.5 22 $6.5 

Source: GAO analysis of agency obligations data. 

aFigures differ slightly from those reported by the NNI in the Supplement to the President’s FY2008 Budget 

due to rounding error or modifications made to the project-level data after they were reported by agencies to 

the NNI. 

We found that the miscategorization of these 22 projects resulted largely from a 

reporting structure for nanotechnology research that does not easily allow agencies 

to recognize projects that use nanotechnology to improve the environment or enhance the detection of environmental contaminants, and from the limited guidance 

available to the agencies on how to consistently report EHS research. From Fiscal 

Years 2001 to 2004, the NSET subcommittee categorized Federal research and development activities into nine categories, known as ‘‘grand challenges,’’ that included one focused on ‘‘nanoscale processes for environmental improvement.’’ Agencies initiated work on many of these 22 projects under the grand challenges categorization scheme. Starting in Fiscal Year 2005, NSET adopted a new categorization scheme, based on PCAs, for agencies to report their nanotechnology research. 

The new scheme eliminated the research category of environmental improvement 

applications and asked agencies to report research designed to address or understand the risks associated with nanotechnology as part of the societal dimensions 

PCA. 

The new scheme shifted the focus from applications-oriented research to research 

focused on the EHS implications of nanotechnology. However, the new scheme had 

no way for agencies to categorize environmentally focused research that was underway. As a result, NSF and NIOSH characterized these projects as EHS focused for 

lack of a more closely related category to place them in, according to program managers. Furthermore, neither NSET nor OMB provided agencies guidance on how to 

apportion the dollars for a single project to more than one program component area, 

when appropriate. This is especially significant for broad, multiphase research 

projects, such as NSF’s support to develop networks of research facilities. Of the five 

agencies we reviewed, only NSF apportioned funds for a single project to more than 

one PCA. 

In addition to research reported to the NNI as being primarily focused on the 

EHS risks of nanotechnology, some agencies conduct research that is not reflected 

in the EHS totals provided by the NNI either because they are not considered Federal research agencies or because the primary purpose of the research was not to 

study EHS risks. For example, some agencies conduct research that results in information highly relevant to EHS risks but that was not primarily directed at understanding or addressing those risks and therefore is not captured in the EHS total. 

This type of research provides information that is needed to understand and measure nanomaterials to ensure safe handling and protection against potential health 

or environmental hazards; however, such research is captured under other PCAs, 

such as instrumentation, metrology, and standards. Because the agencies that conduct this research do not systematically track it as EHS-related, we could not estabVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00028 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
25 

lish the exact amount of Federal funding that is being devoted to this additional 

EHS research. 

Processes to Identify and Prioritize Needed EHS Research Appear 

Reasonable and Are Ongoing but a Comprehensive Research Strategy 

Has Not Yet Been Developed 

All eight agencies in our review have processes in place to identify and prioritize 

the research they need related to the potential EHS risks of nanotechnology. Most 

agencies have developed task forces or designated individuals to specifically consider 

nanotechnology issues and identify priorities, although the scope and exact purpose 

of these activities differ by agency. Once identified, agencies communicate their EHS 

research priorities to the public and to the research community in a variety of ways, 

including publication in agency documents that specifically address nanotechnology 

issues, agency strategic plans or budget documents, agency websites, and presentations at public conferences or workshops. We determined that each agency’s nanotechnology research priorities generally reflected its mission. For example, the priorities identified by FDA and CPSC are largely focused on the detection and safety 

of nanoparticles in the commercial products they regulate. On the other hand, EHS 

research priorities identified by NSF reflect its broader mission to advance science 

in general, and include a more diverse range of priorities, such as the safety and 

transport of nanomaterials in the environment, and the safety of nanomaterials in 

the workplace. 

In addition to the efforts of individual agencies, the NSET subcommittee has engaged in an iterative prioritization process through its NEHI working group. Beginning in 2006, NEHI identified but did not prioritize five broad research categories 

and 75 more specific subcategories of needs where additional information was considered necessary to further evaluate the potential EHS risks of nanotechnology. 

NEHI obtained public input on its 2006 report and released another report in August 2007, in which it distilled the previous list of 75 unprioritized specific research 

needs into a set of five prioritized needs for each of the five general research categories. The NEHI working group has used these initial steps to identify the gaps 

between the needs and priorities it has identified and the research that agencies 

have underway. NEHI issued a report summarizing the results of this analysis in 

February 2008. 

Although a comprehensive research strategy for EHS research had not been finalized at the time of our review, the prioritization processes taking place within individual agencies and the NNI appeared to be reasonable. Numerous agency officials 

said their agency’s EHS research priorities were generally reflected both in the 

NEHI working group’s 2006 research needs and 2007 research prioritization reports. 

Our comparison of agency nanotechnology priorities to the NNI’s priorities corroborated these statements. Specifically, we found that all but one of the research priorities identified by individual agencies could be linked to one or more of the five general research categories. According to agency officials, the alignment of agency priorities with the general research categories is particularly beneficial to the regulatory 

agencies, such as CPSC and OSHA, which do not conduct their own research, but 

rely instead on research agencies for data to inform their regulatory decisions. 

In addition, we found that the primary purposes of agency projects underway in 

Fiscal Year 2006 were generally consistent with both agency priorities and the 

NEHI working group’s research categories. Of these 97 projects, 43 were focused on 

Nanomaterials and Human Health, including all 18 of the projects funded by NIH. 

EPA and NSF funded all 25 projects related to Nanomaterials and the Environment. 

These two general research categories accounted for 70 percent of all projects focused on EHS risks. 

Furthermore, we determined that, while agency-funded research addressed each 

of the five general research categories, it focused on the priority needs within each 

category to varying degrees. Specifically, we found that the two highest-priority 

needs in each category were addressed only slightly more frequently than the two 

lowest-priority needs. 

Moreover, although the NEHI working group considered the five specific research 

priorities related to human health equally important, 19 of the 43 projects focused 

on a single priority—’’research to determine the mechanisms of interaction between 

nanomaterials and the body at the molecular, cellular, and tissular levels.’’ Table 

2 shows a summary of projects by agency and specific NEHI research priority. 

26 

Table 2.—Research Primarily Focused on the Environmental, Health, and Safety Risks of Nanotechnology by Agency and Specific Nanotechnology Environmental and Health Implications 

Working Group Research Priority 

EPA NIH NIOSH NIST NSF Total 

Instrumentation, Metrology, and Analytical Methods 0 0 1 2 8 11 

1. Develop methods to detect nanomaterials in biological matrices, the environment, and the workplace 1 7 8 

2. Understand how chemical and physical modifications affect the properties of nanomaterials 0 

3. Develop methods for standardizing assessment of 

particle size, size distribution, shape, structure, and 

surface area 1 1 2 

4. Develop certified reference materials for chemical 

and physical characterization of nanomaterials 0 

5. Develop methods to characterize a nanomaterial’s 

spatio-chemical composition, purity, and heterogeneity 1 1 

Nanomaterials and Human Health 4 18 10 0 11 43 

1. Develop methods to quantify and characterize exposure to nanomaterials and characterize nanomaterials in biological matricesa 1 1 4 2 8 

2. Understand the absorption and transport of nanomaterials throughout the human body a 1 1 2 4 

3. Establish the relationship between the properties of 

nanomaterials and uptake via the respiratory or digestive tracts or through the eyes or skin, and assess body burden a 5 3 1 9 

4. Determine the mechanisms of interaction between 

nanomaterials and the body at the molecular, cellular, and tissular levels a 1 10 3 5 19 

5. Identify or develop appropriate in vitro and in vivo 

assays/models to predict in vivo human responses to 

nanomaterials exposure a 1 1 1 3 

Nanomaterials and the Environment 5 0 0 0 20 25 

1. Understand the effects of engineered nanomaterials 

in individuals of a species and the applicability of 

testing schemes to measure effects 1 2 3 

2. Understand environmental exposures through identification of principle sources of exposure and exposure routes 1 1 

3. Evaluate abiotic and ecosystem-wide effects 6 6 

4. Determine factors affecting the environmental 

transport of nanomaterials 2 9 11 

5. Understand the transformation of nanomaterials 

under different environmental conditions 2 2 4 

Health and Environmental Exposure Assessment 0 0 3 0 2 5 

1. Characterize exposures among workers 2 1 3 

27 

4GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain Collaboration among Federal Agencies, GAO–06–15 (Washington, D.C.: Oct. 21, 2005). 

Table 2.—Research Primarily Focused on the Environmental, Health, and Safety Risks of Nanotechnology by Agency and Specific Nanotechnology Environmental and Health Implications 

Working Group Research Priority—Continued 

EPA NIH NIOSH NIST NSF Total 

2. Identify population groups and environments exposed to engineered nanoscale materials 0 

3. Characterize exposure to the general population 

from industrial processes and industrial and consumer products containing nanomaterials 0 

4. Characterize health of exposed populations and environments 0 

5. Understand workplace processes and factors that 

determine exposure to nanomaterials 1 1 2 

Risk Management Methods 1 0 7 0 5 13 

1. Understand and develop best workplace practices, 

processes, and environmental exposure controls 4 2 6 

2. Examine product or material life cycle to inform 

risk reduction decisions 1 1 2 

3. Develop risk characterization information to determine and classify nanomaterials based on physical 

or chemical properties 1 2 3 

4. Develop nanomaterial-use and safety-incident trend 

information to help focus risk management efforts 0 

5. Develop specific risk communication approaches 

and materials 2 2 

Total 10 18 21 2 46 97 

Source: GAO analysis of agency data. 

aPriorities given equal weight. 

Coordination Processes Have Fostered Interagency Collaboration and 

Information-Sharing 

Agency and NNI processes to coordinate research and other activities related to 

the potential EHS risks of nanotechnology have been generally effective, and have 

resulted in numerous interagency collaborations. All eight agencies in our review 

have collaborated on multiple occasions with other NEHI-member agencies on activities related to the EHS risks of nanotechnology. These EHS-related activities are 

consistent with the expressed goals of the larger NNI—to promote the integration 

of Federal efforts through communication, coordination, and collaboration. The 

NEHI working group is at the center of this effort. 

We found that regular NEHI working group meetings, augmented by informal discussions, have provided a venue for agencies to exchange information on a variety 

of topics associated with EHS risks, including their respective research needs and 

opportunities for collaborations. Interagency collaboration has taken many forms, including joint sponsorship of EHS-related research and workshops, the detailing of 

staff to other NEHI working group agencies, and various other general collaborations or memoranda of understanding. 

Furthermore, the NEHI working group has adopted a number of practices GAO 

has previously identified as essential to helping enhance and sustain collaboration 

among Federal agencies.4 For example, in 2005 NEHI clearly defined its purpose 

and objectives and delineated roles and responsibilities for group members. Furthermore, collaboration through multiagency grant announcements and jointly sponsored workshops has served as a mechanism to leverage limited resources to achieve 

increased knowledge about potential EHS risks. 

Finally, all agency officials we spoke with expressed satisfaction with their agency’s participation in the NEHI working group, specifically, the coordination and colVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00031 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
28 

laboration on EHS risk research and other activities that have occurred as a result 

of their participation. Many officials described NEHI as unique among interagency 

efforts in terms of its effectiveness. Given limited resources, the development of ongoing relationships between agencies with different missions, but compatible nanotechnology research goals, is particularly important. NIH officials commented that 

their agency’s collaboration with NIST to develop standard reference materials for 

nanoparticles may not have occurred as readily had it not been for regular NEHI 

meetings and workshops. In addition, NEHI has effectively brought together research and regulatory agencies, which has enhanced planning and coordination. 

Many officials noted that participation in NEHI has frequently given regulators the 

opportunity to become aware of and involved with research projects at a very early 

point in their development, which has resulted in research that better suits the 

needs of regulatory agencies. 

Many officials also cited the dedication of individual NEHI working group representatives, who participate in the working group in addition to their regular agency duties, as critical to the group’s overall effectiveness. A number of the members 

have served on the body for several years, providing stability and continuity that 

contributes to a collegial and productive working atmosphere. In addition, because 

nanotechnology is relatively new with many unknowns, these officials said the agencies are excited about advancing knowledge about nanomaterials and contributing 

to the informational needs of both regulatory and research agencies. Furthermore, 

according to some officials, there is a shared sense among NEHI representatives of 

the need to apply lessons learned from the development of past technologies, such 

as genetically modified organisms, to help ensure the safe development and application of nanotechnology. 

In closing, Mr. Chairman, while nanotechnology is likely to affect many aspects 

of our daily lives in the future as novel drug delivery systems, improved energy storage capability, and stronger, lightweight materials are developed and made available, it is essential to consider the potential risks of this technology in concert with 

its potential benefits. Federal funding for studying the potential EHS risks of nanotechnology is critical to enhancing our understanding of these new materials, and 

we must have consistent, accurate, and complete information on the amount of 

agency funding that is being dedicated to this effort. However, this information is 

not currently available because the totals reported by the NNI include research that 

is more focused on uses for nanotechnology, rather than the risks it may pose. Furthermore, agencies currently have limited guidance on how to report projects with 

more than one research focus across program component areas, when appropriate. 

As a result, the inventory of projects designed to address these risks is inaccurate 

and cannot ensure that the highest-priority research needs are met. 

Mr. Chairman, this concludes my prepared statement. I would be happy to respond to any questions that you and other Members may have. 

Senator KERRY. Well, that’s great. I’d like to pick up on it. 

Senator Stevens has to run in a few minutes. Do you want to ask 

or are you OK? 

Senator STEVENS. I’m OK. 

Senator KERRY. OK. Thanks. Let me follow up on what you just 

said about the testimony. Maybe I can get you guys playing off 

each other a little bit. 

Director Robinson, you say that you found this process of 

prioritizing the research reasonable but you also found that it falls 

short of the expectations, and on your score, Director Russell, you 

say that the NNI Working Group has been comprehensive enough 

and we don’t need something further. So there’s a slight divergence 

here and we’re trying to figure out where to go on that path. 

Can you elaborate, Director Robinson, on your views of the strategy document and why you don’t think it provides sufficiently 

prioritized guidance, and then the second part of the question, how, 

because of the lack of sufficient guidance, that could have an impact on this discipline and on the future? 

Mr. ROBINSON. Yes, Senator. Again, the process itself, it’s hard 

to argue with. I mean, the folks are working together quite well. 

They sat down. They hashed out priorities across their agencies. 

29 

They arrived at a set of 25 needs. There doesn’t seem to be a huge 

amount of contention that these encompass the most important research needs facing this subject. 

The document itself, I’ve got to tell you, the strategy paper itself 

is a little hard to follow. I mean, when you sit down to try to go 

through that, it’s not easy to get through. 

But on one of the more important fronts, however, it doesn’t lay 

out who’s responsible for what, who’s accountable for delivering 

what, and hold them responsible for delivering the research that 

they’re supposed to do to add up to this collective whole. Secondarily, it lays out 25 or so priorities and essentially provides them 

equal weight. 

So it would be more helpful to know what is the most important 

of the most important in a true budget scarcity environment. Something has to be sacrificed. 

Senator KERRY. What’s the impact of not knowing? 

Mr. ROBINSON. Well, at the end of the day, I don’t think you can 

be absolutely certain or the public can be absolutely certain by 

looking at that document that the Federal Government has a full 

thorough systematic effort in place to ensure that nanotechnology 

risks are being fully and completely addressed and that—— 

Senator KERRY. Can I stop you there? Let me stop you there. 

Director Russell, what do you say to that? 

Mr. RUSSELL. So a couple of things. 

Senator KERRY. Can you pull the mike up a little? 

Mr. RUSSELL. Sure. I’ve got to turn it on, too. A couple things. 

One is that there’s no question that we can continue to improve the 

process by which we identify from a bottom-up approach which 

areas need to be researched and how much money we have to 

spend in each area. 

The strategic document, which I actually think is well put together, is fairly lengthy and quite specific, but it is not a roadmap, 

and I think that’s maybe where there’s a difference between what 

GAO is saying and what we’re saying. 

The strategy is how we’re going to move forward. I think what 

Director Robinson is suggesting is what they would love to see as 

an actual roadmap. That is something that we certainly can look 

at and try to figure out what makes the most sense going forward. 

One of the things that we have done is we’ve asked the National 

Research Council to actually review the strategic document and 

give us recommendations and so we’re waiting for that review 

and—— 

Senator KERRY. When will that be forthcoming? 

Mr. RUSSELL. I don’t know—March of next year is when we’re 

going to get that. 

Senator KERRY. Not till next year? 

Mr. RUSSELL. It takes the NRC awhile to actually—this was published—this document here, which we are discussing, was published in February of this year and then the NRC has a very specific series of reviews that it does which takes some time. 

Senator KERRY. Go ahead. 

Senator STEVENS. I’ve got to go but I wanted to ask just two 

questions. 

30 

Mr. Russell, I’m reminded of Norm Augustine’s report that indicated that in India, they’re producing 700,000 engineers and China 

400,000 engineers and we’re producing 70,000 engineers. 

Now, do we have—how does the amount we’re spending on nanotechnology compare to China and India? 

Mr. RUSSELL. Well, we’re spending more than both China and 

India on nanotechnology, although Asia, as a whole, is increasing 

and, roughly speaking, Asia’s spending about the same amount 

now we are spending on nanotechnology. So Asia as a whole as opposed to those specific two countries. 

Senator STEVENS. So our lack of educational activities for more 

people is not shorting us as far as our basic research in nanotechnology? 

Mr. RUSSELL. Compared today to India and China, that’s true. 

Now, I would assume, because China is spending more money generically on R&D and ramping up faster than we are over time on 

R&D, that at some point, they probably will end up spending more. 

So that’s clearly something that we need to be cognizant of. 

Senator STEVENS. I think you ought to give us annual reports on 

that. 

Mr. Robinson, let me ask you this. In terms of your report and 

this idea of transparency, do you believe that every one of these research projects ought to have a set-aside of money to go into the 

aspects of safety and health as related to the research project? 

Mr. ROBINSON. No, I wouldn’t suggest that. My main point is 

that if we say we’re spending X millions of dollars on EHS research, let’s make sure that the money’s actually going in that direction and that it will be transparent for what the actual purpose 

of the research is. 

Senator STEVENS. Who is—are we supposed to have another 

agency look into the safety and health aspects of nanotechnology? 

Mr. ROBINSON. No, we don’t call for that, Senator, no. 

Senator STEVENS. You don’t—— 

Mr. ROBINSON. We didn’t call for that. We didn’t—— 

Senator STEVENS. Who’s going to do it? That’s what I’m saying. 

Mr. ROBINSON. Well, the NNI Program, I think, right now is 

doing a credible job of assembling the research needs and attacking 

most of them. I’m not sure—— 

Senator STEVENS. Including health and safety? 

Mr. ROBINSON. Short of saying how—whether the dollars are 

adequate, I would say the process that’s used to arrive at and undertake the research that’s to be undertaken certainly is not open 

to substantial challenge, I don’t think. 

Senator STEVENS. All right. Thank you. 

Senator KERRY. Yes, Mr. Russell? 

Mr. RUSSELL. I was just going to jump in. I think the answer is 

that there are a number of different agencies that are all doing this 

research and when you put them all together as coordinated by the 

NNI, in the case of Fiscal Year 2009 request, you get roughly $75 

million. 

Senator KERRY. Why the resistance to doing what people would 

call a roadmap/comprehensive strategy? Thanks, Ted. 

Mr. RUSSELL. I don’t think there’s—it’s a matter of a resistance 

in terms of doing it. 

31 

Senator KERRY. Why would there be the automatic instinct that 

everybody’s got to know where to go here? I mean, this is the EHS 

concern is real. 

Mr. RUSSELL. No, absolutely. Not only is it—— 

Senator KERRY. Don’t we want people in the public to have as 

much information and sense of where we’re heading as possible? 

Mr. RUSSELL. Yes, absolutely, and as I was saying, what has 

been done to date, every year the NNI has been putting out more 

detailed and more specific EHS reports and in this case just in February came up with a strategic plan. 

Creating a roadmap obviously is an additional step and an additional work activity and it’s something that we can certainly look 

into doing. It is—— 

Senator KERRY. Do you agree that it is the appropriate group to 

do it? 

Mr. RUSSELL. The NNI? I think—— 

Senator KERRY. Yes. NNI. 

Mr. RUSSELL. So the NEHI, which is a subgroup of the Subcommittee that’s responsible for dealing with the Nanotechnology 

Program is indeed the right working group to be working on these 

issues and has been very active in working on these issues. So absolutely. 

Senator KERRY. Fair enough. How effectively in your judgment, 

Mr. Russell, are we sharing and coordinating this effort with other 

countries? 

Mr. RUSSELL. Actually, I think we’re doing that well. As a matter 

of fact, I think we are doing more than almost all other countries, 

especially and specifically about EHS, but let me give you an example. 

Just this week, the OECD is holding a meeting on this specific 

issue. EPA is chairing that meeting. It’s on Nanotechnology and 

specifically EHS Issues and so we’re working very hard to coordinate with the rest of the world, not just on EHS, though, because 

EHS is just one issue with nano. 

Obviously one of the things we want to make sure is that we win 

the commercialization battle as well and there we’re working very 

hard internationally on issues like standards where it’s really critical that we end up with the world adopting standards that are 

beneficial to our companies just as much as they are good for the 

world in terms of new nanotechnology products. 

Senator KERRY. Now let me come to the structure of this thing. 

The Nanotechnology Research and Development Act originally 

called for a National Nanotechnology Advisory Panel to the President and to the whole NNI. 

President Bush fought for that authority to be put into the 

PCAST, the President’s Council of Advisors on Science and Technology. 

My question to you is isn’t their mandate so broad as a whole 

that it just doesn’t have the kind of specific expertise and knowledge that you want with respect to the nanotechnology sector? 

Mr. RUSSELL. Let me answer that in two ways. One is, one of the 

reasons the President very much wanted PCAST, which is the 

panel you just described, to advise him on nanotechnology is that 

he actually meets with PCAST on an ongoing basis. 

32 

PCAST is made up of leading CEOs of tech companies and presidents of universities, very prestigious people. They actually have a 

group that advises them, what’s called a TAG, an advisory group 

specific to nanotechnology. Those are nanotechnology scientists and 

so those nanotechnology scientists as a fairly large group of people 

are directly advising presidents of universities, the head of the National Academy of Engineers, for example, now soon to be our head 

of the Smithsonian, who is currently head of Georgia Tech, as well 

as venture capitalists and presidents of large corporations, who are 

on PCAST, and so really having PCAST review and speak to nano 

really helps in terms of its status within the policymaking process. 

So I think it’s a very useful function to have PCAST doing that. 

Senator KERRY. Does it stifle it in any way? Does it cut it off? 

Mr. RUSSELL. I don’t think so. I think it has exactly the opposite 

effect. 

Senator KERRY. How would you say PCAST has guided and advised the NNI thus far? 

Mr. RUSSELL. Well, it has actually very directly interacted with 

the NNI and directly given advice, written a report. It’s done a very 

good report on the state of technology, nanotechnology, in terms of 

the U.S. and the rest of the world, which has been a very valuable 

document. 

Senator KERRY. The National Research Council’s 2006 review 

suggested otherwise a little bit. Are you familiar with it? 

Mr. RUSSELL. I am familiar with it. I haven’t looked at that recently. 

Senator KERRY. They found that the NNI does not have the benefit of access to an independent standing technical advisory panel, 

even though there is. I’m quoting them, ‘‘ongoing national need for 

such a body,’’ and they recommended the establishment of an independent advisory panel with specific operational expertise in 

nanoscale science and engineering. 

Why wouldn’t we want to follow that counsel? 

Mr. RUSSELL. Because I think what you will lose by doing that— 

the way the system works now, and I really think it’s been working 

very well, is you have that specific expertise, the expertise that the 

Academy is talking about which is part of what’s called the TAG, 

which is the advisory council, that specific nanotechnology scientists, to PCAST. 

So you have a large number of nano experts talking directly to 

very well-respected people, like Norm Augustine, who are on 

PCAST. Having Norm Augustine and others like him talking to the 

President about nanotechnology really helps nano. I think we 

would lose a lot if we broke that chain. 

Senator KERRY. Mr. Robinson, do you want to comment? 

Mr. ROBINSON. Senator, this topic is a little bit beyond the scope 

of our initiative, so I wouldn’t have any more to add. 

Senator KERRY. OK. That’s fair. Let me ask either of you if you’d 

like to comment on this concept that has been suggested to the 

Committee that part of the problem with the way that the program 

is currently constituted is that the agencies don’t have a clear 

sense of how to work together in order to maximize their budgets, 

maximize their resources, and make sure there’s a clear cut government-wide strategy for forwarding nanotechnology research. 

33 

Is there anything specific about the current structure that you 

think, as we think about the reauthorization, that ought to be 

changed? Either of you? 

Mr. RUSSELL. I must say, and obviously I work with a lot of different types of interagency programs, and of the various programs 

that have many agencies involved and in this case we have 25 separate agencies, nano is one of the best coordinated programs that 

we have in the science arena, and I actually think the GAO report 

really echoes that and so I don’t think—you can always make improvements, no question, but I think we want to be really careful 

that we don’t blow up what has really been a successful model and 

a long-term model. 

I mean, you know, we’ve now been with this model for 8 years 

and under this model, we’ve seen a tripling of the budget. We’ve 

seen the establishment of a national coordinating office. We’ve seen 

the passage of legislation which this Committee put forward. So I 

think it’s been a successful model. 

Mr. ROBINSON. One thing I would add to that is I would agree 

that, among my 35 years of doing this, this is one of the situations 

when we look at collaboration and where we’d have to say this is 

pretty good by Federal standards. Not the least of which, it is important to mention that research bodies and regulatory bodies are 

sort of working together, crossing normal sort of barriers and this 

is a real advantage to this particular operation. 

The thing that we would want to bring to the dance, however, 

is that at the end of the day, there’s nobody ensuring that all the 

work that’s supposed to be done is orchestrated in a systematic 

fashion to reach conclusion at the same point and address all the 

barriers and all the knowledge gaps that the public probably expects from its government; that it’s going to protect itself from any 

potential unintended ‘‘I Am Legend’’ kind of consequences that I 

think some folks probably have in their minds. 

Senator KERRY. Thank you very much. Senator Thune? 

STATEMENT OF HON. JOHN THUNE, 

U.S. SENATOR FROM SOUTH DAKOTA 

Senator THUNE. Thank you, Mr. Chairman. I want to thank you 

for holding the hearing and thank both the panels that are testifying, one now and one later, for their testimony, and I think it’s 

important that to keep our country competitive, we always push 

the boundaries of science in accordance with reasonable ethical 

standards and public safety measures. 

Nanotechnology is the frontier of the scientific community and 

the U.S. National Nanotechnology Initiative is an important part 

of fully actualizing the benefits of this very exciting technology, and 

as our witnesses, I think, are highlighting, nanotechnology is already playing a part, an important part in our everyday lives. 

Over the past 14 months, the number of nano-enabled consumer 

products has doubled. Consumers across the country are benefiting 

from this research, even if in many cases they’re unaware of its origins. 

So thanks to the investment of public and private sector resources and the ingenuity of America’s scientists, the influence and 

the benefits of nanotechnology are going to continue to lift the 

34 

standard of living for Americans and for individuals around the 

world. 

As we move forward with reauthorizing the National Nanotechnology Initiative, I think we need to encourage greater focus on 

safety and greater transparency within the National Nanotechnology Initiative and I would also encourage my colleagues on the 

Committee to consider an increased role for renewable energy within the National Nanotechnology Initiative, and I again want to 

thank our witnesses for their testimony, and I look forward to 

working with my colleagues on the Committee as we strengthen 

this very important initiative. 

I guess I’d like to just ask a couple of questions, if I could, related to agricultural and energy issues. Agriculture is obviously 

very important in my state and advances in biotechnology have 

greatly increased the yields and efficiency of producing many of our 

crops, and I guess my question has to do with what advances do 

you see being made in nanotechnology in the agricultural field? 

How far off are these advances? 

Given the food shortages that are being caused by increasing demand for food abroad? Do you think we should be directing more 

funding toward the research of nanotechnology that will promote 

agriculture? 

Mr. RUSSELL. I can talk to the energy field a little more easily 

than I can talk directly to agriculture. Clearly, there are benefits 

associated with nanotechnology, and I would think where you 

might see that particularly is in things like improved fertilizers 

and improved utilization of nano to create new types of crops. 

But let me give you an energy example that is real and that 

could make a huge difference for all of us and that’s with lighting. 

Senator THUNE. What’s that? 

Mr. RUSSELL. Lighting. Nano-enabled LEDs can be twice as efficient as fluorescent light bulbs and they have none of the real problems associated with them and if you look at overall energy consumption in this country, lighting is a massive piece of the puzzle 

and so there, you’re really seeing where nanotechnology can make 

a truly significant difference. 

One of the problems with LEDs is getting white light and 

through nanotechnology, we can solve that problem and that would 

be a real increase in efficiency and a real decrease in our energy 

need for the country. 

Senator THUNE. My assumption, based on the answer to that 

question, though, is there hasn’t been a lot of thought given to how 

nanotechnology might impact crop production and biotechnology. 

Mr. RUSSELL. I wouldn’t actually say that. I’m just less familiar 

with that area, but I’m happy to get you examples for the record 

because there is work ongoing in that area as well. 

[The information referred to follows:] 

The NM supports extensive nanotechnology R&D in biotechnology and agriculture. For example, the USDA program on Nanoscale Science and Engineering for 

Agriculture and Food Systems aims to develop nanoscale detection and intervention 

technologies for enhancing food safety and agricultural biosecurity; effective delivery 

of micronutrients and bioactive ingredients in foods; and product identification, 

preservation, and tracking. The program also supports social science researches to 

address public perception and acceptance of nanotechnology applications in agriculture and food systems. 

35 

The NMI is also supporting research using nano-fabricated surfaces to study how 

certain bacteria affect the water-transporting tissues in plants. The nanotechnology 

approach enables the study of the plants without destroying them, allowing collection of more and better data. Understanding how bacteria colonize these nano-structured vessels is leading to development of novel plant disease control strategies. 

Senator THUNE. Coming back to your response about the energy 

issue, one of the greatest challenges, I think, that our country faces 

right now is this dangerous dependence that we have on foreign 

sources of energy and I also believe that ethanol made from crops 

and that sort of thing is an immediate solution to this problem and 

one that we need to continue to develop, and I think we have to 

commercialize cellulosic ethanol as soon as possible to meet that 

growing demand for fuel. 

There’s a certain—there’s a cap on what we can generate from 

corn. That varies. Most people think somewhere in the 15 billion 

gallon range and we use about a 140 billion gallons of fuel in this 

country every year. So we’re at about 7.5 billion gallons of production right now. So even if we max out what we can do in corn, 

we’re still a long ways from having significant impact. 

On the other hand, when you start getting into the cellulosic 

field, which is advanced biofuels made from other types of biomass, 

switch grass, wood chips, those sorts of things, you can dramatically increase the amount of renewable energy that we can 

produce, and one of the technological obstacles to producing cellulosic ethanol is perfecting the enzymatic reactions that break down 

cellulose to usable sugars that can make ethanol. 

So I guess the question I have is, is there a role for nanotechnology in perfecting that process, and has the initiative focused on fuel 

production, in addition to some of the things that you referenced 

with regard to light? 

Mr. RUSSELL. Again, Senator, I’m happy to get you for the record 

the specifics of what the Department of Energy is doing. The Department of Energy is one of the significant contributors to the 

Nano Initiative and there is absolutely no question that nanotechnology—one of the real breakthroughs by using nano is to reduce, 

for example, expensive catalysts associated with reactions and the 

reason for that is pretty clear. 

[The information referred to follows:] 

In order to convert cellulosic biomass (e.g., wood, switchgrass, corn stover, and 

wheat straw, and other agricultural and forest residues) into biofuels, complex enzymes must break down the cell walls of the feedstock plants. Optimization of these 

enzymes depends on a detailed understanding of how they interact with the plant 

cells at the nanoscale. As result, the three new DOE Bioenergy Research Centers 

are using many of the same tools used by nanoscience researchers for this aspect 

of their research, including a range of powerful new capabilities for imaging matter 

at the nanoscale. This nanoscale imaging is integrated into a systems approach that 

also utilizes a range of other tools, including rapid genomic sequencing and highthroughput screening, metagenomics, and other techniques that are specific to 

genomics-based systems biology. Nanotechnology tools are helpful in investigating 

cell-wall physical and chemical properties, how they function, and how certain structural features inhibit or facilitate enzymatic interactions and subsequent conversion 

to sugar (for eventual conversion by microbes to ethanol as well as to hydrocarbons, 

including ‘‘green’’ gasoline, diesel, and even jet fuel). Specifically, researchers do not 

have a good understanding of the solution physics and thermodynamics that govern 

the protein-domain biological functions at the nanometer scale. The new tools of 

nanotechnology can help develop system-level descriptions of these processes, including the biomolecular mechanics that govern interactions at the cellulose surface. 

For example, DOE is using nanotechnology tools to help design enzymes (biocataVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00039 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
36 

lysts) that can more efficiently break down cellulosic feedstock into sugar, which can 

then be processed by microbes into ethanol and other fuels, including hydrocarbons. 

This research is being conducted by DOE’s three Bioenergy Research Centers 

(http://genomicsgthenergy.govicenters/index.shtml), which are led by ORNL, LBNL, 

and Univ. of Wisconsin (in close collaboration with Michigan St.). 

Obviously when you can distribute chemicals at the nanoscale, 

you can dramatically reduce the amount of either the toxic or the 

expensive catalysts you need for individual reactions. 

So nanotechnology has generically proven very valuable in these 

kind of reactions in terms of making them cost effective, which obviously is a huge part of the equation when you’re talking about 

cellulosic. It’s not that we don’t know how to do cellulosic, it’s hard 

to do it at scale, it’s hard to do it at a reasonable cost. 

Senator THUNE. In your reference to—I know the DOE’s real involved with this initiative which I think is a good thing because I 

think that the energy applications are very real and can be very 

meaningful. 

How would you rate the coordination among the Federal agencies 

that are involved with the effort? Are there things that can be done 

to improve that? 

Mr. RUSSELL. Well, generically and this is largely because 

they’ve all bought into the effort itself, it’s excellent. As I stated in 

my testimony, we have 25 agencies who are voluntarily participating and the reason that’s important is they all think they’re getting something out of it and since they think they’re getting something out of it, they actually are actively participating in the program rather than simply being forced to participate. 

So for that very reason, actually the interaction is excellent and 

you don’t see the kind of problems you see with coordination where 

agencies think that they’re either being forced to do something or 

that another agency might be stealing their budget and so that’s 

really a differentiator in this case and I think it’s worked very well. 

Senator THUNE. Thank you. Thank you, Mr. Chairman. Thank 

you for your testimony. 

Senator KERRY. Thank you very much, Senator Thune. Just a 

last question quickly. Tell America what you think. What are we 

looking at here? What do you see the future of nanotechnology conceivably providing? Are there areas where you see the most impact, 

perhaps the products and types of things that will be most exciting 

to Americans? 

Mr. RUSSELL. Well, I think there will be a variety of areas and 

that’s one of the wonderful things about nanotechnology because it 

really crosscuts almost all the areas you can imagine in terms of 

commercializable products. 

Clearly, today, biomedical is an amazing and a growing field. 

Just today in the Washington Post, in the Business section, they 

had a very interesting article about cancer fighting drugs that can 

be targeted through nanoparticles directly at just the cancer. 

You’re seeing similar breakthroughs with replacing bones, making bone screws out of actual bone, and other advances in the biomedical field, and in other areas, like coatings, there is tremendous 

current work going on where you’re seeing much stronger and better and longer-lasting coatings. 

37 

Also in the environmental field, and this goes to GAO’s point 

that about $7 million of pro-environment research was categorized 

as environmental impacts, nanotechnology, because it can reduce 

the waste stream, because we can use less of dangerous products, 

not just expensive products, in terms of how we manufacture 

things can make a real difference in terms of the amount of waste 

that’s produced that’s produced when we are producing things. 

So I think those are some of the many areas you’re going to see 

breakthroughs. The other is in materials and having stronger, 

lighter materials which again saves energy and allows us to do all 

sorts of interesting things is clearly an area where nanotechnology 

has really taken off. 

Mr. ROBINSON. And I would agree, you know, beyond the biomedical front, obviously the energy potential, if you can develop 

these nano-based thin photovoltaics that essentially can be incorporated into windows, paints, roofs that make every house its own 

energy generator, I mean phenomenal potential there. 

But referencing back to Senator Thune’s point, one of the things 

that we want to make sure in our work which was indeed concentrated on EHS issues, we want to make sure that we don’t have 

a repeat similar to biotech crops where the public’s confidence or 

at least other potential buyers’ confidence was shaken and it damaged our ability to enter the marketplace and that is sort of at the 

root of this effort. 

We need to make sure that everything’s aboveboard, transparent 

and, as best we can determine, all the risks are identified and attacked in the most systematic efficient way possible, and that’s at 

the root of our testimony today. 

Senator KERRY. Well, I appreciate it. We appreciate your testimony today. I’m going to leave the record open for a couple of 

weeks in the event any other colleagues have any questions they 

want to submit in writing, but we thank you for coming today. 

Thank you for the analysis. Thank you, Director Russell, for your 

help in understanding this as we go forward. 

Mr. RUSSELL. Thank you, Mr. Chairman. 

Senator KERRY. Could we ask for the second panel to come forward right away and we’ll get started? Appreciate that. 

Mr. Matthew Nordan, the President of Lux Research, Incorporated; Mr. David Rejeski, Director, Foresight and Governance 

Project, Project on Emerging Nanotechnologies, Woodrow Wilson 

Center; Dr. P. Lee Ferguson, Assistant Professor, Department of 

Chemistry and Biochemistry, University of South Carolina; Dr. 

Anita Goel, Nanobiosym, Incorporated; and Dr. James Heath, 

Nanosystems Biology Cancer Center at the California Institute of 

Technology. 

We welcome you all. Thank you for being here. Why don’t we just 

begin with you, Mr. Nordan? We’ll run right down the line here 

and we welcome your testimonies. Again, all your testimonies will 

be placed in the record in full. If you could summarize in 5 minutes, that would be great. 

38 

STATEMENT OF MATTHEW M. NORDAN, PRESIDENT, 

LUX RESEARCH, INC. 

Mr. NORDAN. Good afternoon, Mr. Chairman. Lux Research advises corporations and investors on the unique perspective—— 

Senator KERRY. Advises about the unique perspectives of nanotechnology? 

Mr. NORDAN. Commercialization. 

Senator KERRY. Commercialization. 

Mr. NORDAN. On the basic measure of scientific output, the NNI has been a great success. The $7.2 billion that it has channeled 

since launch has funded prodigious research in areas ranging from 

noninvasive cancer therapies to high-efficiency solar panels, but 

more than this, the NNI has catalyzed a virtuous cycle of innovation. 

The NNI has excited corporate interest in nanotech. It helped spark $2.4 billion in private R&D spending on the topic last year 

which exceeded government funding by 23 percent. Stimulated by 

the NNI, venture capitalists have opened their checkbooks. Last 

year, VC funding for U.S.-based nanotech startups totaled $632 

million. That’s four times the figure in the year before the NNI, 

and finally, NNI-funded initiatives have sparked new enthusiasm 

about the physical sciences broadly among students, from the postgraduate level down to high school. 

Nanotechnology is now having a significant commercial impact. 

Because nanotech is a toolkit that’s being deployed behind the 

scenes in virtually every manufacturing industry, it can seem invisible. There’s an all-too-commonly held misperception that all we 

have to show for our nanotech funding is stain-resistant pants but 

this view is dead wrong. 

From the billions of dollars in nano-enabled pharmaceuticals sold 

last year by the likes of Abbott to the nanocomposites in coatings, 

the chip in millions of vehicles from General Motors, nanotech is 

on track to exceed my firm’s projection of enabling $2.6 trillion in 

goods sold by 2014, about 15 percent of manufacturing output. 

Nanotech is also creating new companies and new jobs. In my 

home state of Massachusetts, the Arsenal Complex in the City of 

Watertown was 750,000 square feet of empty crumbling space in 

the mid 1990s, but now its biggest tenant is A1–2–3 Systems which 

manufactures high-performance batteries with nano-structured 

electrodes based on research by Yet Ming-Chiang at MIT, precisely 

the type of work that the NNI funds. In four short years, A1–2– 

3 has gone from a few dozen employees to more than 1,000 and it’s 

helped to shift the center of battery innovation from East Asia to 

the U.S. 

Now my company conducts an annual assessment of international competitiveness in nanotech. We rank 19 nations worldwide. On an absolute basis, the U.S. remains the world leader, but 

the U.S. does not lead and not by a long stretch when the size of 

our economy is taken into account. 

For instance, when you look at government funding on an absolute basis, the U.S. topped the charts last year, but when the same 

figures are considered on a per capita basis at purchasing power 

parity, the U.S. takes eighth place with funding half that of Taiwan and behind Germany, Sweden and France. 

39 

Other nations are gaining rapidly. Nanotech funding is growing 

in the EU at twice our rate. Russia recently funded a state nanotechnology corporation with $5 billion of public financing and the 

citation rate of nanotech journal articles in China, which is a measure of their quality, has doubled in the last decade. 

Now with these facts in mind, the NNI should certainly be reauthorized but as nanotech shifts from discovery to commercialization, change is required. Most of the changes that will help transition NNI-funded research to market really have nothing to do with 

nanotechnology in particular. They address broader issues. This 

should come as no surprise given nanotech’s diversity and breadth. 

For example, rapidly growing companies need skilled human capital. This means major new investment in science and technology 

training for U.S. students, as Senator Stevens referred to, but it 

also requires easing the visa process for foreign nationals and expanding the H1V program. 

Recall A1–2–3 Systems. Had Yet Ming-Chiang returned to his 

native country, its 1,000 employees might well be in Taiwan. Startups that want to access public markets face immense administrative costs to comply with regulations like Sarbanes-Oxley. Reducing 

these costs will unshackle them. We should note that of 14 

nanotech startups that have gone public to date, most of them have 

done so on foreign exchanges where the cost of doing business is 

much lower. 

Finally, Congress can introduce financial mechanisms that help 

small companies collaborate with big ones. This is particularly important in nanotech by, for example, enabling small firms to transfer their net operating losses to corporate partners. 

There are, however, a number of smaller changes specific to 

nanotech that are also necessary. I’ll focus on two. First, a reauthorized NNI should fund not just basic research but also 

precompetitive R&D into nanomaterials application development 

and manufacturing scale-up. 

The Department of Energy’s Nano Manufacturing Initiative is a 

model case study for this. 

Second, a reauthorized NNI must address potential environmental health and safety risks as we’ve discussed much more aggressively, bringing regulatory clarity to companies that are begging for it and presenting a comprehensive interagency roadmap 

for EHS research. 

I appreciate your inviting me here to speak. I’m confident that 

with your informed decisions the next 7 years of the NNI will be 

even brighter than the first seven. 

I’m pleased to answer any questions. 

[The prepared statement of Mr. Nordan follows:] 

PREPARED STATEMENT OF MATTHEW M. NORDAN, PRESIDENT, LUX RESEARCH, INC. 

The National Nanotechnology Initiative (NNI) is a great success; it has not only 

funded prodigious fundamental research, but has also catalyzed a virtuous cycle of 

innovation manifested in corporate R&D and venture capital. The landscape is different today than when the NNI commenced in 2001, however. Nanotech’s discovery 

phase has given way to commercialization—tens of billions of dollars worth of products now incorporate nanotech—and other nations are eroding the U.S.’s dominant 

position. As the NNI is reauthorized, its focus should shift to application development and manufacturing scale-up—and its approach to environmental, health, and 

safety (EHS) issues must be overhauled. 

40 

1Source: October 2004 Lux Research report ‘‘Sizing Nanotechnology’s Value Chain.’’ 

The NNI Has Catalyzed a Virtuous Cycle of Innovation 

Nanotechnology is the purposeful engineering of matter at scales of less than 100 

nanometers (nm) to achieve size-dependent properties and functions. Nanotech is 

not a new industry or market, but rather an enabling set of technologies that impact 

a wide variety of industries through a nanotech value chain. This value chain starts 

with nanomaterials like carbon nanotubes and dendrimers, which are incorporated 

into intermediate products like memory chips and drug delivery systems, which are 

in turn used to make enhanced final goods like mobile phones and cancer therapies 

(see Figure 1). Lux Research projects that new, emerging nanotechnology applications will affect nearly every type of manufactured product through the middle of 

the next decade, becoming incorporated into 15 percent of global manufacturing output totaling $2.6 trillion in 2014 (see Figures 2 and 3).1


424NORD1.eps 424NORD2.eps
41 

2Source: 2007 Lux Research reference study ‘‘The Nanotech Report, 5th Edition.’’ 

3Source: March 2008 Lux Research report ‘‘How Venture Capitalists Are Misplaying 

Nanotech.’’ 

Introduced in 2001 and signed into law in 2003, the U.S. National Nanotechnology Initiative is the Federal Government’s coordinating program for publicly-funded 

nanotechnology research, which has inspired similar efforts in countries worldwide 

from Germany to South Korea. By the core measure of scientific output, the NNI 

has been a great success—U.S. scientists have published 55,661 journal articles on 

nanoscale science and engineering since 2001, 27 percent of the world’s total. But 

in addition to this, the very presence of the NNI has catalyzed a virtuous cycle of 

innovation, manifested in: 

• Corporate R&D spending. Large U.S. corporations from GE to Motorola spent 

$2.4 billion in nanotechnology R&D in 2007, up 22 percent from 2006 and 557 

percent from 2000, the year before the NNI’s introduction. The 2007 figure was 

23 percent higher than U.S. Government nanotechnology funding at the Federal 

and state level combined.2 These efforts include in-house research like GE’s 

Nanotechnology Advanced Technology Program, broad collaborations like Cabot 

Corporation’s Fine Particle Network, and joint ventures like DA Nanomaterials, 

created by DuPont and Air Products. Without the NNI as a widely-publicized 

focusing mechanism for nanotechnology research, it’s unlikely that this intense 

corporate focus on nanoscale science and engineering would have materialized. 

• Venture capital (VC) funding. Venture capitalists are always on the lookout for 

compelling investment themes, as well as non-dilutive sources of financing that 

can help sustain the companies they invest in through notoriously rocky early 

stages. The NNI has provided both, serving as a validator that has helped open 

VCs’ wallets to materials science investments in a fashion never before seen. 

In 2007 VC firms put $632 million into U.S.-based nanotech start-ups in 2007, 

more than four times the figure in the year before the NNI was initiated (see 

Figure 4).3


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• New companies and new jobs. Consider A123Systems, which uses nanostructured lithium iron phosphate electrodes to make advanced batteries now being 

evaluated for use in electric vehicles like GM’s Chevy Volt. In the mid–1990s, 

the Arsenal complex in the City of Watertown, Massachusetts was 750,000 

square feet of empty, crumbling space. Now, A123Systems is its biggest tenant, 

commercializing battery devices based on research by Yet-Ming Chiang at 

MIT—precisely the type of research that the NNI funds. In just 4 years, A123 

has gone from a few dozen employees to more than 1,000—and helped to shift 

the center of battery innovation from east Asia to the United States. 

The Nanotech Landscape Is Very Different Today than When the NNI 

Launched 

When the NNI took shape in 2001, nanotechnology activity focused on early-stage 

laboratory research with little commercial impact, and the U.S. was alone in the 

world in having a nationwide coordinating program for nanotech. Today, both factors have changed. Nanotechnology has shifted from its discovery phase into its 

commercialization phase—and at the same time, the dominant competitive position 

of the United States has been eroded by other nations. 

Nanotech Commercialization is Eclipsing Discovery 

In the last 7 years, emerging nanotechnology has increasingly become a fact of 

life and of business, as the technology has shifted from an era of discovery to one 

of commercialization. In this fashion, nanotechnology follows the example of other 

world-changing technologies like polymer science and biotechnology. For these 

emerging technologies, everything starts with the discovery phase—a period of basic 

research and application development—which has a characteristic time span, give 

or take a bit, of about 20 years. It’s then that a tipping point gets reached, triggering the commercialization phase—where the technology’s long-term impact is 

manifested (see Figure 5). 


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For instance, plastics’ discovery phase started in the 1920s, when scientist Wallace Corrothers at DuPont began work on synthesizing nylon. In 1937, he was 

issued his patent on the material. Two years afterward—about 20 years after discovery began—American women bought 64 million pairs of nylon stockings; once the 

commercialization threshold was reached, it took off fast. In biotechnology, James 

Watson and Francis Crick characterized DNA in 1953, and 20 years later, right on 

cue, Stanley Cohen and Robert Boyer applied genetic engineering techniques to synthesize insulin for the first time. Genentech, the first biotech start-up, was founded 

in 1976, and commercialization has since skyrocketed: In 2006, revenues of publiclytraded biotech companies topped $65 billion. In information technology, Vint Cerf 

and Robert Kahn proposed the Internet protocol in 1974. The number of Internet 

users grew gradually to the single-digit millions up through 1993, but began to skyrocket in about 1994, the year Netscape’s browser was released—reinventing communication and commerce in the process. 

Nanotech’s discovery phase started in the mid–1980s with the invention of scanning probe microscopes that enabled scientists to visualize matter at the nanoscale 

for the first time. Innovations have reached the market in electronics, as 

A123Systems’ nanostructured battery electrodes appeared on store shelves in Black 

& Decker’s Dewalt line of power tools; in healthcare, as nanoparticulate drug reformulations like Abbott’s cholesterol drug Tricor have found their way into doctors’ 

repertoire; and in materials and manufacturing, as PPG’s coatings have improved 

the performance of millions of automobiles. According to our research, approximately $88 billion in manufacturing output worldwide incorporated emerging nanotechnology in 2007. 

The Dominant Position of the U.S. Is Being Eroded 

Each year, Lux Research conducts an annual assessment of international competitiveness in nanotechnology, ranking 19 nations worldwide on their nanotechnology 

activity and technology commercialization strength. On an absolute basis, the U.S. 

remains the world leader in nanotech. Two factors, however, should give U.S. policymakers pause: 

• The U.S. does not lead on a relative basis. Relative to our population and the 

size of our economy, the U.S. pales in comparison to other countries when it 

comes to nanotechnology activity. For example, when government funding is 

considered on an absolute basis, the U.S. topped the charts in 2007. However, 


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4Source: December 2007 Lux Research report ‘‘International Activity Drives Nanotechnology 

Forward.’’ 5Source: Science Citation Index as of December 10, 2007; search terms (country), (year), and 

(quantum dot OR nanostruc* OR nanopartic* OR nanotub* OR fulleren* OR nanomaterial* OR 

nanofib* OR nanotech* OR nanocryst* OR nanocomposit* OR nanohorn* OR nanowir* OR 

nanobel* OR nanopor* OR dendrimer* OR nanolith* OR nanoimp* OR nano-imp* OR dip-pen). 

when the same figures are considered on a per capita basis at purchasing power 

parity, the U.S. takes eighth place, with funding half that of Taiwan, and behind Germany, Sweden, and France (see Figure 6).4

• Other countries are catching up. Since we began performing our international 

competitiveness rankings in 2005, the position of the U.S. has remained static 

while other countries have vaulted upwards in their nanotechnology activity 

(see Figure 7). For example, nanotech funding is growing in the EU at twice 

the rate in the United States, putting the EU on track to claim the mantle of 

nanotechnology leadership due to a renewed focus on nanoscale science and engineering in the 7th Framework Programme for research. Russia recently funded a state nanotechnology corporation with $5 billion of public financing. And 

scientists in China published nearly as many scientific journal articles on 

nanoscale science and engineering in 2007 as those in the U.S. did, at 7,282 to 

7,528 (see Figure 8). While the quality of these publications has been suspect 

in the past, the citation rate of nanotech journal articles from China—a measure of their quality—has doubled in the last decade.5


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A Commercially-Dominated Landscape Requires Change to Unlock the 

NNI’s Value 

Clearly, the NNI should be reauthorized. But in the context of growing nanotech 

commercialization and increased international competitiveness, the onus is on Congress to eliminate roadblocks to market introduction for nanotechnology applications. Most of these changes are not specific to nanotech, although a few key ones 

are. 

Nanotech’s Pervasiveness Means that Most Required Changes are General 

Many of the changes that will help transition NNI-funded research to market 

have nothing to do with nanotechnology specifically, but address broader issues in 

technology commercialization. Given nanotechnology’s diversity, and the breadth of 

product categories that it touches, this is to be expected: As goes technology in general, so goes nanotech. These changes include: 


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• Attracting U.S. students to science and engineering, and retaining foreign ones. 

Funding for nanotechnology R&D will amount to nothing without a steady 

stream of trained scientists and engineers entering the work force. The U.S. 

should strengthen programs designed to inspire students with wonder for the 

physical sciences in K–12 and undergraduate education to nurture homegrown 

talent. But it should also reconsider the effect of visa tightening on the inflow 

of foreign science and technology graduate students, and expands H1-B visa 

programs to allow students that have earned advanced degrees in science and 

engineering in the U.S. to remain here—rather than repatriating taking with 

them the skills they acquired in the U.S. The lesson of A123Systems is instructive: Had Yet Ming-Chiang returned to his native country, its 1,000 employees 

would likely be in Taiwan. 

• Reducing the cost of doing business for start-ups seeking public markets. Startup companies looking to make initial public offerings (IPOs) on the public markets face immense administrative costs to comply with regulations such as Sarbanes-Oxley. Easing these burdens will unshackle them. It’s important to note 

that of the 14 nanotech start-ups that have gone public, most have done so on 

foreign exchanges where the cost of doing business is lower. 

• Introducing financial mechanisms to encourage collaboration between small and 

large firms. Nanotechnology commercialization has followed a pattern similar to 

biotech, in which small, innovative companies develop breakthrough technologies that incumbent corporations bring to market: Silver nanoparticle antimicrobial company Nucryst Pharmaceuticals relied on wound care dressing 

maker Smith & Nephew to get to market, while A123Systems found its partner 

in Black & Decker. Congress can grease the wheels of nanotechnology commercialization by creating financial mechanisms that help small firms to collaborate 

effectively with large ones. One example of such a measure would be enabling 

small companies to transfer their net operating losses to their corporate partners—allowing those partners to reap the tax benefits of research investments, 

which the loss-making smaller companies can’t claim. 

A Few Nanotech-Specific Changes Are Necessary 

In addition to these general reforms, a smaller number of changes specific to 

nanotech are also required. There are two specific actions we think Congress should 

take now: 

• Shift some of NNI’s focus to application development and manufacturing scaleup. A reauthorized NNI should focus on not just on basic research, but also on 

precompetitive R&D into nanomaterials application development and manufacturing scale-up. Currently the technical challenges that are limiting nanotech 

commercialization are not as much in synthesizing nanomaterials or understanding their fundamental properties as in learning how to integrate them into 

products and manufacturing them economically in large volumes. The Department of Energy’s Nanomanufacturing initiative, run out of its Industrial Technology Program, is a model case study—it aims to introduce shared Nanomanufacturing centers as pilot facilities on the model of the NNI’s existing user centers for nanoscale analytical equipment. 

• Take a completely different approach to environmental, health, and safety (EHS) 

issues. In our work with companies looking to take advantage of nanotech innovation, the single concern that comes up more than any other is potential EHS 

risks of nanomaterials. While it’s of course incumbent on companies developing 

nano-enabled products to test their own products to ensure safety, there’s an 

important role for government to play in resolving these concerns—by funding 

basic research on nanomaterials EHS risk that no individual firm can afford, 

and by establishing clear regulatory guidelines for companies working with 

nanomaterials. 

On the first point, the NNI should be generously funding basic research on the 

EHS risks of nanomaterials—just as NNI-funded research on nanoscience has 

supported deployment of real-world nanotech applications, the results of NNIfunded EHS work would help companies complete their own EHS evaluations. 

Unfortunately, funding levels remain too low to have the desired impact, and, 

even more critically, the NNI has never effectively addressed EHS issues surrounding nanotech with a comprehensive, interagency plan for required EHS research. The Nanotechnology Environmental and Health Implications (NEHI) 

Working Group report on EHS issues has not filled this gap—it fails to 

prioritize specific materials and applications for research, avoiding the tradeoffs 

that are inherent in any meaningful strategy—and the EPA’s internal review 

of its own nanomaterials EHS activities, by definition, does not cross agencies. 

47 

This lack of coordination is hampering development, and must change. The best 

way to move forward on this front would be to execute the nanomaterials EHS 

strategy by the National Academies’ Board on Environmental Studies and Toxicology—Congress has already appropriated funds for this study, but the work 

has not yet been started. 

Second, ambiguity surrounding how nanomaterials will be regulated must be 

dispelled. It’s still often not clear how current regulations apply to nanoparticles 

or whether and when agencies will issue new ones—leaving firms that work 

with nanomaterials confused about how to plan for regulatory rulings. The companies we speak with are actually eager for appropriate regulatory guidance 

about nanomaterials, to ensure a level playing field and to help them guarantee 

the safety of workers, consumers, and the environment. While companies are 

generally pleased about how the EPA, for example, has communicated with 

them so far, they’re also frustrated by how slow those agencies have been to 

set specific guidance, as witnessed by the glacial pace of the EPA’s voluntary 

Nanoscale Materials Stewardship Program. Seven years after the NNI’s launch, 

it’s still unclear to most commercial entities when and how the materials they 

work with will be treated under the EPA’s Toxic Substances Control Act—forming a real commercialization gating factor. 

At Lux Research, we applaud the efforts that have taken place so far under the 

National Nanotechnology Initiative, which have made the U.S. a world leader in 

nanotechnology and are bringing real economic benefits to our Nation. We’re confident that a renewed NNI, with adjustments like those outlined above, will increase 

these benefits—and enable nanotechnology to help address the challenges the country faces in combating disease, moving toward energy independence, and sustaining 

economic growth. 

Senator KERRY. Thank you very much, Mr. Nordan. Very helpful. 

Mr. Rejeski? 

STATEMENT OF DAVID REJESKI, DIRECTOR, PROJECT ON 

EMERGING NANOTECHNOLOGIES, WOODROW WILSON 

INTERNATIONAL CENTER FOR SCHOLARS 

Mr. REJESKI. Chairman Kerry, I’d like to thank you for the invitation to talk directly to you and also to the Committee. 

I appeared before this Committee about 2 years ago and today 

what I would like to do is address what’s changed since that time 

I appeared here, what hasn’t and what I believe must if nanotechnology commercialization is going to be successful in the future. 

Let me begin by providing an update on the state of commercialization of nano-based products. Two years ago, we had 230 

manufacturer-identified nano-enabled consumer products in our inventory. The number is now exceeding 600. It’s doubled in the last 

14 months with products from essentially 320 companies and 20 

countries. 

The main nano-engineered material in these products is now silver which is used in over a 140 products, such as this nano-silver 

toothpaste, which is from Korea and we bought in Gaithersburg. I 

would not use this because I don’t really know what the risks are 

and I’ll guarantee you nobody in our Government knows. 

The other thing that’s happened is the—— 

Senator KERRY. What kind of toothpaste? 

Mr. REJESKI. —nano-silver. 

Senator KERRY. What is nano-silver? 

Mr. REJESKI. Essentially the toothpaste has been—there’s nanosilver in this and it’s nanoscale that’s introduced as an antimicrobial. So it’s designed to have significant antimicrobial powers 

once it’s put in your mouth. It obviously raises issues about what 

48 

does it do when you swallow it. If I have periodontal disease, you 

know, is it going to into the bloodstream, et. cetera? 

Senator KERRY. Does it say on the tube what it is? 

Mr. REJESKI. Well, it’s in Korean. 

Senator KERRY. It’s in Korean? 

Mr. REJESKI. Yes. That presents a problem. 

Senator KERRY. You bought it where? 

Mr. REJESKI. Gaithersburg. And, you know, we’ve got—right 

now, there are nine toothpastes that contain nano-engineered materials in the U.S. marketplace. 

Senator KERRY. What are they, just out of interest? Do you 

know? 

Mr. REJESKI. It’s largely antimicrobial silvers and also whitening 

calcium peroxide, but again, you know, the issue is obviously who’s 

tested this, you know, what are some of the risks. It’s out there. 

Consumers can buy it. 

Senator KERRY. Well, that applies to about 75,000 chemicals that 

are in the marketplace. 

Mr. REJESKI. Right. Yes. We’re just adding nano to the long list 

of other chemicals that we know very little about. 

Senator KERRY. Would that fall under TOSCA? 

Mr. REJESKI. This probably would fall partially under FDA regulation, though the actual chemical inputs would fall under TOSCA. 

Senator KERRY. It’s an interesting question as to where that liability lies, but we’ll look at that. Go ahead. 

Mr. REJESKI. Let me just continue with some other observations. 

I’d say that the area where the largest market penetration is are 

also areas where we have the weakest—— 

Senator KERRY. Your smile is radiating, I want you to know. 

Mr. REJESKI. Well, we can pass this around. 

Senator KERRY. Geiger counter. 

Mr. REJESKI. So a lot of the products are penetrating in areas 

where we really don’t have significant oversight, such as the Consumer Product Safety Commission, which spent about $20,000 last 

year doing a literature research on nanotech. That’s out of our $1.5 

billion NNI. 

I think the other thing I want to talk about is the fact that the 

American consumer learned a painful lesson last year and that’s 

that the oversight system in this country is failing. The public’s 

had to deal with lead in toys that was banned 30 years ago, rat 

poison in pet food, antifreeze additives in toothpaste, E.coli in 

meat. These are not novel toxins. So consumers are nervous, our 

surveys show it, and so are other people that are going to be, I 

think, critical to nanotech commercialization. 

The financial community is taking another look at nanotech. A 

number of insurance companies have now placed nanotechnology in 

their top category of emerging risks. I talked last month to people 

at Lloyd’s of London and they basically said there are two things 

that are critical to reducing risks with nanotech: transparency and 

oversight and regulation. We have none of those. 

State and local governments are moving to provide their own 

guidance to nanotech firms. We’ve seen that in Berkeley, California. We’re going to see it shortly in Cambridge, Massachusetts, 

and the State of Wisconsin is doing some work. 

49 

I think NGO positions are hardening. A recent report by Friends 

of The Earth called for a total moratorium on the use of nano in 

all foods and food packaging. I think if there was ever a honeymoon 

with the NGO’s, it is over, and I think that’s something that the 

Government has squandered over the past 2 years. 

Finally, the actual firms, especially small firms, are nervous because they lack clear guidance from the Government. One senior 

safety manager at a Massachusetts corporation told us, ‘‘At this 

time, we don’t understand what regulatory requirements may be 

uniquely applicable to nanotech.’’ 

These problems do not bode well for nanotech commercialization. 

So let me talk a little bit about what hasn’t changed and I think 

what needs to be done as the Congress turns their attention to the 

reauthorization of what I hope they will call the 21st Century 

Nanotechnology R&D and Commercialization Act because that’s 

what it’s all about now. 

The three areas are critical. The first, the GAO mentioned, is 

transparency. The reauthorization bill must make the NNI fully 

transparent and accountable in terms of investments to address the 

risks. Public confidence in nanotech can’t be built on hidden agendas or exaggerated numbers and we believe a separate external advisory board needs to be essentially established to provide guidance 

and oversight for the NNI. 

Strategy. We need a comprehensive strategy, Congress has been 

waiting few years for this, that addresses existing and emerging 

risks, sets governmentwide priorities, ties funding levels to priorities and ensures that the right that the right risks are being addressed by the right agencies at the right time in the R&D commercialization cycle. 

The strategy also needs a minimum funding level for nano-related EHS research, order of magnitude increases for EHS funding 

at our key regulatory agencies. That includes EPA, FDA, USDA, 

and the Consumer Product Safety Commission. 

We need to provide public-private partnerships and we need 

funding and a strategy for clean and green nanotech. 

The final area is engagement. Public awareness of nanotech is 

stuck at a low level. We haven’t moved the awareness meter or 

nanometer in the past few years compared to basically where we 

started. 

The Federal Government has no strategy to engage the public at 

a wider level and fill the knowledge gaps about nanotech and I 

think that’s going to have serious implications essentially for longterm success. This needs to be remedied—— 

Senator KERRY. What do you think is the most responsible entity 

for that? 

Mr. REJESKI. I think it’s government-wide, but I think the coordination again has to come from the top level. I think the Government needs to think about potentially bringing in an external entity that really knows how to do this. 

Let me conclude with sort of one following recommendation. I 

think the greatest challenge we’re facing is basically how do we develop effective governance systems for 21 Century technology, one 

that’s going to work with nanotech and all the technologies beyond, 

such as things like synthetic biology? 

50 

1 Nanotechnology Consumer Product Inventory, Washington, D.C.: Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, 2005. Available at http:// 

www.nanotechproject.org/consumerproducts, accessed April 16, 2008. 

So I think it’s time to actually do a high-level commission, something that could be set up by the National Academies of Science 

and Public Administration, to establish them and actually have 

them undertake this larger task so that we aren’t sitting here in 

another 3 years having the same discussion with the next technology, and I think there’s simply too much at stake here. 

I’d like to thank the Committee for giving me an opportunity to 

address you. 

[The prepared statement of Mr. Rejeski follows:] 

PREPARED STATEMENT OF DAVID REJESKI, DIRECTOR, PROJECT ON EMERGING

NANOTECHNOLOGIES, WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS

I would like to thank Chairman Kerry, Ranking Member Ensign, and the Members of the Senate Committee on Commerce, Science, and Transportation’s Subcommittee on Science, Technology, and Innovation for holding this hearing on the 

‘‘National Nanotechnology Initiative: Charting the Course for Reauthorization.’’ 

My name is David Rejeski, and I direct the Project on Emerging Nanotechnologies 

(PEN), an initiative of the Woodrow Wilson International Center for Scholars and 

The Pew Charitable Trusts. It is dedicated to helping business, government, and the 

public anticipate and manage the possible health and environmental implications of 

nanotechnology. As part of the Wilson Center, the Project is a non-partisan, independent policy research organization that works with researchers, government, industry, non-governmental organizations (NGO’s), and others to find the best possible solutions to developing responsible, beneficial, and acceptable nanotechnologies. The opinions expressed in this testimony are my own and do not necessarily reflect views of the Wilson Center or The Pew Charitable Trusts. 

Our goal is to take a long-term look at nanotechnologies, to identify gaps in nanotechnology information, data, and oversight processes and to develop practical strategies and approaches for closing those gaps and ensuring that the extraordinary potential benefits of nanotechnologies will be realized. We aim to provide independent, 

objective information and analysis, which can help inform critical decisions affecting 

the development, use, and commercialization of nanotechnologies across the globe. 

All research results, reports, and the outcomes of our meetings and programs are 

made widely available through publications and our website: http://www.nanotech 

project.org. 

In short, both the Wilson Center and The Pew Charitable Trusts believe there is 

tremendous opportunity with nanotechnology to ‘‘get it right.’’ Societies have missed 

this chance with other new technologies and, by doing so, forfeited significant social, 

economic, and environmental benefits. 

When I last appeared before the Senate Commerce Committee in May 2006, I illustrated the rapid commercialization of nanotechnology by providing analysis from 

the Project’s then newly released inventory of nanotechnology consumer products. 

I also identified a number of key challenges and factors hindering nanotechnology 

commercialization, including lack of public engagement, lack of effective oversight 

and governance mechanisms, and lack of coordinated risk research strategies. 

Today, I would like to address what has changed since that time, what has not, and 

what must change if nanotechnology commercialization is to be successful in the future. 

What Has Changed 

I would like to begin by providing an update on the state of commercialization 

of nano-based consumer products and then share some observations. These products 

are important because consumer products will be most of the public’s first experience with nanotechnology. 

• The number of nano-enabled consumer products has increased rapidly. Two 

years ago, we had 212 manufacturer-identified, nano-enabled consumer products in our Consumer Products Inventory. The number now exceeds 600, a number that has doubled within the last 14 months alone.1 Since our inventory includes only manufacturer-identified nanotechnology products, there likely are 

hundreds of more products on the market that are not identified as such. This 

51 

2 ‘‘Over the past 2 years, scale up of multi-wall carbon nanotube production has led to a dramatic price decrease down to $150/kg for semi-industrial applications. According to [NanoSEE 

2008: Nanomaterials Industrial Status and Expected Evolution], the run for industrial CNT production plants has started in order to achieve a sustainable business with the commercialization 

of these high-tech materials with a mid-term price target of $45/kg.’’ ‘‘Nanotechnology Industry 

is Moving from Research to Production with over 500 Consumer Nano-Products Already Available,’’ NanoVIP.com. Available at http://www.nanovip.com/node/6020, accessed April 17, 2008. 3Testifying before a Senate Subcommittee in 2007, CPSC Commissioner Thomas H. Moore, 

who has served at the agency since 1995, summed up the situation: ‘‘I do not pretend to understand nanotechnology and our agency does not pretend to have a grasp on this complicated subject either. For Fiscal Year 2007, we were only able to devote $20,000 in funds to do a literature 

review on nanotechnology.’’ Available at: http://www.cpsc.gov/pr/moore2007.pdf, accessed April 

17, 2008. 4Taylor, Michael. Regulating the Products of Nanotechnology: Does FDA Have the Tools It 

Needs?, Washington, DC: Project on Emerging Nanotechnologies, Woodrow Wilson International 

Center for Scholars, 2007. Available at http://www.nanotechproject.org/fileldownload/files/ 

PEN5lFDA.pdf, accessed April 18, 2008. 

number also does not take into account the hundreds of commercial and industrial current uses of nanotechnology and nanomaterials. 

• Production and distribution of nanotechnology products is increasingly global. 

The products in our inventory come from 321 companies in 20 countries. All of 

these products are available in shopping malls or over the Internet, and we 

have purchased many of them on-line. Thanks to business-to-business (B2B) 

and business-to-consumer (B2C) e-commerce, nanotechnology products easily 

flow across international borders, raising control, trade, and oversight issues. 

• Silver has become the most commonly used nano-engineered material in consumer products. The type of nano-engineered substances in these products has 

shifted dramatically from materials like carbon to silver, which is now used in 

over 140 products, primarily as an antimicrobial. However, with production 

costs of carbon nanotubes dropping rapidly, this mix could shift again.2

• The number of children’s products is on the rise. Within the past year, an increasing number of products on sale are targeted at children, including: pacifiers, toothbrushes, baby bottle brushes, and stuffed animals. These products 

originate from the U.S., Australia, China, Germany, and Korea. This remains 

a category to watch as nanotechnology’s commercialization proceeds, especially 

since young children and babies generally have a greater vulnerability to chemicals and other toxins. 

• Products are penetrating the market in areas where oversight regimes are weak. 

For instance, as shown in Figure 1, about a half of the products in our inventory would fall under the purview of the Consumer Products Safety Commission 

(CPSC), an agency which, last year, according to CPSC Commissioner Thomas 

Moore, spent only a total of $20,000 to do a literature review on nanotechnology.3 Other areas of high growth where oversight is weak include cosmetics and 

dietary supplements, both areas where the Food and Drug Administration 

(FDA) has very limited regulatory authority.4

52 

5 ‘‘FDA Links More Deaths to Blood Thinner,’’ Associated Press, April 8, 2008. Available at: 

http://ap.google.com/article/ALeqM5iT7Y6m5N3h8XK-CDe9bU7wuYNCcQD8VTUN6O0, 

accessed April 18, 2008. 

Figure 1. Growth in the number of manufacturer-identified, nanotechnology-enabled products 

on the market from 2005 to 2007 (in red) showing products under possible CPSC jurisdiction 

(in blue). 

This suite of already-commercialized products tells us something about the emerging face of the nanotechnology industry and the challenges we face as we begin to 

introduce nanotechnology into the marketplace. These changes are signs that a set 

of issues related to consumer safety and health are emerging that were not as apparent when our inventory was first released. In addition, the current state of oversight regimes should raise serious concerns for policymakers tasked with the challenge of spurring nanotechnology innovation in a responsible and sustainable manner. It is important to keep in mind that the willingness of the public to ‘‘buy nano’’ 

will be affected by changes that impact the overall climate in the commercial marketplace and influence consumer trust and confidence. Let me explore some of these 

changes. 

Over the past year, American consumers have painfully learned that the Federal 

oversight system is failing. The public has had to deal with lead in toys (a use that 

was banned 30 years ago by the CPSC), rat poison in pet food, antifreeze in toothpaste, and E. coli in meat. Most recently, over 100 deaths were tied directly to a 

compromised blood thinner.5

These were equal opportunity failures involving multiple government agencies: 

the FDA, U.S. Department of Agriculture (USDA), and CPSC. In most cases, the 

agencies were not dealing with exotic toxins but ones with long histories of pernicious effects. One logical question consumers will have is: ‘‘If the government can’t 

protect my children from lead, how will they deal with nanotechnology?’’ 

Not surprisingly, our latest polls on public awareness of nanotechnology show declining trust in the government’s ability to manage risks with emerging technologies. National surveys conducted on behalf of the Project by Peter D. Hart Research Associates in August 2006 and August 2007 indicate declining levels of confidence in the USDA and FDA, as well as businesses and companies, to maximize 

the benefits and minimize the risks of scientific and technological advancements 

(Figure 2). Considering the events of the past year, it would not be surprising to 

see an even greater drop in the levels of confidence in government regulatory agencies when we repeat our national survey this summer. 

Public trust is the ‘‘dark horse’’ in nanotechnology’s future. If government and industry do not work to build public confidence in nanotechnology, consumers may 

reach for the ‘‘No-Nano’’ label in the future. Public perceptions can have large ecoVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00056 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE

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6 Estimate according to Biotechnology Industry Organization. Available at: http:// 

www.bio.org/foodag/background/eumoratorium.asp, accessed April 18, 2008. 7 Additional claims can be found on product website. Available at http://www.fulvic.org/ 

html/nanolbio-sim.html, accessed April 22, 2008. 

nomic impacts. The European Union’s (EU) de facto moratorium on the approval of 

new genetically modified food products, driven largely by public concerns, is costing 

American farmers an estimated $300 million per year in lost sales.6

Figure 2. Percentage of respondents with ‘‘Great deal/fair amount of confidence’’ in each to 

maximize benefits and minimize risks of scientific/technological advancements. Results are from 

surveys conducted in August 2006 and August 2007. Each survey had 1,014 respondents and 

margin of error of ±3.1 percentage points. 

Consumer confidence will be further undermined if companies continue to make 

claims about nanotechnology in their products that cannot be supported. Last 

month, the Environmental Protection Agency (EPA) fined a California company 

$208,000 for making unsubstantiated claims involving the anti-bacterial benefits of 

a nano-silver coating for computer mice and keyboards. Since that time, the claim 

about the use of nanomaterials has been removed from the manufacturer’s website, 

though the product appears to have remained unchanged. This phenomenon is one 

that has been seen with other products, including food storage containers and 

stuffed animals. 

In addition to disappearing product labels, the nanotechnology commercial landscape is awash with hyperbolic product claims so obtuse that no consumer could 

possibly unravel their meaning. Companies are creating a literal nanotechnology 

‘‘Tower of Babel.’’ Here are a few examples from our Consumer Products Inventory: 

NanO Bio-Sim 

‘‘This product is essential for one’s optimum health. The elimination of Candida, 

parasites, worms, yeast, fungi, and amoebas from the body is the fundamental base 

of any cure that will return health to the body . . . Once Bio-Sim is absorbed by 

the body, the sugar and the vinegar begin attracting the parasites, fungi, Candida, 

worms, and amoebas from their hiding places. Then, the NanO silica act as cutting 

knives on the intruders. Fortunately, this action only affects the pathogens and 

leaves the healthy body intact because of the perfect sizing of the diatomaceous 

earth.’’ 7


424REJES2.eps 424REJES3.eps
54 

8This and other claims are available in the Project’s Consumer Products Inventory. Available 

at http://www.nanotechproject.org/consumerproducts, accessed April 16, 2008. 9 Ibid. 

10Lloyd’s Emerging Risks Team. Nanotechnology: Recent Developments, Risks and Opportunities, 2007. Available at http://www.lloyds.com/Lloyds Market/Tools and reference/Exposure 

Management/Emerging risks.htm, accessed April 17, 2008. 11Zurich’s view was covered in the following article: ‘‘Nanotechnology, climate change, infrastructure among top risks,’’ Canadian Underwriter, November 22, 2007. Available at http:// 

www.canadianunderwriter.ca/issues/ISArticle.asp?id=76768&issue=11222007, accessed April 

17, 2008. 

Eczemel Nano-Cream 

‘‘Due to their specific composition, nanoparticles have a very high affinity to the 

horny layer of the skin and are used as transport systems which help the different 

active agents to penetrate the skin more readily. The capsules of nanoparticles consist of monolayers of phosphatidylcholine, a naturally occurring substance that nature uses for the basic structure of the membranes of each cell. Nanoparticles contain within their nucleus the active substances, which are gradually released in the 

skin.’’ 8

MesoPlatinum 

‘‘Promotes increased mental focus and concentration. Promotes enhanced mental 

acuity. Supports healthy tissue regeneration of the heart tissue, thymus and the entire endocrine system. Promotes increased creativity. Promotes very vivid dreams. 

Promotes improved memory. Supports DNA repair. Promotes increased libido in 

both males and females.’’ 9

Discussions about nanotechnology should not be just about the risks, but also 

about benefits. Most nano-enabled products carry a price premium over their nonnano counterparts. What, exactly, are consumers getting for their money, and who 

can help sort this out? 

The developments I have outlined do not bode well for nanotechnology commercialization. American consumers are nervous—so are other people who matter to the 

long-term success of nanotechnology, including insurers and investors, state and 

local governments, NGO’s, other countries, and nanotechnology companies. Let me 

summarize some of these concerns. 

Insurers and Investors: The financial community is taking another look at nanotechnology. The Lloyd’s of London Emerging Risks Team just issued a report on 

nanotechnology that noted that ‘‘due to the potential impact to the insurance industry if something were to go wrong, nanotechnology features very highly in Lloyd’s 

top emerging risks.’’ 10 When I talked recently to staff at Lloyd’s, they said that two 

things are critical to the insurance sector in terms of reducing risks: transparency 

and regulation. We have neither at the moment and the Federal Government is 

doing little to remedy this problem. Similar to Lloyd’s, Zurich Insurance’s Canadian 

office ranked nanotechnology in the top tier of emerging global risks (along with climate change and deteriorating infrastructure).11 A recent UK exercise involving 35 


424REJES4.eps 424REJES5.eps
55 

12 ‘‘Scanning the risk horizon for emerging threats,’’ Lloyd’s. com, 8 April 2008. Available at 

http://www.lloyds.com/NewslCentre/FeatureslfromlLloyds/Scanninglthelrisklhorizonl 

forlemerginglthreats0904 08.htm, accessed April 17, 2008. 13Lewis, Esq., Sanford, Richard Liroff, Ph.D., Margaret Byrne, M.S., Mary S. Booth, Ph.D., 

and Bill Baue. ‘‘Toxic Stock Syndrome: How Corporate Financial Reports Fail to Apprise Investors of the Risks of Product Recalls and Toxic Liabilities,’’ IEHN, April 2008. Available at: 

http://www.iehn.org/publications.reports.toxicstock.php, accessed April 18, 2008. 14Lipson, Sam 2004. ‘‘The Cambridge Model of Biotech Oversight,’’ at: http:// 

www.genewatch.org/genewatch/articles/16–5lipson.html 15The group recently issued its first workshop report with a second now being planned. The 

report is available at: http://www.mass.gov/dep/toxics/sourcest.htm#ec, accessed April 22, 

2008. 16Keiner, Suellen. ‘‘Room at the Bottom? Potential State and Local Strategies for Managing 

the Risks and Benefits of Nanotechnology.’’ Washington, DC: Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, 2007. Available at http:// 

www.nanotechproject.org/publications/archive/roomlatlbottom/. 17 ‘‘Nanotech Exposed in Grocery Store Aisles,’’ Friends of the Earth, March 11, 2008. Available at: http://www.foe.org/nanotech-exposed-grocery-store-aisles. 18 ‘‘SVTC Nanotech Report: Regulating Emerging Technologies in Silicon Valley and Beyond,’’ 

Silicon Valley Toxics Coalition. Available at: http://www.etoxics.org/site/PageServer?page 

name=svtclnanotech, accessed April 21, 2008. 

representatives from government, NGO’s, and academia also identified nanotechnology as the top risk to ecosystems (above climate change and the possible impact of 

novel pathogens).12

One reason insurers and investors are nervous is the fear that some companies 

are not being transparent. Last week, the Investor Environmental Health Network, 

in collaboration with investment managers, who have more than $41 billion in combined assets, released a report raising concerns that companies are not apprising 

investors of potential nanotechnology risks. The report notes that, ‘‘. . . companies 

dealing with nanomaterials . . . are not disclosing the evidence of health risks of 

nanotechnology products, nor the lack of adequate product testing prior to their 

sales.’’ 13

State and Local Governments: Tired of waiting for Federal action, municipal governments are moving to provide specific guidance to nanotechnology firms in places 

like Berkeley, CA, and, soon, in Cambridge, MA. Interestingly, when Cambridge 

passed the world’s first biotechnology ordinance in the mid-1970s, companies did not 

flee. The city provided a unique location where the rules of the road were known 

and the public was comfortable with established safety precautions. It is now home 

to 55 biotechnology firms.14 Last year, the state of Massachusetts established an 

Interagency Nanotech Council to discuss nanotechnology issues 15 and, most recently, a state lawmaker in Wisconsin has sought answers from state officials about 

potential reporting requirements for firms involved with nanotechnology. Also, a recent analysis by our Project indicates that five states with significant nanotechnology activities (CA, MA, NY, NJ, MI) could take a more proactive approach to nanotechnology oversight based on legal authorities that go beyond those of the Federal 

Government.16 This is not an optimal solution (since it could disaggregate markets), 

but history has shown that state action is often a prerequisite for Federal movement 

on emerging environmental and public health issues. As Justice Brandeis once 

noted, the states are the ‘‘laboratories of democracy,’’ and they often drive public 

policy innovation. 

NGO’s: During the last year, the positions taken by NGO’s have hardened. A recent report by Friends of the Earth called for a complete moratorium on the use 

of nanotechnology in all foods and food packaging until more is known about the 

risks to humans and the environment.17 In early April, the Silicon Valley Toxics Coalition called for ‘‘new comprehensive state and Federal regulatory policies that adequately address the potential hazards posed by nanotechnology.’’ 18 Increasingly, 

NGO’s are growing impatient with a lack of transparency by government and slow 

action on oversight. If there ever was a honeymoon with the NGO community, it 

is over. 

Other Countries: Countries are responding to this evolving commercialization climate differently, which generates its own set of issues. Internationally, the EU is 

clearly moving in the direction of a more precautionary approach to nanotechnology 

oversight raising the potential of a three-tiered governance system at a global 

level—reflecting diverging approaches by the EU, the U. S., and countries like 

China. Large disparities in nanotechnology oversight systems at a global level would 

be highly counterproductive and create an uneven playing field for U.S. companies 

who want to operate in the global marketplace. Variations in oversight also open 

the door to potentially dangerous products flowing across our borders, as we have 

seen in the case of substandard products from China. 

56 

19This report identified regulatory and compliance risk as its number one risk. Obviously, this 

has high relevance to any industry using nanotechnology. Source: Ernst & Young (in collaboration with Oxford Analytica). Strategic Business Risk 2008—The Top 10 Risks for Business, 2008. 20 John E. Lindberg and Margaret M. Quinn. A Survey of Environmental, Health and Safety 

Risk Management Information Needs and Practices among Nanotechnology Firms in the Massachusetts Region. Washington, DC: Project on Emerging Nanotechnologies, Woodrow Wilson 

International Center for Scholars, 2007. Available at http://www.nanotechproject.org/process/ 

assets/files/5921/file.pdf. 21We have compared the GAO findings with both the NNI numbers and our Project’s inventory and included that analysis in the Appendix to this testimony. 22Moynihan, D.P. 1998. Secrecy: The American Experience, New Haven, CT: Yale University 

Press. 

Firms: Increasingly, nanotechnology firms, especially small firms, are nervous because government has failed to provide a clear and predictable path to compliance. 

A new report by Ernst & Young on strategic business risks identified regulatory and 

compliance risk as the number one risk companies face today and will likely face 

in the future.19 Recently, our Project released the results of a New England focused 

survey, conducted by researchers at University of Massachusetts-Lowell, that investigated how nanotechnology firms (especially small- and medium-size firms) are 

dealing with environmental, health and safety (EHS) management and what information they need to address risks proactively.20 The survey produced two key findings. The first is that most nanotechnology firms recognize the existence of potential 

risks. The second, however, is that the firms (especially small firms) feel that they 

lack: (a) information on the health and environmental risks of nanomaterials and 

(b) the necessary guidance from suppliers, industry, governmental regulatory bodies, 

and others to manage risks associated with these materials and processes. As one 

senior safety manager in a Massachusetts corporation said, ‘‘At this time, we don’t 

understand what regulatory requirements may be uniquely applicable to nanotechnology and nanoparticles.’’ Compliance is hard if the compliance criteria are unknown. 

Interestingly, the one entity that thinks things are fine is our Federal Government—specifically, the National Nanotechnology Initiative (NNI)—which has provided continued public reassurances that risk research is more than sufficient and 

existing oversight systems adequate for nanotech. As Congress approaches the reauthorization of the 21st Century Nanotechnology Research and Development Act, 

they need to carefully weigh the evidence for and against the Federal Government’s 

position and the ultimate cost of a miscalculation. 

What Has Not Changed and What Needs to Change 

Let me now talk about what has not changed over the past 2 years and what 

needs to be remedied as the Congress turns its attention to the reauthorization of 

the 21st Century Nanotechnology Research and Development Act and looks beyond. 

Three issues must be addressed by the Act: transparency, strategy, and engagement. 

1. Transparency: The Reauthorization Bill must make the NNI fully transparent 

and accountable in terms of its investments and strategy to address the risks of 

nanotechnologies. 

During a three-year period, our Project has spent between $50,000 and $60,000 

in staff time analyzing and making public Federal Government expenditures that 

address nano-related risks to workers, consumers, and the environment. It has not 

been an easy task, but, more importantly, it should never have been necessary. The 

Federal Government’s data on risk research, including spending levels, detailed 

project descriptions, and all assumptions driving the analysis, should have been online and transparent from the very beginning of the NNI. 

Unfortunately, the recent study by the Government Accountability Office (GAO) 

has failed to remedy this problem since the detailed data that the GAO collected 

for their analysis is also not being made publicly available.21 The existing lack of 

transparency undermines public trust, undercuts our ability to build workable public-private partnerships, raises suspicions among NGO’s, and weakens the basis for 

international collaboration on risk research. It also makes any form of accountability to the Congress, for instance, virtually impossible. Finally, a strong risk 

strategy cannot be built on a weak quantitative foundation that cannot be validated 

by external stakeholders. Secrecy about the data underlying the government’s approach to risk compromises our national investments in nanotechnology. As the late 

Senator Patrick Moynihan was fond of saying: ‘‘Secrecy is for losers.’’ 22

Our analyses consistently show that the Federal Government is inflating investments in risk analysis and management by orders of magnitude and, by doing so, 

distorting the perceptual environment where nanotechnology investment and comVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00060 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
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23Project specific data underpinning this analysis can be found in the Project on Emerging 

Nanotechnologies Environment, Health and Safety Research Inventory. This inventory is in the 

process of being adopted and updated by the Organization for Economic Cooperation and Development, Working Party on Manufactured Nanomaterials. Available at: http://www.nano 

techproject.org/inventories/ehs/, accessed April 15, 2008. 24Further independent assessment of research funded in 2006 reveals funding for highly-relevant risk research was closer to $20 million. The discrepancy appears to be due to relevant 

research that that the NNI missed in their analysis—another indicator that the government is 

not on top of what research is being funded, and lacks sufficient transparency for effective accountability. Available at: http://www.nanotechproject.org/inventories/ehs/, accessed April 8, 

2008. 

mercialization takes place. These assurances of large investments in risk research 

(combined with statements of adequate oversight) provide a false sense of confidence 

and actually shift risks onto consumers, workers, investors, and, ultimately, onto insurers and re-insurers. 

The Act must require that a comprehensive, public, on-line EHS research database be created and also mandate annual updates. This should be done within 6 

months following the passage of the Act. Collaboration with international organizations, such as the OECD, should be supported to expand the collection and on-line 

publication of EHS research data internationally. Finally, the collection, analysis, 

and publication of other data key to understanding nanotechnology commercialization should be undertaken by the Department of Commerce, such as data on industry structure, venture capital investments, job creation, and domestic and international market growth. 

Increased transparency must be combined with increased oversight. The existing 

reviews of the NNI through the President’s Council of Advisors on Science and Technology (PCAST) are inadequate. PCAST is already stretched too thin and lacks the 

depth and breadth of knowledge necessary to review the critical EHS component of 

the NNI along with other areas crucial to the successful commercialization of nanotechnology. 

Given the size of our investments in the NNI and its implications for economic 

growth, a separate external advisory board (independent of PCAST) should be created that has broad representation from the nanotechnology community, including 

universities, NGO’s, investors, and a range of businesses, especially small businesses, which often lack a voice in our policy deliberations. Finally, the NNI should 

fully support the external review of the EH&S risk research strategy by the National Academies’ Board on Environmental Studies and Toxicology (BEST). This review has received broad support from a variety of stakeholders including the American Chemistry Council, Dupont, Evonik (formerly Degussa), the NanoBusiness Alliance, and the Environmental Defense Fund. Given the existing lack of transparency 

regarding the government’s risk related research, reviews by independent entities 

are critical to maintaining accountability. 

2. Strategy: After 4 years of waiting, the Congress has still not received a comprehensive, top-down strategy to address existing and emerging nanotechnology 

risks. 

Though the NNI strategy for addressing risks has improved, it still lacks a clear 

set of government-wide priorities tied directly to funding levels, which would ensure 

that the right agencies are focused on the right risks at the right time in the research and development and commercialization cycle. The recent GAO report 

praised the level of collaboration between agencies involved in the NNI, but collaboration between agencies is an insufficient condition for success. Like soccer, moving 

the ball down the field as a team does not necessarily result in a goal—for that you 

need strategy and leadership. In short, what the NNI currently calls a strategy is 

really a collection of what individual agencies ‘‘can’’ do and not what they ‘‘should’’ 

do. 

Any risk strategy also needs appropriate funding to work. I support a 10 percent 

floor for EHS funding because PEN’s extensive analyses indicate that funding for 

highly-relevant risk research has been exaggerated for at least the past 3 years, and 

this underinvestment needs to be corrected, especially as more nanotechnology products flow into the marketplace and raise questions about public safety and challenges for government regulators. A PEN analysis of current research projects listed 

in the NNI’s ‘‘Strategy for Nanotechnology-Related Environmental, Health, and 

Safety Research’’ found that only 62 of the 246 projects listed were highly relevant 

to addressing EHS risks of nanotechnology.23 These 62 projects accounted for an estimated $13 million in research and development funding for 2006—far lower than 

the $68 million cited by the NNI document as being focused on EHS research.24 In 

58 

25Press release and additional information on analysis is available at: http://www.nano 

techproject.org/news/archive/ehs-update/, accessed April 21, 2008. 26Full quote from testimony reads, ‘‘While we believe that 10 percent of the total funding for 

nanotechnology research and development is a reasonable estimate of the resources that will 

be required to execute the strategic plan, we also believe that actual resource levels should be 

driven by the strategic plan as they will vary significantly across agencies.’’ From testimony for 

hearing on ‘‘The National Nanotechnology Initiative Amendments Act of 2008,’’ April 16, 2008. 27FDA Science and Mission at Risk: Subcommittee on Science and Technology, November 

2007. Available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007–4329bl02l01l 

FDA%20Report%20on%20science%20and%20Technology.pdf, accessed April 21, 2008. 28See Dr. Andrew Maynard’s testimony for hearing on ‘‘The National Nanotechnology Initiative Amendments Act of 2008,’’ April 16, 2008. Available at: http://www.nanotechproject.org/ 

process/assets/files/6689/maynardlwrittenlapril08.pdf, accessed April 21, 2008. 

fact, our analysis now shows that the EU is spending almost twice the U.S. investment in highly-relevant EHS risk research.25

Research programs like the NNI do not automatically guarantee an optimal allocation of public money. Sometimes, key constituents or topics are left unfunded or 

under addressed. Recognizing this problem, the government has set minimal funding requirements. The Federal Government does this with small businesses in our 

set-asides for Small Business Innovation Research grants and with the Human Genome Project by dedicating 5 percent of all Project research spending to examine 

ethical, legal, and social implications that the policy community knew would accompany the development and application of genomics. The reauthorization proposal to 

set aside 10 percent of the total NNI budget for nanotechnology EHS research has 

received support from a wide range of stakeholders including the NanoBusiness Alliance, American Chemistry Council, and NGO’s, including the Environmental Defense Fund. As Sean Murdock, director of the NanoBusiness Alliance, said in his 

recent testimony before the House Science and Technology Committee, ‘‘. . . we believe that 10 percent of the total funding for nanotechnology research and development is a reasonable estimate of the resources that will be required to execute the 

strategic plan . . .’’ 26

The strategy must also increase, by orders of magnitude, the funding available for 

risk research at agencies with oversight missions such as the EPA, FDA, USDA, 

and CPSC. Our analysis has found that only $4.5 million for 36 projects at the EPA, 

$5.1 million for 45 projects at the National Institute for Occupational Safety and 

Health, and $56,501 for 9 projects at the USDA is dedicated to projects focusing on 

the risks of nanotechnology for FY2006. 

Government oversight based on weak science is not acceptable. In some of these 

agencies, there may also be a lack of human resources and the scientific expertise 

needed to assess nanotechnology risks. Consequently, the Federal risk research 

strategy must involve a human resources component, including an analysis of expertise gaps and plans on how they will be funded and filled. The recent assessment 

of the FDA’s scientific capacity by their own science board uncovered a number of 

limitations that are directly relevant to nanotechnology: 

• The development of medical products based on ‘‘new science’’ cannot be adequately regulated by the FDA. 

• There is insufficient capacity in modeling, risk assessment, and analysis. 

• The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.27

The strategy should support specific mechanisms to facilitate public-private partnerships focused on closing knowledge gaps in nanotechnology risk assessment and 

management and leveraging scarce funds across sectors. The NNI should evaluate 

a number of models for public-private partnerships using the following criteria: 

• Independence. The selection, direction, and evaluation of funded research would 

have to be science-based and fully independent of the business and views of 

partners in the organization. 

• Transparency. The research, reviews, and operations of the organization should 

be fully open to public scrutiny. 

• Review. Research supported by the organization should be independently and 

transparently reviewed. 

• Communication. Research results should be made publicly accessible and fully 

and effectively communicated to all relevant parties. 

• Relevance. Funded research should have broad relevance to managing the potential risks of nanotechnologies through regulation, product stewardship, and 

other mechanisms.28

59 

29 Jim Hutchison’s technique is able to create a gram of gold nanoparticles for $500, down from the $300,000 per gram cost for traditional methods. Schmidt, Karen. Green Nanotechnology: It’s Easier Than You Think, Washington, D.C.: Project on Emerging Nanotechnologies, 

Woodrow Wilson International Center for Scholars, 2007. Available at: http://www.nanotech 

project.org/publications/archive/greenlnanotechnologylitsleasierlthan/, accessed April 18, 

2008. 30 Rejeski, David. ‘‘How About An X-Prize for Green Nanotechnology?’’ Nanotechnology Now, 

2007. Available at: http://www.nanotech-now.com/columns/?article=134. 

Two models should be adapted, funded, and evaluated over the next 3 years. 

Finally, there is still not enough attention being paid to engineering the risks out 

of nanotechnology manufacturing and products. Recent research at the Massachusetts Institute of Technology (MIT) has shown that carbon nanotubes may contain 

high concentrations of toxic impurities like chromium and lead—if we continue 

down this path, the nanotechnology revolution risks being a dirty one, not a green 

one. We have the ability to enable ‘‘green’’ nanotechnology production and products—reducing toxic inputs, energy use, emissions, end-oflife impacts, and ultimately financial liabilities—but presently we lack a coherent strategy and the resources to do this. University of Oregon researcher Jim Hutchinson has been able 

to create gold nanomaterials through ‘‘green’’ synthesis that is not only safer and 

faster than traditional means but also much less expensive.29 The longer the government and industry delay investments in ‘‘greening’’ the nanotechnology production infrastructure, the more we may have to invest to manage risks after the fact. 

Based on PEN analysis, I recommend dedicating $20–30 million annually to establish at least one major university center on ‘‘green’’ nanotechnologies and a prestigious and highly-visible award to spur green nanotechnology innovation.30 The 

goal should be to make the U.S. the world’s leader in ‘‘green’’ nanotechnology. 

3. Engagement: Public awareness of nanotechnology is stuck at a low level. The 

same surveys mentioned earlier have actually shown a decrease in the number of 

Americans who have ‘‘heard a lot’’ about nanotechnology from August 2006 to August 2007. Despite an annual U.S. public and private sector investment of over $4 

billion in nanotechnology research and development, 80–90 percent of Americans 

have heard ‘‘very little’’ or ‘‘nothing’’ about nanotechnology. The original 21st Century Nanotechnology Research and Development Act specified that the government 

provide: 

‘‘. . . through the National Nanotechnology Coordination Office . . . for public 

input and outreach to be integrated into the Program by the convening of regular and ongoing public discussions, through mechanisms such as citizens’ panels, consensus conferences, and educational events, as appropriate; . . .’’ 

Unfortunately, this mandate came with no funding, and the National Nanotechnology Coordination Office has not fulfilled this mission. 

At this critical juncture, the Federal Government has no strategy to engage the 

public and fill the knowledge gap about nanotechnology, which could have serious 

implications for nanotechnology’s long-term success. Significant resources and ingenuity need to be committed to this area. An essential element missing from previous 

efforts has been genuine citizen engagement. We are still talking to the American 

public about nanotechnology through TV shows, websites, and museum exhibits— 

this is not public engagement. Some experiments on engagement have been run by 

various National Science Foundation-funded nanotechnology centers, but there is no 

effort being made to scale these up to reach significant numbers of people nationwide (we need to engage thousands, not dozens). 

As the commercialization of nano-based products accelerates, how the public 

learns about nanotechnology, from whom, and with what message will be critical to 

assuring public confidence in the applications and support for further government 

funding. We need large-scale education and citizen deliberation on how to balance 

the opportunities and risks presented by nanotechnology that engages the diverse 

perspectives of the American public, helps identify a collective public agenda, generates buy-in from stakeholders, and raises awareness about the issues. For nanotechnology to succeed, the strategy for public engagement will be as critical as the 

strategy for risk assessment and management and will require adequate funding 

and top-level attention. It cannot be approached piecemeal or as an afterthought. 

The NNI should bring in an outside entity with proven capabilities in running large 

multi-stakeholder dialogues on key national policy issues and provide adequate 

funding to run a one-year, national dialogue on nanotechnology. 

Conclusions 

Let me close by putting forth a greater challenge to the Committee and our government. For the commercial success of any emerging technology, we need a better 

60 

31 ‘‘Environmental, health and safety research needs for engineered nanoscale materials,’’ The 

National Nanotechnology Initiative, September 2006. Available at: http://www.nano.gov/ 

NNIlEHSlresearchlneeds.pdf, accessed April 22, 2008. 32 ‘‘Nanotechnology. Better guidance is needed to ensure accurate reporting of Federal research focused on environmental, health and safety risks,’’ U.S. Government Accountability Office, 2008. Acronyms—NIH: National Institutes of Health; NIOSH: National Institute for Occupational Safety and Health; NIST: National Institute of Standards and Technology. 

approach to governance that can support strategic risk research, provide adequate 

oversight, and engage the broader public in our technological future. With nanotechnology, industry and government are struggling to balance science, innovation, and 

the pressures for rapid commercialization with a need to address risks and public 

concerns early and proactively. This situation does not surprise people who were 

part of the debates around agricultural biotechnology in the 1990s or watched the 

tortuous path of nuclear power through the 1950s and 60s. The recurrence of issues 

around risk assessment, oversight, and public dialogue—irrespective of the technology involved—indicates that these challenges have deeper origins that will not 

respond to quick fixes. The government is not organized for the tasks at hand, and 

the challenges we face will only grow more complex as nanotechnology and biotechnology increasingly converge and new scientific fields, such as synthetic biology, 

emerge. 

We need to bring together the best minds in the Nation to develop a governance 

system for 21st century technologies, a system that will work with nanotechnology 

and the technologies beyond. A high-level commission (organized by the national 

academies of Science and Public Administration) should be established to undertake 

this task. 

Finally, let me say that I applaud the Committee for focusing our attention on 

issues affecting the successful commercialization of nanotechnology. Nanotechnology 

is no longer just a large government research project. Products are moving out of 

the lab into the market and onto store shelves. This is success, but it is not guaranteed forever. The next two to 3 years will be critical to ensuring that our investments pay off, and the structure and functions of the NNI will play an important 

role in making sure we can maximize the benefits of nanotechnology while minimizing the risks. 

APPENDIX

Comparison of Nanotechnology Risk-Research Funding for 2006 

Definitions of risk-relevant research used in funding assessments: 

NNI 

In the context of this comparison, the given NNI definition of EHS-relevant research is ‘‘research whose primary purpose is to understand and address potential 

risks to health and the environment posed by this technology.’’ 31

GAO 

From the GAO assessment of EHS-relevant research, it appears that the same 

definition of relevance was used as established by the NNI (see above). From the 

GAO report: 

‘‘To assess whether or not the primary purpose of the research conducted by 

these agencies addressed the EHS risks of nanotechnology, we reviewed qualitative data on all projects funded by EPA, NIH, NIOSH, NIST, and NSF in Fiscal Year 2006. To minimize bias and to ensure the consistency of our evaluation, the team independently conducted project reviews by using publicly available and agency documentation, such as project abstracts or grant applications, 

to make our determinations. For categorization of projects that appeared questionable to us, we discussed the categorization with agency officials and modified our determination as appropriate given the additional support provided by 

the agency.’’ 32

PEN 

PEN defines highly relevant research as: 

‘‘Research that is specifically and explicitly focused on the health, environmental and/or safety implications of nanotechnology. Also included in this category are projects and programs where the majority of the research undertaken 

is specifically and explicitly focused on the health, environmental and/or safety 

implications of nanotechnology. Examples of research in this category would inVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00064 Fmt 6633 Sfmt 6621 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
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33Maynard, Andrew. Testimony for U.S. House of Representatives Committee on Science and 

Technology Hearing on: The National Nanotechnology Initiative Amendments Act of 2008, April 

16 2008. Available at http://www.nanotechproject.org/process/assets/files/6689/maynardl writtenglapril08.pdf, accessed April 21, 2008. 34 Acronyms—DOD: Department of Defense; DOE: Department of Energy. 35 ‘‘Nanotechnology. Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health and Safety Risks,’’ U.S. Government Accountability 

Office, 2008. 36 Numbers in parentheses represent the number of projects where finding information is 

available. This assessment was carried out on projects listed in the document ‘‘Strategy for 

nanotechnology-related environmental, health and safety research,’’ The National Nanotechnology Initiative, 2008. Available at: http://www.nano.gov/NNI EHS Research Strategy.pdf, 

accessed April 22, 2008. 37 Number in parentheses represents estimated annual funding, accounting for missing budget 

data. 

clude research to understand the toxicity of specific nanomaterials, research 

into exposure monitoring and characterization to further understand potential 

impact, research into biological interactions and mechanisms that is focused on 

answering specific questions associated with potential risk. Examples of research that would not be included in this category would include exploratory research into biological mechanisms outside the context of understanding impact, 

general instrument development, and research into therapeutics applications 

which also incorporate an element of evaluating impact.’’ 33

Assessment of Projects Primarily Focused on Addressing Nanotechnology ESH Implications 

Number of Active Projects, 2006 

Agency 34 NNI-assessment of 

EHS-relevant projects 35

GAO-assessment of 

EHS-relevant projects 35

PEN-assessment of highly relevant 

EHS projects listed by the NNI 36

EPA 10 10 10 (10) 

NIH 18 18 11 (5) 

NIOSH 23 21 21 (21) 

NIST 2 2 4 (0) 

NSF 66 46 10 (10) 

DOD — — 7 (2) 

DOE — — 0 

USDA — — 2 (1) 

Total 119 97 65 

Assessment of Projects Primarily Focused on Addressing Nanotechnology ESH Implications 

Estimated Funding of Active Projects, 2006 

Agency NNI-assessment of 

EHS-relevant projects 35

GAO-assessment of 

EHS-relevant projects 35

PEN-assessment of highly relevant 

EHS projects listed by the NNI 

EPA 3.6 3.6 1.3A

NIH 5.6 5.6 0.8 B

NIOSH 4.3 4.2 4.9 

NIST 2.4 2.4 NA 

NSF 21.1 14.7 1.4 C

DOD — — 1.4 

DOE — — 0 

USDA — — 0.1 

Total $37 million $30.5 million $9.9 million ($13 million) 37

A EPA funding reported by NNI and GAO represents funding for a 3-year period. PEN figures are an estimate of annual funding for 2006. B The PEN assessment found many National Institutes of Health (NIH) research projects to have some relevance to addressing nanotechnology risks, but the majority of these projects were not primarily focused in 

risk-related research. CMany of the NSF projects were found to have a degree of relevance to nanotechnology risk, but few were 

specifically focused on addressing environment, health and safety issues. 

Senator KERRY. We’re delighted. Thank you. Very helpful. 

Dr. Ferguson? 

62 

STATEMENT OF P. LEE FERGUSON, PH.D., ASSISTANT 

PROFESSOR, DEPARTMENT OF CHEMISTRY AND 

BIOCHEMISTRY, UNIVERSITY OF SOUTH CAROLINA 

Dr. FERGUSON. Good afternoon. I wish to thank you, Senator 

Kerry and the other members of the Subcommittee, for inviting me 

to testify today. 

I’m Lee Ferguson, an Assistant Professor at the University of 

South Carolina. 

Since 2003, I have led a team of researchers investigating the 

fate and effects of nanomaterials in the environment. I feel strongly 

about the need to continue and to expand this research and I’m 

happy to talk with you today about it. 

My primary point is that development and commercialization of 

nanotechnology may present unforeseen hazards to environmental 

and human health. It is therefore essential that scientific research 

be continued to address this issue. 

Since the initial authorization of the National Nanotechnology 

Initiative, the Federal Government has supported scientific research into the environmental and health impacts of nanotechnology. There now exists a growing body of work addressing the risks 

associated with nanomaterials. However, it is clear that we have 

much to learn. 

The current state of the science with respect to environmental 

health and safety issues of nanotechnology can be summarized 

briefly. We have learned that nanomaterials are very difficult to 

measure accurately in environmental and biological systems. It has 

become clear that existing analytical methods are simply inappropriate or insufficient to make these measurements. 

We’ve also learned that nanomaterials may be transported in the 

environment in ways that are not necessarily predictable from existing scientific models and that nanomaterials may interact directly with pollutants of concern, such as PCBs and heavy metals. 

Finally, there are indications of risks associated with exposure of 

humans and ecosystems to nanomaterials. These risks include direct toxicity and uptake of nanomaterials into biological tissues. 

Through the NNI, the Federal Government has developed a 

strategy aimed at prioritizing research needs with respect to environmental health and safety issues of nanotechnology. This 

prioritization is essential so that an organized effort can be made 

to address environmental and health impacts of nanotechnology as 

this technology is developed. This last point is critical. We cannot 

afford to wait until nanotechnology is fully developed to begin assessing its risks and hazards to human health and the environment. 

I wish to highlight specific areas of research that I believe deserve particular attention. Without methods for detecting and characterizing nanomaterials in the environment and in human tissues, 

nanomaterial exposure assessment is impossible. 

Research into analytical methods and metrology of nanomaterials 

is a top priority and support for this work should be accelerated 

within the NNI. 

With respect to research on environmental and human health effects of nanomaterials, I stress the need to develop standardized 

testing methods that are appropriate to assessing toxicity and bioVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00066 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
63 

1For example, since 2003 the U.S. EPA National Center for Environmental Research has coordinated extramural funding efforts among EPA, NSF, DOE, NIOSH, and NIEHS to address 

environmental and health effects of nanomaterials (http://es.epa.gov/ncer/nano/index.html). 

logical uptake of nanomaterials and their manufacturing byproducts. 

There’s a critical need to assess the human and ecological exposure after release of nanomaterials into the ambient environment. 

We still have very limited knowledge of the treatability of nanotechnology waste as well as the routes by which nanomaterials 

may enter and move within our air and water. 

Finally, our ability to assess and predict risk of emerging nanotechnologies to human and environmental health depends on understanding the mechanisms by which nanomaterials act on biological systems. This understanding represents a grand scientific 

challenge and will require a will require a significant and well-supported effort. 

During reauthorization of the NNI, I ask you to consider the resources that are needed now and in the future for addressing these 

concerns. As you’ve heard, between 2005 and 2009, expenditures 

within the NNI on EHS research have increased from 3 percent to 

approximately 5 percent of the total NNI budget. 

A significant increase in our scientific understanding of the environmental and health impacts of nanotechnology will require a 

more substantial investment. A realistic target in the very near 

term should be to increase the level of funding for EHS research 

on nanotechnology to exceed 10 percent of the NNI budget. 

I wish to close by saying that we have a unique opportunity now. 

Through the NNI, we have begun to address the EHS risks of 

nanotechnology simultaneously with the development of this technology. We have only to look at the lessons learned from PCBs and 

other legacy chemical contaminants to realize the dangers of waiting until new technologies mature to assess their environmental 

and health risks. 

I urge this Committee to consider these concerns during the reauthorization of NNI. 

Thank you for considering my testimony. 

[The prepared statement of Dr. Ferguson follows:] 

PREPARED STATEMENT OF P. LEE FERGUSON, PH.D., ASSISTANT PROFESSOR, DEPARTMENT OF CHEMISTRY AND BIOCHEMISTRY, UNIVERSITY OF SOUTH CAROLINA

Oral Testimony 

Good afternoon. I wish to thank Senator Kerry and the other members of the Subcommittee for inviting me to testify today. I am Lee Ferguson, an assistant professor at the University of South Carolina. Since 2003, I have led a team of researchers investigating the fate and effects of nanomaterials in the environment. I 

feel strongly about the need to continue and expand this research, and I’m happy 

to talk with you about it. 

Primary point: Development and commercialization of nanotechnology may 

present unforeseen hazards to environmental and human health—it is essential that 

scientific research be continued to address this issue. 

Since the initial authorization of the National Nanotechnology Initiative in 2003, 

the Federal Government has supported scientific research into the environmental 

and health impacts of nanotechnology.1 There exists now a growing body of work 

addressing the risks associated with nanomaterials; however, it is clear that we still 

have much to learn. 

What we know: The current state of the science with respect to environmental, 

health, and safety issues of nanotechnology can be summarized briefly. 

64 

2The five primary research categories identified for priority research consideration are: (1) Instrumentation, Metrology, and Analytical Methods; (2) Nanomaterials and Human Health; (3) 

Nanomaterials and the Environment; (4) Human and Environmental Exposure Assessment; and 

(5) Risk Management Methods. These categories and the associated research strategies are outlined in three documents: National Science and Technology Council 2006, The National Nanotechnology Initiative: Environmental, Health, and Safety Research Needs for Engineered 

Nanoscale Materials, http://www.nano.gov/NNIlEHSlresearchlneeds.pdf; National Science 

and Technology Council 2007, Prioritization of Environmental, Health, and Safety Research 

Needs for Engineered Nanoscale Materials, http://www.nano.gov/PrioritizationlEHSl 

ResearchlNeedslEngineeredlNanoscalelMaterials.pdf; and National Science and Technology 

Council 2008, The National Nanotechnology Initiative: Strategy for Nanotechnology-Related Environmental, Health, and Safety Research, http://www.nano.gov/NNIlEHSlResearchl Strategy.pdf. 

• We have learned that nanomaterials are very difficult to measure accurately in 

environmental and biological systems. It has become clear that existing analytical methods are simply inappropriate or insufficient to make these measurements. 

• We also have learned that nanomaterials may be transported in the environment in ways that are not necessarily predictable from existing scientific models 

and that nanomaterials may interact directly with pollutants-of-concern such as 

PCBs and heavy metals. 

• Finally, there are indications of risks associated with exposure of humans and 

ecosystems to nanomaterials. These risks include direct toxicity and uptake of 

nanomaterials into biological tissues. 

Federal prioritization: Through the NNI, the Federal Government has developed 

a roadmap aimed at prioritizing research needs with respect to environmental, 

health, and safety issues of nanotechnology.2 This prioritization is essential so that 

an organized effort can be made to address environmental and health impacts of 

nanotechnology as this technology is developed. This last point is critical—we cannot afford to wait until nanotechnology is fully developed to begin assessing its risks 

and hazards to human health and the environment. 

Future research needs: I wish to highlight specific areas of research that I believe 

deserve particular attention: 

• Without methods for detecting and characterizing nanomaterials in the environment and in human tissues, nanomaterial exposure assessment is impossible. 

Research into analytical methods and metrology of nanomaterials is a top priority and support for this work should be accelerated within the NNI. 

• With respect to research on environmental and human health effects of nanomaterials, I stress the need to develop standardized testing methods that are 

appropriate to assessing toxicity and biological uptake of nanomaterials and 

their manufacturing byproducts. 

• There is a critical need to assess routes of human and ecological exposure after 

release of nanomaterials into the ambient environment. We still have very limited knowledge of the treatability of nanotechnology wastes as well as the 

routes by which nanomaterials may enter and move within our air and water. 

• Finally, our ability to assess and predict risk of emerging nanotechnologies to 

human and environmental health depends on understanding the mechanisms 

by which nanomaterials act on biological systems. This understanding represents a grand scientific challenge and will require significant and well-supported effort. 

During reauthorization of the NNI, I ask you to consider the resources that are 

needed now and in the future for addressing these concerns. Between 2005 and 

2009, expenditures within the NNI on EHS research have increased from 3 percent 

to approximately 5 percent of the total NNI budget. A significant increase in our 

scientific understanding of the environmental and health impacts of nanotechnology 

will require a more substantial investment. A realistic target in the very near term 

should be to increase the level of funding for EHS research on nanotechnology to 

exceed 10 percent of the NNI budget. 

I wish to close by saying that we have a unique opportunity now—through the 

NNI we have begun to address the EHS risks of nanotechnology simultaneously 

with the development of this technology. We have only to look at the lessons learned 

from PCBs and other legacy chemical contaminants to realize the dangers of waiting 

until new technologies are mature to assess their environmental and health risks. 

I urge this Committee to consider these concerns during the reauthorization of the 

NNI. Thank you for considering my testimony. 

65 

3 U.S. EPA STAR Program: Chemical and biological behavior of carbon nanotubes in estuarine 

sedimentary systems. Award # RD–83171601 P. Lee Ferguson, PI.; G. Thomas Chandler; and 

Walter A. Scrivens, University of South Carolina, Columbia, SC. 4For example, since 2003 the U.S. EPA National Center for Environmental Research has coordinated extramural funding efforts among EPA, NSF, DOE, NIOSH, and NIEHS to address 

environmental and health effects of nanomaterials (http://es.epa.gov/ncer/nano/index.html). 5Maynard AD, Baron PA, Foley M, Shvedova AA, Kisin ER, Castranova V. Exposure to carbon nanotube material: aerosol release during the handling of unrefined single-walled carbon 

nanotube material. J Toxicol Environ Health A 2004; 67: 87–107. 6 Nel A, Xia T, Madler L, Li N. Toxic potential of materials at the nanolevel. Science 2006; 

311: 622–627. 7 U.S. Environmental Protection Agency. 2007. Nanotechnology White Paper. Washington, 

D.C. EPA/100/B–07/001. p. 40–41. 8Ferguson PL, Chandler GT, Templeton RC, DeMarco A, Scrivens, WA, Englehart, B. Influence of sediment-amendment with single-walled carbon nanotubes and diesel soot on bioaccumulation of hydrophobic organic contaminants by benthic invertebrates. Environ. Sci. Technol. 

2008; in press. 9Lam CW, James JT, McCluskey R, Hunter RL. Pulmonary toxicity of single-wall carbon 

nanotubes in mice 7 and 90 days after intratracheal instillation. Toxicol Sci 2004; 77: 126–134. 

Written Statement 

I wish to thank Senator Kerry and the other members of the Subcommittee for 

inviting me to testify about the current status and future needs of research into the 

environmental, health, and safety issues of nanotechnology. I am Lee Ferguson, an 

assistant professor of chemistry and biochemistry at the University of South Carolina. Since 2003, I have led a team of researchers at USC, funded by the U.S. EPA 

Science to Achieve Results (STAR) program 3 and organized within the USC NanoCenter investigating the fate and health effects of nanomaterials in the environment. Our overall goal is to elucidate the potential for manufactured nanomaterials 

to be transported within the aquatic environment and the associated hazards of 

such transport to both aquatic and human life. I feel strongly about the need to continue and expand this research, and I’m happy to talk with you about it. 

Primary point: Development and commercialization of nanotechnology may 

present unforeseen hazards to environmental and human health—it is therefore essential that scientific research be conducted to address this issue. 

Since the initial authorization of the National Nanotechnology Initiative in 2003, 

the Federal Government has continuously supported intramural and extramural scientific research into the environmental and health impacts of nanotechnology.4 As 

a consequence, there exists now a growing body of work addressing the risks associated with nanomaterials; however, it is clear that we still have much to learn. 

What we know: The emergence of nanotechnology is an exciting opportunity that 

could result in significant contributions to the treatment of disease, development of 

more effective polymer composites, fuel cells and capacitors, and clean-up of polluted 

groundwater. Although the use of nanoparticles may allow for significant advances 

in science and technology, assessment of potential negative health and environmental impacts on humans, non-human biota, and ecosystems is imperative before 

their widespread production and use. The same properties that make these particles 

desirable, may also contribute to their toxic potential and extensive studies to address both the acute and chronic effects of nanoparticles are necessary to determine 

if negative health and environmental impacts outweigh the potential benefits. In 

humans, a concerning route of exposure is via direct inhalation, both in the workplace where these particles are manufactured and used, and from the innate environment contaminated with particles released from anthropogenic and natural 

sources.5,6 Other routes of exposure that are currently a concern include dermal and 

dietary. The current state of the science with respect to environmental, health, and 

safety issues of nanotechnology can be summarized briefly. 

• We have learned that nanomaterials are very difficult to measure accurately in 

environmental and biological systems—this greatly complicates assessment of 

occupational and environmental exposure as well as occurrence and fate of 

these materials in the environment. It has become clear that existing analytical 

methods (e.g., those designed for detecting and quantifying chemical contaminants) are simply inappropriate or insufficient to make these measurements.7

• We also have learned that nanomaterials may be transported in the environment in ways that are not necessarily predictable from existing models for more 

conventional contaminants, and that nanomaterials may interact directly with 

pollutants-of-concern such as PCBs and heavy metals, potentially leading to mobilization and enhanced toxicity.8

• Finally, there are clear indications of risks associated with exposure of humans 

and ecosystems to nanomaterials. These risks include direct toxicity and uptake 

66 

9Lam CW, James JT, McCluskey R, Hunter RL. Pulmonary toxicity of single-wall carbon 

nanotubes in mice 7 and 90 days after intratracheal instillation. Toxicol Sci 2004; 77: 126–134. 10Templeton RC, Ferguson, PL, Washburn, KM, Scrivens, WA, Chandler, GT. Life-cycle effects of single-walled carbon nanotubes (SWNTs) on an estuarine meiobenthic copepod. Environ. 

Sci. Technol. 2006; 40: 7387–7393. 11This strategy is outlined in three documents: National Science and Technology Council 

2006, The National Nanotechnology Initiative: Environmental, Health, and Safety Research 

Needs for Engineered Nanoscale Materials, http://www.nano.gov/NNIlEHSlresearchl 

needs.pdf; National Science and Technology Council 2007, Prioritization of Environmental, 

Health, and Safety Research Needs for Engineered Nanoscale Materials, http://www.nano.gov/ 

PrioritizationlEHSlResearchlNeedslEngineeredlNanoscalelMaterials.pdf; and National 

Science and Technology Council 2008, The National Nanotechnology Initiative: Strategy for 

Nanotechnology-Related Environmental, Health, and Safety Research, http://www.nano.gov/ 

NNIlEHSlResearchlStrategy.pdf. 

of nanomaterials into biological tissues.9,10 However, the mechanisms by which 

nanomaterials exert biological effects are poorly known and there is a clear 

need for basic research directed at new methods for assessing ‘‘nanotoxicology’’. 

Federal prioritization: Through the NNI, the Federal Government has developed 

and refined a roadmap aimed at identifying and prioritizing research needs with respect to environmental, health, and safety issues of nanotechnology.11 The five primary research categories identified are: (1) Instrumentation, Metrology, and Analytical Methods; (2) Nanomaterials and Human Health; (3) Nanomaterials and the Environment; (4) Human and Environmental Exposure Assessment; and (5) Risk Management Methods. 

The Nanoscale Science, Engineering, and Technology (NSET) subcommittee of the 

National Science and Technology Council (NSTC) has done a commendable job of 

focusing the disparate interests of the Federal agencies party to the NNI such that 

an organized effort can be made to address environmental and health impacts of 

nanotechnology as this technology is developed. This last point is critical—we cannot 

afford to wait until nanotechnology is fully integrated within our commercial enterprises to begin assessing its risks and hazards to human health and the environment. 

Future research needs and challenges: Nanomaterials have not been well characterized in terms of their environmental occurrence, behavior, and toxic potential 

even though they may contribute to occupational and general air/water pollution 

through manufacturing and waste disposal as well as through inclusion in drug delivery and therapeutic applications. Large data gaps exist with regard to our basic 

understanding of the potential for manufactured nanoparticles to cause deleterious 

effects on human as well as ecological systems. 

In assessing possible health and environmental effects of manufactured nanomaterials, it is important to study their impact in relevant model systems and in 

chemical forms reflective of occupational/environmental exposures. There are many 

different types of nanoparticles/nanomaterials and each of these will have a behavior (for example toxicity or transport) dictated by chemical and physical factors 

unique to the material. Below, I comment on specific areas of research within the 

framework outlined by the NSET subcommittee that I believe deserve particular attention: 

• Without methods for detecting and characterizing nanomaterials in the environment and in human tissues, exposure assessment and environmental occurrence 

and fate studies are impossible. I wholeheartedly agree with the NSET subcommittee that research into analytical methods and metrology of nanomaterials is a top priority and support for this work should be accelerated within 

the NNI. 

• With respect to research on environmental and human health effects of nanomaterials, I stress the need to develop standardized testing methods that are 

appropriate to assessing toxicity and biological uptake of nanomaterials. 

• It is clear from my own work as well as that of others that we must consider 

not only the health and environmental risks of manufactured nanomaterials but 

also that of byproducts generated during manufacturing. This is a relatively unexplored area of research and should be considered. 

• There is a critical need to assess routes of human and ecological exposure after 

release of nanomaterials into the ambient environment. We still have a very 

limited knowledge base regarding the treatability of nanotechnology wastes as 

well as the routes by which nanomaterials may enter and move within our air 

and water. This should be a top priority for EHS research within the NNI. 

67 

• Finally, our ability to accurately assess and predict risk of emerging nanotechnologies to human and environmental health is critically dependent on our understanding of the mechanisms by which nanomaterials act on biological systems at the cellular and molecular level. This understanding represents a grand 

scientific challenge and will require significant and well-supported effort. 

As you look to reauthorization of the NNI, I ask you to consider the resources that 

are critically needed now and in the future for addressing these emerging concerns. 

In 2005, expenditures through the NNI budget on nanotechnology-related EHS research totaled approximately $35 million or 3 percent of the total NNI budget. As 

of today, the NNI budget request for 2009 allocates $76 million or approximately 

5 percent of the total request to research on EHS issues of nanotechnology. It is 

very clear that a significant increase in our collective scientific understanding of the 

environmental and health impacts of nanotechnology will require a more substantial 

investment. A realistic target in the very near term should be to increase the level 

of funding for EHS research on nanotechnology to meet or exceed 10 percent of the 

NNI budget. 

I wish to close by saying that we have a unique opportunity now—through the 

efforts of the NNI we have begun the process of addressing EHS risks of nanotechnology simultaneously with the development of this technology. We have only to look 

back at the lessons learned from PCBs and other legacy chemical contaminants to 

realize the dangers of waiting until new technologies are mature to assess their environmental and health risks. I urge this Committee to consider these concerns during the reauthorization of the NNI. Thank you for considering my testimony. In the 

Appendix below I have included a summary of the research currently being conducted at the University of South Carolina on environmental and human health 

issues in nanotechnology. 

Appendix: Ongoing Research at the University of South Carolina on the 

Environmental Fate and Health Effects of Manufactured Nanomaterials 

Research Team: Dr. Lee Ferguson, Dr. Tara Sabo-Attwood, Dr. G. Thomas Chandler, Dr. John Ferry, Dr. Tom Vogt, Dr. Gene Feigley, Dr. Alan Decho, Dr. Sean 

Norman, Dr. Lee Newman, and Dr. Shosaku Kashiwada 

Although the use of nanomaterials may allow for significant advances in science 

and technology, assessment of potential negative health and environmental impacts 

on humans, non-human biota, and ecosystems is imperative. The same properties 

that make these particles desirable, may also contribute to their toxic potential. Our 

research team at USC is studying the potential toxic effects that various nanoparticles have on humans, microbial communities, and aquatic ecosystems. This is an 

interdisciplinary effort which involves cooperation among chemists, physicists, biologists, toxicologists, and microbial ecologists, among others. The focus of our research 

efforts are described below. For more information, please visit http://www.nano 

.sc.edu/thrust—nanoenvir.asp. 

Subproject #1: Pulmonary Toxicity of Nanomaterials 

Project leaders: Tara Sabo-Attwood and Gene Feigley 

In humans, the dominant route of exposure is suspected to occur via direct inhalation, both in the workplace where these particles are manufactured and used, and 

from the environment contaminated with particles released from anthropogenic and 

natural sources. Health-effects studies of air exposure to nanomaterials will require 

design of novel inhalation toxicology facilities and filtration technologies not available presently in the United States. Our group is uniquely qualified to design, build 

and test a small-scale prototype facility to assess aerosol generation, fate and transport. Construction of this prototype will lead to the development of inhalation exposure protocols for relevant animal models to assess the toxicological impacts of nanoparticles. In addition, we have already established complimentary in vitro studies 

that reveal toxic effects of single-walled carbon nanotube (SWNT) in human lung 

cells, and are currently exploring the molecular mechanisms responsible for this toxicity. 

68 

Subproject #2: Environmental Fate, Transport and Toxicity of Carbon 

Nanomaterials in Aqueous Systems 

Project leaders: Tom Chandler, Lee Ferguson, Shosaku Kashiwada 

Project Focus: 

Synthesis of unique radioisotope-labeled nanomaterials for toxicological, fate and environmental transformation studies 

Single-walled carbon nanotube (SWNT) fate in aquatic/sedimentary systems is 

still largely under-explored. The USEPA has supported research by our team at 

USC aimed at elucidating the toxic effects and environmental fate and transport behavior of SWNT in estuarine environments. Our results have shown that manufacturing byproducts of SWNT are toxic to estuarine meiobenthic copepods and that 

copepods ingest but do not bioaccumulate SWNT from sediments. In addition, we 

have shown that SWNT are highly sorptive to hydrophobic organic contaminants 

such as PCBs and PAHs, and that organisms ingesting SWNTs with associated organic contaminants can bioaccumulate the associated organics in their tissues. Studies on environmental fate of SWNT under simulated estuarine conditions reveal that 

SWNT materials aggregate strongly and agglomerate to natural particles (e.g., clay 

and sand) in the presence of high ionic strength solutions (e.g., seawater), but that 

this behavior is inhibited by the presence of high concentrations of dissolved organic 

matter. 

As part of our EPA-funded research, we have been developing a repository of 

pure, radio-labeled carbonaceous nanomaterials for national environmental toxicology and chemistry uses. With our collaborator Research Triangle Institute, Inc. 

we have custom synthesized single-walled carbon nanotubes. We are using these 

materials to perform experiments aimed at uptake/bioaccumulation and linked 

acute/chronic toxicity of SWNTs in at least two model invertebrate systems, fish and 

marine invertebrates (copepods). The 14C-SWNT materials are also being used to 

study particulate sorption, aggregation, transport in porous media, and bio/ 

phototransformation in a laboratory setting. 

Subproject #3: Microbial Applications and Degradation of Nanomaterials 

Project leaders: Alan Decho, Sean Norman, John Ferry 

Biofilms consist of bacteria cells attached to a surface that produce a large network of extracellular polymeric secretions (EPS). In doing so, bacterial cells are able 

to protect themselves against antimicrobial agents, and manipulate their local environment. Biofilms commonly occur in natural and engineered environments. However, their presence often incurs multibilllion dollar costs for hospitals (e.g., most 

hospital-acquired infections are biofilms), industry (e.g., cause metal corrosion and 

biofouling, reduce heat transfer efficiency), potable water system maintenance (i.e., 

protect pathogenic bacteria against chlorination), as well as being important in natural environments. Our research focuses on using nannoparticles to detect and monitor biofilms, study how the nanoparticles are captured and sequestered, and determine if the bacteria degrade these particles in various settings. 

• Biofilm Nanosensors: Understanding biofilm processes, and controlling their 

costly effects is important has important economic, health, and environmental 

implications. The development of specific Nanosensors for monitoring bacterial 

processes within biofilms is an important step in the in-situ detection and monitoring of biofilm processes. Our studies aim to develop specific sensors that can 

be ‘captured’ by a biofilm, then provide important physical/chemical/metabolic 

information regarding processes occurring within the biofilm. 

• Capture and Sequestration of NanoParticles by Biofilms. Bacterial biofilm are 

an efficient filter for particulates, colloids and dissolved molecules. They are 

likely important in the capture and concentration of nanoparticles under different Environmental conditions. We strive to: (1) understand how biofilms sequester nanoparticulates, and (2) manipulate biofilms to enhance capture efficiency. 

• Biofilm Test Systems: This phase involves the development of biofilm culture 

systems that accurately mimic natural biofilm populations. Such systems will 

be coupled to CSLM, Raman/CSLM, and other analysis instrumentation for precise testing of antimicrobial approaches on living and engineered nanosurfaces. 

Microbial Interactions and Degradation 

This project is directed at determining the influence of nanomaterials on environmental microbial activity. Nanomaterials have unique antimicrobial properties that 

may be exploited in environmental disinfection and/or infection control. There are 

69 

also therapeutic applications for this research relative to artificial implants, prostheses, etc. 

Specific Goals: Particular attention will be paid to questions such as: Do the materials in question support or inhibit the formation of biofilm communities? Are microbial communities capable of affecting the structure of associated nanomaterials (i.e., 

metabolically transforming them)? Do nanomaterials exert selective population pressure on microbial communities (i.e., selectively targeting one particular type of microbe vs another in mixtures)? 

We will develop ‘nanoprobes’ (fluor-, SERS-based) for biofilm investigations in environmental studies. We will also develop/build biofilm flow-through cells and bioreactors for live culturing, and observation, of biofilms in the presence/absence of 

nanomaterials using our new confocal (CSLM) and Raman-confocal systems in 

ENHS. 

Subproject #4: Photocatalysis of Reactions Mediated by Nanomaterials 

Project leaders: John Ferry, Tom Vogt 

Project Focus: 

Development of nanostructured materials with applications for environmental 

modification or remediation is the focus of this project. We are primarily interested 

in developing mixed metal oxide visible light activated photocatalysts for effecting 

sunlight activated oxidation in the aqueous phase. The materials focus will be active 

catalysts (nanoparticulate metal oxides) that engage in direct electron transfer with 

substrates and passive materials that may exhibit catalytic properties by promoting 

close association (such as various nanocarbons). We will monitor the degradation of 

catalytically active nanomaterials in environmental matrices, using microscopic and 

molecular techniques. We will assay the catalytic activity of the material during 

degradation, which is an exploratory evaluation of the structure activity relationship. We will assay the physico-chemical behavior of the material upon exposure to 

environmental conditions (e.g., aggregation, adsorption of ‘‘poisons’’ that affect catalyst activity, etc). We will explore application venues for materials that are effective 

photoactivated oxidants (drinking water and surface disinfection, biomedical applications, etc). 

Subproject #5: Plant Interactions with Nanoparticles 

Project leaders; Lee Newman, Tara Sabo-Attwood, Jason Unrine, Cathy Murphy 

Project Focus: 

Plant uptake and response to nanoparticles will have significance on many levels. 

First and foremost is to understand the parameters of plant uptake of the particles; 

what types (i.e., chemical composition) of particles are taken up, is there a size limit 

or shape preference, do the chemicals used to cap the particles impact uptake? 

Could plant compounds affect the bioavailability of particles in a natural system? 

In independent studies, we have already exposed the model plant, Nictoianna 

xanthi, to several different sized gold nanosphere, gold nanosheres with different 

capping chemicals, and silver nanospheres. Through simple light microscopy we 

have identified spheres of 3–5nm within the vascular tissue of the roots of the 

plants, and aggregation of larger spheres on the outside of the roots. We have observed enhanced precipitation of the particles when exposed to root exudates. We 

have also had a plants analyzed by one the using the beam lines at Brookhaven 

National Laboratory’s Synchrotron Light Source, and had XANES collected for selected areas of the plants analyzed. We found that the particles were retained as 

gold, and not gold salts within the plant, and that the pattern of accumulation differed within the plant tissues. 

Senator KERRY. Thank you, Dr. Ferguson. 

Dr. Goel? 

STATEMENT OF ANITA GOEL, M.D., PH.D., FOUNDER, 

CHAIRMAN, AND SCIENTIFIC DIRECTOR, NANOBIOSYM, INC. 

AND FOUNDER, CHAIRMAN, AND CEO, 

NANOBIOSYM DIAGNOSTICS, INC. 

Dr. GOEL. Thank you, Chairman Kerry and members of the Subcommittee, for inviting me to share this testimony with you. 

My name is Dr. Anita Goel. I’m the Chairman and CEO of 

Nanobiosym, Inc., and Nanobiosym Diagnostics. Nanobiosym foVerDate Nov 24 2008 12:11 May 24, 2012 Jkt 074321 PO 00000 Frm 00073 Fmt 6633 Sfmt 6601 S:\GPO\DOCS\74321.TXT SCOM1 PsN: JACKIE
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cuses on creating innovation at the nexus of physics, medicine and 

nanotechnology. Nanobiosym Diagnostics is focused singlemindedly on commercializing a chip technology we’ve developed out 

of that nexus which will enable a future cell phone-like device in 

which you could put a drop of blood or saliva on a chip, stick it into 

the device and within a few minutes be able to diagnose what kind 

of infectious disease a person has. 

This has, of course, many markets in the developed world, but 

we’re also looking at commercializing this in the developing world. 

I want to share with the Committee a few aspects of our experience 

in doing that. 

Taking the ability of diagnosing disease out of a pathology lab 

and the basement of a hospital and putting it into people’s own 

hands will have a transformative effect on healthcare globally, because it will bring the ability to diagnose disease into doctors’ offices, patients’ bedsides, people’s homes, or even into rural remote 

villages around the world. 

My own background for the past 5 years I’ve been a nanotechnology entrepreneur and over 15 years have been a scientist in the 

field of nanotechnology, originally beginning at Stanford before the 

word ‘‘nanotechnology’’ became a buzzword and then at Harvard 

and MIT where I did my Ph.D. in Physics and an M.D. in medicine, 

two fields which traditionally haven’t talked to each other but in 

my own mind come together at the nanoscale. 

The National Nanotechnology Initiative has been critical to my 

company. It has not only helped us in terms of direct funding but 

it has been instrumental in creating the landscape and the infrastructure for innovation and that’s been important in creating the 

environment that was needed for what we did. 

I believe that the next 5 years could be even more profound if 

we make the right decisions, because as a Nation, we’re really 

poised at the juxtaposition or a junction between basic R&D and 

commercialization. At Nanobiosym, we are not only commercializing our research by translating these basic insights into products, but also seeking to maximize the impact these insights can 

have on global challenges. 

From our experience in bridging the gamut from basic R&D innovation to establishing proof of concept to commercializing products 

and also penetrating into emerging global markets, I believe there 

are four key lessons that we have learned that I would like to suggest to this Committee to consider as they build the roadmap for 

the NNI reauthorization. 

Number (1) Let’s talk about education. Obviously we need a 

qualified work force, but more than that, we need to think about 

the kind of people we are creating. We need to look at transcending 

conventional boundaries in our educational system, the boundaries 

between different academic disciplines, the boundaries between 

academia and corporate training programs, and even between the 

United States and international training programs. 

Just like other countries send their students and people to train 

in our country, I think we need to send our people worldwide not 

only to train about nanotechnology but also to learn about the 

broader global context. 

71 

Number (2) Bridging the gap between fundamental research and 

products and commercialization. There are programs like the SBIR 

and the TIP Program which are very instrumental in bridging that 

valley of death, if you will, but, you know, there are other countries 

that are investing very heavily into very concentrated areas as a 

strategy, economic development strategy, if you will, to leapfrog 

themselves into a major player in the nanotechnology economy. 

I think an analogy can be drawn with the automobile industry 

where, as you know, many countries can focus on building the best 

bumper or the best headlight. As Americans, however, we’re 

uniquely positioned to create an entire nanotechnology economy. 

Just as we created the automobile economy that enabled us to capitalize on its mobility and create a whole system of jobs and infrastructure. 

I think we need to focus on how nanotechnology works at the 

systems level, not only in basic research but also bridging into commercial products and solving global problems. 

Number (3) The third key lesson is the broader impact nanotechnology can have on global challenges, whether it be the energy crisis, the environmental problem or healthcare. 

Because it’s such an interdisciplinary field where many fields 

come together in one melting pot and it has impact across various 

sectors, it really provides unique fresh approach to create, if you 

will, disruptive solutions to existing global challenges. 

In my company, for example, not only are we looking at taking 

our technology to impact the way healthcare is practiced here and 

around the world but we are seeing that the same platform technology has impact on food testing, water safety testing, environmental testing, even crop pathogen testing. 

So the same platforms can have many different kinds of applications. We need to think more broadly and more holistically in 

terms of how we leverage what we have. There’s a lot of concern 

these days about the potential negative impacts on safety or on the 

environment of nanotechnology. I think that nanotechnology can 

help be part of the solution, not the problem, if we broaden our 

view. 

Number (4) Fourth, I think there’s a historically unique opportunity right now to bring emerging technologies into emerging global markets. I think that fields like nanotechnology are going to 

force us to think and even act globally. 

In our company, for example, we follow the precedent of the cell 

phone industry. In the telecom field, you saw a paradigm shift 

when communications and computing devices became portable. You 

saw even poor villagers and beggars in developing world countries 

starting to use cell phones once the cost came down. Part of it is 

they didn’t have the land line infrastructure to displace. 

We envision driving a similar paradigm shift in the healthcare 

industry where the ability to diagnose disease can be taken out of 

a hospital and put into people’s own hands and even transported 

to remote areas of the world. I believe the key to doing that is cutting the cost, making it affordable, but also forming global partnerships. 

Part of our strategy as a company has been, and I would propose 

the Committee consider this as part of their roadmap, is that we 

72 

as Americans should engage other global partners in addressing 

global challenges and adopting some of the developing world problems as part of our own because part of those problems help stimulate new solutions. 

Finally, I would like to thank you, Chairman Kerry, as well as 

the members of the Committee. Let me end by saying I believe we 

are uniquely poised to harness nanotechnology to fuel and revitalize our own economy if we think about it in a more global fashion. 

Thank you very much. 

[The prepared statement of Dr. Goel follows:] 

PREPARED STATEMENT OF ANITA GOEL, M.D., PH.D., FOUNDER, CHAIRMAN, AND

SCIENTIFIC DIRECTOR, NANOBIOSYM, INC. AND FOUNDER, CHAIRMAN, AND CEO, 

NANOBIOSYM DIAGNOSTICS, INC. 

Chairman Kerry, Ranking Member Ensign, and members of the Subcommittee, I 

would like to thank you for the opportunity to testify on the reauthorization of the 

National Nanotechnology Initiative. 

My name is Dr. Anita Goel, and I am the Founder, Chairman, and Scientific Director of Nanobiosym, Inc. and the Founder, Chairman, and CEO of Nanobiosym 

Diagnostics, Inc. Nanobiosym was founded as an idea lab and research institute to 

innovate at the convergence of physics, medicine and nanotechnology. Nanobiosym, 

and its commercial partner Nanobiosym Diagnostics, have been privately developing 

Gene-RADAR, a portable nanotechnology-enabled platform that can rapidly and 

accurately detect genetic fingerprints from any biological organism. The company’s 

vision is to give patients worldwide real-time access to their own diagnostic information via low-cost handheld devices. We are based in Medford, Massachusetts. 

I first began working as a scientist in the field of nanotechnology over fifteen 

years ago at Stanford University—well before the term ‘‘nanotechnology’’ had become a buzz word. I simultaneously trained as both a physicist and physician, with 

my PhD in Physics from Harvard University and my MD from the Harvard-MIT 

Joint Division of Health Sciences and Technology (HST). For almost 5 years now, 

I have been a nanotechnology entrepreneur as the Founder, Chairman, and CEO 

of Nanobiosym and Nanobiosym Diagnostics. We are developing commercial products targeted for global markets—in both the developed and developing worlds. 

What is Nanotechnology? 

Nanotechnology to me is the ability to probe and control matter and systems on 

increasingly finer scales, at the nanoscale (10∧-9 m) and smaller. This is important 

because it gives us a new level of control over matter. Nanotechnology is a platform 

science which combines several traditional fields such as physics, chemistry, biology, 

and medicine. The applications that stem from these capabilities likewise cut across 

several different sectors from medicine and energy to the environment and materials science. For example, the ability to control the assembly and arrangement of 

atoms and molecules in a nanomaterial could give it the durability of steel and the 

weight of plastic. 

Nanotechnology provides a platform for innovation across conventional boundaries 

of science, technology, and commerce. Furthermore, by its intrinsic multidisciplinary 

nature, it fosters collaboration across conventional political and economic boundaries. 

Nanobiosym and the National Nanotechnology Initiative 

Nanobiosym has been the direct beneficiary of the National Nanotechnology Initiative. Without the resources that the Initiative brought to bear—not only funding, 

but also coordination and a sense of national priority—Nanobiosym would not be 

where it is today. We have been fortunate to work with several of the agencies participating in the Initiative, and have received multiple rounds of competitive funding 

grants from DARPA, AFOSR, Phase I and Phase II SBIR funding from DOE, and 

now more recently were awarded a defense contract from DTRA as some of our technology platforms transitioned from the pure R&D stage to the more applied or 

prototyping stage. 

As the Subcommittee considers how best to update and improve the Initiative, I 

hope that our experience as an emerging nanotechnology company (in moving across 

the gamut from science and technology innovation, to proof of concept development 

73 

and developing commercial products for global markets) will help identify what has 

worked well and what could be improved to encourage other companies like us. 

The Need for Reauthorization 

As Congress begins to consider reauthorizing the National Nanotechnology Initiative, it is important to understand that because the original authorization was so 

successful, the Nation’s nanotechnology landscape dramatically changed in the last 

5 years. The 21st Century Nanotechnology Research and Development Act focused 

primarily on basic research. This led to dynamic growth in America’s nanotechnology research infrastructure primarily in academic settings, and sowed the seeds of 

nanotechnology commercialization throughout the country. 

Today, 5 years later, we are beginning to see the results of this initial investment, 

as nanotechnology-enabled products start to enter the marketplace across the spectrum of industry sectors, from water purification to materials engineering to 

healthcare. While the success of the first 5 years gives us great hope, however, I 

cannot impress upon the Subcommittee enough that the growth of the next 5 years 

could be exponential. Building on the success of the National Nanotechnology Initiative’s first 5 years, the United States has a historic opportunity to drive nanotechnology to maximize its impact on global challenges, including health, environment, 

energy, and even building the new global economy. 

The reauthorization of the National Nanotechnology Initiative should focus on 

four new areas in addition to basic research: 

1. improving nanotechnology education, which will supply a qualified workforce 

for the American and global nanotechnology economy; 

2. bridging the gap between research and commercialization, which will help 

America drive the global nanotechnology revolution; 

3. addressing environmental, health, safety, and other global challenges, which 

will ensure that we can enjoy the many benefits of nanotechnology while addressing any risks that may arise; and 

4. bringing emerging technologies into emerging global markets. 

Each of these four areas has a direct impact on my company. Progress in each 

will enable Nanobiosym to bring its lifesaving products to market faster, to expand 

and provide quality jobs for more people, and to market our products to global markets in both the developed and developing world. 

A Roadmap for Harnessing Nanotechnology to Drive the New Global 

Economy 

1. Nanotechnology Education 

If America is going to compete effectively in the global nanotechnology revolution, 

we need a highly skilled and qualified work force. We need scientists, engineers, and 

technicians who have a vision for nanotechnology, seek to innovate with it, and are 

capable of working at the nanoscale. We need professors and teachers who can educate about the nano world and we need business professionals who can turn the scientists’ work into useful products. It is already difficult to meet the demand for 

PhDs with nanotechnology backgrounds, and that demand will only increase in the 

coming years. 

We need to spark interest in nanoscience, starting in grade school. We need to 

build a nanotech pipeline in education which will allow for a steady stream of qualified personnel to supply our labs and companies. 

Nanotechnology education, like nanotechnology research, is necessarily multidisciplinary. Because nanotechnology spans physics, materials science, chemistry, and 

biology, it needs to be taught throughout the science curriculum. And like other subjects, nanotechnology is best learned by doing. Programs that improve access to 

basic nanotechnology tools will help inspire a new generation of students to pursue 

careers in science because they will be able to see firsthand nanotechnology’s potential. 

Our education system must start transcending conventional boundaries between 

academic disciplines, between academic and corporate training programs, and between U.S. and international training experiences. I would suggest the creation of 

more international exchange programs. Just as other countries send their students 

here, we should start sending our people around the world to be trained not only 

in nanotechnology but its broader international context. 

The reauthorization bill will be an excellent investment in America’s future if it 

promotes nanotechnology education from grade school through graduate school. If 

it does not, we will continue to rely in the short term on foreign science students 

74 

who will often end up returning to their home countries to compete against us after 

completing their studies. 

2. Bridging the Gap Between Nanotechnology Research and Commercialization 

As the Members of this Subcommittee know, America’s competitiveness in the 

global market is being tested in the field of nanotechnology, where Russia, China, 

Japan, the European Union, and other nations are making major investments in 

translating basic research into marketable nanotechnology products. Often, foreign 

governments are pursuing a strategy of letting American researchers do the basic 

science, then using their resources to commercialize that research and gain the economic benefit. Having invested in the early days of nanotechnology research and innovation, we should not miss the opportunity to fully commercialize our own research. 

Programs such as Small Business Innovation Research, Small Business Technology Transfer, and the new Technology Innovation Program are vital mechanisms 

for bringing technology out of the lab and into the marketplace. They provide needed resources and expertise to emerging small businesses, and they help bring new 

technology and new jobs into existence. They bridge the ‘‘valley of death’’ that lies 

between basic research funding and late-stage commercial funding—a valley that 

would otherwise swallow many more promising companies. As the Subcommittee 

drafts the reauthorization legislation, I urge you to ensure that these programs play 

a major part in the bill. 

In my own experience, programs like SBIR have enabled companies like ours to 

stay focused on more disruptive innovations even when they are not the lowest 

hanging fruit in terms of revenue generation. In practice, such programs keep 

American innovation at the cutting edge as we continue to meet real-time market 

needs. 

Rapid commercialization is important, but goal-oriented research also will help accelerate the path to market for nanotech companies. Many emerging countries are 

focusing on this strategy to leapfrog themselves into significant roles in the global 

economy. For example, countries like Taiwan have determined that, although they 

may not be able to challenge the United States across the board, they can compete 

effectively if they concentrate their resources. By conducting goal-oriented research 

in a key area such as electronics or display technologies, they can achieve a strong 

position in those markets. 

We can do the same thing. Already, we have had tremendous success with goaloriented research in cancer treatment and other health-related areas. Identifying 

and pursuing other key goals, such as nanomedicine, energy, electronics, or water 

purification, will help ensure that we are getting the most for our research money. 

As someone who practically embodies the concept of ‘‘multidisciplinary research,’’ 

I would encourage the Subcommittee to see to it that goal-oriented research centers 

cross traditional scientific and agency boundaries. The National Science Foundation 

and the Department of Energy should be working together; NIST should be working 

with EPA; and so forth. I have seen the beginnings of such multidisciplinary research under the current National Nanotechnology Initiative, and the results are indeed encouraging. I see this in my own company every day, and I know it works. 

Goal-oriented work and cooperation will go far to expedite commercialization and 

provide a more efficient path to market for many businesses and products. I caution 

the Committee, however, not to get trapped by lesser goals while losing sight of the 

bigger picture. It is one thing to make products based on nanotechnology research; 

it is another to build a nanotechnology economy. The goal-oriented nanotech research of competing economies is understandable given their resources. But it is one 

thing to be simply the supplier of a bumper, or a headlight, or a mechanical part 

for an automobile; it is another thing to build an economy based on the mobility 

the automobile enabled, which spawned multiple new industries and employed millions. So it could be with nanotechnology. 

It is true that goal-specific research will be important, as will support for commercialization and collaboration between agencies. It will be this understanding of the 

nano-based economy that will differentiate us from our competitors and allow us to 

make the best decisions about where to invest our resources. This understanding 

will also enable us to take a fresh approach to American leadership in the new global economy. 

3. The Broader Impact of Nanotechnology on Environmental, Health, Safety and 

other Global Challenges 

A comprehensive, strategic approach to understanding the environmental, health, 

and safety effects of nanotechnology is a necessary component of any Federal plan 

at this point. With nanotechnology products entering the commercial market, it is 

75 

important that we know how nanoparticles behave in the body and in the environment. Just as important is the need to communicate with consumers so that they 

understand the efforts that are underway to determine and address any risks that 

may exist. The last thing that any nanotechnology company wants is for a lack of 

safety data to scare consumers into staying away. The field has learned the lessons 

of the genetically-modified food debacle. 

That said, however, Nanobiosym’s experience represents a different part of the 

issue. Amid the concern about potential negative environmental, health, and safety 

impacts, it is easy to forget that nanotechnology can be much more of an environmental, health, and safety solution than a problem. For example, Nanobiosym’s 

products will improve health both here and in the developing world by rapidly diagnosing infectious disease. Soon, we plan to expand into water and food testing. 

When it hits its stride, my company will be an environmental, health and safety 

solution, not a problem. 

Although I am proud of our technology and the contribution it will make, many 

other nanotechnology companies are making similar contributions to environmental, 

health, and safety issues. From fuel cells to LED lights, from cancer treatments to 

antibacterial surfaces, and from strong composite materials to aircraft metal fatigue 

sensors, nanotechnology products are beginning to clean up the environment, cure 

people and keep them healthy, and save lives by preventing accidents. These trends 

will only accelerate as nanotechnology becomes more widespread. 

4. Bringing Emerging Technologies into Emerging Global Markets 

I envision that the new global economy will take shape as the economies of major 

nations become more interdependent and intertwined via science, technology, and 

commerce. Nanotechnology by its very multidisciplinary and international nature is 

thus likely to play a major role in driving the new global economy. 

Nanotechnology will spur American entrepreneurs to think and act even more 

globally. As Americans, we should take a bold step toward global leadership in the 

nanotechnology revolution by engaging other players around the world and also by 

embracing global challenges (such as the energy crisis, global health, and the environment) as our own including those of the developing world. Together we should 

focus on using our best scientific and technological tools to solve real-world problems. 

For example, at Nanobiosym we have developed a technology platform that has 

both biodefense applications and clinical diagnostic markets here in the U.S. as well 

as in the developing world. The very nature of the way innovation and commercialization is proceeding in nanotech enables us to reach out to a global market. For 

example our product, because of its portability and small size, has a large potential 

in the developing world. Similar to the cell phone industry which has made a disruptive impact on telecommunications in emerging markets, there are six billion 

people on Earth and everybody gets infected at some point in their life. If we can 

make our products cheap enough we can improve global healthcare as well as cater 

to the needs of a growing multibillion-dollar market. 

Conclusion 

I would like to thank you, Chairman Kerry, Ranking Member Ensign, and the 

members of the Subcommittee once again for the invitation to testify today, and for 

your leadership in working to ensure that America can harness the nanotechnology 

revolution to not only revitalize its economy but also drive and help shape the new 

global economy. Building on the success of the National Nanotechnology Initiative’s 

first 5 years, the United States has a historic opportunity to drive nanotechnology 

to maximize its impact on global challenges. The economic and humanitarian benefits of driving this nanotechnology revolution will be tremendous, and the reauthorization of the National Nanotechnology Initiative will go a long way toward putting 

America at the forefront of this global revolution. 

As the CEO of an emerging nanotechnology business with global aspirations, I am 

certainly grateful for the support. 

Senator KERRY. Thank you very much, Dr. Goel. 

Dr. Heath? 

76 

STATEMENT OF JIM HEATH, ELIZABETH W. GILLOON 

PROFESSOR AND PROFESSOR OF CHEMISTRY; DIRECTOR, 

NANOSYSTEMS BIOLOGY CANCER CENTER, CALIFORNIA 

INSTITUTE OF TECHNOLOGY 

Dr. HEATH. Senator Kerry and colleagues, about a decade ago, 

the late Rick Smalley sat before this very same Senate Committee 

when it was considering the National Nanotechnology Initiative. 

Rick won the 1996 Nobel Prize in Chemistry for his discovery of 

C60, known as Buckminsterfullerenes and the class of all carbon 

molecules known as the fullerenes—molecules which in many ways 

have become the poster children of nanotechnology. 

I also had a part in that discovery. It was my dissertation work 

and Rick was my Ph.D. advisor and thus it’s a special honor to be 

here today. 

Senator KERRY. Can you pull the microphone closer to you? 

Dr. HEATH. How’s that? 

Senator KERRY. Thanks. 

Dr. HEATH. Anyway, thus it’s a special honor to be here today 

and I want to recall a little bit of Rick’s testimony from a decade 

ago. 

He said, and I quote, ‘‘I sit before you here today with very little 

hair on my head.’’ That’s obviously a quote. ‘‘As a result of chemotherapy. I’m not complaining. Twenty years ago, I would already be 

dead, but 20 years from now, we will no longer have to use this 

blunt tool. Nanotechnology will have given us engineered drugs 

which are nanoscale cancer-seeking missiles, a molecular technology that specifically targets just the cancer cells and leaves everything else blissfully alone. I may not live to see it but I am confident it will happen.’’ 

Well, Rick was prophetic on both accounts. He didn’t live to see 

it but it’s happening now and it’s happening faster than he envisioned it happening. 

One example comes from my colleague at Caltech, Mark Davis. 

Mark is a member of the Cancer Center I direct. It was one of the 

few nanotechnology-based cancer centers the NCI founded a few 

years ago. Mark developed a nanotherapeutic that begins to mimic 

Rick’s cancer-seeking nanotech missiles. He put this into a Phase 

I trial and a patient came into this Phase I trial that had late-stage 

metastatic pancreatic cancer. 

I know there’s a lot of—probably a number of folks in this room 

that have had cancer but if you had had late-stage metastatic pancreatic cancer, you probably wouldn’t be here today. The survival 

rate for that disease is almost zero. 

In these Phase I trials, the patients that come in are ones that 

have failed every other type of therapy. They’re on their last hope 

basically, and this patient had two to 3 months left to live. Well, 

as of today, and this is 2 years later, this patient is still living, is 

cancer free, and went to through the entire trial without even hair 

loss. That’s a stunning result. 

Now the chemotherapy was actually a typical chemotherapeutic 

drug. It was one that would lead to side effects, such as hair loss 

or cardiac arrest, but the nanotherapeutic, which was the delivery 

system that delivered that drug, basically permitted the dose to be 

77 

lowered twenty-fold and therefore lowering the toxicity. It also directed more effective delivery of the drug to the cancer. 

The scientific foundation for that drug is what the National 

Nanotechnology Initiative has delivered. Each of the nanoparticles, 

for example, is designed to look friendly to the immune system, to 

stay in the blood for days until it finds the tumor, and not to release their drug payload until the nanotherapeutic is actually inside the cancer cells. None of this is by accident. 

In fact, a lot of the research that went into making that happen 

we might think of as Environmental Health and Safety kind of research but it would never be classified as such because you actually 

have to do it to make the stuff work. This I would argue that in 

many ways we’re vastly underestimating the amount of money 

that’s going into EH&S-type work because it accompanies a lot of 

this type of research. 

We are faced with some staggering scientific and technological 

problems today, ranging from energy and healthcare and the environment, and nanotech solutions are virtually at the forefront of 

every single one of these problems. For example, in my own lab, 

we have developed a technology that goes from a finger prick of 

blood to 50 protein diagnostic measurements, all within the time 

scale that’s actually faster than the blood clotting. 

Now that we’re beginning to harness that technology for use in 

our soldiers in Afghanistan and Iraq but we’re also using it within 

our cancer center. In Afghanistan and Iraq, there’s many instances 

where this technology can be utilized to help dramatically shorten 

the time between diagnosis and treatment after trauma. The therapy can help save lives. This is an emerging and really interesting 

issue. I hope someone asks me about it. 

Now is not the time to further regulate this field. The therapeutics and the diagnostic devices that I’ve just talked about go 

through very demanding procedures, the same FDA approval procedures that anything else goes through, and these procedures are 

the gold standard. They work. 

The NSF and the NIH have both taken very seriously the aspects 

of the health impact of nanotech and they’ve launched major initiatives in these areas. However, the example of a nano drug vastly 

reducing side effects, not increasing them, has been the story when 

the foresight and the resources are available to ensure that the 

science is done correctly. Right now that part is working. 

I want to conclude with what I think is probably a looming crisis. 

In fact, I know it’s a looming crisis. I was recently at a meeting 

where a bunch of experts were bemoaning the fact that drug trials, 

clinical trials of drugs are now becoming an offshore endeavor. 

Well, I’m here to tell you that every aspect of that process, from 

the basic science to the engineering to the product testing to the 

manufacturing is becoming an offshore endeavor. This is not just 

for drugs, but for many fields. 

We are in serious danger of losing our competitive advantage in 

a number of high-tech arenas. We achieve world scientific and technological leadership by taking on high-risk, high pay-off goals and 

sticking with those goals. However, our scientific enterprise, I believe, is becoming risk-averse. 

78 

1 Richard E. Smalley testimony before the Senate Committee on Commerce, Science and 

Transportation, May 12, 1999. 2The NanoSystems Biology Cancer Center is one of a few Cancer Centers for Nanotechnology 

Excellence (CCNEs) that the National Cancer Institute funded starting in late 2005. 3M. E. Davis and M. E. Brewster, ‘‘Cyclodextrin-based pharmaceutics: Past, present, future,’’ 

Nat. Rev. Drug. Disc., 3, 1023 (2004). 

Other countries see this chink in our armor and are challenging 

us. The National Nanotechnology Initiative constitutes one of our 

high-risk, high-yield investments and it’s working, but in other 

areas, we are losing our edge. 

I think our great country has a history of achieving its goals by 

combining bold scientific visions, strong political leadership, effective public education and significant and sustained investment in 

our scientific foundation. Through that, we have maintained our 

global technological and economic leadership. I think finding ways 

to sustain that mix rather than finding ways to regulate an emerging and fragile field should be the focus of this debate. 

Thank you. 

[The prepared statement of Dr. Heath follows:] 

PREPARED STATEMENT OF JIM HEATH, ELIZABETH W. GILLOON PROFESSOR

AND PROFESSOR OF CHEMISTRY; DIRECTOR, NANOSYSTEMS BIOLOGY CANCER

CENTER, CALIFORNIA INSTITUTE OF TECHNOLOGY

Senator Kerry, Members of the Committee, and Colleagues: 

Nearly a decade ago the late Rick Smalley sat before a Senate committee that was 

considering the National Nanotechnology Initiative. Rick won the 1996 Nobel Prize 

in Chemistry for his part in the discovery of C60 and the fullerenes. I also had a 

part in that—it was my dissertation work, and Rick was my Ph.D. advisor. Thus, 

it is a special honor to be testifying here today, and I want to recall a bit of Rick’s 

testimony from a decade ago. 

‘‘I sit before you today with very little hair on my head . . . a result of chemotherapy . . . I’m not complaining. Twenty years ago . . . I would already be 

dead. But twenty years from now . . . we will no longer have to use this blunt 

tool. . . . Nanotechnology will have given us . . . engineered drugs which are 

nanoscale cancer-seeking missiles, a molecular technology that specifically targets just the . . . cancer cells . . ., and leaves everything else blissfully alone 

. . . I may not live to see it, but . . . I am confident it will happen.’’ 1

Rick was prophetic on both accounts. He didn’t live to see such advances, but they 

are happening now. One example comes from my Caltech colleague, Mark Davis. 

Mark is a member of a cancer center that I direct. It is one of a few innovative cancer centers that the NCI funded a few years ago to develop nanotechnology tools 

for battling cancer.2 Mark’s lab developed a nanotherapeutic that begins to mimic 

Rick’s nanoscale cancer-seeking missiles.3 I’ll begin with a story about a patient 

from a Phase I clinical trial of this drug. Phase I trials are a last recourse for those 

who have failed everything else, and this patient came to Mark’s trial with latestage, metastatic pancreatic cancer, and a prognosis of 2–3 months left to live. 

There are several cancer survivors in this room. However, if any of you had had 

metastatic pancreatic cancer, it is unlikely you would be here today. The survival 

rate for this terrible disease is almost zero. That patient entered the trial almost 

2 years ago, and is still alive, cancer free, and went through the entire trial without 

even hair loss. That is a stunning result—the drug itself was a typical 

chemotherapeutic with toxic side effects that range in severity from hair loss to cardiac arrest. However, the delivery agent, which was a nanotechnology, permitted the 

dose to be lowered 20-fold, and directed more effective drug delivery to the cancer. 

The scientific foundation for this drug is what the national nanotechnology initiative has delivered. Each of Mark’s nanoparticles is designed to look friendly to the 

immune system, to stay in the blood for days until they find the tumor, and to not 

release their drug payload until they are inside a cancer cell. 

This is just the beginning. 

79 

4 Rong Fan, Ophir Vermesh, Alok Srivastava, Brian K.H. Yen, Lidong Qin, Habib Ahmad, Gabriel A. Kwong, Chao-Chao Liu, Juliane Gould, Leroy Hood, and James R. Heath. ‘‘Integrated 

Blood Barcode Chips,’’ under review to Nature Biotechnology 4/08. 

We are faced with some staggering scientific challenges today—ranging from energy to health care to the environment. For virtually all of these problems, nanotechnology-enabled solutions are at the forefront of the scientific search for answers. 

In my lab we have developed a nanotechnology-enabled chip that carries out almost 50 diagnostic measurements from a fingerprick of blood—all before the blood 

even clots.4 This chip has applications for our soldiers in Iraq and Afghanistan 

where shortening the time between injury, diagnosis, and treatment can save lives. 

It also has applications to routine health care. 

Now is not the time to further regulate this field. Mark’s therapeutics and our 

diagnostic devices go through the same demanding FDA approval processes as 

standard drugs and health care technologies—that process sets the global standard, 

and it works. 

The NSF and the NIH are taking seriously the tasks of understanding the environmental and health impacts of nanotechnologies—both agencies have established 

significant programs to understand those risks. 

However—the example of a nanodrug vastly reducing toxic side effects—not increasing them, has been the story when the foresight and resources are available 

to ensure that the science is done correctly. Right now, that part is working. 

Finally, I want to turn to a looming crisis. I was recently at a meeting where various experts were bemoaning the fact that clinical drug trials are increasingly offshore endeavors. In fact, the entire process, from the basic science of discovery, to 

engineering, product testing, and manufacturing, is moving off shore—and not just 

for drug discovery. We are in serious danger of losing our competitive advantage in 

a number of high tech arenas. We achieve world scientific & technological leadership by taking on high risk, high payoff goals, and sticking with those goals. However, our scientific enterprise is becoming risk averse. Other countries see this chink 

in our armor, and are challenging us. The National Nanotechnology Initiative constitutes one of our high risk/high yield investments. It is clearly working, although 

it is a serious struggle to stay ahead of the curve. In other areas, we are losing our 

edge. 

Our great country has a history of achieving goals by combining bold scientific vision, strong political leadership, effective public education, and significant and sustained investment in our scientific foundation. That is how we have maintained our 

global technological and economic leadership. Finding ways to sustain that mix, 

rather than finding ways to regulate an emerging and fragile field, should be the 

focus of this debate. 

Thank you. 

Senator KERRY. Thank you very much, Doctor. That was a very 

interesting, provocative, and thoughtful testimony. 

Let me ask you. When you suggest, as you did, that we should 

not, I think you used the word ‘‘interfere,’’ am I correct, and therefore not interrupt this chain of important research which you’re 

doing and it is important and I understand that, how do you respond to the other testimony and to others who are suggesting that 

we don’t know what some of the impacts of these nanoparticles are 

and some of the uses that are out there? How do you balance this 

non-interference and obvious need to be competitive and move 

down the road with need of the rights, the public’s right to know, 

and adequate protection for the public against the product like that 

where you may be brushing your teeth with something that you 

learn in 10 years actually does you great harm? 

Dr. HEATH. Well, I would argue that the vast amount of nanotechnology that’s investigated today is done on a very small scale 

in the lab where we’ve never gone in and interfered with the 

science and it’s probably not appropriate to do so because that’s not 

a place where it’s going to have an impact. 

80 

Whenever any of these technologies actually make it out into the 

commercial arena, the very nature of that process mandates that 

these things are investigated very thoroughly. thoroughly. I can tell 

you mostly from the healthcare arena that it’s a demanding process. I was a meeting where a bunch of people doing nanotech are 

staggered by these regulations. 

Senator KERRY. Staggered by? 

Dr. HEATH. By the regulations of trying to—it’s what every drug 

has to do to go through FDA or—— 

Senator KERRY. You’re talking about a drug and drugs indeed 

have a certain protocol and a higher standard. What about other 

products that come into the market? I mean obviously this toothpaste doesn’t. 

Dr. HEATH. Right. 

Senator KERRY. There are countless other products. My wife and 

I just wrote a book, she wrote the chapter on toxins and, you’ve got 

these extraordinary numbers of toxins that are in products that 

people aren’t even aware of. Whether it’s phthalates in plastic that 

we now know is carcinogenic, bisphenol, or other things that kids 

suck on and are in toys or elsewhere, and people really don’t know 

the consequences. 

Dr. HEATH. Well, I think that we have some issues in terms of 

products that get released that we don’t have very much oversight 

on. I don’t think that’s a nanotechnology problem. I think if you 

compared what happens in the cosmetic industry where people are 

applying all kinds of things to the body,—— 

Senator KERRY. That’s crazy. 

Dr. HEATH.—you don’t have near the amount of oversight over 

that industry. Nanotech is—— 

Senator KERRY. We actually have none. 

Dr. HEATH. Yes. That’s right. If we single out nanotech, right 

now it’s a very fragile field. It’s young. I know we talked about 

these major things going into products. 

Senator KERRY. Well, wouldn’t you say—— 

Dr. HEATH. It’s small potatoes. 

Senator KERRY. When you say single it out, I’m not sure we’re 

singling it out, but given its potential to be in so many different 

products and the extraordinary power within the marketplace that 

it may well have, doesn’t it behoove us to try to get this right upfront? 

Dr. HEATH. Absolutely, and I would say just like—you know, several years ago, when the AIDS crisis hit, our knowledge of the 

human immune system went up dramatically because of that crisis. 

At the moment, because of National Nanotechnology Initiative, 

we know a tremendous amount of what nanotechnology matters 

and materials and et. cetera do inside the human body and the environment that we never would have known otherwise. 

I think we’re learning this and we haven’t had a uniform way to 

maybe categorize it, although I believe there are some agencies 

that are beginning to do that, but if we made a regulation now, it’d 

be based upon ignorance, I believe. But I do believe it’s a good time 

to try to begin categorizing it in a rational way. 

Senator KERRY. I mean what if the regulation is a reaction to ignorance in a sense in that it is requiring a certain protocol to be 

81 

followed before X, Y or Z product is placed out there? Is that so onerous? 

Dr. HEATH. No. In fact, I think that’s done now. 

Senator KERRY. Should we demand a transparent protocol by 

which something is coming to the market? 

Dr. HEATH. At least in all the commercial endeavors I’ve been involved in, that is exactly what happens now because of the current 

standards and practices. 

Senator KERRY. Except for those 75,000. I think we only have 

6,000 FDA-approved chemicals that are out in the marketplace out 

of some 82,000 that I know are ‘‘out in the marketplace,’’ some of 

them to a lesser or greater degree than others, obviously. Cosmetics is an example where estrogenic substances have been used 

in some of these products which wind up in fact potentially giving 

people cancer. 

Hair straighteners, for instance, have been shown to be particularly malicious among African American young women who wind 

up with a greater incidence of breast cancer and other things. Nobody has done a complete linkage, but there’s a lot of evidence now 

about endocrine disruptors and other impacts out there. Books are 

being written by researchers, oncologists, and others that are all 

looking at this. 

It seems to me the warning signs are flashing and we ought to 

just be careful. That’s all. Nobody wants to interfere. 

Anybody else want to respond to this? Yes, Dr. Goel? 

Dr. GOEL. Yes. I would like to add that I think that it’s not a 

matter of whether to apply regulations or not, it’s about where to 

apply the regulations and when to apply them. 

I think what Dr. Heath said at the level of the basic science innovation, that’s probably not the best place to apply the restrictions. 

Senator KERRY. Are we trying to? Is anybody trying to apply it 

there? 

Dr. GOEL. I think that the hype that gets created about the negative aspects of nanotechnology may tend to discourage certain 

kinds of funding to basic science nanotechnology which could have 

an adverse effect. 

Senator KERRY. So we should be wary of that and wary of interfering at the basic level, correct? 

Dr. GOEL. In terms of a mentality. I think the other thing is one 

must be clear that not all kinds of nanotechnology are this general—the same kind of bad consequence. Maybe you’re referring to 

nanomaterials or nanochemicals. Nanotechnology is broader than 

that. 

Senator KERRY. Agreed. 

Dr. GOEL. And what it defines and refers to is much broader 

than that and so I think it’s a very narrow projection of what nanotechnology is. 

Senator KERRY. How would you define it? 

Dr. GOEL. Nanotechnology? 

Senator KERRY. Yes. 

Dr. GOEL. I love to define it. 

Senator KERRY. What? 

Dr. GOEL. In my mind, it really is the ability to probe and control 

matter at increasingly finer scales, 10 to the minus 9 meters and 

82 

beyond and smaller, and why that’s important is because when we 

can learn to control and manipulate matter and probe matter on 

that level, we can effect the properties of systems and nanomaterials is one example. 

In our example, we control the molecules which improves the 

precision and accuracy with which we can read out information. 

Senator KERRY. Where are you in that process? Do you actually 

have an ability to—— 

Dr. GOEL. We have a prototype. 

Senator KERRY. A prototype? 

Dr. GOEL. Yes. 

Senator KERRY. Which is bigger than what you’re holding in your 

hand? 

Dr. GOEL. No, this is the chip. 

Senator KERRY. That’s the prototype chip? 

Dr. GOEL. Yes. 

Senator KERRY. What’s the read-out? 

Dr. GOEL. The read-out is bigger than our Blackberry I show 

here. 

Senator KERRY. So that is yet to come? 

Dr. GOEL. Yes, exactly. 

Senator KERRY. Dr. Ferguson. 

Dr. FERGUSON. Yes, I would comment—— 

Senator KERRY. Let me just give you all a heads up. I have a 

meeting I’ve got to run to before too long. So I may have to truncate this a bit but we’ll try to keep going. 

Dr. FERGUSON. Senator Kerry, I would say that the examples 

that Dr. Heath highlighted about biomedically relevant nanoparticles certainly would be well understood by the time they get to 

the point they’d be used in biomedicine from lots of study by the 

FDA and the developers, but I would say that your example of, for 

example, at Tuskalis with 75,000 compounds that are out there in 

our environment is a great example of why we should be spending 

the effort upfront right now to study and understand at the scientific level the behavior in both environmental systems as well as 

biological systems of as broad a range of nanomaterials as possible. 

The big problem here is that for nanotechnology, we’re really 

talking about a very, very broad scientific field that encompasses 

lots of different materials with different chemistries and different 

surface properties and so it’s very difficult to say whether nanotechnology, nanomaterials in general are dangerous, are not dangerous, are safe or not safe. 

Senator KERRY. Well, let’s come back to the panel’s original discussion then. Does that say something about what ought to be required in terms of a strategy or roadmap? Where do you all come 

out on that? 

Dr. FERGUSON. I think that’s essential. I think that there should 

be some rational prioritization of the types of nanomaterials and 

the types of nanotechnologies that are assessed in terms of environmental and human health safety and so I think of this as a chemist 

and the ideal would be to come up with models that we can fit new 

nanomaterials into as they become available where we have some 

applicable—some idea of how these new materials will behave with 

reference to materials we’ve studied in the past. 

83 

That’s the best way, I think, to leverage our scientific knowledge. 

Senator KERRY. Mr. Rejeski. 

Mr. REJESKI. I think one of the most important things we can actually do is provide adequate resources to some of these agencies 

that provide oversight. I mean the FDA an incredibly powerful 

brand for people that are trying to bring products into the market. 

The FDA’s own science board just did a fairly extensive examination of their capacities and one of the things they said was the development of new medical products based on what they said was 

new science, which would include genomics nanotech, cannot be 

adequately regulated by the FDA at this moment. 

I mean, basically, we’ve just witnessed over a hundred deaths on 

an FDA-approved product, a blood thinner. So I think, you know, 

one of the things that we’re looking at, and it’s a much wider area, 

is just making sure that these agencies, such as the FDA, the Consumer Product Safety Commission, EPA, have the resources. They 

are totally starved under the NNI because 60 percent of the environmental health and safety research is going to the NSF. 

NSF is a phenomenal agency but NSF will not answer any of the 

questions that we’re going to have to answer around this product. 

Meanwhile, all the agencies that really are required to provide 

oversight and the science that’s behind oversight because we don’t 

want oversight built on inadequate science are starved, and I think 

that’s part of the strategy that we haven’t gotten right yet and it’s 

critical now as we move more of these products, whether they’re 

medical applications, whether they’re cosmetic, whatever it is, into 

the commercial realm. 

So I think part of it is actually doing something that we need to 

do generally in the government and obviously the Congress has 

been holding hearings about consumer product safety, about the 

EPA, but I think a strong FDA helps in the long run because the 

entire world cares about the FDA’s clinical trial process. 

Senator KERRY. I’m going to come to you, Mr. Nordan, in just a 

minute, but who was it, Dr. Ferguson or Dr. Goel, who mentioned 

the negative hype? That’s what I thought, Dr. Goel. 

It seems to me the only way to push back against the negative 

hype is going to be to do the scientific research and develop a kind 

of transparent accountable understanding of the American people 

of what they’re dealing with, isn’t it? 

Dr. GOEL. I agree, yes. I think that—— 

Senator KERRY. Can you do that adequately without running into 

the problem that I think Dr. Heath appropriately raises, which is, 

scaring everybody away and creating such an albatross of a process 

that you reduce innovation? 

Dr. GOEL. I think absolutely. 

Senator KERRY. What’s the key to that? 

Dr. GOEL. The key to that is letting the research happen, remove 

the shackles around the creative research process, let that happen. 

Senator KERRY. Right. 

Dr. GOEL. Once the research tries to, as he said, get out of the 

lab and go into the marketplace and starts to cross the gamut, then 

bring in the regulatory thresholds that you would apply to any 

other product. 

Senator KERRY. Does that work for you, Dr. Heath? 

84 

Dr. HEATH. I think if those regulatory bars you have to jump 

over are carefully thought out, absolutely. 

Senator KERRY. But if they come after the initial research 

steps—— 

Dr. HEATH. It’s kind of nice to know what’s down the road so 

that you, you know, focus your efforts in—— 

Senator KERRY. Was that any different from where you are now? 

Dr. HEATH. No, I would say for the drugs—so let me be very 

clear. I believe for anything that’s nanotherapeutic or drug-related, 

we have a great process. We do not need to step into new regulations. 

Senator KERRY. Right. 

Dr. HEATH. For other stuff that may not be certain things you 

ingest, it could be a chemical, could be a face powder, could be a 

solar cell, we may need to have a certain level of standards that 

we establish. 

Senator KERRY. Good line to draw. I accept that. Mr. Nordan. 

Mr. NORDAN. To give some insight from how the business community views this, we work with a large number of corporations 

across a large number of industries, from electronics through to 

chemicals and also in life sciences. 

I would tell you that we should not conflate in this discussion 

laboratory research and regulation of manufactured goods that are 

manufactured to large scale. I don’t think there is anyone who is 

calling for or deeply focused on setting limits, as we’ve seen, for example, with stem cell research, on what scientists can and cannot 

do in the nanoscale regime in the laboratory. 

It’s a very different issue when you come to manufactured goods, 

and I think what’s unique in nanotechnology is that you have both 

large companies, like Dupont, as well as small ones, like Alta 

Nanotechnologies, that are asking for regulatory clarity. 

Normally you think of this as trying to duck regulations and 

duck red tape and in this case, you have folks at large chemical 

companies, electronics firms, medical products companies who are 

simply asking not for new regulations but for regulatory clarity on 

what currently applies. 

A client of ours that I spent some time with recently, a CTO of 

a billion dollar, multibillion dollar chemicals, multinational chemicals company on the East Coast, and sat down with him, went 

through some nanotechnology research. We were batting some 

questions back and forth. He said, ‘‘You know what, Matthew? It’s 

amazing to me that 7 years after the introduction of the National 

Nanotechnology Initiative, I don’t know whether TOSCA applies to 

my products or not.’’ 

You would not suit up and go into a football game if you didn’t 

know what the rules were and when someone could tackle you and 

businesses are very concerned about bringing products to market, 

that in some cases their rivals in Europe and in East Asia are 

doing that well ahead of them, not because they’re concerned about 

the consequences of regulation but because they don’t know what 

the rules of the game are. 

Senator KERRY. Fair enough. That’s very important. That’s a 

very important view obviously for us to factor in as we think about 

this. 

85 

How about the foreign competition piece? Will this work if we 

have a fairly commonsensical but nevertheless accountable and 

transparent system but the Chinese don’t? 

Mr. NORDAN. Well, if I could take a shot at that, I think that 

there are places in the world where there are straightforward commonsense mechanisms that might be considered more onerous than 

the United States where there is actually much more active nanotechnology research and development, at least on behalf of large 

corporations. 

We normally think of Europe as being a generally more cautious 

and more precautionary group of societies when it comes to new 

chemicals, new materials. Regulations like REACH, for example, is 

a very broad-ranging chemical regulation in the EU or an example 

of that. Yet when you compare the Dows and Duponts and GE 

Plastics of the world with their rivals in Europe, companies like 

Salve and BASF and DSM, you actually find that the European 

companies have been much more aggressive in conducting research 

on nanoparticles and being very straightforward and transparent 

with the public on how they’re being used and launching products 

that are actively pitched for their nanobenefits, nanobenefits, and 

I think that comes down to regulatory clarity. 

I don’t think there is an incompatibility between straightforward 

common sense application of regulatory regimes and aggressive 

commercial activity in nanotech. I think the European example argues that they can come together. 

Senator KERRY. Well, folks, regrettably, I’ve got to be over in the 

Capitol for a briefing on Syria and North Korea and what’s going 

on. I apologize for breaking up, but as I said, I’ll leave the record 

open. 

I appreciate all of you coming here. This is really very, very helpful. We obviously want to get this thing reauthorized and do this 

well and if you have further thoughts you would like to share with 

the Committee, the record is open. We welcome your further comments based on what you’ve heard today or if you think you’d like 

to extrapolate a little bit, we’d welcome that. 

It’s an interesting topic. I regret more people weren’t able to be 

here, but Thursday afternoon, having just had our last vote sort of 

affects what happens here a little bit, I apologize for that. Everybody has pretty intensive schedules. 

But this is a topic everybody is intrigued by and learning more 

about. We’ve clearly learned around here to try as hard as we can 

not to get in the way and I think we’re getting better at that, not 

to overreach but to come up with something that’s really thoughtful 

and workable. We’ll do our best here to be able to try to do that 

because we want this sector to flourish. 

I’m convinced that this, together with a few other things, like artificial intelligence, robotics and communications and so forth, are 

the future for us in terms of high value-added jobs and technology 

advances and so forth, life sciences obviously, bio, but this is a big 

deal for us. 

So we want to try to get it right and I hope you’ll help us do that. 

You certainly have to a great degree today. 

So all the way from California and elsewhere, thanks so much 

for coming in. We really appreciate it. 

86 

We stand adjourned. 

[Whereupon, at 4:25 p.m., the hearing was adjourned.] 

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