[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]


 
                        ENVIRONMENTAL AND SAFETY
                       IMPACTS OF NANOTECHNOLOGY:
                        WHAT RESEARCH IS NEEDED?

=======================================================================

                                HEARING

                               BEFORE THE

                          COMMITTEE ON SCIENCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                               __________

                           NOVEMBER 17, 2005

                               __________

                           Serial No. 109-34

                               __________

            Printed for the use of the Committee on Science


     Available via the World Wide Web: http://www.house.gov/science




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                                 ______

                          COMMITTEE ON SCIENCE

             HON. SHERWOOD L. BOEHLERT, New York, Chairman
RALPH M. HALL, Texas                 BART GORDON, Tennessee
LAMAR S. SMITH, Texas                JERRY F. COSTELLO, Illinois
CURT WELDON, Pennsylvania            EDDIE BERNICE JOHNSON, Texas
DANA ROHRABACHER, California         LYNN C. WOOLSEY, California
KEN CALVERT, California              DARLENE HOOLEY, Oregon
ROSCOE G. BARTLETT, Maryland         MARK UDALL, Colorado
VERNON J. EHLERS, Michigan           DAVID WU, Oregon
GIL GUTKNECHT, Minnesota             MICHAEL M. HONDA, California
FRANK D. LUCAS, Oklahoma             BRAD MILLER, North Carolina
JUDY BIGGERT, Illinois               LINCOLN DAVIS, Tennessee
WAYNE T. GILCHREST, Maryland         RUSS CARNAHAN, Missouri
W. TODD AKIN, Missouri               DANIEL LIPINSKI, Illinois
TIMOTHY V. JOHNSON, Illinois         SHEILA JACKSON LEE, Texas
J. RANDY FORBES, Virginia            BRAD SHERMAN, California
JO BONNER, Alabama                   BRIAN BAIRD, Washington
TOM FEENEY, Florida                  JIM MATHESON, Utah
BOB INGLIS, South Carolina           JIM COSTA, California
DAVE G. REICHERT, Washington         AL GREEN, Texas
MICHAEL E. SODREL, Indiana           CHARLIE MELANCON, Louisiana
JOHN J.H. ``JOE'' SCHWARZ, Michigan  DENNIS MOORE, Kansas
MICHAEL T. MCCAUL, Texas
VACANCY
VACANCY


                            C O N T E N T S

                           November 17, 2005

                                                                   Page
Witness List.....................................................     2

Hearing Charter..................................................     3

                           Opening Statements

Statement by Representative Sherwood L. Boehlert, Chairman, 
  Committee on Science, U.S. House of Representatives............    14
    Written Statement............................................    15

Statement by Representative Bart Gordon, Minority Ranking Member, 
  Committee on Science, U.S. House of Representatives............    15
    Written Statement............................................    16

Prepared Statement by Representative Vernon J. Ehlers, Chairman, 
  Subcommittee on Environment, Technology, and Standards, 
  Committee on Science, U.S. House of Representatives............    17

Prepared Statement by Representative Jerry F. Costello, Member, 
  Committee on Science, U.S. House of Representatives............    18

Prepared Statement by Representative Eddie Bernice Johnson, 
  Member, Committee on Science, U.S. House of Representatives....    18

Prepared Statement by Representative Michael M. Honda, Member, 
  Committee on Science, U.S. House of Representatives............    18

Prepared Statement by Representative Russ Carnahan, Member, 
  Committee on Science, U.S. House of Representatives............    19

Prepared Statement by Representative Sheila Jackson Lee, Member, 
  Committee on Science, U.S. House of Representatives............    19

                               Witnesses:

Dr. E. Clayton Teague, Director, National Nanotechnology 
  Coordination Office
    Oral Statement...............................................    21
    Written Statement............................................    22
    Biography....................................................    27

Mr. Matthew M. Nordan, Vice President of Research, Lux Research, 
  Inc.
    Oral Statement...............................................    28
    Written Statement............................................    30
    Biography....................................................    41
    Financial Disclosure.........................................    42

Dr. Krishna C. Doraiswamy, Research Planning Manager, DuPont 
  Central Research and Development
    Oral Statement...............................................    42
    Written Statement............................................    44
    Biography....................................................    47
    Financial Disclosure.........................................    48

Mr. David Rejeski, Director, Project on Emerging 
  Nanotechnologies, Woodrow Wilson International Center for 
  Scholars
    Oral Statement...............................................    48
    Written Statement............................................    50
    Biography....................................................    62
    Financial Disclosure.........................................    63

Dr. Richard A. Denison, Senior Scientist, Environmental Health 
  Program, Environmental Defense, Washington, D.C.
    Oral Statement...............................................    63
    Written Statement............................................    65
    Biography....................................................    74
    Financial Disclosure.........................................    76

Discussion.......................................................    77

             Appendix 1: Answers to Post-Hearing Questions

Dr. E. Clayton Teague, Director, National Nanotechnology 
  Coordination Office............................................    94

Dr. Krishna C. Doraiswamy, Research Planning Manager, DuPont 
  Central Research and Development...............................    99

David Rejeski, Director, Project on Emerging Nanotechnologies, 
  Woodrow Wilson International Center for Scholars...............   101

Dr. Richard A. Denison, Senior Scientist, Environmental Health 
  Program, Environmental Defense, Washington, D.C................   105

             Appendix 2: Additional Material for the Record

Letter to Chairman Sherwood Boehlert from David Rejeski, 
  Director, and Dr. Andrew Maynard, Chief Science Advisor, 
  Project on Emerging Nanotechnologies, Woodrow Wilson 
  International Center for Scholars, dated December 13, 2005.....   112

Inventory of Research on the Environmental, Health and Safety 
  Implications of Nanotechnology, Dr. Andew Maynard, Chief 
  Science Advisor, Project on Emerging Nanotechnologies, Woodrow 
  Wilson International Center for Scholars.......................   115

Statement by Keith Blakely, Chief Executive Officer, 
  NanoDynamics, Inc..............................................   129

Approaches to Safe Nanotechnology: An Information Exchange With 
  NIOSH, National Institute for Occupational Safety and Health 
  Centers for Disease Control and Prevention, October 1, 2005....   132

Informed Public Perceptions of Nanotechnology and Trust in 
  Government, Jane Macoubrie, Senior Advisor, Project on Emerging 
  Nanotechnologies, Woodrow Wilson International Center for 
  Scholars.......................................................   155


 ENVIRONMENTAL AND SAFETY IMPACTS OF NANOTECHNOLOGY: WHAT RESEARCH IS 
                                NEEDED?

                              ----------                              


                      THURSDAY, NOVEMBER 17, 2005

                  House of Representatives,
                                      Committee on Science,
                                                    Washington, DC.

    The Committee met, pursuant to call, at 10:00 a.m., in Room 
2318 of the Rayburn House Office Building, Hon. Sherwood 
Boehlert [Chairman of the Committee] presiding.


                            hearing charter

                          COMMITTEE ON SCIENCE

                     U.S. HOUSE OF REPRESENTATIVES

                        Environmental and Safety

                       Impacts of Nanotechnology:

                        What Research Is Needed?

                      thursday, november 17, 2005
                         10:00 a.m.-12:00 p.m.
                   2318 rayburn house office building

1. Purpose

    On Thursday, November 17, 2005, the Committee on Science of the 
House of Representatives will hold a hearing to examine current 
concerns about environmental and safety impacts of nanotechnology and 
the status and adequacy of related research programs and plans. The 
Federal Government, industry and environmental groups all agree that 
relatively little is understood about the environmental and safety 
implications of nanotechnology and that greater knowledge is needed to 
enable a nanotechnology industry to develop and to protect the public. 
The hearing is designed to assess the current state of knowledge of, 
and the current research plans on the environmental and safety 
implications of nanotechnology.

2. Witnesses

Dr. Clayton Teague is the Director of the National Nanotechnology 
Coordination Office, the office that coordinates federal nanotechnology 
programs. The office is the staff arm of the Nanoscale Science, 
Engineering, and Technology Subcommittee of the National Science and 
Technology Council (NSTC). NSTC includes all federal research and 
development (R&D) agencies and is the primary coordination group for 
federal R&D policy.

Mr. Matthew M. Nordan is the Vice President of Research at Lux Research 
Inc., a nanotechnology research and advisory firm.

Dr. Krishna C. Doraiswamy is the Research Planning Manager at DuPont 
Central Research and Development, and is responsible for coordinating 
DuPont's nanotechnology efforts across the company's business units.

Mr. David Rejeski is the Director of the Project on Emerging 
Nanotechnologies at the Woodrow Wilson International Center for 
Scholars.

Dr. Richard Denison is a Senior Scientist at Environmental Defense.

3. Overarching Questions

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

4. Brief Overview

          Nanotechnology is expected to become a major engine 
        of economic growth in the coming years. According to Lux 
        Research,\1\ a private research firm that focuses on 
        nanotechnology, in 2014 there could be $2.6 trillion worth of 
        products in the global marketplace which have incorporated 
        nanotechnology--15 percent of manufacturing output. Lux also 
        predicts that in 2014, 10 million manufacturing jobs 
        worldwide--11 percent of total manufacturing jobs--will involve 
        manufacturing these nanotechnology-enabled products.
---------------------------------------------------------------------------
    \1\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October 
2004.

          There is a growing concern in industry that the 
        projected economic growth of nanotechnology could be undermined 
        by real environmental and safety risks of nanotechnology or the 
---------------------------------------------------------------------------
        public's perception that such risks exist.

          The small size, large surface area and unique 
        behavioral characteristics of nanoparticles present distinctive 
        challenges for those trying to assess whether these particles 
        pose potential environmental risks. For example, nanoscale 
        materials such as buckyballs, nano-sized clusters of carbon 
        atoms, behave very differently than their chemically-equivalent 
        cousin, pencil lead. There is an unusual level of agreement 
        among researchers, and business and environmental organizations 
        that basic scientific information needed to assess and protect 
        against potential risks does not yet exist.

          In December 2003, the President signed the 21st 
        Century National Nanotechnology Research and Development Act 
        (P.L. 108-153), which originated in the Science Committee. This 
        Act provided a statutory framework for the interagency National 
        Nanotechnology Initiative (NNI). Among other activities, the 
        Act called for the NNI to ensure that research on environmental 
        concerns is integrated with broader federal nanotechnology 
        research and development (R&D) activities.

          Federal funding for the NNI has grown from $464 
        million in fiscal year 2001 (FY01) to a requested $1.1 billion 
        in FY06. Of the requested FY06 level, the President's budget 
        proposes that $38.5 million (four percent of the overall 
        program) be directed to research on environmental and safety 
        implications of nanotechnology.

5. Background

    The National Academy of Sciences describes nanotechnology as the 
``ability to manipulate and characterize matter at the level of single 
atoms and small groups of atoms.'' An Academy report describes how 
``small numbers of atoms or molecules. . .often have properties (such 
as strength, electrical resistivity, electrical conductivity, and 
optical absorption) that are significantly different from the 
properties of the same matter at either the single-molecule scale or 
the bulk scale.'' \2\
---------------------------------------------------------------------------
    \2\ Small Wonders, Endless Frontiers: A Review of the National 
Nanotechnology Initiative, National Research Council/National Academy 
of Sciences, 2002.
---------------------------------------------------------------------------
    Nanotechnology is an enabling technology that will lead to 
``materials and systems with dramatic new properties relevant to 
virtually every sector of the economy, such as medicine, 
telecommunications, and computers, and to areas of national interest 
such as homeland security.'' \3\ As an enabling technology, it is 
expected to be incorporated into existing products, resulting in new 
and improved versions of these products. Some nanotechnology-enabled 
products are already on the market, including stain-resistant, wrinkle-
free pants, ultraviolet-light blocking sun screens, and scratch-free 
coatings for eyeglasses and windows. In the longer run, nanotechnology 
may produce revolutionary advances in a variety of industries, such as 
faster computers, lighter and stronger materials for aircraft, more 
effective and less invasive ways to find and treat cancer, and more 
efficient ways to store and transport electricity.
---------------------------------------------------------------------------
    \3\ Id.
---------------------------------------------------------------------------
    The projected economic growth of nanotechnology is staggering. In 
October 2004, Lux Research, a private research firm, released its most 
recent evaluation of the potential impact of nanotechnology. The 
analysis found that, in 2004, $13 billion worth of products in the 
global marketplace incorporated nanotechnology. The report projected 
that, by 2014, this figure will rise to $2.6 trillion--15 percent of 
manufacturing output in that year. The report also predicts that in 
2014, ten million manufacturing jobs worldwide--11 percent of total 
manufacturing jobs--will involve manufacturing these nanotechnology-
enabled products.\4\
---------------------------------------------------------------------------
    \4\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October 
2004.
---------------------------------------------------------------------------

6.  How Might Environmental and Safety Risks Affect the 
                    Commercialization of Nanotechnology?

Lux Research Report on Environmental and Safety Risks of Nanotechnology
    In May, 2005, Lux Research published a comprehensive analysis of 
how environmental and safety risks could affect the commercialization 
of nanotechnology.\5\ While a limited number of studies have been done 
on specific environmental impacts, the report concludes that the few 
that have been done raise sufficient cause for concern. This leads to 
what the report calls a fundamental paradox facing companies developing 
nanotechnology: ``They must plan for risks without knowing precisely 
what they are.'' The report then identifies two classes of risk that 
are expected to effect commercialization: ``real risks that 
nanoparticles may be hazardous and perceptual risks that they pose a 
threat regardless of whether or not it is real.'' The report calculates 
that at least 25 percent of the $8 trillion in total projected revenue 
from products incorporating nanotechnology between 2004 and 2014 could 
be affected by real risks and 38 percent could be affected by perceived 
risk.''
---------------------------------------------------------------------------
    \5\ Lux Research, ``A Prudent Approach to Nanotech Environmental, 
Health and Safety Risks.'' May 2005
---------------------------------------------------------------------------
    The report describes that varying levels of risk are suspected for 
different types of nanomaterials and products and for different phases 
of a product's life cycle. For example, some nanoclay particles raise 
little initial concern because they would be locked up in composites to 
be used in automotive bodies. On the other hand, cadmium-selenide 
quantum dots that could be injected into the body for medical imaging 
tests are highly worrisome due to the toxicity of cadmium-selenide and 
the fact that they would be used within the human body.
    Another factor that contributes to the potential risk of different 
nanotechnology-related products is the expected exposure of people and 
the environment over the product's life cycle.
    The manufacturing phase is the first area of concern because 
workers potentially face repeated exposure to large amounts of 
nanomaterials.\6\ During product use, the actual risk will vary 
depending in part on whether the nanoparticles have been fixed 
permanently in a product, like within a memory chip in a computer, or 
are more bio-available, like in a sun screen where exposure may be more 
direct or may continue over a long period of time. Finally, the 
greatest uncertainties exist about the risks associated with the end of 
a product's life because it is difficult to predict what method of 
disposal, such as incineration or land disposal, will be used for a 
given material, and there has been little research on, for example, 
what will happen to nanomaterials within products stored in a landfill 
over 100 years.
---------------------------------------------------------------------------
    \6\ Lux Research's findings on worker exposure are consistent with 
the concerns expressed in the recent report on the NNI by the 
President's Council of Advisors on Science and Technology. The report, 
National Nanotechnology Initiative at Five Years: Assessment and 
Recommendations of the National Nanotechnology Advisory Panel, is 
available online at http://www.nano.gov/
FINAL-PCAST-NANO-REPORT.pdf.
---------------------------------------------------------------------------
    The Lux Research report finds that nanotechnology also faces 
significant perceived risks. These risks are driven by people's general 
concerns about new technologies that they may be exposed to without 
being aware of it. However, public perceptions of nanotechnology are 
still up in the air and may be influenced by the press and non-
governmental organizations. The report argues that, with a concerted 
effort to emphasize the benefits of nanotechnology, communicate honest 
assessments of toxicological effects, and engage all interested 
stakeholders from the outset, the public could be made comfortable with 
this new technology.
Woodrow Wilson International Center Study on Public Perceptions
    A more in-depth survey of public perception of nanotechnology was 
recently completed by Woodrow Wilson Center's Project on Emerging 
Technologies.\7\ The study found that the public currently has little 
knowledge about nanotechnology or about how risks from nanotechnology 
will be managed. This lack of information can lead to mistrust and 
suspicion. However, the study shows that when people learned more about 
nanotechnology and its promised benefits, approximately 80 percent were 
supportive or neutral about it. Once informed, people also expressed a 
strong preference for having more information made available to the 
public, having more testing done before products were introduced, and 
having an effective regulatory system. They do not trust voluntary 
approaches and tend to be suspicious of industry. The lesson, according 
to the report, is that there is still time to shape public perception 
and to ensure that nanotechnology is developed in a way that provides 
the public with information it wants and establishes a reasonable 
regulatory framework.
---------------------------------------------------------------------------
    \7\ Informed Public Perception of Nanotechnology and Trust in 
Government, Project on Emerging Nanotechnologies, Woodrow Wilson 
International Center for Scholars is available online at http://
www.pewtrusts.com/pdf/Nanotech-0905.pdf.
---------------------------------------------------------------------------

7. Emerging Environmental and Safety Concerns

    Initial research on the environmental impacts of nanotechnology has 
raised concerns. For example, early research on buckyballs (nano-sized 
clusters of 60 carbon atoms) suggests that they may accumulate in fish 
tissue. Although it may turn out that many, if not most, nanomaterials 
will be proven safe in and of themselves and within a wide variety of 
products, more research is needed before scientists can determine how 
they will interact with people and the environment in a variety of 
situations.
    Nanotechnology's potential to affect many industries stem from that 
fact that many nanoscale materials behave differently than their 
macroscale counterparts. For example, nano-sized quantities of some 
electrical insulating materials become conductive, insoluble substances 
may become soluble, some metals become explosive, and materials may 
change color or become transparent. These novel features create 
tremendous opportunities for new and exciting applications, but also 
enable potentially troubling new ways for known materials to interact 
with the human body or be transported through the environment. It is 
difficult and would be misleading to extrapolate from current 
scientific knowledge on how materials behave in their macro-form to how 
they will behave in nano-form, and new techniques to assess toxicity, 
exposure, and ultimately public and environmental risks from these 
materials may be needed.
Widely Recognized Research and Development Needs
    Businesses, non-governmental organizations, academic researchers, 
federal agencies, and voluntary standards organizations all have 
efforts underway to address concerns about the environmental and safety 
implications of nanotechnology. However, a number of organizations, 
including business associations and environmental groups, worry that 
environmental R&D is not keeping pace with the rapid commercialization 
and development of new nanotechnology-related products. There is 
widespread agreement on the following research and standards needs:

          Nanotechnology needs an accepted nomenclature. For 
        example, ``buckyballs'' is the equivalent of a trade name; it 
        does not convey critical information about the content, 
        structure, or behavior of nanoparticles as traditional chemical 
        nomenclature does for traditional chemicals. The lack of 
        nomenclature creates a variety of problems. For example, it is 
        difficult for researchers to know whether the nanomaterial they 
        are working with is the same as that presented in other 
        research papers. Similarly, it is difficult for a company to 
        know whether it is buying the same nanomaterial from one 
        company that it previously bought from another.

          Nanotechnology needs an agreed upon method for 
        characterizing particles. Nanoparticles unique size enables 
        unusual behavior. At these small sizes, particles can have 
        different optical and electrical properties than larger 
        particles of the same material. In addition, the large surface 
        area of nanoparticles relative to their mass makes 
        nanoparticles more reactive with their surroundings. Further 
        complicating efforts to characterize nanomaterials is that 
        small changes to some nanoparticles, such as altering the 
        coatings of buckyballs, significantly modify the physical 
        properties (and hence the potential toxicity) of the particles.

          A great deal more information is needed on the 
        mechanisms of nanoparticle toxicity. Early studies suggest that 
        a variety of nanoparticles damage cells through oxidative 
        stress. (Oxidation is believed to be a common source of many 
        diseases such as cancer.) A better understanding of the 
        chemical reactions that nanoparticles provoke or take part in 
        within living organisms will enable researchers to more 
        effectively predict which nanomaterials are most likely to 
        cause problems.

          Basic information on how nanomaterials enter and move 
        through the human body are needed. Early studies point to wide 
        variations in the toxicity of nanomaterials depending on the 
        how exposure occurred--through the mouth, skin contact, 
        inhalation, or intravenously. Particles in the range of 1-100 
        nanometers are small enough to pass through cell walls and 
        through the blood-brain barrier, making them particularly 
        mobile once they enter the body. There is also concern that 
        some nanoparticles could lodge in the lungs and might be so 
        small as to be overlooked by the body's defense mechanisms that 
        would normally remove these invaders from the body.

          More research is needed on how and why some 
        nanoparticles appear to behave one way as individual particles, 
        but behave differently when they accumulate or agglomerate. One 
        study of buckyballs, for example, found that while individual 
        buckyballs are relatively insoluble, they have a tendency to 
        aggregate, which makes them highly soluble and reactive with 
        bacteria, raising concerns about their transport in watersheds 
        and their impact on ecosystems.

    According to a variety of experts, many of whom are familiar with 
the development of the largely mature databases available on the 
behavior and toxicity of various chemicals, development of a parallel 
collection of information on nanotechnology-related materials may take 
as long as 10-15 years.
Call for a Governmental Program on Environmental and Safety 
        Implications of Nanotechnology
    Recently, the American Chemistry Council and the environmental 
organization, Environmental Defense, agreed on a Joint Statement of 
Principles that should guide a governmental program for addressing the 
potential risks of nanoscale materials.\8\ They call for, among other 
things,
---------------------------------------------------------------------------
    \8\ Environmental Defense and American Chemistry Council 
Nanotechnology Panel, Joint Statement of Principles, Comments on EPA's 
Notice of Public Meeting on Nanoscale Materials, June 23, 2005. The 
full statement is available online at http://
www.environmentaldefense.org/documents/4857-ACC-
ED-nanotech.pdf.

          ``a significant increase in government investment in 
        research on the health and environmental implications of 
---------------------------------------------------------------------------
        nanotechnology,''

          ``the timely and responsible development of 
        regulation of nanomaterials in an open and transparent 
        process,''

          ``an international effort to standardize test 
        protocols, hazard and exposure assessment approaches and 
        nomenclature and terminology,''

          ``appropriate protective measures while more is 
        learned about potential human health or environmental 
        hazards,'' and

          a government assessment of ``the appropriateness of 
        or need for modification of existing regulatory frameworks.''

8. Federal Government Activities

    The National Nanotechnology Initiative (NNI) is a multi-agency 
research and development (R&D) program begun in 2001 and formally 
authorized by Congress in 2003.\9\ Currently, 11 federal agencies have 
ongoing programs in nanotechnology R&D, while another 11 agencies 
participate in the coordination and planning work associated with the 
NNI. The primary goals of the NNI are to foster the development of 
nanotechnology and coordinate federal R&D activities.\10\
---------------------------------------------------------------------------
    \9\ In 2003, the Science Committee wrote and held hearings on the 
21st Century National Nanotechnology Research and Development Act, 
which was signed into law on December 3, 2003. The Act authorizes $3.7 
billion over four years (FY05 to FY08) for five agencies (the National 
Science Foundation, the Department of Energy, the National Institute of 
Standards and Technology, the National Aeronautics and Space 
Administration, and the Environmental Protection Agency). The Act also: 
adds oversight mechanisms--an interagency committee, annual reports to 
congress, an advisory committee, and external reviews--to provide for 
planning, management, and coordination of the program; encourages 
partnerships between academia and industry; encourages expanded 
nanotechnology research and education and training programs; and 
emphasizes the importance of research into societal concerns related to 
nanotechnology to understand the impact of new products on health and 
the environment.
    \10\ The goals of the NNI are to maintain a world-class research 
and development program; to facilitate technology transfer; to develop 
educational resources, a skilled workforce, and the infrastructure and 
tools to support the advancement of nanotechnology; and to support 
responsible development of nanotechnology.
---------------------------------------------------------------------------
    Federal funding for the NNI has grown from $464 million in FY01 to 
a requested $1.1 billion in FY06. Of the requested FY06 level, the 
President's budget proposes that $38.5 million (four percent of the 
overall program) be directed to research on environmental, health, and 
safety implications of nanotechnology (see Table 1).\11\
---------------------------------------------------------------------------
    \11\ There is of course additional federal funding being spent on 
fundamental nanotechnology R&D that has the potential to inform future 
studies on environmental and safety impacts, so the $38.5 million may 
be a low estimate of the relevant research underway.




    To coordinate environmental and safety research on nanotechnology, 
the National Science and Technology Council organized in October 2003 
the interagency Nanotechnology Environmental and Health Implications 
Working Group (NEHI WG), composed of agencies that support 
nanotechnology research as well as those with responsibilities for 
regulating nanotechnology-based products. NEHI WG is in the process of 
developing a framework for environmental R&D for nanotechnology that it 
expects to release in January 2006. To provide useful guidance to 
agencies, Congress, academic researchers, industry, environmental 
groups, and the public, the research framework will need to define the 
scale and scope of the needed research, set priorities for research 
areas, provide information that can affect agency-directed spending 
decisions, and be specific enough to serve as overall research strategy 
for federal and non-federal research efforts.
    Currently, over 60 percent of the environmental research funding is 
provided by the National Science Foundation (NSF). In FY05 and FY06, 
NSF is putting a small amount of funding (approximately $1 million each 
year) into a joint solicitation on investigating environmental and 
human health effects of manufactured nanomaterials with the 
Environmental Protection Agency, the National Institute for 
Occupational Safety and Health (NIOSH), and National Institute of 
Environmental Health Sciences (NIEHS). However, the majority of the 
NSF's funding in this area is distributed to projects proposed in 
response to general calls for nanotechnology-related research; projects 
are selected based on the quality and potential impact of the proposed 
research. It is not distributed based on the research needs of 
regulatory agencies such as EPA, OSHA or FDA. Currently NSF and the 
research community base their understanding of priorities in 
environmental research on a 2003 workshop ``Nanotechnology Grand 
Challenge in the Environment,'' \12\ but the federal framework being 
developed by the NEHI WG should provide helpful, updated guidance for 
future research solicitations and proposals.
---------------------------------------------------------------------------
    \12\ ``Nanotechnology Grand Challenge in the Environment: Research 
Planning Workshop Report,'' from the workshop held May 8-9, 2003, is 
available online at http://es.epa.gov/ncer/publications/nano/
nanotechnology4-20-04.pdf.
---------------------------------------------------------------------------
    EPA's Office of Research and Development is the second largest 
sponsor of research on the environmental implications of 
nanotechnology, providing approximately 10 percent ($4 million) of the 
federal investment. At the beginning of the NNI, EPA focused its 
research program on the development of innovative applications of 
nanotechnology designed to improve the environment, but in FY03, EPA 
began to shift its focus to research on the environmental implications 
of nanotechnology. In FY04 and FY05, EPA has increasingly tailored its 
competitive solicitations to attract research proposals in areas that 
will inform decisions to be made by the agency's regulatory programs. 
In January 2006, EPA is planning to release an agency-wide 
nanotechnology framework that will describe both the potential 
regulatory issues facing the agency and the research needed to support 
decisions on those issues.
    NIOSH sponsors eight percent ($3 million) of research on 
environmental and safety implications of nanotechnology, and its 
activities are driven by the fact that minimal information is currently 
available on dominant exposure routes, potential exposure levels and 
material toxicity. NIOSH is attempting fill those gaps by building on 
its established research programs on ultra-fine particles (typically 
defined as particles smaller than 100 nanometers). The National 
Toxicology Program, an interagency collaboration between NIOSH and 
NIEHS, also supports a portfolio of projects studying the toxicity of 
several common nanomaterials, including quantum dots, buckyballs, and 
the titanium dioxide particles that have been used in cosmetics. NIOSH 
published a draft research strategy in late September 2005.

Private Sector Research
    There is little information about how much individual companies are 
investing in research on the environmental and safety implications of 
nanotechnology. There are, however, a variety of activities underway in 
industry associations emphasizing the importance of research in this 
area. Members of the American Chemistry Council's ChemStar panel, for 
example, have committed to ensuring that the commercialization of 
nanomaterials proceeds in ways that protect workers, the public and the 
environment. Other elements of the chemical and semiconductor 
industries have formed the Consultive Boards for Advancing 
Nanotechnology, which has developed a list of key research and 
evaluation, identifying toxicity testing, measurement, and worker 
protection.

Potential Regulatory and Policy Issues.
    Some companies, especially large firms that operate in many 
industry sectors, have significant experience dealing with 
environmental issues and risk management plans, are comfortable dealing 
with potential environmental and safety implications arising from 
nanotechnology. However, many companies that are involved with 
nanotechnology-related products are small, start-up companies or small 
laboratories with less experience in this area. According to the Lux 
Research report described above, some of these small enterprises do not 
carry out testing because they lack the resources to do so, while 
others do not do so because of fear they might learn something that 
could create legal liability or create barriers to commercializing 
their product.
    At EPA, the regulatory program offices are trying to determine 
whether and to what degree existing regulatory programs can and should 
be applied to nanotechnology. For example, EPA is considering how the 
Toxic Substances Control Act (TSCA) will apply to nanotechnology, 
having recently approved the first nanotechnology under that statute. 
(See Appendix A for a recent Washington Post article discussing the 
issue). Enacted in 1976, TSCA authorizes EPA to regulate new and 
existing chemicals and provides EPA with an array of tools to require 
companies to test chemicals and adopt other safeguards. Decisions on 
conventional chemicals under TSCA are driven by a chemical's name, test 
data, and models of toxicity and exposure. Because much of this 
information does not yet exist for nanotechnology, EPA is having a 
difficult time deciding how best to proceed. The lack of information 
led to EPA's recent proposal to create a voluntary program under which 
companies would submit information that would help the agency learn 
about nanotechnology more quickly. EPA is now evaluating all of its 
water, air and land regulatory responsibilities to determine whether 
and how EPA should handle nanotechnology in these areas.
    Other federal agencies with regulatory responsibilities, such as 
the Food and Drug Administration and the Occupational Safety and Heath 
Administration, are also trying to determine how they will address 
environmental and safety concerns related to nanotechnology.
    A number of observers, including the United Kingdom's Royal 
Society,\13\ have suggested a precautionary approach to nanotechnology 
until more research has been completed. They urge caution especially 
regarding applications in which nanoparticles will be purposely 
released into environment. Examples of these so-called dispersive uses 
are nanomaterials used to clean contaminated groundwater or those that 
when discarded enter the sewer system and thereby the Nation's 
waterways.
---------------------------------------------------------------------------
    \13\ The United Kingdom's Royal Society and Royal Academy of 
Engineering's report ``Nanoscience and Nanotechnologies: Opportunities 
and Uncertainties'' was published in July 2004 and is available online 
at http://www.nanotec.org.uk/finalReport.htm
---------------------------------------------------------------------------

9. Witness Questions

    The witnesses were asked to address the following questions in 
their testimony:
Questions for Dr. Clayton Teague
    In your testimony, please briefly describe current federal efforts 
to address possible environmental and safety risks associated with 
nanotechnology and address the following questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          How much is the Federal Government spending for 
        research on environmental and safety implications of 
        nanotechnology? Which agencies have the lead? What additional 
        steps are needed?

Questions for Mr. Matthew Nordan
    In your testimony, please briefly describe the major findings of 
the Lux Research report on environmental and safety issues associated 
with nanotechnology and address the following questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Questions for Dr. Krishna Doraiswamy
    In your testimony, please briefly describe what DuPont is doing to 
address possible environmental and safety risks associated with 
nanotechnology and answer the following questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Questions for Mr. David Rejeski
    In your testimony, please briefly describe the major findings of 
the Wilson Center's recent study on public perceptions about 
nanotechnology and answer the following four questions:

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Questions for Dr. Richard Denison

          What impacts are environmental and safety concerns 
        having on the development and commercialization of 
        nanotechnology-related products and what impact might these 
        concerns have in the future?

          What are the primary concerns about the environmental 
        and safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Are current federal and private research efforts 
        adequate to address concerns about environmental and safety 
        impacts of nanotechnology? If not, what additional steps are 
        necessary?

Appendix A

                 Nanotechnology's Big Question: Safety

              Some Say Micromaterials Are Coming to Market

                       Without Adequate Controls

                          The Washington Post
                       October 23, 2005, page A11
            By Juliet Eilperin, Washington Post Staff Writer

    With little fanfare, the Environmental Protection Agency has for 
the first time ruled on a manufacturer's application to make a product 
composed of nanomaterials, the new and invisibly small particles that 
could transform the Nation's engineering, industrial and medical 
sectors.
    The agency's decision to approve the company's plan comes amid an 
ongoing debate among government officials, industry representatives, 
academics and environmental advocates over how best to screen the 
potentially toxic materials. Just last week, a group of academics, 
industry scientists and federal researchers, working under the auspices 
of the nonprofit International Life Sciences Institute, outlined a set 
of principles for determining the human health effects of nanomaterial 
exposures.
    By year-end, the EPA plans to release a proposal on how companies 
should report nanomaterial toxicity data to the government.
    ``Toxicity studies are meaningless unless you know what you're 
working with,'' said Andrew Maynard, who helped write the institute's 
report and serves as chief science adviser to the Project on Emerging 
Nanotechnologies at the Woodrow Wilson International Center for 
Scholars, a Washington-based think tank.
    Because of their tiny size, nanomaterials have special properties 
that make them ideal for a range of commercial and medical uses, but 
researchers are still trying to determine how they might affect humans 
and animals. Gold, for example, may behave differently when introduced 
at nanoscale into the human body, where it is chemically inert in 
traditional applications.
    The institute's report urged manufacturers and regulators to 
evaluate the properties of nanomaterials in laboratory tests, adding: 
``There is a strong likelihood that the biological activity of 
nanoparticles will depend on physiochemical parameters not routinely 
considered in toxicology studies.''
    The EPA decided last month to approve the ``pre-manufacture'' of 
carbon nanotubes, which are hollow tubes made of carbon atoms and 
potentially can be used in flat-screen televisions, clear coatings and 
fuel cells. The tubes, like other nanomaterials, are only a few ten-
thousandths the diameter of a human hair.
    Jim Willis, who directs the EPA's chemical control division in the 
Office of Pollution Prevention and Toxics, said he could not reveal the 
name of the company that received approval for the new technology or 
describe how that technology might be marketed. He added, however, that 
the EPA reserved the right to review the product again if the company 
ultimately decides to bring it to market.
    Nanomaterials are already on the market in cosmetics, clothing and 
other products, but these items do not fall under the EPA's regulatory 
domain. EPA officials judge applications subject to the Toxic 
Substances Control Act (TOSCA), a law dating from the mid-1970s that 
applies to chemicals.
    In a Wilson Center symposium last Thursday, Willis said ``it is a 
challenge'' to judge nanotechnology under existing federal rules.
    ``Clearly, [TOSCA] was not designed explicitly for nanoscale 
materials,'' he said, but he added that chemicals ``have quite a number 
of parallels for nanoscale materials'' and that ``in the short-term, we 
are going to learn by doing.''
    Scientific studies also suggest nanoparticles can cause health 
problems and damage aquatic life. For instance, they lodge in the lungs 
and respiratory tract and cause inflammation, possibly at an even 
greater rate than asbestos and soot do.
    ``Nanoparticles are like the roach motel. The nanoparticles check 
in but they don't check out,'' said John Balbus, health program 
director for the advocacy group Environmental Defense. ``Part of this 
is a societal balancing act. Are these things going to provide such 
incredible benefits that we're willing to take some of these risks?''
    Nanomaterials have possible environmental advantages as well. For 
instance, they can absorb pollutants in water and break down some 
harmful chemicals much more quickly than other methods.
    ``Just because something's nano doesn't mean it's necessarily 
dangerous,'' said Kevin Ausman, Executive Director of Rice University's 
Center for Biological and Environmental Nanotechnology. He added that 
when it comes to nanotechnology's toxic effects, ``we're trying to get 
that data before there's a known problem, and not after there's a known 
problem.''
    Companies such as DuPont are pushing to establish nanotechnology 
safety standards as well, in part because they have seen how 
uncertainties surrounding innovations--such as genetically modified 
foods--have sparked a backlash among some consumers.
    ``The time is right for this kind of collaboration,'' said Terry 
Medley, DuPont's Global Director of corporate regulatory affairs. 
``There's a general interest on everyone's part to come together to 
decide what's appropriate for this technology.''
    Chairman Boehlert. The hearing will come to order.
    I want to welcome everyone to this important hearing on the 
environmental and safety implications of nanotechnology, an 
issue that is likely to get increasing public attention over 
the next several years, but it is a matter that already has 
claimed the attention of this committee, and it did so some 
time ago.
    As I think everyone knows, the Science Committee has been a 
leader in pushing the Federal Government to invest in 
nanotechnology, and in creating the statutory structure to be 
sure that we stay focused on nanotechnology research and 
development in a productive way. Our National Nanotechnology 
Research and Development Act, which the President signed just 
four years ago, made it clear that nanotechnology R&D had to 
include research on the environmental implications of the 
technology, not as a sideline, but as a fundamental, integrated 
part of the research program, and we have been watching closely 
to make sure that happens.
    The need for more research on the environmental and safety 
aspects of nanotechnology is made amply clear by our non-
governmental witnesses this morning, who speak in their written 
testimony with remarkable unity. Boy, that is refreshing to 
hear from this side. Their message is clear, and it must be 
heeded: if nanotechnology is to fulfill its enormous economic 
potential, then we have to invest more right now in 
understanding what problems the technology might cause.
    This is the time to act, before we cause problems. This is 
the time to act, when there is a consensus among government, 
industry, and environmentalists. As Mr. Rejeski says in his 
testimony, this is our chance to get it right, to learn from 
past mistakes we made with new technologies.
    The writer Kurt Vonnegut once defined the information 
revolution as the idea that people could actually know what 
they are talking about, if they really want to. That is exactly 
the kind of information revolution we need in nanotechnology.
    I am pleased to say that the Administration also seems to 
feel that way, as Dr. Teague will describe this morning. But we 
need an even greater commitment from the Administration on this 
issue. We will be closely reviewing the so-called framework on 
this matter that is due out early next year, as well as the 
fiscal 2007 budget request due out in February, to ensure that 
funding is adequate.
    So, let me close by thanking our witnesses at the outset 
for the excellent, clear, and persuasive testimony they have 
prepared for today's hearing. This is exactly the kind of 
hearing that the Science Committee should be having, and that 
only we are likely to have, that is, bringing attention to an 
important issue before it becomes a crisis, before it becomes 
hopelessly polarized, before all the debate becomes 
depressingly predictable.
    So I look forward to today's hearing, and I promise you 
that we will continue to press forward with this issue.
    With that, the Chair is pleased to recognize Mr. Gordon of 
Tennessee.
    [The prepared statement of Chairman Boehlert follows:]

          Prepared Statement of Chairman Sherwood L. Boehlert

    I want to welcome everyone to this important hearing on the 
environmental and safety implications of nanotechnology--an issue that 
is likely to get increasing public attention over the next several 
years. But it's a matter that has already claimed the attention of this 
committee for some time.
    As I think everyone knows, the Science Committee has been a leader 
in pushing the Federal Government to invest in nanotechnology and in 
creating the statutory structure to be sure that we stay focused on 
nanotechnology research and development (R&D) in a productive way. And 
our National Nanotechnology Research and Development Act, which the 
President signed four years ago, made it clear that nanotechnology R&D 
had to include research on the environmental implications of the 
technology--not as a sideline, but as a fundamental, integrated part of 
the research program. And we have been watching closely to make sure 
that happens.
    The need for more research on the environmental and safety aspects 
of nanotechnology is made amply clear by our non-governmental witnesses 
this morning, who speak in their written testimony with remarkable 
unity. Their message is clear and must be heeded: if nanotechnology is 
to fulfill its enormous economic potential, then we have to invest more 
right now in understanding what problems the technology might cause.
    This is the time to act--before we cause problems. This is the time 
to act--when there is a consensus among government, industry and 
environmentalists. As Mr. Rejeski says in his testimony this is our 
chance to ``get it right''--to learn from past mistakes we made with 
new technologies.
    The writer Kurt Vonnegut once defined the ``information 
revolution'' as the idea that people could actually know what they're 
talking about, if they really want to. That's exactly the kind of 
information revolution we need in nanotechnology.
    I'm pleased to say that the Administration also seems to feel that 
way, as Dr. Teague will describe this morning. But we need an even 
greater commitment from the Administration on this issue. We will be 
closely reviewing the so-called ``framework'' on this matter that is 
due out early next year as well as the fiscal 2007 budget request due 
out in February to ensure that funding is adequate.
    So let me close by thanking our witnesses at the outset for the 
excellent, clear and persuasive testimony they have prepared for 
today's hearing. This is exactly the kind of hearing that the Science 
Committee should be having--and that only we are likely to have--that 
is, bringing attention to an important issue before it becomes a 
crisis, before it becomes hopelessly polarized, before all the debate 
becomes depressingly predictable.
    So I look forward to today's hearing, and I promise you that we 
will continue to press forward with this issue.

    Mr. Gordon. Thank you, Mr. Chairman, and once again, let me 
say I want to concur with your opening statement.
    Also, I feel there is no question that this committee 
understands the importance of nanotechnology, and recognizes 
the strong justification for a robust federal research 
investment. The Committee has held several hearings to evaluate 
the promise of nanotechnology. In 2003, the Committee took the 
lead in passing the 21st Century Nanotechnology Research and 
Development Act, which is now funded at over $1 billion a year.
    However, from the outset, we also recognized that risks may 
arise from this technology; this is the subject of today's 
hearing. Some research has suggested that nanoparticles could 
cause human health problems, and may damage aquatic life, but 
research in this area is in its infancy, and the tools are not 
available to identify and assess the risks associated with 
nanomaterials, yet many products containing nanoparticles are 
already on the market, in cosmetics, clothing, and other 
products. Some estimates are that there are as many as 700 
products already on the market.
    Maybe there are no harmful effects. We simply do not know 
the necessary information to know if there are or aren't. What 
is clear is the commercialization of the technology is 
outpacing the development of science-based policies to assess 
and guard against adverse environmental health and safety 
consequences. The horse is already out of the barn. Thus, 
prudence suggests the need for urgency in having the science of 
health and environment implications catch up to or even better, 
surpass the pace of commercialization. We need to develop the 
tools and procedures to determine if nanomaterials are harmful, 
and if so, what specific controls may be needed.
    From the beginning, the National Nanotechnology Initiative 
has included funding for research to address environment, 
health, and safety aspects of the technology, but funding 
levels have been fairly anemic. At present, the total funding 
in this area is under $40 million for the $1.1 billion 
initiative, and the majority of the funding is concentrated at 
the National Science Foundation, and while I applaud the 
National Science Foundation's efforts, I am concerned that 
other key agencies remain minor players. For example, related 
funding at the Environmental Protection Agency is only $4 
million.
    So, the main questions I have here are: Is environment, 
health, and safety research directed toward the most and 
important priorities? Is it funded at appropriate level, and do 
all communities of interest have a voice in establishing the 
research goals and the priorities? I also encourage any 
suggestions our witnesses may have on ways to improve the 
environment, health, and safety component of the National 
Nanotechnology Initiative.
    And following up on our chairman's concern about 
nanotechnology reaching its full potential, I think it is very 
important that we understand these issues, not only to protect 
ourselves, in terms of whatever health impact there might be, 
but also, in what you might call marketing. We have seen how 
genetically altered foods, in most situations, I think folks 
would say that they are healthy and safe, yet there has been 
resistance in the public in many parts of the world to these 
products, because that research came behind the actual 
products. So, if we are going to have successful 
commercialization, and make the best use of these 
nanotechnology products, then it is important that the public 
know well up front that they are safe, or if they are not safe, 
where they are not, and how that can be corrected. So, I hope 
we can learn more about that today.
    And thank you, Mr. Chairman, for calling this hearing.
    [The prepared statement of Mr. Gordon follows:]

            Prepared Statement of Representative Bart Gordon

    I want to join Chairman Boehlert in welcoming everyone to this 
morning's hearing. There is no question that this committee understands 
the importance of nanotechnology and recognizes the strong 
justification for a robust federal research investment.
    The Committee has held several hearings to evaluate the promise of 
nanotechnology. And in 2003, the Committee took the lead in passing the 
21st Century Nanotechnology Research and Development Act, which is now 
funded at over $1 billion per year.
    However, from the outset, we also recognized that risks may arise 
from this technology, and that is the subject of today's hearing. Some 
research has suggested that nanoparticles could cause human health 
problems and may damage aquatic life. But research in this area is in 
its infancy, and the tools are not available to identify and assess the 
risks associated with nanomaterials.
    Yet, many products containing nanoparticles are already on the 
market--in cosmetics, clothing and other products. Some estimate their 
presence in as many as 700 products. Maybe there are no harmful 
effects. We simply do not have the necessary information to know if 
there are or if there aren't.
    What is clear is that commercialization of the technology is 
outpacing the development of science-based policies to assess and guard 
against adverse environmental, health and safety consequences. The 
horse is already out of the gate.
    Thus, prudence suggests the need for urgency in having the science 
of health and environmental implications catch up to, or even better 
surpass, the pace of commercialization.
    We need to develop the tools and procedures to determine if 
nanomaterials are harmful, and if so, what specific controls may be 
needed.
    From its beginnings, the National Nanotechnology Initiative has 
included funding for research to address environment, health and safety 
aspects of the technology. But funding levels have been fairly anemic.
    At present, total funding in this area is under $40 million for the 
$1.1 billion initiative, and the majority of that funding is 
concentrated at the National Science Foundation. While I applaud NSF's 
efforts, I am concerned that other key agencies remain minor players. 
For example, related funding at the Environmental Protection Agency is 
only $4 million.
    The main questions I have today are:

          is environment, health and safety research directed 
        toward the most important priorities,

          is it is funded at an appropriate level, and

          do all communities of interest have a voice in 
        establishing the research goals and directions?

    I also encourage any suggestions our witnesses may have on ways to 
improve the environment, health and safety component of the National 
Nanotechnology Initiative.
    Thank you, Mr. Chairman, for calling this hearing. I look forward 
to the insights that this expert panel will provide today.

    Chairman Boehlert. And thank you very much, Mr. Gordon, and 
thank you for your partnership. We are together on this 
important subject.
    [The prepared statement of Mr. Ehlers follows:]

         Prepared Statement of Representative Vernon J. Ehlers

    Thank you Chairman Boehlert. I am pleased that the Committee is 
holding this important hearing today.
    The promise of nanotechnology is startling. Benefits are 
anticipated in every facet of our lives; medicine, energy production, 
and electronics may be revolutionized by nanotechnology. But with this 
promise, there is also growing concern that the potential short and 
long-term impacts of nanomaterials on people and the environment are 
largely unknown. The very properties that make nanomaterials so 
promising in applications--their small size, large surface area, and 
unusual behavior when compared to their macro-scale materials--make 
them potentially troubling when they come in contact with people and 
the environment. That is why today's hearing is so important.
    I look forward to hearing today from our witnesses about these 
potential risks. What do we know now about these risks? What additional 
research is needed? What are the Federal Government and the private 
sector doing to answer these questions? Are we looking at the potential 
risks across the entire life cycle of nanomaterials--manufacture, use 
and disposal?
    As we move forward with our federal investments in nanotechnology, 
we need to maintain the public's trust. That will require smart 
investments in research, accurate assessments of risk, and steady 
communication with the public about what researchers know and don't 
know. It will also require that environmental research and an 
appropriate regulatory framework for nanotechnology keep pace with the 
rapid growth of innovation and discovery. Without open communication 
and a trustworthy regulatory framework, misinformation and unfounded 
fear could undermine the potential economic rewards of nanotechnology.
    I am happy that our witnesses represent a cross-section of 
stakeholders, because cooperation will be a necessary part of both 
conducting research and sharing its results with the public. I look 
forward to hearing from our witnesses about how much we know on this 
topic and how much we still have to learn. Mr. Chairman, I yield back 
the balance of my time.

    [The prepared statement of Mr. Costello follows:]
         Prepared Statement of Representative Jerry F. Costello
    Good morning. I want to thank the witnesses for appearing before 
our committee to examine current concerns about environmental and 
safety impacts of nanotechnology and the status and adequacy of related 
research programs and plans.
    Relatively little is understood about the environmental and safety 
implications of nanotechnology. The lack of knowledge about the effects 
of nanoparticles and the absence of established methods to assess their 
impacts on the environment and human health is troubling since 
nanomaterials are already on the market in cosmetics, clothing and 
other products. Further, there are no established scientific protocols 
for either safety or environmental compatibility testing for 
nanomaterials.
    I am pleased we are having this hearing today because greater 
knowledge is needed to enable a nanotechnology industry to develop and 
to protect the public. Regulation for certain types of applications of 
nanomaterials could eventually be needed and Congress needs more 
information on the environmental and safety impacts of nanotechnology 
to better protect the public.
    I look forward to hearing from the panel of witnesses.

    [The prepared statement of Ms. Johnson follows:]
       Prepared Statement of Representative Eddie Bernice Johnson
    Thank you, Mr. Chairman and Ranking Member.
    I would like to extend a warm welcome to today's witnesses and 
thank them for engaging in a discussion on the potential health risks 
and environmental impacts of nanomaterials.
    Scientists at the University of Texas at Dallas have produced 
transparent carbon nanotube sheets that are stronger than the same-
weight steel sheets and can be used for organic light-emitting 
displays, electronic sensors, artificial muscles, and broad-band 
polarized light sources that can be switched on one ten-thousandths of 
a second.
    In the August 19th issue of the prestigious journal Science, 
scientists from the NanoTech Institute at UTD and a collaborator 
reported such assembly of nanotubes into sheets at commercially usable 
rates.
    This development is significant. I have always advocated in favor 
of increased support for research, and I feel that we should carefully 
consider the health and environmental impacts of nanotechnology in 
general.
    I am interested to know the status of research in this area and how 
the Congress can direct policies to support this research.
    Thank you, Mr. Chairman.

    [The prepared statement of Mr. Honda follows:]

         Prepared Statement of Representative Michael M. Honda

    I thank the Chairman and Ranking Member for holding this important 
hearing today. On our side of the aisle, we have been talking about 
environmental, health, and safety impacts of nanotechnology since the 
Committee first considered nanotechnology legislation. Our former 
colleague, Mr. Bell, offered amendments to focus work on toxicological 
studies and environmental impact studies and to set aside funding for 
environmental research and development, but unfortunately the 
Administration opposed these efforts and thus Members from the other 
side moved in lock step to oppose those amendments.
    I'm glad those on the other side have finally come to realize that 
we need to talk about this aspect of nanotechnology too, in addition to 
the enormous potential that it has for good. I expect that the 
witnesses will note in their testimony that we are not spending enough 
on environmental, health, and safety research, and I hope that this 
will finally wake everyone up to the need to invest in these areas.
    Nanotechnology is exciting because of the novel and interesting 
properties that arise when things get very small. Aircraft parts can be 
made lighter, computer logic circuits can be made faster, and pants can 
be made moisture and stain resistant. But the same effects that lead to 
novel properties at the nanoscale also have the potential to cause 
problems. Nanoparticles are on the same length scale as biological 
systems, meaning that they can pass through cell walls. Some early 
experiments in which fish were exposed to nanoscale carbon have found 
accumulation of the nanomaterials within the fish and some brain 
damage. While those experiments were not indicative of what a typical 
exposure might be, they certainly draw attention to the need for more 
study of the potential health impacts of these materials.
    Industry is wary about the uncertainty associated with these 
materials--it is difficult to ascertain what the potential impacts 
might be, and so it is hard to know what precautions to take or even 
what research needs to be done. Because of this, EPA and other 
regulatory agencies are on uncertain footing, unsure about whether 
existing law such as the Toxic Substances Control Act can be applied 
effectively to nanotechnology or whether new regimes will be needed. 
All of this uncertainty impacts the willingness of investors to support 
nanotechnology companies and may impact the willingness of consumers to 
purchase nanotechnology products.
    We are still at the nascent stages of this technology, and so the 
time to focus on environmental, health, and safety impacts is now, when 
we can still head off potential problems. If we wait much longer, we 
may find ourselves in a situation where we have ``let the cat out of 
the bag'' and we need to take drastic measures in response.
    I look forward to hearing the thoughts of the witnesses on what we 
should be focusing on and the amount of resources we need to be 
dedicating to this effort.

    [The prepared statement of Mr. Carnahan follows:]

           Prepared Statement of Representative Russ Carnahan

    Chairman Boehlert and Ranking Member Gordon, thank you once again 
for hosting this hearing. Dr. Teague, Mr. Nordan, Dr. Doraiswamy, Mr. 
Rejeski, and Dr. Denison, thank you for taking the time and effort to 
appear before us today and share your views on the environmental and 
safety implications of nanotechnology.
    Nanotechnology holds great promise in the area of materials and 
manufacturing, information technology and medicine. I am eager to see 
what this technology can do for our nation's health and am hopeful that 
the utilization of nanotechnology will someday positively affect our 
economy and job market.
    Still, I am very concerned that studies have shown nanoparticles 
can penetrate deep into the lung, causing tissue damage, and can also 
settle in the nasal passages, carried directly into brain cells. 
Clearly, these limited studies require us to conduct further research. 
I am pleased that there is general consensus among industry and 
environmental groups that more research on the subject is needed.
    Thank you for your time today. I look forward to hearing your 
testimony.

    [The prepared statement of Ms. Jackson Lee follows:]

        Prepared Statement of Representative Sheila Jackson Lee

    The National Academy of Sciences describes nanotechnology as the 
``ability to manipulate and characterize matter at the level of single 
atoms and small groups of atoms.'' An Academy report describes how 
``small numbers of atoms or molecules. . .often have properties (such 
as strength, electrical resistivity, electrical conductivity, and 
optical absorption) that are significantly different from the 
properties of the same matter at either the single-molecule scale or 
the bulk scale.
    Nanotechnology is an enabling technology that will lead to 
``materials and systems with dramatic new properties relevant to 
virtually every sector of the economy, such as medicine, 
telecommunications, and computers, and to areas of national interest 
such as homeland security.'' As an enabling technology, it is expected 
to be incorporated into existing products, resulting in new and 
improved versions of these products. Some nanotechnology-enabled 
products are already on the market, including stain-resistant, wrinkle-
free pants, ultraviolet-light blocking sun screens, and scratch-free 
coatings for eyeglasses and windows. In the longer run, nanotechnology 
may produce revolutionary advances in a variety of industries, such as 
faster computers, lighter and stronger materials for aircraft, more 
effective and less invasive ways to find and treat cancer, and more 
efficient ways to store and transport electricity.
    The projected economic growth of nanotechnology is staggering. In 
October 2004, Lux Research, a private research firm, released its most 
recent evaluation of the potential impact of nanotechnology. The 
analysis found that, in 2004, $13 billion worth of products in the 
global marketplace incorporated nanotechnology. The report projected 
that, by 2014, this figure will rise to $2.6 trillion--15 percent of 
manufacturing output in that year. The report also predicts that in 
2014, ten million manufacturing jobs worldwide--11 percent of total 
manufacturing jobs--will involve manufacturing these nanotechnology-
enabled products.
    The report describes that varying levels of risk are suspected for 
different types of nanomaterials and products and for different phases 
of a product's life cycle. For example, some nanoclay particles raise 
little initial concern because they would be locked up in composites to 
be used in automotive bodies. On the other hand, cadmium-selenide 
quantum dots that could be injected into the body for medical imaging 
tests are highly worrisome due to the toxicity of cadmium-selenide and 
the fact that they would be used within the human body.
    Another factor that contributes to the potential risk of different 
nanotechnology-related products is the expected exposure of people and 
the environment over the product's life cycle. The manufacturing phase 
is the first area of concern because workers potentially face repeated 
exposure to large amounts of nanomaterials. During product use, the 
actual risk will vary depending in part on whether the nanoparticles 
have been fixed permanently in a product, like within a memory chip in 
a computer, or are more bio-available, like in a sun screen where 
exposure may be more direct or may continue over a long period of time. 
Finally, the greatest uncertainties exist about the risks associated 
with the end of a product's life because it is difficult to predict 
what method of disposal, such as incineration or land disposal, will be 
used for a given material, and there has been little research on, for 
example, what will happen to nanomaterials within products stored in a 
landfill over 100 years.
    I look forward to the testimony of our witnesses.

    Chairman Boehlert. Just to set the stage, let me recite a 
couple of figures that I think will get your attention. The 
National Nanotechnology Initiative has grown from $464 million 
in Fiscal Year 2001, $464 million, to a requested, in the 
Administration's budget, $1.1 billion for Fiscal Year '06. The 
Lux Research study is very, very interesting, the Lux study 
found that in 2004 $13 billion worth of products in the global 
marketplace incorporated nanotechnology. That same report 
projects by 2014, just 10 years, that figure will rise to $2.6 
trillion. Fifteen percent of the projected manufacturing output 
in 2014. The report also predicts that in 2014, 10 million 
manufacturing jobs, or 11 percent of total manufacturing jobs 
around the globe, will involve manufacturing these 
nanotechnology-enabled products. Enormous, enormous. You can 
see why it has our attention.
    With that, let me welcome our first panel of very 
distinguished witnesses, and thank you at the outset for being 
facilitators for, and resources for this committee. Dr. Clayton 
Teague, Director, National Nanotechnology Coordination Office. 
Mr. Matthew Nordan, Vice President of Research, in the 
aforementioned Lux Research. Dr. Krishna Doraiswamy, Research 
Planning Manager, DuPont Central Research and Development. Mr. 
David Rejeski, Director, Project on Emerging Nanotechnologies, 
Woodrow Wilson International Center for Scholars. And finally, 
Dr. Richard Denison, Senior Scientist from Environmental 
Defense.
    Gentlemen, it is a pleasure to have you here. We would ask 
that in your opening statements, that you try to summarize in 
five minutes or so. We will not be that arbitrary. We are not 
going to interrupt you in mid-sentence, mid-paragraph, or mid-
thought, but if you would condense your opening statements, 
your full statements will be inserted in the record at this 
juncture, but if you try to summarize and capsulize your 
thinking, that allows for more dialogue between the two of us. 
And one of the things I have learned after many years of 
experience on Capitol Hill, when we have distinguished 
panelists like you, it is a great opportunity for us to learn a 
lot.
    With that, Dr. Teague, you are up first.

    STATEMENT OF DR. E. CLAYTON TEAGUE, DIRECTOR, NATIONAL 
               NANOTECHNOLOGY COORDINATION OFFICE

    Dr. Teague. Good morning. Mr. Chairman and Members of the 
Committee, thank you for inviting me to testify at this 
hearing. I am certainly honored by your invitation.
    Let me say at the outset that I and all members of the 
Nanoscale Science Engineering and Technology Subcommittee, 
which I will refer to as NSET, appreciate greatly the 
productive relationship that we have had with Chairman Boehlert 
and his staff. These relationships have been very supportive in 
advancing all aspects of the NNI, and so I want to say a very 
hearty thank you on behalf of everyone.
    It is a privilege for me also to speak on behalf of the 24 
agencies that participate in the NNI, and their representatives 
on the NSET Subcommittee. For the past two and a half years, I 
have had the opportunity of working with staff members from 
these agencies, and from that experience, I want to assure you 
that they are sincerely dedicated to the missions of their 
agencies, particularly including protecting public health and 
the environment.
    Nanotechnology is a truly transformational technology, 
promising, as you have just said, widespread applications in 
many fields, ranging from energy and medicine to agriculture 
and manufacturing. With such a powerful promise, the 
Administration is committed to fostering this emerging 
technology. The Administration is equally committed to 
achieving these benefits in a responsible manner, which means 
including strong considerations of the environmental health and 
safety, I will just use the acronym, ``EHS,'' implications from 
now on. Toward this end, one of the overarching goals of the 
NNI, as stated in its strategic plan, is to support the 
responsible development of this new field.
    Concerning the subject of this hearing, there are three key 
messages that I would like to leave you with today. First, the 
agencies involved in the NNI are working together in a very 
proactive way, and we have put in place broad and strong 
coordination in planning activities to understand and address 
the environmental, health, and safety implications of 
nanotechnology.
    Second, through the NNI, the Federal Government is funding 
forefront EHS research, and much progress in understanding the 
EHS implications have been made. Finally, the NNI is supporting 
studies that are providing useful preliminary information, but 
as again, you have just indicated, much research is still 
needed. In all these efforts, the NNI is engaged and 
coordinating with industry, and other countries to promote the 
responsible development of nanotechnology.
    In the limited time of my oral testimony today, I can only 
provide a few examples of our efforts to put in place an 
effective process to deal with the EHS implications of this 
technology. Let me just give you several of those. First of 
all, the NSET Subcommittee members' agencies have committed 
about $39 million in Fiscal Year 2006 to fund research whose 
primary purpose, let me just repeat that, whose primary purpose 
is to understand and address the EHS implications of 
nanotechnology.
    Wide ranging research is underway, and new results are 
coming in almost every day about this area. Within the NSET 
Subcommittee, we formed a subgroup that has been active since 
August of '03, to identify and establish priorities for 
research needs that support regulatory decision-making. This 
working group has participation from some 50 members, again, 
from 24 federal agencies, and it has proven to be an extremely 
effective forum for communication and coordination among the 
research and regulatory agencies. Regulatory authorities have 
been identified and stated publicly, certainly on the FDA 
website, the Consumer Product Safety Commission's website, and 
the National Institute of Occupational Safety and Health.
    Preliminary recommendations for working safely with 
engineered nanoparticles have been published by the National 
Institute for Occupational Safety and Health, to address 
concerns about working with free nanomaterials in the 
workplace. And one of the handouts today is that particular 
document, called ``Working with Safe Nanotechnology.'' 
Regulatory actions have been taken, and voluntary programs are 
being formulated. For example, EPA is seeking stakeholder input 
for nanoscale materials underneath the Toxic Substance Control 
Act. Collaboration with industry is ongoing, through the NSET 
working groups, with industry-based collaborative boards for 
advancing nanotechnology, which addresses two or more of the 
major industrial sectors involved with nanotechnology. 
International partnerships and cooperation have begun in the 
area of standardization, including the International 
Standardization Organization, the American National Standards 
Institute, the Organization for Economic and Cooperative 
Development, and ASTM International.
    In conclusion, we know that much more research needs to be 
done, and many questions remain unanswered. Answers will not 
come quickly, especially on a subject this complex. Research 
aimed to get answers will require a carefully designed and 
coordinated plan, with shared government and industry 
responsibility and collaboration. We must evaluate research 
very carefully, and if we discover that there are dangers 
associated with specific uses of certain materials, we should 
determine what precautions and restrictions will be necessary, 
including applying and adapting current regulatory authorities. 
Above all, we need to be guided by data and science-based 
decisions. Finally, we need to, and we intend to communicate 
effectively and openly with the public. Nothing else will 
establish trust and credibility.
    Thank you for the opportunity to speak today on this most 
important aspect of nanotechnology, and I will be happy to 
answer any of your questions.
    [The prepared statement of Dr. Teague follows:]

                Prepared Statement of E. Clayton Teague

Introduction

    Mr. Chairman and Members of the Committee, thank you for inviting 
me to testify at this hearing. I consider it a high honor. My name is 
Clayton Teague and I am the Director of the National Nanotechnology 
Coordination Office (or NNCO). The NNCO provides technical and 
administrative support to the Nanoscale Science, Engineering, and 
Technology (or NSET) Subcommittee of the National Science and 
Technology Council's Committee on Technology. The NSET Subcommittee is 
the interagency body that coordinates, plans, and manages the National 
Nanotechnology Initiative (or NNI). It is a privilege for me to speak 
on behalf of all of the 24 agencies that participate in the NNI and 
representatives on the NSET Subcommittee. For the past two and a half 
years, I've had the opportunity of working with staff members of these 
agencies; I assure you they are sincerely dedicated to the missions of 
their agencies--including protecting public health and the environment. 
Many of them unselfishly and intentionally have devoted their entire 
professional careers to these worthy purposes. My testimony today 
reflects and is a tribute to their efforts and initiative.
    The message that I want to communicate to you today is that the 
agencies participating in the NNI are working together proactively and 
have put in place broad and strong coordination and planning activities 
to understand and address the environmental and safety implications of 
nanotechnology. Through the NNI, the Federal Government is funding 
forefront environmental, health, and safety (EHS) research to establish 
a strong foundation and much progress in understanding EHS implications 
has been made. In this effort, the NNI is engaged and coordinating with 
industry and other countries to promote the responsible development of 
nanotechnology. Finally, NNI-supported studies are providing useful 
preliminary information, but more research is needed.
    Nanotechnology is the understanding, control, and use of matter at 
dimensions of roughly one to 100 nanometers, where unique phenomena 
enable novel applications. It is a truly transformational technology, 
promising widespread applications in many fields, ranging from energy 
and medicine to agriculture and manufacturing. As these applications 
move from the laboratory to practical use, nanotechnology has the 
potential to help strengthen the economy, protect homeland and national 
security, improve public health and the environment, and raise the 
quality of life for all people.
    With such powerful promise, the Administration is committed to 
fostering this emerging technology. The Administration is equally 
committed to achieving these benefits in a responsible manner--
including consideration of benefits and possible negative environmental 
and safety implications. (In the updated NNI Strategic Plan released in 
2004, one of the four overarching goals is to ``support responsible 
development of nanotechnology.'') We are here today to discuss these 
implications, and the research that is needed to address them.
    Since it was launched in 2000, the NNI has recognized the need to 
evaluate the environmental and safety implications of this promising 
technology. As the efforts to develop new nanoscale materials and 
devices have grown, so too have efforts aimed at improving our 
understanding of novel properties of nanomaterials, and risks that may 
arise from those properties. This increased understanding has in turn 
guided the agencies' research programs on environmental, health, and 
safety (or EHS) implications of nanotechnology.
    These research programs should continue to be performed 
concurrently with other nanotechnology research. The United States' 
investment in nanotechnology research represents only one quarter on 
the investment by governments worldwide. The global pace of innovation 
is accelerating and other nations are not going to voluntarily slow 
down in their efforts to reap the potential of nanotechnology. The 
current approach whereby EHS research is informed by and performed 
concurrently with scientific, product and process research will ensure 
that environment and safety concerns are addressed, while maximizing 
progress toward realizing nanotechnology's economic and societal value 
to the Nation.
    I want to make two points at the outset.

1. Most nanotechnology-based products pose little chance for public 
exposure and therefore pose little risk to health or the environment. 
Most uses of nanotechnology today are in composites where the 
nanoparticles are bound in a matrix (e.g., in golf clubs or car 
bumpers) or in nanoscale structures that are part of larger devices 
(e.g., in electronic circuits). Contact with these items generally 
poses no greater risk than with the versions not containing engineered 
nanomaterials. Concern is focused on possible risk due to exposure to 
the relatively small number of end-use products that contain ``free'' 
(i.e., unbound) engineered nanomaterials, which may be inhaled, 
ingested, or absorbed through the skin or that may find their way into 
the air, soil, or aqueous environment.

2. Manufacturers already minimize exposure to fine particles in the 
workplace. The greatest likelihood of exposure to engineered 
nanomaterials is during manufacture (of nanoparticles or using 
nanoparticles). It is widely known that inhalation of fine particles in 
conventional industrial operations should be avoided, and the Federal 
Government, particularly National Institute for Occupational Safety and 
Health (NIOSH) and Occupational Safety and Health Administration 
(OSHA), provides guidance that covers areas such as design and use of 
ventilation systems, personal protective equipment use, and laboratory 
practices to minimize such exposure in the workplace. Therefore, 
minimizing inhalation and dermal exposure to engineered nanomaterials 
is recommended and the principles guiding efforts to limit exposure 
should be very similar to those used to limit exposure to other fine 
particles.

    The purpose of these points is not to downplay potential risks 
associated with nanotechnology, but to put these issues in context. 
Exposure to free engineered nanomaterials (as opposed to fine particles 
that are naturally occurring or that are the incidental byproducts of 
human activities such as combustion or welding) is for the most part 
still low. So we are well positioned to assess possible risks before 
nanoparticles become widely used or make their way into the environment 
in large quantities.
    So what is the Federal Government doing to understand and address 
the possible risks of nanotechnology to people and the environment?

    The agencies participating in the NNI are working together 
proactively and have put in place broad and strong coordination and 
planning activities to understand and address the environmental and 
safety implications of nanotechnology.

    Within our interagency NSET Subcommittee, a number of subgroups 
have been established to address specific areas of interest or concern. 
One of these subgroups--established in 2003--is the Nanotechnology 
Environmental and Health Implications (NEHI) Working Group. NEHI brings 
together representatives from some 24 agencies that support 
nanotechnology research or that have regulatory responsibilities to 
exchange information and to identify, prioritize, and implement 
research needed to support regulatory decision-making processes. 
Through the efforts of the NEHI Working Group, regulatory agencies have 
been proactively engaged with each other and the research agencies, 
leading to earlier awareness of relevant issues and expedited 
activities to address them. In addition, those agencies that are 
primarily focused on research have a greater appreciation for the 
issues confronted by the regulatory bodies.
    As an aside, many NEHI Working Group members have commented on how 
unusual it is for issues to be discussed among the regulatory agencies, 
much less with research agencies. In remarks before a National 
Academies panel, Norris Alderson, FDA Associate Commissioner for 
Science, noted that in his more than 30 years with the FDA, he does not 
recall the regulatory agencies sitting down together to discuss a 
subject that crosses regulatory boundaries and authorities before he 
did so in the NEHI Working Group.
    Currently, the NEHI Working Group is developing a coordinated 
approach to nanotechnology research in the area of environmental, 
health, and safety (EHS). With input from industry and other non-
governmental groups, the Working Group is preparing a document that 
identifies and prioritizes information and research needs in this area. 
The document will serve as a guide to the NNI agencies as they develop 
budgets and programs and will inform individual investigators as they 
consider their research directions. It will also provide a measure of 
confidence on the part of policy-makers, such as you, and the public. 
We look forward to sharing this document with this committee when it is 
complete.
    The NSET Subcommittee has also formed a formal working group to 
liaise with various industrial sectors, including both the chemical and 
semiconductor industries. Through these activities, industry is 
providing input to the NNI regarding pre-competitive and non-
competitive research needs that those industries deem critical to the 
successful transition of nanotechnology. Both of these industrial 
sectors have identified EHS research as an important area for 
government and industry research, and their input will inform the NEHI 
Working Group efforts to plan and coordinate NNI programs on the 
subject.
    Finally, the NSET Subcommittee supports a number of international 
activities related to the topic of nanotechnology and EHS. Concerns 
about possible environmental and safety implications of nanomaterials 
are not confined to the United States; research needs are universal. 
Sharing of information, coordination of research agendas, and 
collaboration on non-competitive issues benefits everyone. The NNI 
activities are coordinated through the informal Global Issues in 
Nanotechnology Working Group, formed in 2005 and led by the State 
Department.

    Through the NNI, the Federal Government is funding forefront EHS 
research to establish a strong foundation and much progress in 
understanding EHS implications has been made.

    As stated in the NNI Supplement to the President's FY 2006 Budget, 
the NNI will support nearly $39 million this year on research and 
development whose primary purpose is to understand and address 
potential risks to health and the environment posed by exposure to 
nanomaterials and nanoproducts. This estimate does not include 
considerable research that is taking place as part of efforts that help 
advance understanding of nano-EHS implications but that are not focused 
primarily in this area. For example, many projects funded by the 
National Institutes of Health to develop nanomaterials for therapeutic 
applications routinely include basic toxicity testing, although such 
testing is not the primary purpose of the research. Moreover, this 
estimate does not include substantial investment in research on the 
effects of incidental ultra-fine and nano-particles, such as diesel 
exhaust and power plant emissions.
    The NNI research on environmental and health implications is being 
funded by several agencies, including EPA, NIOSH, NSF, NIH, NIST, USDA, 
DOD, and DOE. Where appropriate, agencies are working together in a 
carefully coordinated effort to address research areas that fall within 
more than one agency's mission or that require multiple agencies' 
expertise.
    Examples of multi-agency activities include:

          EPA, NSF, NIOSH, and NIEHS plan to issue a joint 
        solicitation to support approximately $8 million of research on 
        environmental and human health implications of nanotechnology 
        in 2006. EPA will manage peer review of the proposals, and all 
        four agencies will select from among those that pass review for 
        funding based on agency relevancy and interest. A similar 
        collaboration among EPA, NSF, and NIOSH in 2005 led to about $7 
        million in funding for research on the same topic.

          The Nanotechnology Characterization Laboratory (NCL) 
        is supported by a partnership among the National Cancer 
        Institute, NIST, and the FDA. The NCL, which was established in 
        2005, provides critical expertise and infrastructure for 
        developing and performing safety tests in order to expedite the 
        use of nanomaterials for the diagnosis and treatment of cancer. 
        The expertise of all three agencies is vital to the successful 
        operation of the Laboratory.

          The National Toxicology Program (NTP) is an ongoing 
        partnership among NIH's National Institute of Environmental 
        Health Science (NIEHS), FDA's Center for Toxicological 
        Research, and CDC's NIOSH. Beginning in 2004, the NTP initiated 
        a series of toxicity studies on classes of nanomaterials that 
        are especially promising in a range of applications--carbon 
        ``buckyballs'' and carbon nanotubes, nanoscale powders of metal 
        oxides, and semiconductor ``quantum dots.'' The early results 
        of these studies are expected in the coming year.

    I also want to highlight the research program established in the 
past two years by NIOSH. As discussed above, while free engineered 
nanoparticles are not found in most nanotechnology-based products, 
workplace exposure during manufacture may be cause for some concern. 
Accordingly, NIOSH has launched an aggressive research program to 
assess potential toxicity of nanomaterials found in the workplace, and 
has produced a preliminary document recommending best practices for 
safe handling of nanomaterials in the workplace. Information on these 
and other NIOSH activities with respect to nanotechnology are posted on 
the NIOSH website (http://www.cdc.gov/niosh/topics/nanotech/).
    In addition to the various activities within and among the 
participating federal agencies, the NNI participates in a number of 
bodies on the international level. Such activities will help to promote 
responsible development of nanotechnology worldwide.

    Organization for Economic Cooperation and Development (OECD): 
Within the OECD Environmental Directorate, the Chemicals Committee and 
Working Party on Chemicals, Pesticides and Biotechnology hold regular 
joint meetings. The next such meeting will be hosted by the United 
States in the Washington area on December 7-9 and will take the form of 
a workshop on the safety of manufactured nanomaterials. The objectives 
of the workshop are to determine the state of the art regarding safety 
assessment of manufactured nanomaterials and to identify future needs 
for risk assessment within a regulatory context. The resulting report 
is expected to discuss issues including nomenclature, human health, 
environmental hazards, exposure assessment, and possible regulatory 
frameworks.

    International Life Sciences Institute (ILSI): Representatives from 
EPA and NIOSH participated in a working group convened by the ILSI 
Research Foundation Risk Sciences Institute to develop a screening 
strategy for identifying hazards of engineered nanomaterials. The group 
recently reported on the elements of such a strategy, and recommended 
broad data gathering. The report acknowledges that at this early stage, 
there are insufficient data to support a specific testing protocol.

    The International Dialogue on Responsible Research and Development 
of Nanotechnology: The first Dialogue, sponsored by NSF, was held in 
June 2004 in Alexandria, Virginia, and brought together 25 countries 
and the European Commission (EC) to discuss environmental, health and 
safety issues as well as ethical, legal and other social issues. A 
follow-up meeting was hosted by the EC in Brussels last July, and a 
next meeting is planned in Summer of 2006 to be hosted by Japan.

    International Standardization Organization (ISO) and American 
National Standards Institute (ANSI): A critical aspect of protecting 
health and the environment and a basis of any regulation of chemicals 
and materials are standardized tools and methods for measuring and 
monitoring exposure. Research related to measurement science and 
technology is led by NIST. However, standards are developed jointly by 
all stakeholders through consensus-based processes. In June 2004, in 
response to a letter from Dr. John Marburger, Director of the Office of 
Science and Technology Policy, the American National Standards 
Institute (ANSI) established a Nanotechnology Standards Panel to 
facilitate and coordinate nanotechnology standards development in the 
United States. The NSET Subcommittee and the relevant agencies are 
members of the Panel and its Steering Committee, and are providing 
financial support to facilitate its activities.
    Subsequently, the International Organization for Standardization 
(ISO) has established a Nanotechnologies Technical Committee, which 
held its first meeting last week. As Chair of the ANSI-accredited 
Technical Advisory Group (TAG) to the ISO and leader of the U.S. 
delegation, I am pleased to report that the United States will lead the 
Working Group on Health, Safety, and Environmental Aspects of 
Nanotechnologies. Our first action will be to submit the NIOSH document 
on ``Approaches to Safe Nanotechnology'' to the ANSI TAG as a possible 
work item for the ISO Working Group. If approved the document will be 
put forth to the ISO Working Group as a draft to be further developed 
with inputs from other ISO Technical Committee member countries. Once 
developed and approved by the Technical Committee, the document will be 
issued as an international Publicly Available Specification; an 
informational document available to all countries.
    The ISO Technical Committee's granting of leadership in the area of 
environmental and safety aspects of nanotechnology to the United States 
is an acknowledgement that we are at the forefront in this area.

    NNI-supported studies are providing useful preliminary information, 
but more research is needed.

    Preliminary research to date shows, not surprisingly, that not all 
nanomaterials are alike. Earlier this month, researchers at Rice 
University released results showing that the toxicity of carbon 
nanotubes can be reduced by engineering of the nanotube surface, as 
they had shown earlier for buckyballs. Such data indicate that, unlike 
naturally occurring or incidental nanoparticles, engineered 
nanomaterials may be tailored to reduce toxicity.
    In another study published recently in the journal Pharmaceutical 
Research, a group headed by Dr. Russell Mumper at the University of 
Kentucky, tested nanoparticles coated with polyethylene glycol (PEG), a 
polymer used to protect many types of therapeutic agents from 
elimination by the immune system. The investigators developed a test to 
determine how PEG-coated nanoparticles affected a variety of in vitro 
and in vivo parameters, including blood clotting time, red blood cell 
damage, and platelet aggregation or clumping. They found that a 
concentration of nanoparticles one might expect in the blood stream 
produced no untoward biological effects on blood cells.
    These two studies are only a sampling of the wide range of work 
underway within the NNI. While time does not permit me to describe the 
work taking place across all of the agencies that support research on 
environmental and safety implications of nanotechnology, I encourage 
you to see the NNI FY 2006 Supplement to the President's Budget and the 
NNI website, www.nano.gov, for additional detail.
    Current research is providing data that are helping us understand 
the way nanomaterials interact with biological systems and the 
environment. However, substantial work remains, including in the 
following areas.

          Methods and metrics for determining nanoparticle 
        exposure and dose received among workers, consumers, and the 
        environment, as well as fate and transport once the dose is 
        received.

          Methods for controlling exposure in the workplace, 
        including monitoring and personal protective equipment.

          Analytical methods for characterizing nanomaterials 
        properties and behavior. Most toxicologists and the general 
        research community agree that new toxicity tests/methods are 
        not needed for nanomaterials. What is needed is the application 
        of novel (to toxicologists) physical/chemical characterization 
        and detection methods so that researchers can be assured the 
        materials being studied have the expected and desired 
        properties. The unfortunate fact that so many toxicology papers 
        on nanomaterials are difficult to interpret is not because the 
        toxicology study protocols are not up to the task, it's because 
        the reporting of the characterization of the materials is 
        inadequate.

          Experimental and computational approaches to 
        determine biological effects, including toxicity.

          Methods for assessing and managing risk of 
        nanomaterials.

    The research needed in this area will be addressed by the various 
stakeholders, including not only the Federal Government, but also 
industry and research institutions. The Federal Government will play an 
important role through its broad support of research, including basic 
research on the environmental and health effects of nanomaterials. The 
Government supports research aimed at understanding nanomaterials and 
how they interact with cells, organisms, and the environment. The 
Government also supports research aimed at developing tools and methods 
for measuring and assessing nanomaterials. Such research expands 
knowledge and understanding, and supports the Federal Government's 
regulatory role by enabling science-based decision-making.
    Yet, we know that much more needs to be done, and many questions 
remain unanswered. We should not expect that we will have all of the 
answers quickly. Research takes time, especially on a subject this 
complex. We already know that all nanomaterials are not created equal 
in terms of potential hazard or potential exposure. A carefully 
designed research plan, along with shared Government and industry 
responsibility and collaboration should guide our efforts. We must 
evaluate research results carefully, and if we discover that there are 
dangers associated with certain materials in specific uses, we should 
determine what restrictions might be necessary, including applying 
current regulatory authorities. Above all we need to be guided by 
science, not by irrationality or emotion. Finally, we need to 
communicate effectively and openly with the public. Nothing else will 
establish trust and credibility.
    Thank you for the opportunity to speak today on this important 
aspect of nanotechnology.

                    Biography for E. Clayton Teague

    Clayton Teague has served as Director of the U.S. National 
Nanotechnology Coordination Office (NNCO) since April 2003. Dr. Teague 
is on assignment from the National Institute of Standards and 
Technology (NIST), where he is Chief of the Manufacturing Metrology 
Division in the Manufacturing Engineering Laboratory.
    Dr. Teague has worked in the field now known as nanotechnology for 
most of his professional career, beginning with his metal-vacuum-metal 
tunneling experiments in the 1970's. He continued to work with such 
precision instrumentation as scanning tunneling microscopes, atomic 
force microscopes, displacement and phase-measuring interferometers, 
stylus instruments, flexure stages, and light scattering apparatus, 
which he utilized for ultra-high accuracy dimensional metrology of 
surfaces on micrometer to nanometer-scales.
    Dr. Teague is a member and two-times Past President of the American 
Society for Precision Engineering, and a fellow of the UK Institute of 
Physics. He served as Editor-in-Chief of the international journal 
Nanotechnology for ten years and remains a member of its Editorial 
Board. He holds a B.S. and M.S. in physics from the Georgia Institute 
of Technology and a Ph.D. in physics from the University of North 
Texas. He has authored or co-authored over 70 papers, has presented 50 
invited talks in the technical fields described, and jointly with 
colleagues, has six patents.
    Dr. Teague's work has been recognized with the Gold Medal, Silver 
Medal, and Allen V. Austin Measurement Science Award from the 
Department of Commerce, the Kilby International Award from the Kilby 
Awards Foundation, and an IR-100 Industrial Research and Development 
Award. He is the 2004 winner of a Best of Small Tech Awards for 
Advocacy from Small Times Magazine.

    Chairman Boehlert. Thank you, Dr. Teague. Mr. Nordan.

STATEMENT OF MR. MATTHEW M. NORDAN, VICE PRESIDENT OF RESEARCH, 
                       LUX RESEARCH, INC.

    Mr. Nordan. Good morning, Chairman Boehlert, Ranking Member 
Gordon, and Members of the Committee, and thank you for 
inviting me to testify today.
    My company, Lux Research, advises corporations, investors, 
startups, and public sector institutions on exploiting 
nanotechnology for competitive advantage, and each of these 
groups shares an interest in today's topic: the environmental, 
health, and safety, or EHS risks of nanotechnology.
    The United States needs nanotechnology applications to 
solve critical problems, like treating chronic disease, and 
developing new energy sources, as well as to sustain the 
technology-based economic development that has driven the U.S. 
economy since World War II. We project that in 2014, about one 
sixth of manufacturing output will incorporate emerging 
nanotechnology in some way. The U.S. cannot be left behind in 
this field.
    However, we must also ensure that these applications are 
developed responsibly, without compromising the health of 
citizens or the environment. Now, decades of lessons learned 
from coping with new materials have given businesses well-
established risk analysis frameworks that can be applied to 
nanotechnology, but only if two key requirements are met. 
First, businesses need a solid base of data about nanoparticle 
toxicology. Second, they need clarity about how agencies like 
the EPA and the Consumer Product Safety Commission will 
approach regulation. Today, both of those requirements are 
absent, and this is slowing nanotech commercialization in the 
U.S. Many corporate executives and venture capitalists that we 
have spoken with have told us that they are limiting their 
nanotechnology programs until they can address EHS risks with 
more confidence.
    There are two distinct classes of risk to address. On one 
hand, there are real risks. The fact that some of the many 
diverse types of nanoparticles could be found to be harmful in 
real world usage scenarios. But on the other hand, there are 
perceptual risks. Even if every type of nanoparticles turned 
out to be harmless, public skepticism could still sharply limit 
the use of nanoparticles in products, similar to the situation 
that Mr. Gordon presented with genetically modified organisms 
in Europe. Either class of risk could prevent the U.S. from 
reaping the full benefits of nanotechnology.
    We believe that the Federal Government can take three key 
actions to address both real and perceptual risks, and ensure 
responsible development of nanotech applications. First, the 
government can wield its influence to unify splintered 
toxicology efforts. There are many initiatives worldwide that 
address nanoparticles toxicology, and they are highly 
uncoordinated. As a result, they waste scarce resources 
available to investigate real risks, and they also ignite a 
known fear factor for perceptual risks.
    A globally recognized body of record is needed. Because the 
public will justifiably be skeptical of any industry-convened 
authority, we feel that this body must reside in the public 
sector. We recommend that the U.S. National Science Foundation, 
the European Commission's Nanosciences and Nanotechnologies 
Unit, and Japan's Ministry of Economy, Trade, and Industry 
establish an International Nanoparticle Toxicology Authority to 
unite today's splintered efforts.
    Now, second, the government can fund nanoparticles 
toxicology research. Large corporations like DuPont have the 
resources and incentives to fund such studies on their own, but 
the hundreds of startups that are active in the field do not. 
The only way that we see for nanotech commercialization to 
proceed rapidly through these companies, while ensuring that 
toxicology studies are performed, is for government to supply 
the funds. Now, currently, not enough money is available. Only 
3.7 percent of the $1.05 billion U.S. NNI budget for 2006 is 
earmarked for research on EHS issues.
    We recommend that the Federal Government establish a 
National Nanotechnology Toxicology Initiative to address these 
issues. With an annual budget geared like an insurance policy 
of sorts for nanotech development, the annual funding required 
likely lies between $100 million and $200 million per year, two 
to four times today's spending. To ensure commercial relevance, 
the initiative should allocate research funding through a 
market-based mechanism. Such a mechanism would require 
companies to submit their materials for testing, as a condition 
of receiving government research grants.
    Finally, government can eliminate regulatory ambiguity for 
industry. No regulatory agency that we are aware of has 
articulated a clear and unambiguous plan for how it will 
approach nanotechnology. The EPA serves as a telling case. It 
is relying on a working group to suggest voluntary guidelines 
that has taken a long time to come to decisions. We feel that 
these dynamics will neither provide regulatory clarity nor do 
so in a timely manner. This regulatory clarity is needed both 
to address real risks, but also perceptual ones. 
Nongovernmental organizations that have called for outright 
bans on nanotech R&D have cited absent regulation as their key 
concern.
    We recommend that the EPA, as well other agencies exposed 
to these issues, including the FDA, NIOSH, and the CPSC, 
establish and communicate clear plans for resolving regulatory 
ambiguity. These plans should describe the potential range of 
outcomes, the questions that will lead to choosing one outcome 
over another, the process for answering those questions, and 
closed-ended timeframes for completion. We recommend completion 
dates no later than the end of 2006.
    Asbestos was mined by the ton for 30 years before lab 
research showed it to be harmful. In contrast, nanoparticles 
toxicity experiments are being conducted proactively today, in 
parallel with development of the materials themselves. Because 
of this, I am confident that nanotech EHS issues will be 
addressed responsibly, if they see wise action by government.
    Thank you again for inviting me to speak, and I am pleased 
to answer any questions.
    [The prepared statement of Mr. Nordan follows:]

                Prepared Statement of Matthew M. Nordan

 Nanotech Environmental, Health, and Safety (EHS) Risks: Action Needed

    The U.S. must cultivate nanotechnology applications to solve 
pressing strategic problems and drive economic growth, but must also 
ensure that the health and safety of its citizens are not compromised. 
Established frameworks for assessing EHS risks can be applied to 
nanotech, but not enough hard data about the hazard and likely exposure 
of nanoparticles exists to make firm determinations. The U.S. 
Government can speed responsible development by uniting splintered 
nanoparticle toxicology efforts, funding core toxicology research at 
two to four times today's level, and eliminating regulatory ambiguity 
for industry.

EHS Issues Are the Wildcard in Nanotech Development

    The U.S. needs nanotechnology applications to solve critical 
problems in fields including energy generation, electricity 
distribution, treatment of chronic diseases like cancer and 
Alzheimer's, and environmental remediation--as well as to sustain the 
technology-based innovation that drives the U.S. economy. The U.S. 
Government has responded admirably to this challenge by delivering 
ample funding for nanotech research through the National Science 
Foundation, the Department of Defense, the National Institutes of 
Health, and other agencies--as well as a culture of support for the 
commercialization of this research through vehicles like Small Business 
Innovation Research (SBIR) grants, which help start-up companies turn 
nanotech innovations into products.
    However, the U.S, also needs nanotech applications to be developed 
responsibly, ensuring the health and safety of citizens in both the 
short- and long-term. As awareness of nanotechnology has grown, so has 
concern over its environmental, health, and safety (EHS) risks--the 
prospect that nano-enabled products might harm workers, consumers, or 
ecosystems. The debate concentrates on nanoparticles: bits of matter 
with sub-100 nm dimensions which may either be miniature chunks of 
established materials (like Nanophase's nanoscale zinc oxide, used in 
sunscreens), or highly ordered structures that only form at the 
nanoscale (like CarboLex's single-walled carbon nanotubes, which may be 
soon used in flat-panel displays) (see Figure 1).\1\
---------------------------------------------------------------------------
    \1\ For a more detailed discussion of the nanotechnology EHS 
debate, see the May 2005 Lux Research report ``A Prudent Approach to 
Nanotech Environmental, Health, and Safety Risks.''




    Concerns arise over these engineered nanoparticles for three 
reasons: 1) they are known to have unique physical, chemical and 
biological properties; 2) ``incidental nanoparticles'' with similar 
dimensions, formed unintentionally through processes like welding and 
diesel combustion, are already known to be harmful if inhaled, 
swallowed, or absorbed through the skin; and 3) early studies have 
shown cause for concern over some types of engineered nanoparticles. 
Many parties are involved in nanotech EHS debate, including corporate 
EHS officers, start-ups, non-governmental organizations (NGOs), 
regulatory agencies, insurers, toxicology researchers, journalists, and 
consumers (see Figure 2).

Two Distinct, Equally Important Classes of Risk Impact Nanotech

    Two distinct classes of EHS risks will impact whether 
nanotechnology applications will generate economic growth and improve 
quality of life--or be abandoned:

          Real risks. As toxicity and exposure data on 
        nanoparticles builds, one, many, or all types could indeed be 
        found harmful to people or to the environment. If many or most 
        types of nanoparticle proved hazardous, nanotech 
        commercialization would rightfully slow down or stop.

        
        
        
        

          Perceptual risks. Even if studies showed every 
        commercially relevant nanoparticle to be harmless in every 
        real-world usage scenario, public skepticism about the safety 
        of nanoparticles could still build and sharply limit the use of 
        nanoparticles in products--similar to the situation encountered 
        with genetically modified organisms (GMOs) in Europe.

    Responsible development of nanotechnology--to ensure that the U.S. 
obtains the full benefits of nanotechnology applications--requires 
addressing both real and perceptual risks.

The Good News on Real Risks: Established Frameworks Exist to Assess 
                    Threats

    Because engineered nanoparticles are both new and highly diverse, 
there's a widespread perception that no acceptable methods exist for 
assessing their EHS risks. This isn't true. Decades of lessons learned 
from coping with new materials from polymers to DDT have yielded well-
established risk analysis frameworks, which can be applied to 
nanotechnology in a straightforward fashion. They generally employ four 
steps (see Figure 3):

          Step one: Identify hazard. This step answers the 
        question ``Is there reason to believe this substance could be 
        harmful to people or the environment?'' Many nanotech 
        applications do not involve any nanoparticles at all; they 
        employ bulk structures that have nanoscale features, which are 
        unlikely to pose a novel toxicology risk. Such applications 
        include nanolithography used to pattern ever-smaller features 
        on microchips, nanoscale layers of magnetic material used to 
        make new forms of memory chips, and nanoporous materials used 
        for insulation. Identifying these applications that are very 
        unlikely to be hazardous underscores the point that 
        ``nanotechnology does not equal nanoparticles'' and effectively 
        bounds the risk assessment domain.

          Step two: Characterize hazard. This step answers the 
        question ``How and under what conditions could the substance be 
        harmful?'' There is no one-size-fits-all answer for 
        ``nanoparticles'' as a group; answers will differ for the many 
        different types of nanoparticles that have been developed, 
        which range from those likely to be benign (e.g., nanoclay 
        particles) to those deserving of greater scrutiny (e.g., 
        fullerenes and single-walled carbon nanotubes). Even for a 
        single type of nanoparticle, the level of hazard will vary by 
        dose (even water is toxic when massively ingested) and route of 
        administration (i.e., ingestion versus skin contact).

          Step three: Assess exposure. This step answers the 
        question ``How will people and the environment come into 
        contact with this substance?'' Exposure assessment must factor 
        in real world conditions: Kitchen cabinets are full of cleaning 
        supplies that are deadly, but only if someone drinks them. It's 
        also important to note that most applications of nanoparticles 
        deploy the particles in a fixed form in which they cannot enter 
        the body, because they are (for example) cross-linked in a 
        plastic resin or covalently bonded to a semiconductor 
        substrate. Relatively few applications deploy nanoparticles in 
        a free form--in air or liquids--in which they could be inhaled, 
        be ingested, or penetrate the skin.

           The potential for exposure to nanoparticles used in a 
        product will vary over that product's life cycle, which can be 
        broken down into three key stages (see Figure 4). First, in 
        manufacturing, workers can be exposed to free nanoparticles at 
        higher levels that at any other point of the life cycle, but 
        the risks are the most straightforward to address because 
        manufacturing lines are tightly controlled--many businesses 
        already cope successfully with highly toxic substances. 
        Secondly, consumers may be exposed during use, either 
        deliberately (as in food, cosmetics, and pharmaceutical 
        applications) or unintentionally. Finally, at end-of-life, the 
        environment and ultimately the general population may be at 
        risk when products containing nanoparticles are disposed of; 
        here we see the most unanswered questions because little 
        research has been conducted and experiments are difficult to 
        design.

          Step four: Characterize risk. Only when the first 
        three steps have been completed can one make meaningful 
        judgments about the EHS risks of a specific nanotechnology 
        application. To conclude high risk, a hazard must exist that 
        either workers, consumers, or the environment is significantly 
        exposed to in real-world conditions.

    Based on our ongoing research on the commercialization of 
nanoparticles, we believe that these high-risk cases will be rare 
because the overwhelming majority of applications deploy nanoparticles 
in fixed form, in very small amounts, or both. With that said, action 
is required to identify high-risk applications, to ensure the safety of 
workers in manufacturing plants that make products based on any type of 
nanoparticle, and to gain insight into the EHS issues of nanoparticles 
at end-of-life.




The Bad News on Real Risks: Scarce Hard Data Means Firms Struggle to 
                    Apply Known Frameworks

    If well-established frameworks exist to assess the EHS risks of 
nanoparticles, why is there a debate? To apply these frameworks, 
researchers and start-ups require hard data about hazard and exposure. 
The nanotech EHS debate comes down to an absence of this data.




    Large corporations like DuPont and start-up companies like 
Nanotechnologies Inc. must make decisions now about which 
nanotechnology applications to invest in: They're under pressure from 
shareholders to innovate and don't want competitors to beat them to 
potentially valuable new products. But when they attempt to apply 
established risk assessment frameworks to make wise decisions--and 
decide which applications to pursue for regulatory approval--they face:

          Data that's insufficient to draw conclusions, but 
        sufficient to cause concern. A search on the Science Citation 
        Index as of May 21, 2005 for peer-reviewed articles about 
        toxicity since 1991 revealed only 503 citations for 
        nanoparticles, compared with 2,046 and 1,437 citations 
        respectively for two more conventional (and much narrower) 
        classes of toxins: polychlorinated biphenyls (PCBs) and dioxins 
        (see Figure 5).\2\ Of nanoparticle studies that do exist, many 
        raise cause for concern: Widely-cited work by Eva Oberdorster 
        of Southern Methodist University found that fullerenes damaged 
        the brains of largemouth bass at concentrations of only 0.5 
        parts per million.\3\ Others, however, contradict these 
        findings. Grigoriy Andrievsky of the Ukrainian Academy of 
        Medical Sciences claimed that Oberdorster's effects were due 
        wholly to the solvents she used, not the fullerenes 
        themselves.\4\
---------------------------------------------------------------------------
    \2\ Source: Science Citation Index as of May 21, 2005; search terms 
``(toxici* OR toxico*) AND (X),'' where X = ``dioxin*,'' ``PCB,*'' or 
``(quantum dot OR nanopartic* OR nanotub* OR fulleren* OR nanomaterial* 
OR nanofib* OR nanotech* OR nanocryst* OR nanocomposit*).''
    \3\ Source: ``Manufactured Nanomaterials (Fullerenes, C60) Induce 
Oxidative Stress in the Brain of Juvenile Largemouth Bass,'' 
Oberdorster, E. Environ. Health Perspect. 2004, 112, 1058-1062.
    \4\ Source: ``Is a Fullerene C60 Molecule Toxic?'' Andrievsky, G.; 
Klochkov, V.; Derevyanchenko, L. Institute for Therapy of Ukrainian 
Academy of Medical Sciences, 2004, open letter (contact 
[email protected]).

           Nanoparticle toxicity will vary widely depending on how 
        nanoparticles enter the body, in what quantities, and how 
        they're dispersed, coated, and functionalized. As a result, 
        it's clear that far more research is required to definitively 
        assess the toxicity of a meaningful range of nanoparticle types 
        in real-world usage scenarios. To date, even conducting 
        measurements has been difficult because of a lack of 
        instrumentation and metrics to quantify nanoparticle 
        concentration and mobility. For example, academic studies 
        suggest that for nanoparticles, total surface area rather than 
        total mass is most important in assessing risk--but the 
        pioneering work at the U.S. National Institute for Occupational 
        Safety and Health (NIOSH) on constructing devices to measure 
        the surface area of nanoparticles in the air remains at an 
        early stage.
        
        

          Regulatory regimes in flux. The question of ``which 
        regulatory regime covers a given nanoparticle application 
        today?'' often can't be answered (see Figure 6). For example, 
        the EPA's Toxic Substances Control Act (TSCA) requires new 
        chemicals to be submitted for testing before being sold, but do 
        carbon nanotubes count as a ``new chemical'' or simply a form 
        of previously-approved carbon?\5\ The answers to these 
        questions will be determined by the working groups that 
        organizations like the EPA, the FDA, and NIOSH have only 
        recently formed. The outcome of these debates can't be reliably 
        predicted because proposed solutions vary widely, from 
        voluntary reporting of toxicity data to mandatory labels that 
        might accompany products containing nanoparticles.\6\
---------------------------------------------------------------------------
    \5\ For more information on TSCA's applicability to nanomaterials, 
see the February 14, 2005 Lux Research flash ``Nanotech Health and 
Safety Regulation: It's Already Here, with More on the Way.''
    \6\ Reports from insurer Swiss Re, the U.K.'s Royal Society, and 
the European Commission's Community Health and Consumer Protection 
Directorate General have all stated that there is a case for mandatory 
labeling of products that incorporate nanoparticles.

    These two issues--absent data and regulatory ambiguity--are slowing 
nanotechnology commercialization in the U.S. today. Many corporate 
executives and venture capitalists have told us that they are scaling 
back their nanotechnology programs until they can address EHS issues 
with more confidence. In other countries where EHS issues are not 
prioritized as highly as in the U.S., nanotechnology applications have 
come to market much more quickly: For example, no major U.S.-based 
coatings company has introduced a broad line of paints incorporating 
nanoparticles for anti-microbial, anti-UV, or self-cleaning effects, 
but such products are widespread in China and other east Asian 
countries.
    To be clear, Lux Research does not advocate any departure from 
rigorous testing and regulatory procedures in order to speed products 
to market that incorporate nanotechnology. Many past well-intentioned 
technologies with unanticipated ill effects, such as asbestos, show 
that such a decision would be monumentally unwise for citizens and the 
economy. Instead, we recommend that the federal government use its 
resources and influence to 1) build the base of data required to 
conduct rigorous risk assessment of nanoparticle applications, and 2) 
promptly eliminate ambiguity about which regulatory procedures apply.

Nanotech Looks Primed for Perceptual Risk

    What about perceptual risk? We suggest that U.S. corporations and 
start-ups developing nanotechnology applications have as much to lose 
from perceptual risk as from real ones. Real risks apply to specific 
materials and applications that can be individually addressed, but 
perceptual risk could make commercialization of any nanomaterial 
infeasible. Sociological research has identified reliable attributes of 
new technologies that trigger consumer concern, described in models 
with names like ``fright factors'' and ``principal outrage 
components.'' When rated against these factors, nanotech scores 
poorly--for example, when lined up against the eleven ``fright 
factors'' documented by Peter Bennett of the U.K. Department of Health, 
nanotech rates well on only one and poorly on six (see Figure 7).



    Despite the potential for perceptual risk, consumer perceptions of 
nanotechnology have not yet been set: Surveys of consumers in both the 
U.S. and Europe have universally found very low overall awareness of 
nanotechnology (see Figure 8). Given this, it's astonishing that both 
corporations and start-up companies active in nanotech have done almost 
nothing to date to engage consumers on the topic. We have recommended 
to corporations and start-ups that the best approach to heading off 
perceptual risks involves engaging consumers honestly about 
nanotechnology applications by articulating nanotech benefits, 
communicating toxicology efforts, and working cooperatively with NGOs 
and other stakeholders, as DuPont has done by partnering with 
Environmental Defense.

How the U.S. Government Can Help Address both Real and Perceptual Risks

    Based on our research, we believe that the U.S. Government can help 
industry to develop nanotechnology applications responsibly and help 
consumers to make informed judgments about the benefits and risks of 
products incorporating nanotech. To do so, we feel the government 
should:

          Wield influence to unite splintered toxicology 
        research efforts. Many different initiatives to address 
        nanotech EHS risks exist--from government-sponsored efforts 
        like the EU's Nanosafe2 initiative, to corporate/university 
        hybrids like the International Council on Nanotechnology 
        (ICON), to programs at professional societies like the American 
        Chemistry Council. To the extent that these initiatives 
        replicate the same work, they waste scarce resources available 
        to investigate real risks. To the extent that they send 
        conflicting messages to the public, they ignite a well-known 
        ``fright factor'' for perceptual risk.

           To move nanotech EHS research forward, a clearly identified 
        body of record is needed to coordinate these splintered 
        efforts. For the sake of addressing perceptual risk, we believe 
        a government-backed entity will be superior to any industry-
        backed one, which will almost certainly be perceived as having 
        conflicted incentives. We recommend that the U.S. National 
        Science Foundation, the European Commission's Nanosciences and 
        Nanotechnologies Unit, and Japan's Ministry of Economy, Trade, 
        and Industry join forces to establish an International 
        Nanoparticle Toxicology Authority (INTA) to form a coordinating 
        interface for today's splintered efforts.
        
        

          Accept that the government must ultimately fund 
        fundamental toxicology research on nanoparticles--and allocate 
        funding through a market-based mechanism. Large corporations 
        have a keen interest in performing toxicology research on 
        nanoparticles because their time horizons are long enough to 
        incorporate negative outcomes that take decades to appear--and 
        because institutional shareholders with long positions, like 
        pension funds, hold them accountable. Start-ups, on the other 
        hand, have much shorter time horizons, and thus face financial 
        incentives to bury or disregard EHS issues if they threaten to 
        compromise the company's near-term valuation or likelihood of 
        an exit. Regulation must intervene to align startups' 
        inherently short-term interests with long-term public good.

           Start-ups are generally the earliest commercial developers 
        of new nanoparticles and also the parties least likely to be 
        able to afford expensive toxicology studies. As long as these 
        dynamics hold, the only way we see for nanotech 
        commercialization to proceed rapidly while ensuring that 
        toxicology studies are performed is for governments to supply 
        the funds. Currently, however, not enough money is available to 
        fund the necessary research. Only 3.7 percent of the $1.05 
        billion U.S. National Nanotechnology Initiative (NNI) budget 
        for 2006 is earmarked for research on EHS issues, and spending 
        on nanoparticle research at other relevant government agencies 
        remains low (see Figure 9).
        
        

           We believe the U.S. Government should establish a National 
        Nanotechnology Toxicology Initiative (NNTI) to ensure that 
        fundamental nanoparticle toxicology research is performed. With 
        annual budgets geared as an ``insurance policy'' for nanotech 
        development, the annual funding required in the U.S. likely 
        lies between $100 and $200 million per year--two to four times 
        today's spending. To ensure commercial relevance, the NNTI 
        should allocate research projects through a market-based 
        mechanism based on public nanotechnology R&D funding. This 
        could be linked to SBIR grants: Companies receiving funding for 
        products that incorporate nanoparticles would be obligated to 
        submit their materials for anonymous testing by the NNTI as a 
        condition of the grant. The NNTI would allocate funding for 
        studies of different nanoparticles in proportion to the funding 
        going to their development.

           To ensure that the greatest number of studies is performed 
        without allocating resources toward redundant ones, the NNTI 
        should coordinate research in an international network like the 
        one previously suggested. Finally, the NNTI should also 
        emphasize identifying ways to mitigate undesirable effects of 
        nanoparticles, rather than simply identify those effects. Rice 
        University's Center for Biological and Environmental 
        Nanotechnology, which has both identified EHS risks of the 
        fullerene family of nanoparticles and identified methods of 
        reducing those risks by functionalizing fullerenes, provides 
        the best model to date.

          Eliminate regulatory ambiguity for industry. Many 
        individuals at regulatory agencies in the U.S. are diligently 
        studying nanoparticles, but few agencies have established clear 
        guidelines for how they plan to address them. Most efforts are 
        working groups, like the one currently operating at the 
        Environmental Protection Agency (EPA), which aims to establish 
        voluntary standards in consensus with industry. Such programs 
        take a great deal of time to come to decisions. We believe 
        these time frames must be accelerated, and that more 
        transparency in their decision-making is required.

           Despite natural suspicion to the contrary, most corporations 
        would welcome informed regulation of nanoparticles: ``We want 
        to have some certainty, have some clarity, and have a level 
        playing field,'' one EHS officer from a U.S.-based Fortune 
        1,000 company told us. Not only does knowing what the future 
        regulatory environment will be allow companies to plan 
        accordingly, but having regulations in place limits the 
        possibility that irresponsible behavior by a few companies 
        could lead to a public perception disaster for the field of 
        nanotechnology as a whole. In addition, regulatory guidance 
        will help build public trust and confidence in nanotech, 
        inoculating against perceptual risk: Non-governmental 
        organizations that have called for bans on nanotechnology R&D 
        have often cited the absence of regulation as their key 
        concern.

           We recommend that the EPA, as well as other agencies exposed 
        to these issues including the FDA, NIOSH, and the Consumer 
        Product Safety Commission (CPSC), establish and communicate 
        clear plans for resolving regulatory ambiguity about 
        applications of nanoparticles. These plans should describe the 
        potential range of outcomes, the questions that will lead to 
        choosing one outcome over another, the process for arriving at 
        answers to those questions, and close-ended timeframes for 
        arriving at them. We recommend setting a hard date no later 
        than the end of 2006 for reaching conclusions on these issues.

                    Biography for Matthew M. Nordan
    Matthew Nordan heads Lux's research organization. Under Matthew's 
leadership, the Lux Research analyst team has become a globally 
recognized authority on the business and economic impact of 
nanotechnology. Lux Research serves as an indispensable advisor to 
corporations, start-ups, financial institutions, and governments 
seeking to exploit nanotechnology for competitive advantage.
    Matthew has counseled decision-makers on emerging technologies for 
a decade. Prior to Lux Research, Matthew held a variety of senior 
management positions at emerging technology advisor Forrester Research, 
where he most recently headed the firm's North American consulting line 
of business. Earlier, Matthew lived for four years in the Netherlands 
growing Forrester's operations in Europe, where he launched and led 
research practices in retail, mobile commerce, and telecommunications.
    Matthew has been invited by news outlets including CNN and CNBC to 
comment on emerging technology markets and has been widely cited in 
publications such as The Wall Street Journal and The Economist. He has 
delivered advice to clients and been an invited speaker at conferences 
in North America, Europe, Southeast Asia, Japan, Australia, and South 
Africa. Beyond the corporate sphere, Matthew has participated in 
developing public-sector technology strategy for organizations 
including the World Economic Forum, the European IT Observatory, and 
the Dutch transportation ministry.
    Matthew is a summa cum laude graduate of Yale University, where he 
conducted cognitive neuroscience research on the neural pathways 
mediating emotion and memory.




    Chairman Boehlert. Thank you very much, Mr. Nordan. Dr. 
Doraiswamy.

   STATEMENT OF DR. KRISHNA C. DORAISWAMY, RESEARCH PLANNING 
        MANAGER, DUPONT CENTRAL RESEARCH AND DEVELOPMENT

    Dr. Doraiswamy. Good morning, Chairman Boehlert, 
Congressman Gordon, and Members of the Committee. My name is 
Krish Doraiswamy, and I am DuPont's Research Manager, Research 
Planning Manager, responsible for coordinating and monitoring 
DuPont's R&D activities in nanoscale science and engineering. I 
appreciate this opportunity to discuss the research needed to 
address the safety, health, and environmental implications of 
this new field.
    I will focus on three main points. First, beneficial 
applications of nanoscale materials will emerge faster if we 
understand the environmental and safety implications. Second, 
cooperative efforts are needed to resolve key uncertainties, 
and I will provide examples of what DuPont is doing today to 
address these uncertainties. Third, there is a need for more 
research funding that is strategically targeted on fundamental 
safety, health, and environmental questions.
    On the first point, with the new tools and techniques 
available today, we can design and fabricate new nanoscale 
materials that deliver entirely new properties. These new 
materials promise major advances in many fields. The promise of 
nanoscale materials also raises new questions about how they 
might affect safety, health, and the environment. Most of these 
questions are of particular relevance to nanoparticles that are 
engineered to exhibit new behaviors. These questions need to be 
addressed as new nanomaterials begin to enter the field. 
However, in many cases, we will need better tools and much more 
data to be able to answer these questions. Also, as has been 
pointed out, many important nanoscience discoveries and 
inventions are being made in universities and by startup 
companies, which may lack the experience and the resources to 
adequately address the fundamental safety, health, and 
environmental questions. Such broadly relevant questions should 
be a part of the national agenda for research in nanomaterials.
    My second point is that all stakeholders need to cooperate 
to develop safety standards and test methods, to coordinate 
research and generate reliable data, and to establish 
appropriate oversight. DuPont is already active in several 
cooperative efforts. Here are some examples. DuPont coordinated 
the launch this year of a consortium of more than 14 industry, 
academic, and government organizations. This consortium is 
sponsoring a two-year research project that will help us 
understand workplace safety and health issues relating to 
airborne nanoparticles.
    We are also working with other members of the American 
Chemistry Council to develop recommendations regarding safety, 
health, and environmental questions. We collaborate on 
toxicology research with the Rice University for the Center for 
Biological and Environmental Nanotechnology, and we are 
founding members of ICON, which is the International Council on 
Nanotechnology. We have entered into a partnership with 
Environmental Defense to develop a practical framework to 
identify, manage, and reduce potential risks of nanoscale 
materials, and in addition to these cooperative efforts, we 
have an active internal product stewardship program on 
nanomaterials, which includes toxicity research.
    Efforts like ours are only a part of the answer. We 
recognize and applaud the efforts by several organizations to 
identify safety, health, and environmental research needs, and 
we look forward to the emergence of a well-considered research 
strategy, based on a broad scientific consensus on the key 
questions. In particular, we need research on the physical, 
chemical, and biological characterization of nanomaterials, the 
measurement of nanomaterials in the workplace and in the 
environment, understanding their environmental fate, including 
persistence and bioaccumulation, and developing and applying 
toxicity tests, including validated in vitro screening tests, 
where these are practical.
    Lastly, we need more public funding for strategically 
targeted research, to complement the efforts of companies like 
mine. We need to quickly and systematically develop the 
measurement tools, test methods, and rigorous peer-reviewed 
data that will enable nanotechnology to deliver on its promise. 
This information is broadly relevant to practitioners, and 
needs to be openly shared within the nanotechnology community. 
We therefore believe that this research should be publicly 
funded. Congress should ensure that adequate funding is 
provided, that the effort is strategically targeted, and 
carefully coordinated and actively managed.
    Thank you for the opportunity to testify before you today. 
I will be happy to answer questions.
    [The prepared statement of Dr. Doraiswamy follows:]

              Prepared Statement of Krishna C. Doraiswamy

    Good morning Chairman Boehlert, Congressman Gordon, and Members of 
the Committee. My name is Krish Doraiswamy, and I am a Research 
Planning Manager for DuPont Central Research & Development. In that 
role I am responsible for coordinating and monitoring DuPont's research 
and development activities in Nanoscale Science and Engineering (what 
we refer to as NS&E), and for developing and nurturing collaborative 
R&D relationships. I appreciate this opportunity to share our views on 
the research needed to address the Safety, Health and Environmental 
(SHE) implications of nanotechnology.
    DuPont is a science driven company with a commitment to safety, 
health and environmental protection. As a 200-year-old company, we have 
participated in the development and evolution of many technologies, and 
we are proud to have contributed significantly to the advancement of 
scientific knowledge. At DuPont, we use science to develop products and 
services that improve the quality and safety of people's lives. We also 
use science and our commitment to safety to guide how we develop, 
manufacture and manage our products throughout their life cycle.
    Today, my testimony will make three points:

          Broad applications of nanoscale materials will emerge 
        faster if we understand the safety, health and environmental 
        implications.

          Cooperative efforts are needed to resolve key 
        uncertainties, and I will provide examples of what DuPont is 
        doing today to address these uncertainties.

          There is a need for increased research funding that 
        is more strategically targeted to address fundamental safety, 
        health and environmental questions.

The need to understand SHE implications of nanoscale materials

    DuPont's interest in nanoscale materials is a natural extension of 
our rich and deep knowledge base in materials science and its 
applications. The nanostructure of materials has been a fundamental 
determinant of a material's properties long before NS&E and 
nanotechnology were identified as distinct fields of study. Certain 
nanoscale materials (such as carbon black, pigments, magnetic storage 
media, and silver-based photographic chemicals) have been in commercial 
use for decades, or even centuries.
    However, the emergence of new tools and techniques for the 
measurement, characterization and control of nanoscale features gives 
rise to many new opportunities. We can more precisely tailor known 
materials to more effectively deliver desired properties and to enhance 
functional benefits. For example, new polymer nanocomposites can be 
stronger, lighter, smarter and use less resources than conventional 
plastics. In addition, and more importantly, the new tools and 
techniques enable new generations of nanoparticulate materials and 
nanostructures that can create entirely new product possibilities. 
These new materials may, for example, enable advances in medicine, new 
devices and display technologies, and new approaches to energy 
generation and storage.
    While this rapid expansion of knowledge is creating new 
opportunities, it is also raising new questions about nanoscale 
materials, and their potential impact on health, safety and the 
environment. Many of these questions are of particular relevance to 
particles that are specifically engineered to exhibit new behaviors and 
that measure less than 100 nanometers on at least one dimension. Such 
questions include:

          How do free nanoparticles with novel properties 
        interact with the physiology of humans or other species?

          How is this interaction the same as or different from 
        the behavior of the comparable bulk materials?

          What are the pathways by which exposure to such free 
        nanoparticles can occur, and how can this exposure be measured 
        and controlled?

          Do we have generally accepted tools and methods to 
        answer these questions?

    These questions must be addressed as new nanoscale materials move 
into the market. However, the absence of generally accepted testing 
methods and standards, and the lack of scientifically validated data 
threatens to slow down innovation and significantly delay the 
introduction of new products and applications. An important fact is 
that many of the most interesting discoveries relating to new nanoscale 
materials are being made in universities and by entrepreneurs in start-
up companies. These entities may lack the experience, resources and 
funding needed to adequately address the fundamental safety, health and 
environmental questions. It is our belief that such broadly relevant 
questions should be a significant part of the national agenda for 
research in NS&E.
    Because nanoparticles do not necessarily behave like their larger 
particle relatives, research is needed to develop a uniform, science-
based approach for identification of hazards, assessment of exposure 
and management of risks. This research requires immediate attention.

The need for a cooperative effort, and what DuPont is doing

    These questions are being widely discussed and considered by 
federal agencies, public and private special interest organizations, 
and in several industry, scientific, national and international forums. 
We believe that all parties with an interest or a stake in the 
responsible development and use of these new materials should work 
together to allow nanoscale science and engineering to reach its full 
potential. Specifically, we advocate collaboration in the development 
of responsible safety standards and test methods; the coordination of 
research to generate reliable, peer reviewed data; and the 
establishment of appropriate oversight. DuPont is leading or actively 
participating in programs that seek to address each of these issues. We 
have taken several actions in order to contribute to the responsible 
development and use of nanoscale materials, including:

          DuPont coordinated the launch in June 2005 of a 
        consortium of parties interested in nanoparticle occupational 
        safety and health. This is a multi-stakeholder consortium of 
        more than 14 industry, academic and government organizations 
        formed to sponsor research that will further our understanding 
        of factors relevant to the assessment and control of 
        occupational exposures to engineered nanoparticles.

           This two-year research project will be led by DuPont 
        scientists and will help us understand (a) How airborne 
        nanoparticles may behave in the workplace; (b) How to monitor 
        and measure occupational exposures to airborne nanoparticles; 
        and (c) How to assess the penetration of engineered 
        nanoparticles through candidate barrier materials for personal 
        protective equipment.

           Members of this consortium include: DuPont, Procter & 
        Gamble, Dow Chemical, Air Products & Chemicals, Inc., Degussa, 
        Rohm & Haas, PPG, Intel Corporation, the UK Health & Safety 
        Executive, and the Department of Energy Office of Science.

          We are working with a broad industry group (the 
        Chemstar Panel on nanomaterials, within the American Chemistry 
        Council). This panel is developing recommendations for the EPA 
        and for the chemical industry regarding safety, health and 
        environmental issues and regulatory guidelines for nanoscale 
        materials. As part of this effort, we participated with the Ad 
        Hoc Nano Working Group of the U.S. EPA's National Pollution 
        Prevention and Toxics Advisory Committee (NPPTAC) to develop 
        options for the EPA regarding a voluntary reporting program to 
        share and generate data on nanoscale materials.

          We are supporting research at the Rice University 
        Center for Biological and Environmental Nanotechnology (CBEN), 
        and are founding members of ICON, the International Council on 
        Nanotechnology, also based at Rice University. ICON is a multi-
        stakeholder group, with representation from industry, academia, 
        regulatory and non-governmental organizations to ``assess, 
        communicate, and reduce nanotechnology environmental and health 
        risks while maximizing its societal benefit.'' More information 
        about ICON is available at www.icon.rice.edu.

          We have entered into an agreement with Environmental 
        Defense to jointly develop a framework that can be used to 
        identify, manage and reduce potential health, safety and 
        environmental risks of nanoscale materials across all life 
        cycle stages. This work is just getting started, and we expect 
        to consult extensively with other stakeholders during the 
        project.

          In addition to these cooperative efforts, We have an 
        active internal Product Stewardship program on nanomaterials, 
        including toxicity assessments of lung responses. We are 
        studying nanomaterials in commercial development as well as 
        generic nanoscale particles, and comparing their effects to 
        standard reference particle-types.

    In summary, we are dealing with nanoparticle SHE questions as a 
work in progress on many fronts, with broad engagement of other 
stakeholders to develop robust guidelines.
    However, these efforts go only part of the way toward developing 
the strong foundation of knowledge and tools that are needed by the 
NS&E community. Fortunately, there has been progress on other fronts. 
For example, a report issued last month by the International Life 
Sciences Institute Research Foundation/Risk Science Institute (ILSI), 
and funded by the EPA, recommends the first elements of a screening 
strategy to characterize the potential human health effects from 
exposure to nanomaterials. DuPont toxicologist David Warheit was a 
contributor to the development of the ILSI report.
    DuPont applauds these efforts to carefully define the research that 
is needed, and we believe they provide a good initial foundation for a 
broad SHE-focused research strategy. We believe that broadly 
representative organizations such as the National Academy of Sciences 
could play a role in the further development of this strategy. In 
particular, we endorse the pressing need for research in the following 
areas:

          Understanding the critical physical, biological, and 
        chemical parameters that characterize nanomaterials;

          Measuring, at an appropriate level, the presence of 
        nanomaterials in the environment and particularly in the 
        workplace;

          Understanding and predicting the environmental fate 
        of nanomaterials with particular attention to persistence and 
        bioaccumulation;

          Developing toxicity tests for hazard assessment of 
        nanomaterials, with particular attention to validated in vitro 
        screening tests, to the extent practical, and applying these 
        tests to establish baseline criteria for evaluation of 
        nanomaterials.

The need for increased and strategically targeted SHE research funding

    In our opinion, the research that has the highest priority relates 
to the development of the practical knowledge base that is described 
above, and the development of tools and methods that are broadly 
relevant to practitioners which can be widely shared within the NS&E 
community. We, therefore, believe that this area of research should be 
publicly funded.
    The same message was delivered by DuPont's Chairman & CEO and the 
President of Environmental Defense, in an article they co-authored 
earlier this year in The Wall Street Journal. To quote from this 
article, ``Our government also needs to invest more seriously in the 
research necessary to understand fully nanoparticle behavior.''
    However, the challenge is greater than the mere allocation of 
additional funds for SHE research. The mechanism by which federal 
research funds are allocated today for NS&E is designed to support and 
accelerate discovery and innovation across a wide spectrum of 
autonomous agencies, and to foster unfettered creativity in identifying 
new innovation opportunities. However, we believe that there is a 
better model for supporting research relating to SHE questions. A more 
actively managed, strategically targeted, and carefully coordinated 
approach is needed to achieve our common goal. This goal is to 
systematically develop the measurement tools, test methods and 
rigorous, peer-reviewed data that will enable nanotechnology to deliver 
on its promise. The preferred SHE research model would, therefore, take 
a more prescriptive approach to the selection and prioritization of 
research topics, and would establish metrics to measure progress 
against defined targets.
    In conclusion:

          We believe that Nanoscale Science and Engineering is 
        an important field of knowledge, with rich potential to enable 
        breakthrough innovations that improve the quality of life in 
        many sectors. To fully realize this potential, we need to 
        understand the SHE implications of nanoscale materials.

          Systems need to be agreed and established through a 
        cooperative effort among all the stakeholders, to address and 
        resolve the key uncertainties, and to provide appropriate 
        mechanisms for risk assessment and risk management.

          DuPont is already collaborating actively on the 
        development of a rigorous and consistent terminology, screening 
        strategies, workplace safety measurements and controls, and a 
        framework to define a systematic and disciplined process to 
        identify, manage and reduce potential SHE risks of nanoscale 
        materials across all life cycle stages.

          Federal and private funding for research that 
        addresses safety, health and environmental concerns needs to be 
        coordinated and strategically targeted to achieve the maximum 
        impact in the shortest time.

    Thank you. I will be happy to answer any questions.

                  Biography for Krishna C. Doraiswamy

    Dr. Doraiswamy is responsible for identifying opportunities to 
maximize the value of DuPont's R&D portfolio in nanoscale science and 
engineering, and for developing and nurturing collaborative R&D 
relationships with external entities. He serves on the ANSI-Accredited 
U.S. Technical Advisory Group to the ISO committee developing 
nanotechnology standards. He also serves on the ASTM Nanotechnology 
Committee, and has served on the Business Advisory Board of the 
California NanoSystems Institute (CNSI).
    During his 24 years in DuPont, Dr. Doraiswamy has been actively 
engaged in the development and commercialization of new technologies in 
new business domains. Dr. Doraiswamy has held various prior assignments 
in marketing, strategic planning and business development. He played a 
leadership role in establishing several early stage business ventures 
within DuPont, including DuPont Photonics Technologies, Qualicon (rapid 
pathogen detection systems), and DuPont Holographic Materials. In all 
of these ventures, he was responsible for setting up mission-critical 
business and technology alliances with other major corporations and 
with start-ups.
    Dr. Doraiswamy received his Bachelor's degree in Chemistry from 
Imperial College, London. He has a Ph.D. in Chemistry and an MBA with a 
concentration in Marketing from Carnegie Mellon University.




    Chairman Boehlert. Thank you very much, Mr. Rejeski.

 STATEMENT OF MR. DAVID REJESKI, DIRECTOR, PROJECT ON EMERGING 
   NANOTECHNOLOGIES, WOODROW WILSON INTERNATIONAL CENTER FOR 
                            SCHOLARS

    Mr. Rejeski. I would like to thank Chairman Boehlert, and 
Ranking Member Gordon, and Members of the House Committee for 
holding this hearing.
    Before I share my ideas with you, I thought I would like to 
share some observations from a group that really tends to be 
under-represented. These are quotes from a group in Spokane, 
Washington that we met with on nanotechnology in June. I quote: 
``I found it interesting that so many government agencies are 
potentially responsible for nanotechnology. With so many 
agencies, bureaucracy enters the process because everybody is 
fighting over who is responsible.'' Terrence added, ``until 
something goes wrong.'' At that point, there was a lot of 
laughter in the room. Mickey came back with ``then nobody wants 
the responsibility.'' What kind of gridlock does that cause?
    In every focus group we carried out across America, people 
talked as much about governance as they talked about science 
and technology. The public is asking our government to answer 
four basic questions. The first one, do we understand the risks 
associated with nanotechnology, both today's risks and 
tomorrow's? Second, will our policies protect us and the 
environment from these risks? Third, when and how will you, the 
government, start talking to us about what you are doing, what 
you know, and what you do not know? And finally, if something 
goes wrong with this technology, are you prepared?
    Let me address each of these challenges in order. Are we 
spending enough to understand the risk to workers, consumers, 
and the environment? I cannot tell you the answer to that. I 
can tell you what is needed to address this issue. We need a 
full, transparent disclosure of all government-funded 
environmental, health, and safety-related research, every 
single project, not just the monetary sum of the projects. This 
will allow us to identify gaps, to better partner with industry 
and government in other countries to fill the gaps, and 
strategically invest or disinvest at the margins. We live in a 
world of fiscal constraints, so we can't assume that we are 
going to have another $100 million to spend on this.
    Right now, we are in the process of putting together this 
inventory, and we will release such an inventory on November 
29. We would like to request the committee that they keep the 
docket open until the end of the month, so we can submit 
essentially our initial analysis of the main research gaps. But 
that is not going to be enough. We are going to be dealing with 
the risks of nanotechnologies for decades to come. These risks 
are going to become more complex, not simpler, especially as 
nano and biotechnology converge. No single country will ever 
have enough money to address these risks.
    I believe that it is time to essentially start an 
International Nanorisk Characterization project that is modeled 
roughly on what we did with the Human Genome Project, where we 
essentially prioritize risks on a global level, align teams of 
researchers to address these priorities, and we implement an 
information infrastructure to support global collaboration. In 
the end, we are going to have to leverage every single dollar, 
every single euro, every yen, everything that we have, both 
government and industry.
    The public wants to know: will our oversight and regulatory 
policies protect us? I do not think anybody in this government 
right now can provide a clear answer, and certainly, the 
public, I can tell you, is not confident. Our approach to the 
policies have been, so far, ad hoc and incremental, and we need 
a systematic analysis across agencies, statutes, and programs, 
across agencies, and across the entire international landscape, 
which looks at regulations, voluntary agreements, information-
based strategies, State and local ordinance, and ask this 
question: will this work now, will it work five years from now, 
and will it work 10 years from now? I am especially concerned 
that we lack any kind of coherent strategy to reach small 
businesses and startups with the appropriate information they 
are going to need to protect workers and the environment.
    Now, it is time, I think, to ask the Government 
Accountability Office, as you asked the National Academy of 
Sciences two years ago, the National Academy of Public 
Administration to undertake within one year a systemic analysis 
of the government structure for nanotechnology issues, and 
develop a government-wide, and I stress government-wide, 
blueprint for the regulation and control of these technologies 
that will work not only today, but 10 years from now, and 20 
years from now. I think we owe that to consumers, to workers, 
and also to industry.
    The Federal Government and industry also has to address 
what Mr. Nordan called perception risks. In the end, the 
success of these technologies will depend on the public opening 
its mind and its pocketbook and embracing technologies. It is 
not a given, as we learned with nuclear power and with 
genetically modified organisms. Studies show that people are 
excited about these technologies, but they have little trust 
right now in either government or industry to manage the risks, 
and consistently ask for more transparency. They want more 
disclosure, and they want more involvement. We need to engage 
the public, not just try to educate them.
    The U.S. Government should set a goal to reach out and 
engage at least 3,000 citizens and public opinion leaders 
around the country over the next year. This would require 20 to 
25 town meetings, listening sessions, and civic forums, but I 
think it would help build the foundation we need for greater 
public trust, confidence, and acceptance of these 
nanotechnologies, and ultimately, create more viable and 
growing markets.
    Finally, we need to prepare for the unexpected. 
Nanotechnology is essentially planned disruption. It is not 
something we want to get smug or overconfident about. We could 
be surprised in unpleasant ways, either by the technology 
itself, or by people who mishandle it, mislabel it, or misuse 
the technology. So we do anticipate and plan for and rehearse 
every possible scenario for misuse or accidents. I see no 
evidence whatsoever that this is happening anywhere in the 
government right now.
    In conclusion, let me emphasize that to succeed, we are 
going to need two things. We need good science, and we need 
good governance. Our project through the Wilson Center looks 
forward to working with this committee as you move forward.
    Thank you.
    [The prepared statement of Mr. Rejeski follows:]

                  Prepared Statement of David Rejeski

    I would like to thank Chairman Sherwood Boehlert, Ranking Member 
Bart Gordon, and the Members of the House Committee on Science for 
holding this hearing on the environmental, health, and safety (EH&S) 
implications associated with the development of nanotechnology.
    My name is David Rejeski, and I am the Director of the Project on 
Emerging Nanotechnologies at the Woodrow Wilson International Center 
for Scholars. This Project was created earlier this year in partnership 
with The Pew Charitable Trusts.
    The Project on Emerging Nanotechnologies is dedicated to helping 
ensure that as nanotechnologies advance, possible risks are minimized, 
public and consumer engagement remains strong, and the potential 
benefits of these new technologies are realized. The Project 
collaborates with researchers, government, industry, non-governmental 
organizations (NGOs), and others concerned with the safe applications 
and utilization of nanotechnology.
    Our goal is to take a long-term look at nanotechnologies, to 
identify gaps in the nanotechnology information, data, and oversight 
processes, and to develop practical strategies and approaches for 
closing those gaps. We aim to provide independent, objective 
information and analysis that can help inform critical decisions 
affecting the development, use, and commercialization of 
nanotechnologies throughout the globe.
    In short, both the Wilson Center and The Pew Charitable Trusts 
believe there is a tremendous opportunity with nanotechnology to ``get 
it right.'' Societies have missed this chance with other new 
technologies and, by doing so, have made costly mistakes. We think 
nanotechnology's promised benefits are so great that we do not believe 
the United States and the rest of the world can afford to miscalculate 
or misstep with nanotechnologies.
    As the Committee knows, nanotechnology is expected to become the 
transformational technology of the 21st century. It is the world of 
controlling matter at the scale of one billionth of a meter, or around 
one-100,000th the width of a human hair. Researchers are exploring new 
ways to see and build at this scale, re-engineering familiar substances 
like carbon and gold in order to create new materials with novel 
properties and functions.
    As the National Science Foundation (NSF) highlights, the ability to 
determine the novel properties of materials and systems at this scale 
implies that nanotechnology eventually could impact the production of 
virtually every human-made object--everything from automobiles, tires, 
and computer circuits to advanced medicine and tissue replacements--and 
lead to the invention of products yet to be imagined. Nanotechnology 
will fundamentally restructure the technologies currently used for 
manufacturing, medicine, defense, energy production, environmental 
management, transportation, communication, computation, and 
education.\1\
---------------------------------------------------------------------------
    \1\ M.C. Roco, R.S. Williams and P. Alivisatos. Nanotechnology 
Research Directions: IWGN Workshop Report. Berlin, Germany: Springer, 
2000, p. iii-iv.
---------------------------------------------------------------------------
    NSF predicts that the world market for goods and services using 
nanotechnologies will grow to $1 trillion by 2015. Lux Research 
calculates that in 2004 there were $13 billion worth of products in the 
global marketplace incorporating nanotechnology.\2\ Others estimate 
there are already over 700 products on the market that are made from or 
with nanotechnology or engineered nanomaterials. Worldwide about $9 
billion annually is being spent by governments and the private sector 
on nanotechnology research and development.
---------------------------------------------------------------------------
    \2\ ``Sizing Nanotechnology's Value Chain.'' New York, NY: Lux 
Research, October 2004.

1.  What impacts are environmental and safety concerns having on the 
development and commercialization of nanotechnology-related products 
---------------------------------------------------------------------------
and what impact might these concerns have in the future?

    In the midst of the tremendous excitement over nanotechnology that 
exists in university research laboratories, government agencies, and 
corporate boardrooms, publics throughout the world remain largely in 
the dark. A major study, funded by NSF and conducted in 2004 by 
researchers at North Carolina State University (NCSU), found that 80-85 
percent of the American public has heard ``little'' or ``nothing'' 
about nanotechnology.\3\ This is consistent with similar polling 
results in Europe and Canada. Anecdotally, some researchers believe 
that an even higher percentage of the public remains uninformed about 
nanotechnology.
---------------------------------------------------------------------------
    \3\ Michael D. Cobb and Jane Macoubrie. ``Public Perceptions about 
Nanotechnology: Risk, Benefits and Trust.'' Raleigh, NC: North Carolina 
State University, 2004. Available at http://www2.chass.ncsu.edu/cobb/
me/past%20articles%20and%20working%20papers/
Public%20Perceptions%20about%20Nanotechnology%20-
%20Risks,%20Benefits%20and%20Trust.pdf.
---------------------------------------------------------------------------
    Earlier this year (2005), the Project on Emerging Nanotechnologies 
commissioned a new report by Senior Associate Jane Macoubrie, who co-
authored the NCSU study in 2004. This new report, ``Informed Public 
Perceptions of Nanotechnology and Trust in Government,'' provides an 
in-depth look at what Americans know and do not know about 
nanotechnology.\4\
---------------------------------------------------------------------------
    \4\ Jane Macoubrie. Informed Public Perceptions of Nanotechnology 
and Trust in Government. Washington, DC: Woodrow Wilson International 
Center for Scholars, 2005. Available at http://www.wilsoncenter.org/
news/docs/macoubriereport1.pdf.

    It indicates that U.S. consumers, when informed about 
nanotechnology, are eager to know and learn more. They generally are 
optimistic about nanotechnology's potential contribution to improve 
quality of life. The key benefits the public hopes for are major 
medical advances, particularly greatly improved treatment for cancer, 
Alzheimer's, and diabetes.
    The Project's report findings track closely with work done last 
year (2004) by University of East Anglia researcher Nick Pidgeon for 
Great Britain's Royal Society. Pidgeon found there were few among the 
British public who knew much about nanotechnology. Those that did were 
optimistic that it would make life better. Study participants expressed 
concern about privacy issues and about the high costs of nanotechnology 
research and development to the British taxpayer. Some Britons also 
feared that nanotechnology would turn out to be a case of ``scientists 
trying to play God''--a phrase frequently attributed to the Prince of 
Wales in the press.\5\
---------------------------------------------------------------------------
    \5\ Nanotechnology: Views of the General Public. London, U.K.: BMRB 
Social Research, January 2004, BMRB/45/1001-666. Available at 
www.nanotec.org.U.K./Market%20Research.pdf.
---------------------------------------------------------------------------
    This general public optimism about nanotechnology is what I 
consider the ``good news.'' In the NCSU study, only 22 percent of the 
U.S. participants believed that nanotechnology's risks would exceed its 
benefits. The rest anticipated nanotech's benefits would exceed risks 
(40 percent), or expected risks and benefits to be about equal (38 
percent).

    The ``bad news'' is that both the recent Project on Emerging 
Nanotechnologies report and last year's NCSU study highlight ``no'' or 
``low'' American public trust in government and industry to manage any 
potential risks associated with nanotechnology. This is important 
because, both at home and abroad, the public's risk tolerance is 
weighed against a technology's direct benefit to them or to a group of 
people they consider important--children, senior citizens, the sick, 
the poor, and the disadvantaged. It also is highly dependent on their 
confidence or trust in the people making decisions about the 
technology's development, commercialization, and regulation.

    Worse, the Project on Emerging Nanotechnologies' report showed that 
a lack of knowledge--about nanotechnology-based products, about 
possible health and environmental implications, and about the oversight 
process designed to manage any potential risks--breeds U.S. public 
mistrust and suspicion. In the absence of balanced information, people 
are left to speculate about the possible health and environmental 
impacts of nanotechnology. Rightly or wrongly, without information, 
they often draw on analogies of what they consider past failures to 
effectively manage risks--like dioxin, Agent Orange, or nuclear power.
    A Nature magazine editorial described this Project report--along 
with a recent U.K. citizens' jury conducted by the universities of 
Cambridge and Newcastle--as providing governments with some ``direct 
public guidance on citizens' interests that must be protected if 
nanotechnology is to flourish.'' \6\ For policy-makers, the ``take 
home'' messages from a number of studies are quite clear:
---------------------------------------------------------------------------
    \6\ ``Value-free nanotech?'' Nature 437, September 22, 2005, 451-
452.

          Consumers want more information to make informed 
        choices about nanotechnology's use and greater citizen 
---------------------------------------------------------------------------
        engagement in shaping how the technology is developed.

          There are low levels of trust in government and 
        industry to manage any risks associated with nanotechnology. 
        There is little support for industry self-regulation or 
        voluntary agreements. A majority of the public believes that 
        mandatory government controls are necessary.

          People have clear ideas about how to improve trust. 
        They want government and industry to practice due diligence to 
        ensure manufacturing and product safety. In both U.S. and U.K. 
        studies, this translated into strong support for research and 
        safety testing before products go to market and a focus on 
        better understanding long-term effects on both people and the 
        environment.

    In my view, there is still time to inform public perceptions about 
nanotechnology and to ensure that nanotechnology is developed in a way 
that citizens--as well as the insurance industry, corporate investors, 
NGOs, and regulatory officials--can trust. However, with the production 
of nanosubstances ramping up and more and more nanotech-based products 
pouring into the marketplace, this window is closing fast. Industry 
remains concerned about the possibility of liability for nanoproducts 
with unknown risks in an uncertain regulatory environment. Coordinated 
education and engagement programs will be needed, supported by both 
government and industry. These programs will have to be structured to 
reach a wide range of consumers, cutting across age, gender, and 
socioeconomic status, utilizing a variety of media going beyond 
traditional print, radio, television, film towards non-traditional 
media such as blogs and multi-player on-line games.

2.  What are the primary concerns about the environmental and safety 
impacts of nanotechnology based on the current understanding of 
nanotechnology?

    Over the past 15 years, scientific data on the health and 
environmental impacts of nanostructured materials has been growing 
slowly. Three scientific reviews of the subject recently have been 
written, each of which notes that while some initial information as to 
environmental, health, and safety (EH&S) implications is available, 
much more work remains to be done in this area.
    One overview of the subject by Gunter, Eva, and Jan Oberdorster 
notes that laboratory studies have shown that airborne nanoscale 
materials depositing in the respiratory tract can cause an inflammatory 
response when inhaled.\7\ The small size of engineered nanomaterials 
also makes it easier for their uptake into and between various cells, 
allowing for transport to sensitive target sites in the body, including 
bone marrow, spleen, heart, and brain. Various kinds of nanomaterials, 
including C-60 fullerenes, single-walled nanotubes, and quantum dots, 
have been found to mobilize to mitochondria in cells, potentially 
interfering with antioxidant defenses. However, the translocation rates 
of these materials are uncertain.
---------------------------------------------------------------------------
    \7\ Gunter Oberdorster, Eva Oberdorster, Jan Oberdorster. 
``Nanotoxicology: An Emerging Discipline Evolving for Studies of 
Ultrafine Particles,'' Environmental Health Perspectives, July 2005, 
113(7): 823-839.
---------------------------------------------------------------------------
    In addition, Oberdorster et. al. report that there have been only a 
few studies looking at the effects of engineered nanomaterials on 
environmental systems. Water-borne carbon-60 was found to lead to 
oxidative stress in the brains of largemouth bass, although the 
mechanisms of action were uncertain. The bactericidal properties of 
carbon-60 in water have also been reported, and are being used as 
potential new anti-microbial agents. However, such uses may have 
unforeseen consequences on delicate ecosystems if materials are 
released into the environment. Quoting the authors, ``During a 
product's life cycle (manufacture, use, disposal), it is probable that 
nanomaterials will enter the environment, and currently there is no 
unified plan to examine ecotoxicological effects of [nanoparticles].'' 
\8\
---------------------------------------------------------------------------
    \8\ Gunter Oberdorster, Eva Oberdorster, Jan Oberdorster, p. 836.
---------------------------------------------------------------------------
    An article by Andrew Maynard and Eileen Kuempel\9\ on the impact of 
airborne nanostructured particles on occupational health notes that 
while a number of studies have investigated the toxicity and exposure 
of ultrafine aerosols, there are currently no studies on exposure and 
response to engineered nanomaterials in humans. Nevertheless, our 
experience with ultrafine aerosol particles (particles smaller than 100 
nm that are typically a by-product of a process) in the workplace has 
shown that inhalation of micro- and nano-sized fibers and particles can 
lead to increased rates of cancer, lung disease, and adverse 
respiratory symptoms.
---------------------------------------------------------------------------
    \9\ Andrew Maynard and Eileen Kuempel. ``Airborne Nanostructured 
Particles and Occupational Health,'' Journal of Nanoparticle Research, 
2005, forthcoming.
---------------------------------------------------------------------------
    In addition to size, the shape, solubility, surface chemistry, and 
surface area of ultrafine particles is known to increase inflammation 
and tissue damage. These are not properties that are usually considered 
when evaluating hazards and health impacts. While it should be 
emphasized that little data exists in relation to the human health 
impact of these factors for engineered nanomaterials, similar responses 
can be expected and appropriate risk-management strategies will be 
needed.
    Finally, a recent paper sponsored by the International Life Science 
Institute\10\ (ILSI) highlights a number of these points by noting that 
the unknowns and uncertainties surrounding the current state of EH&S 
research imply that ``there is a strong likelihood that biological 
activity of nanoparticles will depend on physiochemical parameters not 
routinely considered in toxicity screening studies.'' In short, the 
report concludes that ``little knowledge exists regarding specific 
nanomaterial characteristics which may be indicators of toxicity,'' 
requiring additional investigations into the physiochemical 
characterization of these materials and the development of accurate in 
vitro and in vivo testing methods.
---------------------------------------------------------------------------
    \10\ Gunter Oberdorster et. al. ``Principles for Characterizing the 
Potential Human Health Effects from Exposure to Nanomaterials: Elements 
of a Screening Strategy,'' Particle and Fibre Toxicology, October 2005, 
2(8):1-35.
---------------------------------------------------------------------------
    Overall, a comparative reading of these three overview articles and 
other published studies elucidates a number of key points, including:

          Since engineered nanomaterials show behavior that 
        depends on their physical and chemical structure, risk 
        assessment paradigms that have been developed based on 
        traditional, bulk chemistry alone may no longer be valid.

          Inhaled, nanometer-structured, insoluble particles 
        can elicit a greater response in the lungs than their mass 
        would suggest, indicating mechanisms of action that are 
        dependent on particle size, surface area, and surface 
        chemistry, among other properties. However, information is 
        lacking on nanomaterials' structure-related behavior in the 
        body.

          Inhaled, nanometer-diameter particles may leave the 
        lungs through non-conventional routes and affect other parts of 
        the body, including targeting the cardiovascular system, the 
        liver, kidneys, and the brain. Next to nothing is known about 
        the impact of engineered nanomaterials on these organs.

          Nanometer-diameter particles may be able to penetrate 
        through the skin in some cases, although this is still an area 
        of basic research and the chances of penetration appear to be 
        significantly greater for damaged skin. The potential for 
        nanostructured particles present in cosmetics and other skin-
        based products to do harm may be low, but remains unknown.

          Virtually nothing is known about the hazard of 
        engineered nanomaterials ingested as a food additive or by 
        accident.

          Although an understanding of the impact of engineered 
        nanomaterials and nano-enabled products on the environment 
        through their lifetime is considered critical, virtually 
        nothing is known at present.

    Much of the research undertaken so far has raised more questions 
than answers. To date, the majority of research has focused on 
relatively basic engineered nanomaterials. As nanomaterials move from 
simple to complex materials and on to active and multi-functional 
materials, major knowledge gaps need to be filled before useful 
quantitative risk assessments can be carried out and before 
comprehensive, life cycle risk management strategies can be developed. 
As the image below indicates, the technology is developing more rapidly 
than our understanding of the EH&S risks and our ability to respond 
with effective policy measures.




3.  What should be the priority areas of research on environmental and 
safety impacts of nanotechnology? Who should fund and who should 
conduct that research?

    A number of groups have developed, or are in the process of 
developing, lists of research priority areas and questions of interest. 
These organizations include the National Institute for Occupational 
Safety and Health (NIOSH)\11\, Environmental Defense\12\, the 
Semiconductor Research Corporation, and the Chemical Industry Vision 
2020 Technology Partnership.\13\ Despite the diversity of these 
organizations, these gap analyses are generally in broad agreement on 
the areas requiring further research and development. Common themes 
include: Toxicity (human and environmental), exposure and material 
release/dispersion, epidemiology, measurement and characterization, 
control of exposure and emissions, safety hazards, risk management 
models, and product life cycle analysis.
---------------------------------------------------------------------------
    \11\ National Institute for Occupational Safety and Health. 
Strategic Plan for NIOSH Nanotechnology Research: Filling the Knowledge 
Gaps. September 28, 2005. Available at http://www.cdc.gov/niosh/topics/
nanotech/strat---planINTRO.html.
    \12\ Richard A. Denison. ``A proposal to increase federal funding 
of nanotechnology risk research to at least $100 million annually.'' 
Washington, DC: Environmental Defense, April 2005. Available at http://
www.environmentaldefense.org/documents/
4442-100milquestionl.pdf.
    \13\ Semiconductor Research Corporation and Chemical Industry 
Vision 2020 Technology Partnership. ``Joint NNI-ChI CBAN and SRC CWG5 
Nanotechnology Research Needs Recommendations.''

    There also appears to be agreement that the federal support for 
risk-related EH&S research has been spread too thin. As a result, EH&S 
research currently lacks enough depth to adequately address and provide 
substantial answers to many risk management questions that will emerge 
in both the near and long-term future. Therefore, an effective, 
forward-looking, internationally recognized EH&S research strategy 
needs to be developed to fill this gap.
    A major barrier to developing a coherent risk-related research 
agenda of sufficient breadth and depth--within government and in 
conjunction with the private-sector--is a lack of coordination and 
information about the risk-related research the government is currently 
supporting.

    To address this issue, the Project on Emerging Nanotechnologies is 
in the process of compiling a publicly accessible inventory of 
government-supported, risk-related research--both domestically and 
internationally--that is addressing the EH&S implications of 
nanotechnology. It is our hope that this inventory will be a useful 
tool for informing future EH&S-related research strategies and policy 
decisions. Although not comprehensive, it will provide the most 
complete overview of current federally funded research into the EH&S 
implications of nanotechnology to date.
    The first generation of this inventory contains basic information 
on government-funded, risk-related research projects, including 
summaries, outputs, duration, funding sources, and budgets. The 
research is categorized on multiple levels. The first layer of 
categorization analyzes each research project by its relevance to the 
implications of nanotechnology, whether the nanomaterials under 
investigation are intentionally manufactured, incidental or naturally 
occurring, and whether the primary focus is on human health, 
environment, or safety impacts. A second layer of categorization 
classifies the research according to its focus within a simplified risk 
analysis framework. Finally, provision is made for a more detailed, 
third level of classification according to a range of searchable 
keywords and phrases.

    As of early November, the inventory included a total of 154 ongoing 
and completed projects in the United States, accounting for roughly $23 
million per year of federally funded research across eight different 
agencies. The inventory also currently includes 15 projects from 
sources around the world, including Canada, the U.K., and EU countries, 
accounting for roughly $2.6 million per year.
    This inventory will be made available online on November 29th and 
will include our initial analysis of research gaps. We would like to 
submit our preliminary analysis of the federal EH&S research portfolio 
to this Committee and request that the docket be held open until then, 
if possible. Additions to the inventory will be made as new information 
is received, and researchers and research managers will be encouraged 
to contribute new or updated information as their work progresses. The 
inventory is currently undergoing external peer review, along with 
internal checks for accuracy.
    There are a number of key advantages provided by the inventory:

          It can enable the coordination of research between 
        disciplines, agencies, and various stakeholders. It can also 
        enable the coordination of research internationally, reducing 
        the probability of duplicative research in different countries.

          It will allow the government to develop an integrated 
        set of EH&S policies that are designed to make strategic 
        investments based upon what work is already being undertaken. 
        By helping to identify where the need for further funding lies, 
        the current gaps in the EH&S research portfolio can be more 
        easily addressed.

          It will satisfy the public's desire for greater 
        transparency and disclosure of government activities, a desire 
        that has been voiced repeatedly in the surveys and public 
        perception studies discussed earlier.

          It will allow for the government to form partnerships 
        with industry around pre-competitive research, as it becomes 
        evident which exposure and toxicity issues are of interest to 
        firms in the early stages of commercialization. Joint funding 
        for EH&S research would be seen as a broad-based, long-term 
        investment in nanoscale science and technology and would 
        greatly increase our understanding and ability to manage 
        potential risks.

    Preliminary analysis of the data indicates that most critical 
research gaps are being addressed to a certain extent. However, it is 
also apparent that coverage of these issues is very limited, patchy, 
and uncoordinated. Research into exposure and hazard evaluation is 
relatively well represented in the database, and there are a number of 
projects providing information on nanomaterials' behavior that may 
determine impact. Research into how to control nanomaterials' releases 
and exposure effectively is being undertaken, and to a lesser extent, 
research into risk assessment and management methods and models.

    The areas of research that are under-represented by comparison are 
human health effects and environmental impact, and human safety (such 
as fire and explosion hazards). It is also apparent that much of the 
current research portfolio focuses on first generation engineered 
nanomaterials, with very little strategic research addressing more 
complex materials currently under development. NIOSH, EPA, and NSF are 
leading the research highly relevant to the environmental, health, and 
safety implications of engineered nanomaterials, with DOD also making a 
significant contribution. Investigator-driven research funded by all 
four agencies is dominating mission-driven research addressing EH&S 
issues--raising questions over the degree to which currently funded 
projects address strategic issues.
    Evaluating the number or value of research projects addressing 
specific issues in isolation does not provide insight into research 
gaps and strategy limitations. However, when used in conjunction with 
complementary information on research and oversight needs, it provides 
a powerful tool for developing informed, focused, and long-range 
strategies.
    Third, in addition to the need for increased funding and 
coordination, our analysis of the inventory data raises a host of more 
difficult questions related to structural issues. Does a trained 
workforce exist both domestically and internationally to undertake such 
novel research? Do governments have adequate human resources and the 
cooperative mechanisms necessary to manage such an effort effectively? 
Is there sufficient international agreement on technical definitions, 
metrology, and testing frameworks to collaborate and evaluate risk-
related research among many countries?

    At this point, it is uncertain as to whether this emerging policy 
response to concerns over nanotechnology's EH&S implications will be 
able to match the pace of innovation. As developments in nanotechnology 
become more revolutionary, transformative, and discontinuous, the 
governance system must adjust and change accordingly. Failure to do so 
will perpetuate the public's low trust in the government's ability to 
manage technological risk.

4.  Are current federal and private research efforts adequate to 
address concerns about environmental and safety impacts of 
nanotechnology? If not, what additional steps are necessary?

    Our ability to realize the promise of nanotechnology is becoming 
more and more linked to governance and management issues, not just 
science.
    The country that wins the global nanotech race will be the country 
that can manage a suite of potential risks and challenges involving 
pubic perception, effective oversight, and the possibility of surprise. 
Understanding the environmental and health risks is a necessary but 
insufficient condition for success.
    If the goal of the National Nanotechnology Initiative is ultimately 
the creation of economic value, jobs, and innovative products that can 
change people's lives, we need a larger perspective on the tasks ahead 
and, in all probability, newer and smarter management and governance 
approaches that go beyond ``another interagency workgroup.'' Let me 
discuss the risks we face as a society using a broader framework that 
goes beyond EH&S issues. I will focus on areas we need to tackle, and 
discuss what the Federal Government, along with other key stakeholders, 
might do.




Health and Environmental Risks

    From a global perspective, the U.S. Government has responded early 
and comparatively well to the EH&S challenge. As I outlined earlier, 
there are gaps in knowledge that must be closed and this requires more 
open debate and cooperation with industry and other countries. We need 
to acknowledge that the fiscal constraints we face in this country and 
elsewhere may limit our ability to significantly increase research 
dollars. As the analyses by the American Association for the 
Advancement of Science have indicated, U.S. funding for environmental 
research has been flat (in real terms) for more than 20 years. The 
existence of very real fiscal constraints means that effective 
management of the EH&S research enterprise for nanotechnologies is 
imperative, not optional. Every dollar, every euro or yen matters, and 
must be leveraged. The United States should take the lead by putting 
our research cards on the table so we can build winning hands with 
other countries and industry.

    I strongly feel it is time to launch an International Nanorisk 
Characterization Initiative (modeled roughly on the Human Genome 
Project) where we develop priorities across countries, align teams of 
researchers to address these priorities, and implement an information 
infrastructure to support global collaboration. Engaging industry in 
supporting pre-competitive research projects in this portfolio will 
also be necessary. The risk characterization challenges we face today 
are relatively easy compared to what will come as nanotechnology and 
biotechnology converge and as we build ever-more complex and multi-
functional nanostructure and systems of nanostructures. We are at the 
bottom of a very steep learning curve.

Perception Risks

    Recently, a number of reports from the financial sector have 
underscored the importance of addressing and managing perception risks 
related to how the people perceive nanotechnologies.\14\ In the end, 
the success of nanotechnologies will depend on the public opening its 
mind and pocket book and embracing nanotechnology. This is not a given, 
as we have learned from other technologies such as genetically 
engineered foods and nuclear power. Recently, pharmaceutical companies 
have seen profits erode because of declining public trust in their 
organizations and products.\15\
---------------------------------------------------------------------------
    \14\ Lux Research. A Prudent Approach to Nanotech Environmental, 
Health and Safety Risks. 2005 and Innovest Strategic Value Advisors. 
Non-traditional Methods for Valuation of Nanotechnology Producers: 
Introducing the Innovest Nanotechnology Index for the Value Investor, 
2005. http://www.innovestgroup.com/.
    \15\ ``Big Drug Makers See Sales Erode with Their Image.'' The New 
York Times. November 14, 2005, p. A1. This article cites a recent poll 
that shows only nine percent of Americans believed that drug companies 
were generally honest.
---------------------------------------------------------------------------
    Based on the public perception studies from multiple countries, 
which I summarized earlier, the public has clearly articulated their 
concerns about nanotechnologies and what they expect from government 
and industry. To summarize this, they are asking for better due 
diligence involving standardized testing (preferably by independent 
third parties), greater transparency, and the disclosure of test 
results.
    The public's willingness to tolerate risks from new technologies 
also is linked to the perception of early and significant benefits. The 
large-scale benefits from nanotechnology have not yet materialized and 
may not for 3-10 years. For the foreseeable future, I believe there 
will be little public tolerance of oversight failures or mishaps, 
either in the United States or in most European countries. A mishap 
could rapidly chill investment and galvanize public opposition. More 
civil society actors are becoming aware of nanotechnologies and 
carefully watching both government and industry response to possible 
risks.
    How growing numbers of the public learn about nanotechnologies, 
from whom, and with what message, may be critical in shaping long-term 
popular acceptance. The U.S. Government needs a public engagement 
strategy, which is not the same as education. Educating people on 
nanotechnology assumes there is a deficit in their understanding. 
Engagement forces us to admit that the public may have something 
important to say to scientists, industry, and policy-makers and that 
they deserve being part of the larger conversation about how 
nanotechnology develops. Engagement cannot be a public relations 
campaign. As Physicist Richard Feynman once noted, ``For a technology 
to succeed, reality has to take precedence over public relations.''

    The U.S. Government, for example, should set a goal of engaging at 
least 3,000 citizens and public opinion leaders around the Nation over 
the next year. This would require 20-25 town meetings, ``listening 
sessions,'' and civic forums, but it would be time and money well spent 
and would help to raise public awareness and public confidence. 
Associated with this effort, we also need to establish an ongoing and 
scientifically robust mechanism to track public knowledge and attitudes 
toward nanotechnology over time (on a regular six-month basis, for 
instance). Let's call this a NanoBarometer--designed to take the pulse 
of the public and to continually monitor and help to evaluate our 
public engagement efforts.
    Industry also plays a critical role in shaping perception risks. 
Few companies have talked openly about their involvement with 
nanotechnology, no doubt because of large uncertainties concerning 
public reaction and government regulatory intentions, but this 
situation needs to change. In the long run, silence is likely to breed 
suspicions and mistrust on the part of the public.

Structural Risks

    With more and more nanotech-based products entering commerce, a key 
question is whether significant gaps exist in our oversight structure 
and how we can address these. Though agencies have been meeting to 
discuss oversight and the EPA has begun developing a voluntary program, 
our approach on the regulatory side so far has been ad hoc and 
incremental. It is particularly worrisome that many nanotechnology-
based products are entering the market in areas with little, or no, 
government oversight, such as cosmetics and consumer products. The U.S. 
Government approach has been limited by the following:

          A focus on single statutes such as the Toxic 
        Substances Control Act (TSCA) rather than taking an integrated, 
        multi-statute approach

          A focus on products more than the facilities and 
        processes where production occurs

          A general lack of concern with the full life cycle 
        impacts of emerging nanotechnologies (an approach recommended 
        in the U.K. Royal Society Report) \16\
---------------------------------------------------------------------------
    \16\ Nanoscience and nanotechnologies: opportunities and 
uncertainties. London, U.K.: The Royal Society and Royal Academy of 
Engineering, July 2004. Available at http://www.nanotec.org.U.K./
finalReport.htm.

          Too few resources devoted to pollution prevention and 
        the ``greening'' of nanotechnology products and production 
        processes, which could help industry ultimately avoid potential 
---------------------------------------------------------------------------
        risks from the beginning

          Too little discussion of the resource constraints to 
        effective oversight (for instance, do we have the personnel and 
        dollars in the agencies needed for enforcement or testing?).

    Most important, we have not looked forward to consider where 
nanotechnology is heading, assuming decades-old policies and analogies 
to the past will help us respond to the risks of the future. Today, 
nanotechnology is largely chemistry. But in a very short time, it will 
be chemistry and biology, and after that we will be dealing with multi-
functional machines operating at the interface of classical and quantum 
physics.
    Many of the assumptions that governed our approach to chemicals 
regulation may no longer hold. Because the risks of nanomaterials are 
poorly related to mass (and depend on other characteristics like 
surface volume, chemistry, charge, etc.), governments and industry will 
have to rethink the mass-based approaches that have historically shaped 
our toxicology, regulations, and regulatory-related monitoring systems.
    We need a systemic analysis across agency statutes and programs, 
across agencies, and across the international landscape. This should 
include existing regulations, voluntary programs, information-based 
strategies, state and local ordinances, and tort law. All these 
measures need to be evaluated not just in terms of their applicability 
to nanotechnology today, but also in terms of their efficacy in five or 
ten years. We need an oversight blueprint that is proactive, 
transparent, and, for industry, predictable both now and into the 
foreseeable future.
    In 2003, the Congress asked the National Academy of Sciences to 
evaluate the National Nanotechnology Initiative, largely from the 
perspective of the science. We urgently need to examine the governance. 
Now it is time to ask the General Accountability Office or National 
Academy of Public Administration to undertake (within one year) a 
systematic analysis of the governance structure for nanotechnologies 
and develop a government-wide blueprint that will work not only today, 
but also 10 or 20 years from now. We owe that to consumers, to workers, 
and to industry.
    There are also risks that arise from the structure of the 
nanotechnology industry itself. Nanotechnology will not play out in a 
handful of large and well-staffed facilities where oversight and proper 
workforce training are relatively easy. The scientific investment 
strategies of the U.S. Government and dozens of other countries have 
been designed to distribute nanotechnology R&D efforts across hundreds, 
and eventually thousands, of laboratories globally. These labs will in 
turn incubate thousands of small firms involved in a Darwinian struggle 
to push products to market.
    Already there are 1,200 nanotech start-ups worldwide, with more 
than 60 percent in the United States. Added to the university 
laboratories, we have thousands of people working at the messy and 
often unpredictable interface between novel technologies and human 
judgment. Assume that much of the workforce is young--graduate and 
post-doctoral students, and other Generation-Y types with newly minted 
science or engineering degrees--a cohort of people that often tend to 
ignore safety protocols in the workplace.

    The government needs ``push strategies'' directed at small 
businesses, start-ups, and small labs. If someone is running an 8-10 
person nanofirm, we cannot assume they will have significant time and 
resources to devote to environmental, health, or safety issues. The 
government (at Federal, State, and local levels) needs to knock on 
their doors with useful technical and, potentially, financial 
assistance. Mounting information on government websites will not 
adequately address this problem.

    One of the best ways of delivering this information is to use 
``intermediaries'' such as professional societies along with technical 
assistance programs at universities and in the extension services of 
the government. Policy-makers need to constantly ask themselves the 
question, ``Will this program or policy work for small nanotech 
businesses?'' In addition, large companies with the resources to 
address EH&S issues need to develop strategies to push this know-how 
down their supply chains to smaller firms involved in nanotech 
production. Government programs and policies should support and reward 
such supply-chain approaches in industry.

    Small and medium sized firms also need relatively inexpensive and 
rapid methods to screen emerging nanosubstances and products for human 
and ecotoxicity. The Federal Government could help by supporting the 
development of fast-turnaround, standardized toxicity screens that can 
fit into the product development cycles of companies. Such screening 
techniques hopefully would allow environmental and human health 
problems to be identified early and engineered out of products before 
they enter the marketplace.

Wildcards

    Finally, let me say a few words about what I would characterize as 
``wildcard'' risks such as accidental or intentional releases. Here, I 
can only comment that I hope we are doing more than I can presently 
detect. Ed Tenner, a historian of science at Princeton University, once 
observed that there is a ``tendency of advanced technologies to promote 
self-deception.'' Nanotechnology is not something we want to get smug 
or overconfident about. We could be surprised in unpleasant ways, 
either by the technology itself or by people who mishandle, mislabel, 
or misuse the technology. Unfortunately, we have no Department of 
Unintended Consequences in the Federal Government.

    An accidental release of engineered nanomaterials into the 
environment, while probably not posing significant risks, could be a 
public relations nightmare, with a chilling effect on global 
investment. For example, the chief executive of a nanotechnology 
company recently was quoted in the media boasting that his company is 
manufacturing 50 tons of Polyhedral Oligomeric Silsesquioxanes (POSS ) 
chemicals at its supply plant in Mississippi.\17\ A patently harmless 
industrial accident at that facility unrelated to the manufacture of 
these nano-structured chemicals--first discovered 30 years ago by 
General Electric Co.--has the potential to create unnecessary public 
and first responder panic simply because of their association with a 
technology that is unfamiliar and undefined to most citizens, EH&S 
professionals, and government safety officials.\18\ Planning to address 
this gap at the federal, State, community, and factory level is 
essential. I know of no emergency response plans that have been 
developed by the Federal Government or local first responders to 
address such a scenario. Such an accident could occur anywhere, which 
means we need to prepare globally. We need to anticipate, plan for, and 
rehearse every possible scenario we can imagine, to prepare for think 
the unthinkable. Of special importance is the consideration of so-
called ``black swans,'' events with large impacts, incalculable 
probabilities, and surprise effects.\19\
---------------------------------------------------------------------------
    \17\ Pat Phibbs. ``Manufacture of New Carbon Nanotube Approved by 
EPA Under an Exemption.'' Daily Environment. No. 203, October 21, 2005, 
page A1.
    \18\ Robert T. Dixon. ``Hybrid Plastics' nanomaterials: From inner 
molars to outer space,'' Small Times. October 28, 2002.
    \19\ See: Talib, N. The Black Swan: Why Don't We Learn that We 
Don't Learn?, The United States Department of Defense Highlands Forum 
papers, February 2004, at: http://www.fooledbyrandomness.com/
blackswan.pdf
---------------------------------------------------------------------------
    In addition, we should assume that bad practices will occur along 
with good practices as nanotechnology evolves. Everyday, vigilant and 
intelligent people recognize errors around them and can often come up 
with ingenious ways to correct problems. Taken one at a time, these bad 
practices seldom lead to a disaster if recognized early and addressed. 
The challenge is to develop ways for ``error correcting knowledge'' to 
be collected, managed effectively, and channeled into solutions. One 
model for this is the Aviation Safety Reporting System, which collects 
and analyzes voluntarily submitted reports from pilots, air traffic 
controllers, and others involving safety risks and incidents. The 
reports are used to remedy problems, better understand emerging safety 
issues, and generally educate people in the aviation industry about 
safety. A similar system in the U.K., called CHIRP, is designed to 
promote greater safety in both the aviation and maritime industries and 
is run by a charitable trust.

    We should create a Nano Safety Reporting System where concerned 
people working with nanotechnologies--in laboratories, companies, or in 
shipping and transport situations--can share safety issues and 
concerns. The purpose is not finger pointing but encouraging proactive 
learning. This information could be used to design educational 
materials, structure technical assistance programs, and provide a 
heads-up on a host of possible safety issues. Again, the goal is early 
warning of emerging risks and the reduction of possible wildcards.

Management and Coordination

    Addressing the issues outlined above requires a properly resourced 
coordination function and smart management.
    A recent GAO report on results-oriented government makes it clear 
that effective federal collaboration is key to addressing many 21st 
century challenges.\20\ For the most part, we have yet to develop a 
winning formula for collaboration. The National Nanotechnology 
Initiative is one of the most complex interagency endeavors ever 
undertaken by the U.S. Government, now involving over $1 billion per 
year in funding and 25 separate agencies. This increase in the number 
of possible partners across the government leads to an almost 
exponential increase in the number of possible collaborations--of both 
productive and potentially nonproductive natures.\21\
---------------------------------------------------------------------------
    \20\ General Accountability Office (2005). Results-Oriented 
Government: Practices That Can Help Enhance and Sustain Collaboration 
among Federal Agencies, GAO-06-15 , October 21, 2005. Summary available 
at: http://www.gao.gov/docsearch/abstract.php?rptno=GAO-06-15
    \21\ See: Bryan, L. & Joyce, C. (2005). ``The 21st Century 
Organization,'' McKinsey Quarterly, Number 3.
---------------------------------------------------------------------------
    The sum of 25 agency missions does not necessarily add up to a 
coherent federal strategy for addressing risks, engaging the public, 
providing adequate oversight, or managing the unexpected. It is simply 
the sum of the missions, or less. As the GAO report points out, these 
missions are often not mutually reinforcing or can even be in conflict. 
``You end up with a patchwork of programs that can waste funds, confuse 
and frustrate program customers, and limit the overall effectiveness of 
the federal effort.''
    Our approach to social and ethical issues has largely involved an 
``outsourcing'' model where the scientists do the science and 
``ethics'' are dealt with in separate institutions and centers. Policy 
considerations have been dealt with as ``add-ons'' rather than being 
fully integrated into the research planning process. Given the pace of 
development, neither one of these approaches is likely to provide 
government with adequate ``early warning'' and the necessary lead time 
to structure effective policies or responses to emerging social and 
ethical issues.
    Nanotechology is just the latest in a series of upheavals in our 
scientific and industrial landscape, which is being shaped 
simultaneously by rapid and disruptive changes in areas such as 
information technology, biotechnology, and cognitive science. Many 
agencies like FDA and EPA are grappling with the implications of the 
genomics revolution and are hard-pressed to consider nanotechnologies. 
These agencies are stretched thin. The depth of expertise in the 
individual agencies on nanotechnology often involves only 2-3 
professionals. Again, most of these people are scientists, not people 
with public policy or public administration experience.
    The managerial and coordination infrastructure in place simply does 
not match the enormity and importance of the task. We need a beefed up, 
visible federal face for nanotechnologies sending a coherent message to 
the public and industry. I believe that the National Nanotechnology 
Coordinating Office (NNCO) can help in this regard, but it is 
understaffed and under-funded by orders of magnitude. This is not about 
creating an additional bureaucracy; it is about creating coherence and 
the capacity to manage a complex enterprise.
    Again, let me emphasize that we can succeed with the science but 
fail on governance, compromising our competitive position.
    I hope these observations will be helpful to the Committee as they 
consider what steps might be taken to ensure that the promise of 
nanotechnology can be realized.

               Key Questions from Different Perspectives

Scientific/Technical

          Which properties or attributes of engineered 
        nanomaterials are particularly significant to health/
        environmental impacts?

          Are nanomaterials capable of interacting in ways we 
        are currently unaware of, or targeting biological/environmental 
        systems we are unaware of?

          Are there classes of nanomaterials that present a 
        greater or lesser hazard?

          Can we predict chronic/long-term impacts to both 
        humans and ecosystems?

          How will risks change as nanotechnologies evolve 
        (nanobio, nanosystems, systems of systems)? How will we 
        anticipate, evaluate, and manage these risks?

          What are the beneficial applications of 
        nanotechnology to environmental and human health problems? Can 
        nanotechnology be developed so that the benefits outweigh the 
        risks?

          How can we prevent risks posed by the pollution 
        generated in the production of nanomaterials and their 
        associated products?

Policy/Regulatory

          What mechanisms work best to regulate nanotechnology-
        based products?

          Have potential chronic and long-term risks, issues, 
        and consequences been analyzed by policy-makers and government 
        agencies?

          Does sufficient expertise exist in the government to 
        address the EH&S implications of nanotechnology? If not, how 
        will we attract and retain talent?

          What opportunities exist for public-private and 
        international partnerships?

          Will our policies and programs work for small and 
        medium-sized enterprises?

          How can risk management and regulatory models be 
        developed which are relevant to an ever-changing technology?

          How does the structure of the emerging nanotechnology 
        industries affect their response to EH&S issues?

          How have uncertainties and ``domains of ignorance'' 
        been taken into account during the decision-making, policy-
        making, and standard-setting process?

          Who will be responsible, and who will be held 
        accountable, for any unforeseen harm, ill-used, or dangerous 
        applications of nanotechnology?

          Who is responsible for collecting data on 
        nanotechnology industries that can inform policy-making (the 
        Bureau of Labor Statistics, the Census Bureau, etc.)?

          Are we trying to anticipate possible accidental 
        misuse of nanotechnologies? Who in the government should be 
        doing this?

          Is there a need for new legislation or a new 
        department specifically focused on nanotechnology?

Public Perception

          Who does the public trust to handle and manage the 
        EH&S risks?

          How is information related to nanotechnology 
        communicated and made available? What media are most effective 
        (for which age groups, for instance)?

          Are public perceptions being included and used to 
        inform debates about proposed and pending regulations?

          How will the public react in the event of an 
        accident, mishap, or product recall? What would the government 
        message be?

                      Biography for David Rejeski

    David Rejeski directs the Project on Emerging Nanotechnologies. For 
the past four years he has been the Director of the Foresight and 
Governance Project at the Woodrow Wilson Center, an initiative designed 
to facilitate better long-term thinking and planning in the public 
sector.
    He was recently an adjunct affiliated staff at the RAND Corporation 
and a Visiting Fellow at Yale University's School of Forestry and 
Environmental Studies. Before joining the Wilson Center he served as an 
agency representative (from EPA) to the White House Council on 
Environmental Quality (CEQ) and, earlier, worked at the White House 
Office of Science and Technology (OSTP) on a variety of technology and 
R&D issues, including the development and implementation of the 
National Environmental Technology Initiative.
    Before moving to OSTP, he was head of the Future Studies Unit at 
the Environmental Protection Agency. He spent four years in Hamburg, 
Germany, working for the Environmental Agency, Department of Public 
Health, and Department of Urban Renewal and, in the late 1970's, 
founded and co-directed a non-profit involved in energy conservation 
and renewable energy technologies.
    He has written extensively on science, technology, and policy 
issues, in areas ranging from genetics to electronic commerce and 
pervasive computing and is the co-editor of the recent book 
Environmentalism and the Technologies of Tomorrow: Shaping the Next 
Industrial Revolution, Island Press, 2004.
    He sits on the advisory boards of a number of organizations, 
including the EPA's Science Advisory Board, the Greening of Industry 
Network, the Journal of Industrial Ecology, and the University of 
Michigan's Corporate Environmental Management Program. He is a member 
of the External Advisory Board of Nanologue, a European project to 
bring together leading researchers to facilitate an international 
dialogue on the social, ethical and legal benefits and potential 
impacts of nanosciences and nanotechnologies. He has graduate degrees 
in public administration and environmental design from Harvard and 
Yale.




    Chairman Boehlert. Thank you very much. Dr. Denison.

    STATEMENT OF DR. RICHARD A. DENISON, SENIOR SCIENTIST, 
     ENVIRONMENTAL HEALTH PROGRAM, ENVIRONMENTAL DEFENSE, 
                        WASHINGTON, D.C.

    Dr. Denison. Thank you, Mr. Chairman, Ranking Member 
Gordon, and other Members of the Committee. It is a pleasure to 
be here today.
    I share the other witnesses' enthusiasm about the potential 
benefits that nanotechnology offers society. In my five 
minutes, however, I would like to make one key point, that 
federal funding to understand the potential risks of 
nanomaterials must be greatly increased, and that it is very 
much in the interest of proponents of this technology that this 
occur.
    I am going to offer you three reasons for why I believe 
this. First, limited data now available are flashing yellow 
lights that we should not ignore. Second, everyone is better 
off if government takes the lead in developing the 
infrastructure that will be needed to identify and assess 
potential risks of nanomaterials. And third, a major federal 
investment in this area is essential to avoid a public backlash 
against this promising set of technologies.
    Fiscal Year '06 spending directed to risk research amounts 
to only four percent of the total NNI budget for development of 
nanotechnology, about $40 million. As detailed in my statement, 
industry, the insurance and investment communities, as well as 
environmentalists, are all united in calling for a dramatic 
increase in this level of funding. It is a truly remarkable 
convergence, as the Chairman noted at the beginning. We have 
called for such spending to be increased to at least $100 
million annually for at least the next several years. That is 
about 10 percent of the total NNI budget. And the rationale for 
that is fully laid out in my written statement, where we have 
compared to a number of other benchmarks why we think that 
number is the minimum that is needed.
    Two other steps are needed, however, to ensure that the 
right research is done. First, the NNI, or another federal 
research agency, needs to be given the responsibility and the 
authority to develop an overall federal risk research strategy, 
and to implement that strategy across agencies. And second, we 
believe Congress should call on the NNI to request the 
assistance of the National Academies, in particular, the Board 
on Environmental Studies and Toxicology, in this effort.
    Let me now turn to the three arguments I made earlier. 
First, the flashing yellow lights. Concerns about nanomaterials 
arise from two sources: first, their novel properties and 
behavior; and second, some rather surprising results that have 
occurred in the first studies done. These show that 
nanomaterials can cross from the lung, when inhaled, directly 
into the blood. They can even cross from our noses directly 
into our brains. Some of these particles are able to evade the 
body's usual mechanisms for defense, and some of them can 
directly enter cells, where they possibly actually interfere 
with cellular machinery. While none of these findings directly 
implicate the harm of these materials, none of them are saying 
that we should ignore these behaviors and not look any further.
    Let me stress that all of the toxicology work that has been 
done to date has only been short-term in nature. We have no 
chronic toxicity testing that has looked, for example, at 
reproductive effects, or at long-term effects like cancer. But 
even these short-term studies have yielded a number of 
surprises. For example, when carbon nanotubes are instilled 
into the lungs of rodents, they consistently have been shown to 
quickly cause inflammation and also, the presence of unusual 
cell masses called granulomas. One of these studies actually 
used a dose that is equivalent to what a worker would get in 
only several weeks exposure at the current OSHA standard for 
airborne particles in the workplace. This study also found that 
fibrosis developed in exposed animals, even in parts of the 
lung that were far removed from where the particles actually 
deposited.
    Researchers that were developing nanoparticles to target 
and kill tumor cells also found a rather significant surprise. 
All 20 of the materials that they developed for this purpose 
were found to damage other organs: liver, spleen, and kidney, 
and these effects were only observed because of the extensive 
testing that is done in the course of drug development to look 
for adverse side effects. That kind of testing is not routinely 
required in the vast majority of other applications. In short, 
there is growing evidence that nanomaterials can get into vital 
organs and cells, and when they get there, they can do damage.
    My second argument. Government needs to develop what I call 
the enabling infrastructure to address nanomaterials' potential 
risks. This includes standardizing methods and developing tools 
to do everything from monitoring of nanomaterials in the 
environment to understanding how they move through living 
organisms. Government-funded research is essential to create a 
database of information about model or representative 
materials. And none of this is to say that companies don't have 
the obligation, ultimately, to test their own products prior to 
commercialization. That is clearly an obligation that remains. 
But industry needs the infrastructure that I have described in 
order to do its job.
    Last, but not least, my third argument. Failing to make 
these kinds of investments threatens the future of 
nanotechnology. We remember genetically modified organisms, 
where rapid commercialization, coupled with a failure to 
address the risks up front, led to a public backlash, closed 
markets, and product bans.
    Let me end by saying that nanotechnology offers an enormous 
opportunity to apply the lessons that we have learned from 
prior mistakes, identify and take the necessary steps to 
address the risks up front. In short, we believe there is an 
opportunity here to get nanotechnology right the first time.
    Thank you, and I would be very happy to answer questions.
    [The prepared statement of Dr. Denison follows:]

                Prepared Statement of Richard A. Denison

Summary of Responses to the Committee's Questions

Question 1: Are current federal and private research efforts adequate 
        to address concerns about environmental and safety impacts of 
        nanotechnology? If not, what additional steps are necessary?

          Strong consensus that federal funding for risk 
        research should be substantially increased.

                 At least $100 million annually for at least the next 
                several years is needed.

          Needed additional steps:

                 NSET or a federal research agency should develop, 
                direct an overall federal research strategy Draw on 
                expertise of National Academies' Board on Environmental 
                Studies and Toxicology.

          Industry should fund research and testing on its 
        products.

Question 2: What are the primary concerns about the environmental and 
        safety impacts of nanotechnology based on the current 
        understanding of nanotechnology?

          Need for a life cycle view, especially for dispersive 
        applications of nanomaterials.

          Novel properties of nanomaterials that may pose 
        potential risks.

                 Potential to cross cell membranes Translocation of 
                inhaled nanoparticles from lung to brain or into 
                systemic circulation.

          Lack of data on chronic toxicity, surprising results 
        in short-term studies.

                 Carbon nanotubes (CNTs)

                 C60 fullerenes (commonly known as buckyballs)

                 Quantum dots

          Importance of surface area and surface properties

                 Stability of coatings

Question 3: What should be the priority areas of research on 
        environmental and safety impacts of nanotechnology? Who should 
        fund and who should conduct that research?

          Fundamental need for government to develop or revise 
        tools and methods to:

                 Characterize, detect, measure and monitor for 
                nanomaterials

                 Assess biological and environmental fate and behavior

                 Assess acute and chronic toxicity and ecotoxicity

          Government-led research to create database on 
        representative, model nanomaterials

                 Industries using these materials should also help fund 
                this basic work.

          Companies should have responsibility for testing 
        products prior to commercialization.

Question 4: What impacts are environmental and safety concerns having 
        on the development and commercialization of nanotechnology-
        related products and what impact might these concerns have in 
        the future?

          Real potential for public backlash if government does 
        not identify, address risks up front.

                 As with GMOs, could delay or even prevent realization 
                of potential benefits Public identifies up-front safety 
                testing, more information as critical to building 
                trust.

          Extent of safety assessment conducted could become a 
        competitive issue for U.S. industry.

                 Companies indicate they want science-based regulation 
                to provide a more level playing field.

          Public and private interests are best served by 
        identifying potential risks now when they can be avoided, 
        rather than paying later to remediate resulting harms.

I. Introduction\1\
---------------------------------------------------------------------------

    \1\ A biography of Dr. Denison is attached. Several other 
Environmental Defense staff contributed to the preparation and content 
of this testimony: Dr. John Balbus, Health Program Director, Karen 
Florini, Senior Attorney, and Scott Walsh, Project Manager.
---------------------------------------------------------------------------
    A remarkable and unusual consensus has emerged with respect to the 
federal government's role in nanotechnology: Organizations as diverse 
as environmental NGOs, large chemical companies, nanotech startups, 
insurance companies and investment firms all agree that the Federal 
Government should be immediately directing many more of the dollars it 
is currently investing in nanotechnology development toward identifying 
and assessing the potential risks of nanomaterials to human health and 
the environment. This federal investment in risk research is essential 
to developing the basic infrastructure that will enable the private 
sector to fulfill its responsibility to identify, assess and reduce the 
potential risks associated with the nanomaterial containing products 
before they are brought to market.
    Nanotechnology, the design and manipulation of materials at the 
atomic scale, may well revolutionize many of the ways our society 
manufactures products, produces energy, and treats diseases. Hundreds 
of large and small nanotechnology companies are developing a wide 
variety of materials for use in electronics, medical diagnostic tools 
and therapies, construction materials, personal care products, paints 
and coatings, environmental cleanup, energy production and 
conservation, environmental sensors, and many other important 
applications.
    Deliberate exploitation of properties that only become evident at 
the nanoscale is central to these applications. Such properties include 
highly specific binding over a huge surface that arises from tiny 
particle size, absorption and radiation of specific wavelengths of 
light, penetration of cellular barriers, and high tensile strength and 
durability. Carefully controlled, these properties may provide highly 
beneficial products. But these new and enhanced properties also raise 
the possibility of unintended adverse consequences for human health and 
the environment. The same binding properties that allow use of 
nanoparticles to deliver therapeutics to cancer cells may also, for 
example, deliver toxic substances to normal human cells, or to aquatic 
organisms if such materials are released or used in the ambient 
environment. The electrical properties that drive applications in 
computers can lead to oxidative damage in living tissues. It is 
essential that potential harms like these are identified and mitigated 
up front, prior to widespread commercialization and human and 
environmental exposure.

II. Responses to the Committee's Questions

    This testimony provides Environmental Defense's responses to the 
four questions posed by the Committee in its invitation letter.

A. Committee Question #1: Are current federal and private research 
efforts adequate to address concerns about environmental and safety 
impacts of nanotechnology? If not, what additional steps are necessary?

    In our view, current federal and private research efforts are far 
from adequate to address concerns about environmental and safety 
impacts of nanotechnology, and funding for such efforts should be 
substantially increased.
    The U.S. Government, as the largest single investor in 
nanotechnology research and development, needs to spend much more to 
assess the health and environmental implications of nanotechnology and 
ensure that the critical research needed to identify potential risks is 
done expeditiously. Through the National Nanotechnology Initiative 
(NNI), the Federal Government spends roughly $1 billion annually on 
nanotechnology research and development. Of this, environmental and 
health implications research accounted for only $8.5 million (less than 
one percent) in FY 2004, and is expected to increase to only $38.5 
million (less than four percent) in FY 2006.
    In a rare example of convergence from sectors that often have 
highly divergent views, environmentalists, industry and the insurance 
and investment communities are all calling for dramatic increases in 
federal funding on the health and environmental implications of 
nanotechnology. For example, in June 2005 the CEO of DuPont and the 
President of Environmental Defense co-authored an opinion editorial in 
The Wall Street Journal calling for an increase in such funding to at 
least $100 million annually. That same month, the American Chemistry 
Council's Panel on Nanotechnology and Environmental Defense issued a 
Joint Statement of Principles\2\ stating: ``A significant increase in 
government investment in research on the health and environmental 
implications of nanotechnology is essential.'' And in a recent 
report\3\ on nanotechnology, Innovest, a leading investment research 
and advisory firm, has said: ``We strongly support calls by others in 
the investment community for increased government funding of toxicology 
research. The NNI's lack of priority for this issue represents a missed 
opportunity to minimize uncertainty.''
---------------------------------------------------------------------------
    \2\ Environmental Defense and American Chemistry Council 
Nanotechnology Panel, ``Joint Statement of Principles,'' Submitted as 
Comments on EPA's Notice of a Public Meeting on Nanoscale Materials, 70 
FR 24574--Docket OPPT-2004-0122, 23 June 2005, available online at 
www.environmentaldefense.org/documents/4857-ACC-
ED-nanotech.pdf.
    \3\ Innovest (2005). Nanotechnology: Non-traditional Methods for 
Valuation of Nanotechnology Producers. New York, NY. Page 56. Available 
online at www.innovestgroup.com/publications.htm (accessed Nov. 2, 
2005).
---------------------------------------------------------------------------
    Similarly, at a briefing held on March 22, 2005, to preview the 
findings of a report by the President's Council of Advisors on Science 
and Technology (PCAST) that reviewed the NNI, John H. Marburger III, 
Science Adviser to the President and chief of the White House Office of 
Science and Technology Policy, stated that the toxicity studies now 
underway are ``a drop in the bucket compared to what needs to be 
done.'' \4\
---------------------------------------------------------------------------
    \4\ R. Weiss, ``Nanotech Is Booming Biggest in U.S., Report Says,'' 
Washington Post, March 28, 2005, p. A6, available online at 
www.washingtonpost.com/wp-dyn/articles/A5221-2005Mar27.html.
---------------------------------------------------------------------------
    Our and others' calls for the U.S. government to spend at least 
$100 million annually on hazard and exposure research for at least the 
next several years is buttressed by experts' assessments of the cost to 
conduct the needed research, as well as by testing costs associated 
with hazard characterization programs for conventional chemicals, and 
the research budgets for a roughly analogous risk characterization 
effort on risks of airborne particulate matter.\5\ While this level of 
risk research spending will represent a significant increase over 
current levels, it is still less than 10 percent of the overall federal 
budget for nanotechnology development. Moreover, it is a modest 
investment compared to the benefits of risk avoidance and to the $1 
trillion contribution that nanotechnology is projected to make to the 
world economy by 2015.
---------------------------------------------------------------------------
    \5\ A full explication of the basis for the $100 million annual 
figure, which I submitted earlier this year to the National Research 
Council's Committee to Review the NNI, is available online at 
www.environmentaldefense.org/documents/
4446-EnvironmentalDefenseStatement NRCNanopanel25Mar05.pdf
---------------------------------------------------------------------------
    What additional steps are necessary? We recognize that at present 
the NNI's Nanoscale Science, Engineering and Technology Subcommittee 
(NSET) serves primarily as a facilitator and coordinator of 
nanotechnology-related activities among the various federal departments 
and agencies. In our view, ensuring that sufficient and appropriate 
risk research is carried out by the Federal Government may well require 
vesting the NSET or one of the lead federal health or environmental 
research agencies with responsibilities that go beyond these current 
functions. Sufficient authority to oversee and direct federal risk-
related research is essential to ensure first, that the right questions 
are asked and answered, and second, that identified risks are 
comprehensively assessed and do not fall through the cracks between 
statutes, departments and agencies.
    We therefore offer two proposals for your consideration. The first 
is to vest NSET or one of the lead federal health or environmental 
research agencies with:

          the task of developing an overall federal research 
        strategy for identifying and assessing potential risks of 
        nanomaterials;

          the authority to shape and direct the overall federal 
        risk research agenda across agencies to ensure all critical 
        needs are being addressed, ideally with some budgetary 
        authority; and

          the responsibility to ensure that individual agencies 
        have sufficient dedicated staff and resources to conduct or 
        commission the needed research in their areas, and sufficient 
        authority to identify and assess potential risks.

    Our second proposal is that Congress should call on the NNI and its 
member agencies to request assistance from the National Academies, in 
particular the Board on Environmental Studies and Toxicology (BEST). 
BEST should be asked to review the NNI agencies' ongoing research and 
research plans, offer its guidance on appropriate risk screening and 
assessment approaches, and help guide the development and 
implementation of the federal research strategy we call for above, to 
help ensure the right research is done. BEST has played an analogous 
role in the formulation and execution of the U.S. Environmental 
Protection Agency's research strategy for assessing the risks of 
airborne particulate matter.\6\
---------------------------------------------------------------------------
    \6\ Board on Environmental Studies and Toxicology, Research 
Priorities for Airborne Particulate Matter: I. Immediate Priorities and 
a Long-Range Research Portfolio, Committee on Research Priorities for 
Airborne Particulate Matter, National Research Council, 1998; and 
Research Priorities for Airborne Particulate Matter: IV. Continuing 
Research Progress, 2004, both available online at: books.nap.edu/
catalog/6131.html, and books.nap.edu/catalog/10957.html.
---------------------------------------------------------------------------
    Of course, the U.S. Government should not be the sole, or even the 
principal, funder and conductor of nanomaterial risk research. Other 
governments are also spending heavily to promote nanotechnology 
research and development, and they too should allocate some portion of 
their spending to address nanotechnology risks. And although government 
risk research has a critical role to play in developing the basic 
knowledge and methods to characterize and assess the risks of 
nanomaterials, private industry should fund the majority of the 
research and testing on the products they are planning to bring to 
market. Clearly, all parties will benefit if governments and industry 
coordinate their research to avoid redundancy and optimize efficiency.

B. Committee Question #2: What are the primary concerns about the 
environmental and safety impacts of nanotechnology based on the current 
understanding of nanotechnology?

    The primary concerns about nanomaterials' health and safety impacts 
arise both from consideration of the inherent nature and novel 
properties of at least certain nanomaterials, and from surprising 
results seen in many of the relatively small number of nanotoxicity 
studies conducted to date. As described below, various nanomaterials 
have been demonstrated to have the potential to:

          cross physiological barriers (lung-blood and blood-
        brain) and enter the systemic circulatory system, thereby 
        posing risks to organ systems removed from the site of entry;

          evade the body's usual metabolic and immune defense 
        mechanisms;

          penetrate cell membranes;

          directly interact and possibly interfere with 
        cellular components;

          deliver secondary molecules to intracellular targets, 
        or reach non-target cells or organs; and

          persist and accumulate in the body or the 
        environment.

    Scientists are only beginning to examine the extent to which these 
behaviors can result in significant toxicological impacts, and if so, 
at what levels of exposure. Likewise, as yet there is little 
understanding of the mechanisms that lead to the biological effects 
that have been observed in toxicity studies. Such effects, further 
described below, include the potential to:

          kill skin cells in culture;

          damage brain tissue in mammals and in fish;

          impair lung function and generate unusual granulomas 
        in the lungs of rodents; and

          kill microorganisms, including ones that may 
        constitute the base of the food web.

Need for a life cycle view, especially for dispersive applications of 
        nanomaterials
    Some uses of nanomaterials already on the market, and others now in 
the pipeline, will result in exposure of humans or the environment, 
either through direct application or dispersive use. Some of these 
exposures reflect the inherent nature of the product or application, 
such as in uses of nanomaterials in drugs and cosmetics, and in 
remediation of groundwater contamination. Other products may also 
entail substantial exposures, though not necessarily during a product's 
use. For example, tennis rackets, automobile running boards, and other 
products contain carbon nanotubes embedded within resins or other 
matrices. While exposure to individual nanoparticles during such a 
product's intended use seems unlikely, a life cycle view is critical to 
understanding the potential risks. A product's life cycle includes not 
just the product's use phase, but also its manufacture (and the 
manufacture of its components) and its disposal or recycling/
reclamation. Human or environmental exposures during these other stages 
may be substantial. For instance, nanomaterials present in cosmetics 
and sunscreens will be washed off and enter water supplies--as has 
already been demonstrated for pharmaceuticals and ingredients in 
personal care products. And although computer users are highly unlikely 
to inhale carbon nanotubes bound in their computer screen, exposure 
potential may dramatically increase when recyclers ultimately grind up 
those screens for other uses. Human exposures are most obvious for the 
workers doing the grinding, but may also be associated with the various 
stages of the life cycle of the subsequent product(s)--especially if 
knowledge of the presence of nanomaterials is not carried downstream 
along with the material itself.
Novel properties of nanomaterials that may pose potential risks
    Potential to cross cell membranes: In some cases, the very 
properties that make nanomaterials uniquely useful in biomedical or 
other commercial applications also raise the potential for novel 
mechanisms and targets of toxicity. For example, the ability of certain 
nanoparticles to penetrate cell membranes, which new applications to 
deliver targeted therapies exploit, suggests that nanoparticles will 
also be able to cross physiologic barriers and enter body compartments 
that larger particles and smaller molecules do not readily access. 
Particles of different sizes gain entry into the body's cells via very 
different mechanisms. Those larger than 500 nanometers (nm) primarily 
gain entry through active endocytosis; those smaller than 200 nm gain 
entry through a variety of active and non-active mechanisms.\7\ One 
study of 20-nm polystyrene beads suggests that they enter cells by 
passing directly through membranes--without requiring specific 
transport mechanisms. Once inside the cells, these nanoparticles 
distribute throughout the cytoplasm and appeared to bind to a variety 
of cell structures.\8\
---------------------------------------------------------------------------
    \7\ Rejman, J. et al. 2004. ``Size-dependent internalization of 
particles via the pathways of clathrin- and caveolaemediated 
endocytosis.'' Biochem J. 377: 159-69.
    \8\ Edetsberger, M., et al. 2005. ``Detection of nanometer-sized 
particles in living cells using modern fluorescence fluctuation 
methods.'' Biochem. Biophys. Res. Commun. 332(1): 109-116.
---------------------------------------------------------------------------
    The manner in which different individual and aggregated 
nanoparticles may interact with critical cell structures is poorly 
understood, and cannot be inferred from studies of chemical agents or 
randomly generated nanoparticles. Surface modifications may allow 
nanoparticles to bind to cell surface receptors and either avoid 
uptake\9\ or be taken up by specific transport mechanisms, allowing 
cell targeting for therapeutic agents. It is clear that subtle 
variations in nanoparticle surfaces, whether due to intentional coating 
prior to entry into the body or unintentional surface binding or to 
coating degradation once inside the body, can have dramatic impacts on 
where and how nanoparticles gain entry into cells, as well as where and 
how they are transported within cells after entry. Understanding the 
implications of such transport, as well as ensuring the stability of 
surface properties throughout the lifespan of manufactured 
nanoparticles, will be critical to assuring safety.
---------------------------------------------------------------------------
    \9\ Gupta, A. et al. 2004. ``Lactoferrin and ceruloplasmin 
derivatized superparamagnetic iron oxide nanoparticles for targeting 
cell surface receptors.'' Biomaterials. 25: 3029-40.
---------------------------------------------------------------------------
    Preliminary efforts to use nanoparticles for therapeutic 
interventions indicate that at least some nanomaterials have 
unanticipated toxic effects--effects that have been detected only 
because of the testing that routinely occurs in the course of drug 
development. In one example, researchers developing nanoparticles 
designed to target gliosarcoma tumor cells noted that, of twenty such 
materials, all caused adverse effects on the reticular endothelial 
system (comprised of the liver, spleen and peripheral lymph nodes) and 
the kidneys.\10\
---------------------------------------------------------------------------
    \10\ Institute of Medicine of the National Academies. 2005. 
Implications of nanotechnology for environmental health research. The 
National Academic Press. Washington, D.C.
---------------------------------------------------------------------------
    Translocation of inhaled nanoparticles from lung to brain or into 
systemic circulation: Nanoparticles can deposit throughout the 
respiratory tract when inhaled. Some of the particles settle in the 
nasal passages, where they have been shown to be taken up by the 
olfactory nerves and carried past the blood-brain barrier directly into 
brain cells. Smaller nanoparticles have been shown not only to 
penetrate deeply into the lungs, but to readily cross through lung 
tissue and enter the systemic circulation. These and other studies 
suggest that some nanomaterials can evade the lung's normal clearance 
and defense mechanisms. This potential for rapid and widespread 
distribution within the body offers promise of a new array of 
diagnostic and therapeutic applications for these substances--but it 
also heightens the importance of having a full understanding of their 
toxicity.
Lack of data on chronic toxicity, surprising results in short-term 
        studies
    No studies on reproductive toxicity, immunotoxicity, or chronic 
health effects such as cancer or developmental toxicity of 
nanomaterials have yet been published.\11\ Of the limited number of 
short-term studies completed to date, however, several have found a 
variety of adverse effects associated with each of the major classes of 
nanomaterials now being produced.
---------------------------------------------------------------------------
    \11\ Woodrow Wilson International Center for Scholars, Project on 
Emerging Nanotechnologies (2005). ``Nanotechnology. Environmental and 
Health Implications. A database of current research.'' Available at 
www.nanotechproject.net.
---------------------------------------------------------------------------
    Studies in which carbon nanotubes (CNTs) were instilled into the 
lungs of rodents have consistently demonstrated that CNTs cause unusual 
localized immune lesions (granulomas) within thirty days, and other 
signs of lung inflammation.\12\,\13\,\14\ One of 
these studies\15\--which utilized lower doses corresponding to the 
equivalent dose that would be experienced after a few weeks exposure at 
the current OSHA workplace standard for respirable particles--also 
found that single-walled CNTs cause dose-dependent fibrosis even in 
areas of the lung far removed from the sites of particle deposition. 
One study of multi-walled CNTs showed similar lung toxicity, especially 
after the material was finely ground.\16\ Oxidative stress may be part 
of the mechanism behind the damage to lung tissue that has been 
observed in these studies of carbon nanotubes. Single and multi-walled 
CNTs have also been shown to induce oxidative stress in skin 
cells.\17\,\18\,\19\ These studies raise concern 
for potential toxicity at the beginning or end of the life cycle of 
products containing CNTs, through workplace exposures or if CNT-
containing products undergo weathering, erosion or grinding during 
recycling or disposal.
---------------------------------------------------------------------------
    \12\ Lam, C. et al. 2003. ``Pulmonary toxicity of single-wall 
carbon nanotubes in mice 7 and 90 days after intratracheal 
instillation.'' Toxicol. Sci. 77: 126-134.
    \13\ Warheit, D. et al. 2004. ``Comparative pulmonary toxicity 
assessment of single-wall carbon nanotubes in rats.'' Toxicol. Sci. 77: 
117-25.
    \14\ Shvedova, A. et al. 2005. ``Unusual inflammatory and 
fibrogenic pulmonary responses to single-walled carbon nanotubes in 
mice.'' Am. J. Physiol. Lung Cell. Mol. Physiol. 289(5): L698-708.
    \15\ Shvedova et al. 2005, op.cit.
    \16\ Muller, J. et al. 2005. ``Respiratory toxicity of multi-wall 
carbon nanotubes.'' Toxicol. Appl. Pharmacol. 207: 221-31.
    \17\ Monteiro-Riviere, N. et al. 2005. ``Multi-walled carbon 
nanotube interactions with human epidermal keratinocytes.'' Toxicol 
Lett. 155: 377-384.
    \18\ Manna, S. et al. 2005. ``Single-walled carbon nanotube induces 
oxidative stress and activates nuclear transcription factor-kb in human 
keratinocytes.'' Nano Lett. Vol. 5, 9: 1676-1684.
    \19\ Shvedova, A. et al. 2003. ``Exposure to carbon nanotube 
material: assessment of nanotube cytotoxicity using human keratinocyte 
cells.'' J. Toxicol. Environ. Health A. 66:1909-1926.

    C60 fullerenes (commonly known as buckyballs) have been 
less well-studied in mammalian models. A recent study of buckyballs 
found that, although individual buckyballs do not dissolve well in 
water, they have a tendency to form aggregates that are both very 
water-soluble and bacteriocidal, a property that raises strong concerns 
of ecosystem impacts because bacteria constitute the bottom of the food 
chain in many ecosystems.\20\ They are also capable of being 
transported via the gills from water to the brains of fish, where they 
can cause oxidative damage to brain cell membranes.\21\ In experiments 
with human cultured cell lines, buckyballs show high toxicity, causing 
oxidative damage to cell membranes that leads to cell death.\22\
---------------------------------------------------------------------------
    \20\ Fortner, J. et al. 2005. ``C60 in water: nanocrystal formation 
and microbial response.'' Environ. Sci. Technol. 39: 4307-16.
    \21\ Oberdorster, E. 2004. ``Manufactured nanomaterials 
(fullerenes, C60) induce oxidative stress in the brain of juvenile 
largemouth bass.'' Environ. Health Perspect. 112: 1058-62.
    \22\ Sayes, C. et al. 2004. ``The differential cytotoxicity of 
water-soluble fullerenes.'' Am. Chem. Soc. 4: 1881-1887.

    Quantum dots can be made of a variety of inherently toxic 
materials, including cadmium and lead. As some of the key applications 
of quantum dots include diagnostic imaging and medical therapeutics, 
quantum dots have been studied relatively extensively in biological 
systems, although only a small portion of this research has focused on 
potential toxicity. Studies performed to date have mainly been in vitro 
cytotoxicity assays that measure cell damage or death. While results 
have been somewhat inconsistent, studies that used longer exposure 
times were more likely to demonstrate significant toxicity.\23\ Quantum 
dots typically have a core made of inorganic elements, but they are 
generally coated with organic materials such as polyethylene glycol to 
enhance their biocompatibility or target them to specific organs or 
cells. Some coatings initially decrease toxicity by one or more orders 
of magnitude, but the coatings are known to degrade when exposed to air 
or ultraviolet light, after which toxicity increases. While the 
presumption has been that this cytotoxicity is caused by leakage of 
toxic heavy metals (e.g., cadmium or selenium) from the core, there is 
evidence that some of the molecules used as coatings may have 
independent toxicity.\24\ Significant questions remain about the safety 
of quantum dots based on the available in vitro studies.
---------------------------------------------------------------------------
    \23\ Hardman, R. 2005. ``A toxicological review of quantum dots: 
toxicity depends on physico-chemical and environmental factors.'' 
Environ. Health Persp. Nat. Inst. of Environ. Health Sci. doi: 10.1289/
ehp.8284. Available at: http://dx.doi.org. (Accessed on November 4, 
2005).
    \24\ Hardman et al. 2004, op. cit.
---------------------------------------------------------------------------
    Although the doses and methods of administration used in many of 
these studies do not necessarily reflect mirror likely exposure 
scenarios, the results strongly suggest the potential for some 
nanomaterials to pose significant risks.

Importance of surface area and surface properties
    Understanding the behavior of nanoparticles requires careful 
characterization of their surface properties. For a given mass of 
particles, surface area increases exponentially with decreasing 
diameter (and increasing number). This increased surface-area-to-volume 
ratio may be a critical feature in understanding the toxicity of 
nanomaterials. For example, it leads to higher particle surface energy, 
which may translate into higher reactivity.\25\ In addition, the 
combination of high surface area and small size may give nanoparticles 
unusual catalytic reactivity due to quantum effects, such as those seen 
with gold nanoparticles.\26\ This combination of enhanced surface area 
and enhanced surface activity lends far greater complexity to the 
characterization of nanoparticles, and also precludes easy 
extrapolation about potential toxicity.
---------------------------------------------------------------------------
    \25\ Oberdorster, G. et al. 2005. ``Principles for characterizing 
the potential human health effects from exposure to nanomaterials: 
elements of a screening strategy.'' Part. Fibre Toxicol. 2: 8.
    \26\ Daniel, M. et al. 2004. ``Gold nanoparticles: assembly, 
supramolecular chemistry, quantum-size-related properties, and 
applications toward biology, catalysis, and nanotechnology.'' Chem. 
Rev. 104: 293-346.
---------------------------------------------------------------------------
    Stability of coatings: Most research to date has used prototypical 
or ``plain'' nanoparticles, such as uncoated buckyballs and carbon 
nanotubes. The few studies that have looked at the effects of 
variations and coatings have shown that these changes modify (typically 
reduce) the toxicity of the original particle, further complicating the 
picture by raising the question of how these coatings may degrade over 
time within the body or in the environment.
    In sum, the limited information available to date indicates that 
nanomaterials can both: a) exhibit novel properties and behavior that 
facilitate access to organisms, including specific cells or organs, 
raising the potential for biologically significant exposures to occur 
should such materials be released, and b) exhibit toxicity to a range 
of cell and organ types both in vitro and in vivo.

C. Committee Question #3: What should be the priority areas of research 
on environmental and safety impacts of nanotechnology? Who should fund 
and who should conduct that research?

    There is broad agreement among stakeholders that addressing the 
potential risks of nanotechnology will be an unusually complex task. 
Despite its name, nanotechnology is anything but singular; it is a 
potentially limitless collection of technologies and associated 
materials. The sheer diversity of potential materials and 
applications--which is a source of nanotechnology's enormous promise--
also poses major challenges with respect to characterizing potential 
risks.
    Even before the research that will allow hazards and exposures to 
be quantified, a number of more fundamental needs must be addressed. It 
is already clear that even extremely subtle manipulations of a 
nanomaterial can dramatically alter its properties and behavior: Tiny 
differences in the diameters of otherwise identical quantum dots can 
alter the wavelength of the light they fluoresce; slight changes in the 
degree of twist in a carbon nanotube can affect its electrical 
transmission properties. A priority must be to develop the means to 
sufficiently characterize nanomaterials and to systematically describe 
and detect such subtle structural variations--a clear prerequisite to 
being able to conduct and interpret the results of toxicological 
testing and exposure measurements. Emphasis needs to be placed, 
therefore, on developing methods, protocols and tools needed to 
characterize nanomaterials, and to detect and measure their presence in 
a variety of settings (e.g., workplace environment, human body, 
environmental media).
    Among the types of risk research that are needed for specific 
nanomaterials are the following:

          Material characterization (in manufactured form(s), 
        during use, in emissions, in wastes, in products; in 
        environmental media, in organisms)

          Biological fate (extent and rate of absorption, 
        distribution, metabolism, elimination in mammals and other 
        organisms)

          Environmental fate and behavior (persistence, 
        transport between and distribution among media, transformation, 
        bioaccumulation potential)

          Acute and chronic toxicity (related to both human and 
        ecological health)

    For each of these areas, existing testing and assessment methods 
and protocols need to be re-examined to determine the extent to which 
they can be modified to account for nanomaterials' novel 
characteristics or need to be supplemented with new methods. Similar 
challenges will arise with respect to methods and technologies for 
sampling, analysis and monitoring, all of which will be needed to 
detect nanomaterials and their transformation products in living 
systems and in various environmental media.
    Another essential task for government-funded research is helping to 
create an initial database of toxicity data on representative or model 
nanomaterials. Doing so will help guide additional research by the 
private sector on their own nanomaterials, and will also lay the 
groundwork for the ultimate development of so-called ``structure-
activity relationships'' (SARs) for nanomaterials. SARs are now widely 
used to reduce the amount of traditional toxicological testing needed 
to characterize conventional chemicals, by allowing the toxicity of an 
unstudied chemical to be estimated, based on its degree of structural 
similarity to chemicals that have been studied. Use of SARs is 
beneficial for several reasons: it's faster, it's cheaper, and it can 
minimize the need for testing using laboratory animals. But existing 
SAR models cannot simply be applied to nanomaterials: Because the 
models are based on the properties of bulk forms of conventional 
chemical substances, and because nanomaterials' novel and enhanced 
properties result from characteristics (e.g., size, shape) in addition 
to their molecular structure, existing models have little applicability 
to nanomaterials. In other words, the defining character of 
nanotechnology--the emergence of novel properties and behavior that 
cannot be predicted from the properties and behavior of their bulk 
counterparts--effectively precludes our relying on existing knowledge 
about the toxicity of conventional chemicals to predict the toxicity of 
nanomaterials. Only once enough data exist to correlate a 
nanomaterial's properties--or the changes in such properties that occur 
in the body or the environment--with observed patterns of toxicity, 
will nanomaterial-specific SARs be possible.
    In sum, government needs to play the lead role in developing the 
enabling infrastructure for identifying and assessing nanomaterials' 
potential risks, including by developing and standardizing methods for:

          physical-chemical characterization of nanomaterials;

          sampling and analysis;

          detection and monitoring: in workplaces, air/
        waterborne releases, humans and other organisms, environmental 
        media;

          assessing environmental fate and behavior;

          assessing biological fate and behavior, including 
        generating and making available radiolabeled or otherwise 
        traceable samples of key types of nanomaterials, for 
        government's own and others' use in such fate studies;

          testing for acute and chronic toxicity, including the 
        development and validation of non-animal test methods where 
        doing so is scientifically appropriate, in order to minimize 
        animal testing; and

          hazard, exposure and risk assessment.

    As noted above, given its major investment in nanomaterials 
development, it is also appropriate for government to identify and 
conduct a full characterization and testing of a variety of ``model'' 
nanomaterials, although industries already using these materials should 
also help fund this basic work. Government should also take the lead on 
coordinating the efforts of private and public sectors, and for 
international cooperation and coordination of risk research.
    None of the above should be construed, however, as a substitute for 
companies taking responsibility for (and bearing the financial burden 
of) all of the testing needed to ensure the safety of their products 
prior to commercialization. To ensure maximum value and bolster public 
confidence in such research, we believe government and industry should 
commit to make publicly available all results, not just ``interesting'' 
ones that may be publishable in scientific journals or are required by 
law to be reported.

D. Committee Question #4: What impacts are environmental and safety 
concerns having on the development and commercialization of 
nanotechnology-related products and what impact might these concerns 
have in the future?

    While industry representatives may be in a better position to fully 
address this question, let me discuss one type of impact--public 
backlash--that could readily arise, given the growing evidence of 
potential health and environmental risks posed by certain 
nanomaterials, and the government's to-date-inadequate effort to 
identify and address such risks. The ``risks'' at issue here, 
therefore, are not only those related to health and the environment, 
but also risks to the very success of this promising set of 
technologies. If the public is not convinced that nanomaterials are 
being developed in a way that identifies and minimizes negative 
consequences to human health and the environment, a backlash could 
develop that delays, reduces, or even prevents the realization of many 
of the potential benefits of nanotechnology. As demonstrated with 
genetically modified organisms just a few years ago, rapid 
commercialization combined with a failure to address risks early on can 
lead to product bans and closed markets, resulting in this case in 
hundreds of millions of dollars in annual export losses for U.S. 
farmers and companies.
    While little research into public attitudes toward nanotechnology 
has been conducted to date, some recently reported findings\27\ are 
telling. In the context of finding generally low public awareness of 
nanotechnology and, among those with some awareness, a generally 
positive attitude, there were also some warning signs:
---------------------------------------------------------------------------
    \27\ Woodrow Wilson International Center for Scholars, ``Informed 
Public Perceptions of Nanotechnology and Trust in Government,'' 
authored by Dr. Jane Macoubrie, Washington, DC, September 2005, 
available online at www.wilsoncenter.org/news/docs/
macoubriereport1.pdf.

          Public trust in government appears to be low, with no 
        more than half of the surveyed members of the public expressing 
        confidence in Congress' or the Executive Branch's willingness 
---------------------------------------------------------------------------
        or ability to manage nanotechnology-related risks.

          Suspicions of industry abound, with only a small 
        percentage indicating that industry could be trusted to ``self-
        regulate'' and a concern that industry often rushes products to 
        market without adequate testing.

    Equally interesting were the responses concerning how the 
government and industry might best build public trust. For example:

          The two best ways identified by respondents to build 
        public trust were requiring increased safety testing prior to 
        introduction of products onto the market, and provision of more 
        information to inform consumers' choices. Better tracking of 
        risks for materials already on the market also ranked high.

          The lack of information on long-term health and 
        environmental effects of nanotechnology and its products was 
        frequently cited as a major concern.

    Of course, all of these findings stress the need for more and 
better research into potential short- and long-term risks to be 
conducted now, prior to widespread commercialization of nanomaterial-
containing products.
    Finally, there is growing reason to expect that the extent of 
safety assessment conducted prior to market introduction of 
nanomaterial-containing products could well become a competitive issue. 
The investment firm Innovest notes in its recent report:

         ``Off the record conversations with regulators indicate that 
        Europe, the UK, and China are expecting to have some sort of 
        binding requirement for companies within the next two to four 
        years. China clearly states that its standards were designed to 
        create a robust foundation for nanotechnology development in 
        that region and that they expect their standards to impact the 
        competitive landscape for nanotechnology.'' \28\
---------------------------------------------------------------------------
    \28\ Innovest (2005), op. cit.

    Clearly, the U.S. nanotechnology industry will benefit from an 
environment in which it can offer reassurances that the safety of its 
products has been assessed using robust methods and evaluation 
procedures. Industry itself recognizes as much; as the Innovest report 
---------------------------------------------------------------------------
goes on to note:

         ``A significant portion of the more than 60 companies we 
        interviewed indicated an interest in having some sort of 
        standards in place. In many cases, they felt that science-based 
        regulation would provide a more level playing field. The lack 
        of adequate funding for toxicology research is, again, an issue 
        here.. . .Counter to intuition, our research shows that robust, 
        science-based regulation can contribute to healthy market 
        development.''

III. Conclusion

    In our view, both the public and private sectors' best interests 
are served by an investment to identify and manage potential 
nanotechnology risks now, rather than to pay later to remediate 
resulting harms. History demonstrates that embracing a technology 
without a careful assessment and control of its risks can be extremely 
costly from both human and financial perspectives. The failure to 
sufficiently consider the adverse effects of using lead in paint, 
plumbing, and gasoline has resulted in widespread health problems that 
continue to this day, not to mention extremely high remediation costs. 
Asbestos is another example where enormous sums of money were spent by 
private companies for remediation, litigation, and compensation, even 
beyond that spent by the public sector to alleviate harm to human 
health and the environment. Standard & Poor's has estimated that the 
total cost of liability for asbestos-related losses could reach $200 
billion.\29\
---------------------------------------------------------------------------
    \29\ Standard & Poor's, Insurance: Property-Casualty Industry 
Survey, July 15, 2004.
---------------------------------------------------------------------------
    The rapid commercialization of nanotechnology, coupled with the 
potential risks from at least certain nanomaterials as demonstrated in 
initial studies, lends urgency to the call for greater investment in 
risk research from the outset. Government and industry have done a 
great job so far in accentuating nanotechnology's potential upsides and 
in accelerating its development, but they have yet to come to terms 
with their equally critical roles in identifying and avoiding the 
downsides. A far better balance between these two roles must be struck 
if nanotechnology is to deliver on its promise without delivering 
unintended adverse consequences.
    Fortunately, nanotechnology development and commercialization is 
still at an early stage, so it is not too late to begin managing this 
process wisely. Given the length of time it will take to develop an 
adequate understanding of the potential risks posed by such a wide 
variety of nanomaterials, and to apply this knowledge to inform 
appropriate regulation, it is imperative to take action now.
    Nanotechnology offers an important opportunity to apply the lessons 
from prior mistakes by identifying risks up front, taking the necessary 
steps to address them, and meaningfully engaging stakeholders to help 
shape this technology's trajectory. In short, there is an opportunity 
to get nanotechnology right the first time.

                    Biography for Richard A. Denison

    Dr. Denison is a Senior Scientist in Environmental Defense's 
Environmental Health Program, working in its Washington, D.C. office. 
He specializes in hazard and risk assessment and management for 
industrial chemicals (including nanomaterials), and associated policy 
and regulatory issues. Dr. Denison is a member of USEPA's Pollution 
Prevention and Toxics Advisory Committee (NPPTAC), including its 
Workgroup on Nanotechnology, and serves on the Steering Group for 
Nanotechnology of the Organization for Economic Cooperation and 
Development (OECD).
    Dr. Denison manages Environmental Defense's participation in the 
U.S. High Production Volume (HPV) Chemical Challenge Program, initiated 
by Environmental Defense, EPA and the American Chemistry Council to 
provide basic hazard data on the 2,200 chemicals produced in the U.S. 
in the largest quantities. He also represents Environmental Defense in 
proceedings of the Chemicals Committee and the Existing Chemicals Task 
Force of the OECD. He has authored several papers and reports, and is 
active in a variety of activities and fora, pertaining to nanomaterials 
and chemicals regulation and policy at the federal and State levels and 
internationally.
    Dr. Denison earned a Ph.D. in Molecular Biophysics and Biochemistry 
from Yale University in 1982. He joined Environmental Defense in 1987, 
after several years as an analyst and assistant project director in the 
Oceans and Environment Program, Office of Technology Assessment, United 
States Congress.



                               Discussion

    Chairman Boehlert. Thank you very much, Dr. Denison. Thanks 
to all of you for your informed testimony, and we are 
considering that, along with input from a number of other 
sources, as we deliberate.
    Mr. Nordan, I couldn't agree more with your statement. You 
said U.S. must not be left behind in this enterprise. Where are 
we now? I mean, you know, we always, when you are looking 
around the world, you want to see what the competition is 
doing. Where are we now? Are we ahead? And are we running the 
risk of falling behind? Give me your assessment.
    Mr. Nordan. We authored a report earlier this year on this 
topic, and we tried to rank 14 nations globally on two things, 
on the level of nanotechnology activity in the country, say how 
many papers being authored, startups being generated, et 
cetera, on an absolute scale, and then secondly, on the track 
record of the country in being able to convert science and 
technology innovation into inward investment and GDP growth and 
jobs.
    On those two metrics, the U.S. actually comes out on the 
top on nanotechnology activity globally, and comes out near the 
top on technology development strength. So, we would put the 
U.S. in the first position in the world today when it comes to 
nanotech commercialization. That said, there are other 
countries that are catching up very rapidly, China being a 
great example, which has gone from the world's fifth to second 
in nanotechnology publication in about 10 years, and which at 
this point spends, at purchasing power parity, when you correct 
for how far a unit of currency goes in a country, second only 
to the United States on nanotechnology research.
    Now, what is unique, actually, about a month ago, had the 
opportunity to do onsite visits on the ground to 15 
nanotechnology startups and research labs in mainland China, in 
Shenzhen, Beijing, and Shanghai, and what you find there, 
compared with the U.S., is that nanoparticles used in things 
like coatings and composite materials are far more advanced in 
terms of commercialization than in the United States. It is 
very typical to be able to go to a building supply store 
through a retailer, and find paints that contain nanoparticles, 
or plastic materials that contain nanoparticles in China, that 
are somewhat absent in the U.S.
    Now, some of the reason for that is that there has been a 
very big focus on specifically these nanoparticles. Some of it 
is that the Chinese institutions don't have the same EHS 
strictures that exist in the U.S. That does not mean, in any 
way, that we should relax one iota the amount of rigor we 
approach EHS issues with in the United States, but it does mean 
that we have to supply a base of data and eliminate regulatory 
ambiguity rapidly in order to keep up.
    Chairman Boehlert. Thank you very much. That was a very 
good thumbnail sketch. One of the things that always concerns 
us as policy-makers is that we have come to the realization we 
don't know what we don't know, and so, given the large gaps of 
knowledge--this is a broad question that I would like all the 
panelists to address--given the large gaps in knowledge that 
may take many years to fill, how should we ensure protection of 
public health and the environment in the interim? I mean, what 
immediate steps do we need to take? Dr. Teague.
    Dr. Teague. Well, first of all, I would like to say that we 
have recognized exactly what you said within the Federal 
Government, and particularly, within the regulatory agencies, 
and that is the reason that it has been stepping forward, to 
put into place interim measures until we do learn more. The 
document that I mentioned from the National Institute of 
Occupational Safety and Health is put forward as a preliminary 
document, based upon what we do know now, to try to encourage 
everyone to take appropriate measures about the lack of 
knowledge that we have about the potential risks associated 
with nanoscale particles. It has been widely and 
enthusiastically accepted by almost everyone that we have 
introduced it to, including at the International Standards 
Organization meeting, that I attended just last week. All 
countries saw it as a major step forward to have this document 
available, to protect as best we know, people in the workplace.
    If you go to the website, it is there, available for 
anyone, including small manufacturers, anyone can get access to 
the document readily. It is also stated that it is a 
preliminary document, and that as more is learned, it will be 
updated. If you also go to the websites of the Food and Drug 
Administration, the Consumer Product Safety Commission, and 
other of the regulatory agencies, they have put forward what we 
have called their agency position statements about how they 
will interpret their regulatory authorities with respect to 
these particles. All are stating that currently, within the 
available regulatory authorities, they see full capabilities 
for preventing any adverse effects on public health or the 
environment, as we now understand it.
    Chairman Boehlert. Thank you very much. Anyone else care to 
comment on that one? Dr. Denison.
    Dr. Denison. Thank you, Mr. Chairman. We have advocated for 
a number of interim steps, as the data are developed, to look 
at the actual risks. One is that in the context of workplace 
safety, we believe that companies would be prudent if they 
looked at examining and monitoring of the health of workers 
that are potentially exposed to this, for example, so that we 
develop a baseline, and we have, over the course of time, the 
ability to know whether an effect is happening that we don't 
maybe understand yet. Second, materials in the workplaces 
really should be being handled in a way, in the absence of data 
to the contrary, that is basically as if they were hazardous 
materials. In other words, we would be doing everything we 
could to eliminate the possibility of exposure occurring, 
unless we know that that exposure is safe.
    And thirdly, we are very concerned about the subcategory of 
applications of nanomaterials that are dispersive in nature, 
that is, they deliberately or as a result of the use of a 
product, disperse materials into the environment. In the 
absence of data that indicates that that dispersion is actually 
harmless, we think those uses really ought to be looked at 
very, very carefully, and probably avoided or slowed down until 
the data generation catches up.
    Chairman Boehlert. Thank you very much, and I would like to 
go on, but seeing the Committee interest here, and my red light 
is on, and something compelling, Mr. Rejeski?
    Mr. Rejeski. Yeah, I would just add to this, I mean, every 
week, we get calls from small and medium-sized companies. You 
have to realize that the nanotech industry is going to be 
dominated by small startup firms, and they are asking the right 
questions, and they cannot find the information. So, I think it 
is interesting to put this guidance out, but if a company can't 
find it within two mouse clicks of their computer, you have 
lost them. So that, essentially, the government has got to be 
able to develop a portfolio of push strategies to get to these 
companies. Using our extension services, using technical 
assistance programs at universities, because they just don't 
have the time. Essentially, they are in a kind of Darwinian 
struggle to get their product to market. So, again, they are 
asking the right questions. They have a real hard time finding 
the right answers. So, I think we need to think about how do we 
reach those people.
    Chairman Boehlert. Thank you. Now, that is constructive, 
and I do appreciate that. It is a popular sport around the 
country to be critical of government, but you know, we do most 
things right, quite frankly, and every time I fly in a plane, 
you know, I am so thankful that we have got the FAA. Every time 
I go to the pharmacy to get a prescription filled, I am so 
thankful that we have got the Food and Drug Administration. But 
the point is, we can always find ways to do things better, to 
be more immediately responsive to an identified national need, 
and that is the whole purpose of this hearing, and the work we 
are about. So, the constructive comments you have offered are 
not going unnoticed, and we intend to pursue that, but I want 
to pursue my colleagues on the committee, and be mindful of 
their interests, so with that, my time has expired. Mr. Gordon.
    Mr. Gordon. Thank you, Mr. Chairman. As the Chairman 
pointed out, we do have time limitations, so I want to try to 
address some of these issues cumulatively here, or jointly, 
with all of you.
    Do any of the witnesses not agree that the current funding 
level under the National Nanotechnology Initiative is 
inadequate for supporting the environment, health, and safety 
research? Does anyone not agree with that?
    Do you want to disagree with that, that you think we are 
spending enough?
    Dr. Teague. Well, let me clarify the amount that is being 
expended, if I may.
    Mr. Gordon. Well, I prefer, let us get some base 
information, then we can go to that. So, do you disagree that 
we are not spending enough?
    Dr. Teague. I think that the amount that is being spent 
currently----
    Mr. Gordon. Is adequate?
    Dr. Teague.--is certainly within the amount that we have--
--
    Mr. Gordon. Well, I am not trying to be argumentative----
    Dr. Teague. Yes.
    Mr. Gordon. I just want to try to get through some 
questions, then we can talk about it.
    Dr. Teague. Okay.
    Mr. Gordon. Okay, do you think that we are spending enough 
on the research for the health aspects of nanotechnology?
    Dr. Teague. Considering all that goes into that number, and 
the supporting amount, I guess I would say yes.
    Mr. Gordon. Okay. You think we are spending enough. Okay. 
Does anybody agree with him that we are? Okay. So, just for the 
record, I guess you are saying that you are a company man, and 
that the company is doing all right. So, the rest don't seem to 
agree. Now, some of the witnesses suggest that the current 
level should be at least $100 million. Others have had other 
levels. And I would assume, Mr. Teague, you would think that 
$100 million is too much to spend. So, let me ask, do the rest 
of the witnesses think that it would be a good level, or could 
you spend less than that? Does anybody think that it should be 
less than $100 million? Yes, sir.
    Mr. Rejeski. I don't think we can actually answer that 
question. I could tell you right now that based on the 
preliminary analysis we have done, we have got $23 million of 
federal funding in our database. We have got 154 projects 
across eight agencies. That is not everything, but we have 
looked at it, and we have found some areas where we think the 
government is doing, actually, a fairly good job, and they 
should be congratulated. We have found some zeros. We have 
found some really large gaps. We don't think there is enough 
being spent on safety issues, explosion hazards, that sort of 
thing, that could be caused by nanomaterials in the workplace. 
So I think, again, I hate to base the argument on just broad 
numbers, because I think we really need to sort of dive deep 
into the actual funding levels, and I think that is what is 
going to help us.
    Mr. Gordon. Well, that goes back to your original 
testimony. I know you are reinforcing that, but I am just 
trying to get some benchmarks. So, don't know whether $100 
million----
    Mr. Rejeski. I don't know.
    Mr. Gordon.--would be a good place? Okay. So----
    Mr. Rejeski. I don't know. I can't tell you that.
    Mr. Gordon.--we have got one no, and we have got one don't 
know, and I think in the rest of your testimony, you said 
either $100 million or more. Is that correct? Okay. Again, I am 
just trying to get some benchmarks here.
    Dr. Teague. May I comment, sir?
    Mr. Gordon. Yes, sir. Certainly.
    Dr. Teague. In your question to me the last time, I didn't 
fill out my comments that I would like to say relative to 
whether or not it is the right amount of money. Very much, I 
agree with what Mr. Rejeski just said, but I emphasized in my 
opening remarks that the amount of money that is being invested 
in EHS implications research. It is stated as the research and 
development whose primary purpose is to investigate 
environmental, health, and safety implications. So, all of the 
funding----
    Mr. Gordon. Okay. Again, I have got a limited amount of 
time. I am not questioning whether you are doing the best you 
can with the resources you have. I am not questioning you in 
any way. I am just trying to determine whether we should do 
more. That is what I mean. So, let me ask the witnesses as a 
whole this. If no new money were available for research in this 
area, would you recommend reprogramming some of the existing 
funds in the National Nanotechnology Initiative? Does anyone 
not agree with reprogramming, if there would not be additional 
funds available? Would you just raise your hand, and we will 
let you say something about that?
    Mr. Nordan. I think the point that I would make, to go back 
to Mr. Rejeski's comments, is that a pretty fine-grained 
understanding of what the gaps are, and down to the level of 
specific materials and specific projects would be required. 
That said, there are some places that jump out as fairly 
significant holes. The biggest one that we have identified is 
the risk of nanoparticles that are----
    Mr. Gordon. But I guess what I am trying to say is--what I 
am trying to get a calibration here, is these are difficult 
times to----
    Mr. Nordan. Yes.
    Mr. Gordon.--try to get additional funds, and so, it is 
unlikely we are going to see any. Matter of fact, 
nanotechnology has been treated very generously, in terms of 
the rest of the budget. Now, we would like to see more, but in 
a relative term, it has been, you know, very generous. And so, 
I don't think we are going to get a lot of additional funds. Is 
this--is the concern about additional research into safety 
enough that you would recommend reprogramming existing funds to 
do that?
    Mr. Nordan. Definitely one option. There are also other 
options.
    Mr. Gordon. Please, I know that, but that is the option I 
am talking about right now.
    Mr. Nordan. I think that would be feasible.
    Mr. Gordon. Okay. Is there anyone who would not, because 
Mr. Ehlers is trying to push the button on me here. Is there 
anyone here who would not agree that it is enough of a problem, 
or a concern, that if we can't additional funds, that we should 
reprogram funds? Would anybody disagree with that statement? 
Raise your hand. Okay, go right ahead, Mr. Teague.
    Dr. Teague. If I look at the agencies which are currently 
funding the work on research for environmental, health, and 
safety implications, they are within the National Science 
Foundation, they are within the National Institute of 
Occupational Safety and Health. They are within other 
components of HHS or the National Institutes of Health. So if 
you are saying that you need to increase, let us say, the 
amount of funding that would be available to the National 
Institute of Environmental Health Sciences.
    Mr. Gordon. Well, I said within the National Nanotechnology 
Initiative.
    Dr. Teague. They are one of the agencies that is 
contributing to the NNI.
    Mr. Gordon. Yeah.
    Dr. Teague. A very significant one. Then, where would you 
pull it? Would you pull it from the other parts of NIH that are 
investing in cancer research?
    Mr. Gordon. That is one question I would be asking you, but 
if we are trying to establish priorities, it would be most 
likely from funds that are allocated for nanotechnology 
research.
    Dr. Teague. Some of those, we----
    Mr. Gordon. And that would be some reprogramming there.
    Dr. Teague. Some of those which are investigating new 
treatments and new methods of diagnosing cancer.
    Mr. Gordon. Well, if you want to put it in the most harsh 
way, that is the question I am asking you. You know, would it 
be enough of a priority to slow down that cancer research to 
make sure that it was being done in an appropriate way, and 
that is the question I am asking you, and you are saying what? 
No.
    Dr. Teague. I am saying no at the present time.
    Mr. Gordon. And you wouldn't. Okay, but everyone is saying 
yes, is that true? Is that correct?
    Dr. Denison. Could I offer just one comment on this? I 
think there are two types of reprogramming. One is to take 
money from the application side and move it to the implication 
side, which you have been talking about. Even within the 
implications research, though, there are some rather striking 
things. Almost two-thirds of that money that is devoted to EHS 
research is in the National Science Foundation, which is 
probably not where I would suggest that much of that amount of 
money ought to be put. The agencies that have, as a prime 
mission, understanding health and environmental implications 
have a much, much smaller piece of that pie.
    Mr. Gordon. Well, again, we don't live in a perfect world. 
We have to deal within these circumstances that we have, and 
that is what I am trying to get from you, those kind of 
priorities. Excuse me. Thank you, Mr. Ehlers.
    Mr. Ehlers. [Presiding] Indeed, we don't live in a perfect 
world, so I will have to declare the gentleman's time has 
expired. I apologize for being late. I was detained in another 
meeting, but I would, without objection, enter my statement in 
the record. So ordered.
    The normal procedure in this committee is that the Chair 
and the Ranking Member ask questions, then the Chairs of the 
relevant subcommittees and their Ranking Members ask questions, 
and then we go to the rest, but I have a special request, and I 
am next in line, and after that, Mr. Wu, Mr. Inglis, and Ms. 
Hooley, if she arrives. But if none of those four object, I 
would like to recognize Mr. Gutknecht, who has a burning 
question he wishes to ask, and has to depart for another 
meeting.
    Mr. Gutknecht. Mr. Chairman.
    Mr. Ehlers. I hear no objection, so I recognize the 
gentleman from Minnesota.
    Mr. Gutknecht. Mr. Chairman, I don't know how burning it 
is, but I do have to leave, and I was among the first people 
here. And so, I will jump in line.
    Mr. Nordan, you raised the issue, and I have a very keen 
interest. On the Agriculture Committee, we have had this 
ongoing, and you brought up the issue, but we have had this 
ongoing fight over biotechnology and what it really means, and 
I have often said that the pharmaceutical companies and the 
seed companies who develop these technologies have done a 
marvelous job of selling the technology to our farmers. They 
have done a miserable job of explaining it to the consumer, and 
as a result, we continue to have this battle, not only in 
Europe, principally in Europe, but even here in the United 
States.
    I guess I would like to have you perhaps develop this 
thought. What responsibility does industry have to do a better 
job not only of explaining the benefits of this new 
nanotechnology to potential industrial or commercial users, but 
more importantly, of explaining what this all means to the 
consumers and private individuals? So, perhaps you could talk 
about that, and if anybody else wants to talk about it, because 
I am really worried that we are going to go down the same path 
with biotech corn and cotton and beans and so forth.
    Mr. Nordan. I would argue that is happening today. Let me 
talk a bit about the situation, and then talk about the 
challenge.
    The situation is a little puzzling. When it comes to real 
risks, they are somewhat bounded. Right. The field of 
nanoparticles is extremely broad, involving ceramic 
nanoparticles, metal nanoparticles, carbon-based ones, some of 
which are just smaller version of existing structures, some of 
which are unique structures that only form at the nanoscale, 
and if one of those proves to pose an environmental, health, 
and safety risk, there are boundaries around it. It doesn't 
necessarily apply to all the different forms.
    When it comes to perceptual risks, though, it kind of only 
takes one bad apple to spoil the bunch, in terms of public 
perception. So, it is a significantly challenging situation, 
and it is more challenging than biotech, because it is fairly 
straightforward to put some boundaries around what constitutes 
biotechnology, manipulating genes in order to achieve desired 
effects in living organisms. Nanotechnology applications are so 
diverse, ranging from structural materials to cancer treatments 
to energy sources, that it is very difficult to encapsulate 
them in a sentence or two phrase that is easy to understand.
    Given the importance and the primacy of perceptual risks in 
getting consumer adoption of products based on these 
technologies, it comes as something of a shock to us that for 
the most part, industry and specifically startup companies have 
done exceedingly little to engage the public on these topics. 
In fact, when it comes to startup companies, there are many 
cases where they would seem to be avoiding raising the issue, 
because anything that could possibly scare away venture 
capitalists, or keep them from being able to attain a next 
funding round is a topic to address behind the scenes, but not 
something they want to raise publicly, which we believe in the 
long-term is very self-destructive. There are some companies 
out there, like BASF in Germany and like DuPont in the United 
States, that have done an exceptional job of partnering 
publicly and communicating publicly about these issues, but 
that is the exception to the rule, and it is something that 
from a business perspective, is a self-inflicted wound in the 
long-term.
    Mr. Gutknecht. What can we do about that? Because I share 
your concern, and that is why I raise the point. And I think we 
are going to get a long ways down this road before many in 
industry really understand how serious this is.
    Mr. Nordan. Yeah, there are folks on the panel that have 
more experience than I do in public engagement with consumers 
on new technologies, so I would turn to Dr. Doraiswamy and Mr. 
Rejeski and Dr. Denison for that.
    Mr. Gutknecht. Thank you.
    Dr. Doraiswamy. Thank you. I think the question that you 
raise is a very good one, and a very appropriate one. We 
believe that in order to ensure that there is no 
miscommunication or misunderstanding of what nanotechnology is 
and what it can deliver, we do need a more effective process 
for communication and outreach, more transparency in this area 
than maybe people have been accustomed to, and more 
collaboration among all of the stakeholders.
    As an example of the kind of confusion that exists, most of 
the concerns and questions that we have been discussing today 
about safety, health, and environmental implications are, in 
fact, confined to nanoparticles. The fact is that the word 
nanotechnology is much more broadly applied to other kinds of 
materials that do not involve nanoparticles, for example, 
nanostructured membranes that might have pores, for example, 
that are nanosized and could be used in applications like 
protecting against chemical and biological threats. These are 
materials that have very different characteristics from 
nanoparticles, but if we put them all under the same umbrella, 
there is a tendency to confuse them and what the implications 
might be.
    So, in order to resolve some of this confusion, I think we 
do need a more consistent vocabulary, and the standards 
organizations, I think, are working on that. We do need, I 
don't think any one company alone can address the confusion. I 
do think we need a coordinated effort to identify where the 
confusion is likely to arise, to structure the space and 
partition it appropriately, and address our communications to 
where there is the greatest possibility for miscommunication.
    Mr. Gutknecht. Anyone else? Yeah, please.
    Mr. Rejeski. I think one of the things that was striking as 
we went around and ran focus groups around the country, and 
talked to people about nanotech is that the public, the people 
were very, they didn't focus a lot on the thing, whether it was 
the gadget, the golf ball, the cosmetics. They were asking, and 
they really wanted answers to a much larger set of contextual 
questions. They were saying before we trust anybody, we want to 
know who is developing this, who is promoting it? Is this being 
hyped? And then they want a balanced message. They are not 
afraid of hearing bad news. They don't expect a no-risk 
society. They want to know who is evaluating it, and they want 
to know if something goes wrong, who is responsible? And that 
is why I think essentially reducing perceptual risks has an 
awful lot to do with the government's message, because the 
government is really quite often responsible for doing a lot of 
this. They ask about can we trust the FDA, the EPA, what are 
these people doing? So, I think it really says, a balanced 
message, they don't want to be hyped with this stuff. They want 
to hear from the government, in terms of the context. Are we 
creating a context that they can believe in, that they trust 
the risk managers, essentially.
    Mr. Gutknecht. But how would you respond? I mean, the USDA 
and lots of other government scientists have released reports 
about biotechnology used in plants. There has never been a 
study that indicated there was any health risk whatsoever, and 
yet there is still this great perception out there that there 
is a risk.
    Mr. Rejeski. Well, I think a lot of that has to do with the 
fact that we also aren't engaging effectively with a lot of the 
people that are shaping that perception. So that means, I 
think, a much better, you know, sort of outreach strategy with 
the media, with the nongovernmental organizations, essentially 
they got ahead of us on that message. And I think the same 
thing can happen here. I think right now, we have a small 
window of opportunity, now, I think it is about a year where we 
can actually engage. And I think the social dynamics of this 
whole area are changing rapidly right now. There are an awful 
lot of small, extremely media-savvy NGOs getting involved. 
These people know how to get the attention of the press, and 
they can raise a lot of concerns very, very quickly. I think 
the----
    Mr. Ehlers. The gentleman's time has expired. Next, we will 
turn to the gentlewoman from Texas, Ms. Johnson.
    Ms. Johnson. Thank you very much, Mr. Chairman. I guess 
what I really would like to know up front is, in doing the 
research, how protected is the environment around the research, 
and the researchers, are they protected?
    Dr. Denison. I think you have put your finger, 
Congresswoman, on a real issue, that much of the development of 
this technology is happening in universities, in small research 
facilities, that may have a handful of staff, have never heard 
of EPA or OSHA or other agencies, and are very ill-equipped to 
understand even the material that they are working with. So, as 
others have said, outreach to that community and getting 
practical advice that can be delivered directly to people that 
are busy and don't have this as their primary concern is a 
critical part of addressing the supply chain, if you will, the 
beginning of that supply chain, that is leading to these 
issues. So, I think that aspect of the occupational exposure, 
all the way upstream in the development phase, is a critical 
gap in the current structure.
    Dr. Teague. Yes. May I comment on that?
    Ms. Johnson. Sure.
    Dr. Teague. From the Federal Government's perspective, we 
have been reaching out, as I indicated in my opening comments, 
very proactively trying to reach all the people who are working 
with nanoscale materials. The grants themselves specify that 
all consideration must be given to environment, health, and 
safety of the researchers. It is stated in all the grants that 
are awarded by the National Science Foundation, and almost by 
all the agencies that award grants or contracts to researchers, 
have specifications in there for protecting the researchers.
    I mentioned earlier the document that has been developed to 
try to communicate to researchers the necessity for their use, 
and to exercise appropriate precautions in working with 
nanoscale materials by the National Institute for Occupational 
Safety and Health. That is being widely disseminated. In fact, 
coming up next month will be a major meeting of the directors 
of almost all the national centers on nanotechnology, both 
within the Department of Energy, the National Science 
Foundation, and the Department of Defense, in which this 
information will be focused upon and people will be informed 
about the recommended practices, from one, to protect people in 
the workplace, and in the laboratory, as you were just 
indicating.
    Ms. Johnson. A university in my area, the University of 
Texas at Dallas, is very, very interested in nanotechnology 
research, and I don't know if they have hit your radar screen 
or not, but I wonder if they have the information disseminated 
to them.
    Dr. Teague. Whether this particular university has it or 
not, I would have to ascertain. We can make sure that they do. 
It has been announced on the NNI website. We have made it 
available there. It is actually highlighted on the opening 
webpage of the NNI website, and we have thousands of visitors, 
new visitors, per day to that website. So I hope they have it. 
If not, we will ensure that they do.
    If I may go back to some comment about how many clicks it 
takes to get to the NIOSH information. It is actually two 
clicks to get to that information, just to make sure that it is 
not deeply imbedded in the NIOSH website. It is very readily 
accessible.
    Ms. Johnson. Any other comment? Thank you very much. My 
time----
    Dr. Doraiswamy. May I----
    Ms. Johnson. Yes, go ahead.
    Dr. Doraiswamy. Yeah. Since I am representing a company 
that actually does work with these kinds of materials, I wanted 
to share our perspective. For all materials that our research 
professionals and manufacturing workers work with, we have very 
disciplined and demanding standard operating procedures to 
minimize exposure risk and avoid releases.
    We have, over the years, developed very disciplined process 
safety management procedures and process hazards analyses. 
These reviews are very well established in DuPont, and they 
address facilities, engineering controls, personal protective 
equipment, work practices, and so on. We are also, as was 
pointed out earlier, in the process of developing a framework 
with Environmental Defense that we hope to share widely on how 
this kind of discipline can be adopted and applied as 
guidelines for nanoscale materials.
    Ms. Johnson. Thank you very much.
    Mr. Ehlers. The gentlewoman's time has expired. I am next 
in line, and have a question for Dr. Teague. In relating to Mr. 
Nordan's testimony, that suggests that a life cycle 
perspective, that considers manufacturing, use, and disposal is 
needed to consider the potential risks of nanotechnology.
    And Mr. Nordan, I will also suggest that the greatest 
uncertainty about risk arises from end of product life issues. 
Your testimony, so far as I have determined, does not mention 
disposal as an area of concern. I have a great personal concern 
about that. In fact, that is what got me into politics 
originally at the county level, when we had terrible solid 
waste problems, and heap leach flowing into rivers and so 
forth. I had an environmental interest, so I ran for office in 
order to clean up the mess. And I have spent more time in 
landfills, dumps, auto shredders, incinerators, than I suspect 
anyone else in the room.
    What always concerns me is we always tend to find out these 
things too late. Nickel-cadmium batteries, for example, went 
into landfills for years before we finally said no, you have to 
return them to the store and have them disposed of properly. 
So, I am wondering if you agree with Mr. Nordan's comments 
about this. I have always argued, by the way, that disposal is 
the wrong term to use, and when I took office, I tried to get 
the name changed from the Kent County Disposal Facility to the 
Kent County Storage Facility. Just because you put it 
underground and put dirt over it doesn't mean it is gone. It is 
not disposed of. It is still there. We are storing it. And so, 
I have the same concern about nanotechnology products.
    What is the situation? To what extent are you looking at 
disposal areas or end of life issues, and how does that factor 
into the equation?
    Dr. Teague. Well, that it was not being mentioned in my 
testimony, the written or the oral, is definitely an oversight, 
because certainly, the waste stream, the fate and transport of 
nanoscale materials in the environment is of something that is 
being looked at very carefully by a number of the federal 
agencies, in particular, the Environmental Protection Agency.
    Just recently, in fact, in Fiscal Year '05, and in Fiscal 
Year '06, there has been a joint activity between the 
Environmental Protection Agency, the National Science 
Foundation, the National Institute of Environmental Health 
Sciences, and the National Institute for Occupational Safety 
and Health, specifically issuing a joint solicitation to 
conduct research on the fate in transport of nanoscale 
materials in the environment resulting from manufacturing or 
any other movement of those particles into the environment. 
This year, it is projected for '06 that this solicitation will 
be on the order of $8 million a year from all four of those 
agencies, to study this particular aspect of both the 
manufacture and the eventual disposal of any products that have 
nanoscale materials in the product.
    Mr. Ehlers. Well, a very important aspect is the risk 
calculations, and----
    Dr. Teague. Yes.
    Mr. Ehlers. I am a little concerned that this; you say this 
was an oversight in your testimony. That is frequently the 
problem. People don't think about these issues until it is too 
late. Are you looking at the risk factors in each of these 
areas, of end of product life, as compared to manufacturing and 
research and so forth? How are you approaching it?
    Dr. Teague. Well, certainly, there has been a significant 
amount of effort put in to looking at the risks associated with 
not only the manufacture, both in terms of exposure to the 
worker, but also, there has been some work on what people call 
the environmental footprint of different manufacturing 
processes that has been funded, again, by the National Science 
Foundation and the Environmental Protection Agency.
    Just recently, there has been a paper issued by Rice 
University comparing the manufacturing footprint for the 
manufacturing of nanoscale materials to a lot of other types of 
manufacturing. In that, the conclusion from that study is that 
the footprint, environmentally, for manufacturing nanoscale 
materials is certainly less than some of the more conventional 
manufacturing processes, like ore refining. Many of the 
manufacturing processes were actually compared and considered 
to have an environmental footprint comparable to that for the 
manufacture of aspirin and the manufacturing of wine.
    So, that kind of thing, and the risks associated with both 
the manufacture and the eventual fate and transport of it, are 
being looked at quite carefully.
    Mr. Ehlers. Well, let me just suggest--just yesterday, I 
met with the new Assistant Administrator of the EPA, in charge 
of the Office of Research and Development, Dr. Gray, who is a 
specialist in risk assessment. I encourage you to have a 
conversation with him. I want to make sure you are working 
together on this, the end of life issue, and doing the risk 
calculations appropriately.
    I see two other hands up. Mr. Rejeski.
    Mr. Rejeski. Last year, we worked with people at Yale 
University, and we did an inventory of the life cycle analyses 
that have been done, and that are underway, for nanobased 
products, and we would be glad to share that with the 
committee. One of the issues that they raised, and I think it 
is an important one, is whether the life cycle analyses that we 
use with normal materials will actually work with nanoscale 
materials, because a lot of the risk assessment which you 
alluded to essentially relates the mass of the material to the 
risk.
    Mr. Ehlers. Yeah.
    Mr. Rejeski. And we know from nanoscale materials that the 
risk is now associated with surface area, surface charge, 
surface properties, the morphology of the particle. So, I think 
that is a very, very important question, it is a huge question, 
about whether the existing suite we have of doing these kinds 
of analyses, from cradle to grave, will actually be 
transferable to these new nanobased products, and we haven't 
answered that.
    Mr. Ehlers. I would appreciate it if you would provide us 
with that, and without objection, that will be entered in the 
record for this hearing. Dr. Denison.
    Dr. Denison. Just one other quick comment. I think you have 
put your finger on what amounts to a potential regulatory gap. 
For example, the FDA has authority to look at the use of 
nanomaterials in products like sunscreens, pharmaceuticals. We 
know that those products ultimately get washed down the drain. 
They end up in the water supply, and the ability of the FDA to 
actually look at the potential impacts downstream is quite 
limited.
    One recent scientific finding that really amplifies the 
concern you are raising is that buckyballs, these carbon soccer 
ball type materials, in water, actually can aggregate, become 
quite water soluble, and are very potent killers of bacteria, 
bactericides. Now, you might think that is a good thing, but we 
like to say, you want to kill bacteria, perhaps, in a hospital 
bed, but not in a riverbed. So, if these materials are actually 
getting into the environment, and they are killing bacteria 
that are at the base of the food web in ecosystems, that could 
be a really significant impact. So, the life cycle perspective 
you are talking about is critical.
    Mr. Ehlers. Thank you, and I suggest, Dr. Teague, that you 
also talk to the FDA about these risk assessment issues. My 
time has expired.
    We are very Pavlovian in the Congress. When the bells ring, 
we go vote. Dr. Schwartz is next in line--pardon? Pardon? Oh. I 
am sorry. I am sorry. Yes. Mr. Carnahan, the gentleman from 
Missouri, I am sorry. You have five minutes.
    Mr. Carnahan. Thank you, Mr. Chairman. I will make mine 
quick.
    First, for the panel. You have discussed potential risk and 
preliminary studies with the impact of these nanomaterials. Are 
there any documented human health impacts out there that you 
know of? Are we still looking at potential risk?
    Mr. Nordan. Well, there are analogues. If your question is, 
are there studies that exist looking at, for example, the 
impact of exposure to fullerenes on human beings over X years 
of time, definitely not. Those materials haven't been made in 
enough quantity, or released in free form in any way that you 
would see any empirical results. Probably the best analogue 
would be a very large body of research on what are usually 
referred to as ultra-fine particles, that are particles with 
nanosized dimensions that are formed accidentally, either 
through things like welding, or diesel fuel exhaust, or 
volcanic eruptions, that have been shown to have deleterious 
impacts on human health. In fact, that existing base of 
research on particles that weren't purposefully engineered is 
what initially sparked much of the concern over engineered 
nanoparticles.
    Mr. Carnahan. Anyone else on the panel?
    Dr. Teague. Just to emphasize what Mr. Nordan was saying, I 
think it is very important that the committee be aware, I 
suspect you are aware, but there is a significant difference 
between these incidental nanoparticles, which have been with us 
for many years, and what we are calling the engineered 
nanomaterials.
    One of the real powers of nanotechnology is that we have 
the capability to engineer in a controllable way the property 
of matter at this nanoscale. That has really important 
implications, in terms of what was mentioned relative to, say, 
the buckyballs. Because we have this capability to control 
things and engineer things at the nanoscale, we can study them. 
We know how to, now, treat the buckyballs so that they will not 
be detrimental to human health or the environment. We know how 
to functionalize the surface of these small particles in such a 
way to make them more benign to both public health and to the 
environment.
    So, we happily are at an early stage, where we not only can 
study these before the widespread application of the technology 
and production of large volumes of products, we can understand 
their behavior, and we have sufficient control to where we can 
engineer them to be what we would like the properties to be, 
and hopefully, avoid the negative properties, in terms of 
adverse impact upon the environment, or upon public health.
    Mr. Carnahan. And lastly, very quick. I would like to have 
you grade our current crop of scientists and researchers first, 
and then, how you think we are doing with training our next 
generation to deal with this new science of nanotechnology.
    Dr. Teague. My own assessment is that we have, in the 
United States, some of the most outstanding researchers in the 
world in the field of nanotechnology. Further, primarily 
through the National Science Foundation, we have educational 
programs trying to bring them abreast of the whole field of 
nanotechnology, from K through 12, and then on up through the 
graduate schools. Outstanding programs are in that area.
    Just recently, the National Science Foundation formed a 
center for informal learning about nanotechnology. This is to 
go through the museums, to reach out directly to all the public 
to get them more informed about nanotechnology, and hopefully, 
to attract many young people into this new field. This is 
probably one of the new fields which offers as much excitement 
to draw young people into science and engineering as we have 
had for a long time. So, I think it is--we have a lot of 
extremely good scientists in the country, I think some of the 
leading ones in the world, and I think we are putting in place 
efforts across the entire age spectrum to draw new people into 
the field.
    Mr. Carnahan. I am going to wrap it up, and thank you, Mr. 
Chairman.
    Mr. Ehlers. Thank you very much for cutting it short. We 
have a series of three votes. It will take us at least 45 
minutes to get back, so we would like to wrap this up. Dr. 
Schwarz, a quick question, and----
    Mr. Schwarz. Mr. Chairman, thank you very much, a quick 
statement. I represent at least part of the University of 
Michigan, which has taken the lead in a lot of 
nanotechnological advances, and I am also a physician. And this 
is more of a statement than a question, but I want, when you 
formulate guidelines for people engaged in all the different 
forms of nanotechnology, to do this with a great deal of 
thought, with a great deal of objectivity, and may I please 
suggest that we do not do anything, as we formulate these 
regulations, these guidelines, that would allow the Luddites to 
come out of the wall in this country, like they have in other 
areas of research, which I don't have to name, and have put us 
in sixth or seventh or eighth or ninth or God knows what place, 
in that type of research. We need to be number one in 
nanotechnology. And the first thing, and a couple of you have 
tried to do this this morning, and I applaud you for it, is 
define precisely what nanotechnology is. It is not something 
really exact that you can pack in a box. You talked about 
different materials. You talked about the filters, which I 
thought was very, very good. So, it is a very wide field, and 
my admonition, friendly admonition, is please, when we do this, 
let us do it with a good deal of science-based thought, and not 
be hysterical or print anything or do anything that would lead 
other people to be hysterical, like actually some NGOs, I might 
say, whose bread and butter is to instill certain hysterical 
thoughts in the public.
    So, let us stick with sound science, please, sound science, 
facts. Let people know what nanotechnology is, what it can do, 
what it can do from a medical standpoint, scientific 
standpoint, consumer products standpoint, and do it with sound 
science, and not do it to stir up people out in the hustings, 
who don't have time to learn precisely what it is.
    So, that was the statement, Mr. Chairman, and not a 
question, but a very friendly admonition, that this is great 
stuff. The United States needs to be number one, and remain 
number one in this technology, and it can only do that if we 
encourage our researchers, if we encourage the commercial 
sector, and we do our very best to define precisely what 
nanotechnology is, and it is not something that is going to 
hurt us. It is something that is going to help us.
    Thank you, Mr. Chairman.
    Mr. Ehlers. Thank you for the statement, and I would simply 
add to it, make sure all the regulations apply to imports as 
well, so we don't put ourselves at a disadvantage. Next, we 
will go to Mr. Honda for a brief statement.
    Mr. Honda. Thank you, Mr. Chairman. I will be real quick, 
and I will ditto what the doctor said, except I heard you also 
say that we have a role, and we are not functioning properly, 
and we are not looking at it in a very systematic way, so I 
appreciate your input today.
    If you wouldn't mind responding back in writing later on, 
on issues around end of life issues of nanomaterials, 
lifecycle, and the term bioaccumulation, those are the kinds of 
things, I think that we need to understand, so that we are able 
to be partners in educating the public, and engaging them, if 
you will, in that, have a blue ribbon taskforce on nanotech in 
Silicon Valley, and I think that this is going to be a very 
timely kind of a way to approach the rolling out of our 
information, and I guess with industry. With Dr. Doraiswamy, I 
read your material, and I think I heard you say we are doing 
our part, the government has to do their part. I would like to 
hear from you, how much of your budget are you putting into not 
only environmental safety, but part of this whole issue of end 
of life, bioaccumulation, how much are you looking at that, and 
how would you recommend that the government partner with 
industry, and sort of roll this out in a much better way?
    Mr. Ehlers. Mr. Honda, could I suggest----
    Mr. Honda. So, I thank you very much.
    Mr. Ehlers. Could I suggest we just ask him to submit that 
for the record?
    Mr. Honda. Yes.
    Mr. Ehlers. All right. And Mr. Costa.
    Mr. Costa. Thank you very much, Mr. Chairman. We have to 
vote. I will be very brief. I think the committee needs to 
continue to pursue this effort, as it relates to genetically 
modified foods, and risk assessment versus risk management, as 
we try to deal with nationwide standards and protocols that now 
not only have a basis as it relates to our respective states, 
but on an international basis as well. I would like to see us 
pursue that, and direct the experts to allow us to pursue an 
effort that would focus on that risk assessment, risk 
management as it relates to nationwide safety standards.
    Mr. Ehlers. And I would add quickly to that, we also should 
educate the public about risk management, so they totally 
understand it.
    I am sorry we have to run. Thank you very, very much for 
your excellent testimony. It was very useful to us as we 
consider this matter. Further, we will be looking closely at 
this issue. This is not the last hearing on this topic. We will 
continue to watch the issue, but certainly appreciate the 
insight that you have presented to us, and we will continue 
working to strengthen our knowledge, as well as elicit 
information from you, and continue to support research in this 
effort.
    With that, I declare the meeting adjourned.
    [Whereupon, at 11:35 a.m., the Committee was adjourned.]

                              Appendix 1:

                              ----------                              


                   Answers to Post-Hearing Questions


Responses by E. Clayton Teague, Director, National Nanotechnology 
        Coordination Office

Preface

    The responses below are based in part on information received from 
the 25 agencies currently participating in the National Nanotechnology 
Initiative (NNI).
    Please bear in mind that so-called ``nanomaterials'' or 
``nanoparticles'' can refer to particles of nanometer scale that exist 
in nature (e.g., certain types of dust), particles that are produced as 
an incidental byproduct of human activity (e.g., particles from welding 
processes or combustion processes), or particles and materials that are 
purposely engineered in order to take advantage of the unique 
properties that matter can exhibit at the nanometer scale. In this 
response to the Questions for the Record below, the shortened term 
``engineered nanomaterials'' is used for the last category.
    While it is expected that scientific knowledge and experience with 
the other categories of nanometer scale materials has much relevance 
for engineered nanomaterials, the responses below refer only to these 
purposefully manufactured or engineered nanoscale materials.

Questions submitted by Chairman Sherwood L. Boehlert

Q1.  In your testimony, you described an interagency document you are 
working on that will identify and prioritize information and research 
needs in the area of environmental and safety issues associated with 
nanotechnology. When will it be completed and what level of detail will 
be included in this document? Will it be a ``research strategy'' that 
agencies and the research community can use to plan and coordinate 
investments and measure progress?

A1. The document in preparation will outline the areas of research that 
need to be addressed in order to better assess the risks associated 
with engineered nanomaterials. The document is intended to provide 
guidance to the agencies that fund research, as well as industry and 
the research community more broadly, as they plan, prioritize, and 
coordinate investments and activities. The document is intended to be 
sufficiently detailed to guide investigators and managers in making 
project-level decisions, yet broad enough to provide a framework for 
the next five to ten years. The document will be released upon 
completion of the interagency review process, which is expected to be 
in Spring 2006.

Q2.  In his testimony, Dr. Denison called for the National Academies to 
help guide the development and implementation of the federal research 
strategy in the area of environmental and safety issues associated with 
nanotechnology. Do you agree with his suggestion regarding this role 
for the National Academies? If not, why not? What do you think are 
other appropriate roles for the National Academies in this area?

A2. The National Academies is already tasked, per Section 5 of the 21st 
Century Nanotechnology Research and Development Act (Public Law 108-
153), with a triennial external review of the NNI. We agree that this 
review should help guide the federal strategy for research on 
environmental and safety issues associated with nanotechnology. The 
first such review, commissioned by the National Nanotechnology 
Coordination Office (NNCO) on behalf of Nanoscale Science, Engineering, 
and Technology (NSET) Subcommittee, is currently underway; a report is 
expected imminently.
    Dr. Denison's written testimony of November 17 specifically 
recommended that the National Academies Board on Environmental Studies 
and Toxicology (BEST) should help guide NNI research strategy with 
respect to environmental and safety issues. The NNCO has been assured 
that the current National Academies review is drawing on the expertise 
of all the appropriate boards within the Academies, and we do not 
foresee the need for an additional dedicated assessment of 
environmental and safety issues by BEST. One of the five open meetings 
of the National Academies Panel to Review the NNI\1\ was largely 
devoted to discussion of environmental, health, and safety issues. The 
panelists heard presenters from all of the NNI participating agencies 
involved in these issues, as well as representatives of the research 
and stakeholder communities.
---------------------------------------------------------------------------
    \1\ (March 24, 2005, http://www4.nas.edu/webcr.nsf/MeetingDisplay5/
NMAB-J-04-03-A?OpenDocument).
---------------------------------------------------------------------------
    Through the NNCO, the NSET Subcommittee has invested nearly $1.4 
million in the current National Academies study, has high expectations 
of its outcome, and sees no need to modify the Academies role at this 
time. We expect the forthcoming report to provide a balanced assessment 
of the entire NNI investment strategy, taking into account all of the 
complimentary activities among the various NNI Program Component Areas. 
Consistent with the provisions of P.L. 108-153, it should evaluate the 
extent to which the NNI program has adequately considered ethical, 
legal, environmental, and other appropriate societal concerns 
(subsection a, para. 6); make recommendations on policy, programs, and 
budget changes with respect to nanotechnology R&D (including the NNI 
investments in environmental, health, and safety research) (subsection 
a, para. 9); and more generally assess and make recommendations on the 
NNI's activities with respect to the responsible development of 
nanotechnology (subsection c).

Q3.  In his testimony, Mr. Nordan recommended that the Federal 
Government establish a National Nanotechnology Toxicology Initiative. 
Under his proposal, the initiative would be funded at $100 to $200 
million annually, and research funding would be allocated to studies of 
different nanoparticles in proportion to the funding going to their 
development. Companies would be required to submit their materials for 
testing as a condition of receiving Small Business Innovation Research 
grants. Do you support this proposal? If not, why not? If you need 
additional information to evaluate the proposal, what additional 
information do you need?

A3. We cannot support Mr. Nordan's proposal. From the information 
provided in his testimony, his recommendation does not appear to 
adequately consider the existing federal programs for assessing the 
toxicity of materials (such as the National Toxicology Program) nor 
does it properly take into account other current and planned activities 
related to research on nanomaterials toxicology. Furthermore, the 
recommended conditions on Small Business Innovation Research (SBIR) 
grants would place a burden on the recipient companies which other U.S. 
nanotechnology innovators do not share.
    The ultimate goat of the initiative proposed by Mr. Nordan--develop 
nanotechnology safety and responsibly--is one of the four important 
goals of the NNI. Achieving this goal wilt require research to 
understand and address the potential toxicity of engineered 
nanomaterials and to understand how such materials interact with 
biological systems. Research in these areas is supported by several 
agencies, including the National Institute of Environmental Health 
Sciences (NIEHS), the National Institute for Occupational Safety and 
Health (NIOSH), the Environmental Protection Agency (EPA), the 
Department of Defense (DOD), the National Science Foundation (NSF), and 
the National Cancer Institute (NCI). Through coordinated efforts by 
these agencies, the NNI is proceeding appropriately to fund and conduct 
research on the toxicology of engineered nanomaterials with research 
funding increasing as our understanding of this subject grows.
    Arbitrary funding targets such as the proposed $100 million are 
problematic for two reasons. First: formulaic allocation of resources 
in proportion to development funding is a poor substitute for a 
thorough evaluation of research needs. Second: arbitrary funding 
targets for research on nanotoxicology--toxicology of engineered 
nanomaterials--per se raise basic definitional questions as to what 
research should be included appropriately as nanotoxicology. 
Categorization of specific research is problematic because of the great 
breadth of research necessary for risk assessment. For example, a 
particular research project focused on understanding the basic 
properties of interactions of engineered nanomaterials with biosystems 
would likely be classified as fundamental research and not as 
nanotoxicology research. However, such basic research contributes 
significantly to our understanding of this field and provides important 
information for toxicological studies. As a second example, research 
and development for new methods for measurement and characterization is 
not typically categorized as nanotoxicology research. Yet, almost all 
recent examinations of research needed in this area have indicated that 
one of the most critical pieces of information needed for comparing 
toxicological studies of engineered nanomaterials is careful 
characterization of the materials used for such studies. As a final 
example, even a great deal of applied research--such as research into 
exposure to airborne particulate matter in the form of incidental 
nanoparticles (sometimes termed ultrafines)--contributes significantly 
to nanotoxicology understanding, but it too would not be classified as 
such.
    Because of these significant problems associated with arbitrary 
funding targets, the most effective means of addressing concerns in 
this area is by evaluating potential risks, working to prioritize 
research needs, and distributing funding as these needs demand and as 
the merits of specific research proposals warrant. For example, the 
National Toxicology Program, which is performing detailed toxicology 
studies of various nanomaterials, allocates funding based on the 
anticipated magnitude of commercial application and likelihood of 
unintentional exposure.
    Special requirements for toxicological assessment on engineered 
nanomaterials developed through the SBIR and STTR programs would be 
equally arbitrary. Both of these programs support the pre-commercial 
phases of new-product-related R&D at small companies. Mr. Nordan's 
proposal would place a greater burden on them than currently exists for 
pre-commercial products in development through other routes, for 
example at larger companies, universities, or federally-funded R&D 
centers. Requirements for toxicological assessment should have their 
basis in a reasoned analysis of the risks based on likelihood of 
exposure and toxicity, not in the source of development funding, and 
should not interfere with pre-commercial development activities that 
pose minimal risk to the public.

Q4.  In his testimony, Mr. Rejeski called for the creation of an 
International Nanorisk Characterization Initiative, modeled roughly on 
the Human Genome Project. The proposed initiative would prioritize 
risks on a global level, align teams of researchers to address these 
priorities, and create an information infrastructure to support global 
collaboration. Do you support this proposal? If not, why not? If you 
need additional information to evaluate the proposal, what additional 
information do you need?

A4. We cannot support Mr. Rejeski's proposal. However, the agencies 
participating in the NNI recognize the importance and the value of 
building international cooperation and engagement in the responsible 
development of nanotechnology. The agencies participating in the NNI 
also agree with the need to ``prioritize risks on a global level, align 
teams of researchers to address these priorities, and create an 
information infrastructure to support global collaboration'' and have 
been actively pursuing those objectives. The NNI encourages other 
nations to develop nanotechnology in a responsible manner by engaging 
in risk-related research as part of their own nanotechnology 
initiatives. Agencies participating in the NNI have pursued and are 
pursuing coordination of risk-related research through joint calls for 
proposals, workshops, data sharing, bilateral engagement, and other 
activities within existing international forums, including the 
Organization for Economic Cooperation and Development (OECD), the 
International Organization for Standards (ISO), and the Asia-Pacific 
Economic Cooperation (APEC). In addition to participating in, and in 
some cases leading, nanotechnology activities in these longstanding 
international bodies, the NNI launched in June 2004 the International 
Dialogue for the Responsible Research and Development of 
Nanotechnology, which brought together 25 nations plus the European 
Commission with the goal of stimulating dialogue among a diversity of 
nations on issues of mutual concern. More activities and efforts will 
certainly be necessary in the years ahead, but a new initiative does 
not appear to be the best solution at this time. Instead we believe 
that the most effective use of resources is to work diligently within 
the mechanisms that have already been established, while identifying 
any needs that may not be covered within the purview of those 
mechanisms.

Q5.  In his testimony, Mr. Rejeski called for the U.S. Government to 
set a goal of reaching out and engaging at least 3,000 citizens and 
public opinion leaders around the country over the next year in a 
discussion of nanotechnology to help build greater public trust in this 
area. He suggested that this could be done through 20-25 town meetings, 
listening sessions, and civic forums. Do you believe that this is an 
appropriate goal and an appropriate method to accomplish this goal? If 
not, why not? If you need additional information to evaluate the 
proposal, what additional information do you need?

A5. Without question, public outreach is an important and appropriate 
goal of the NNI. As such, the NNI already has initiated a number of 
outreach activities consistent with the overall intent of Mr. Rejeski's 
suggestion. The Boston Museum of Science reports that 5,400 people 
participated in presentations and discussions about nanotechnology at 
the museum in 2004. An exhibit created by Cornell University and funded 
by NSF has drawn 1.5 million visitors since it began touring U.S. 
cities in 2003. This children's exhibit, It's a NanoWorld, has been on 
display at Disney's Epcot Center and other venues, has taught parents 
and teachers about nanotechnology and started discussions with them on 
the topic.
    This year the NSF created two Centers of Nanotechnology in Society 
and a nationwide network of science museums. Participants in these 
projects will be engaging in public outreach and identifying best 
practices for public dialogue. The NSF-sponsored Center for Learning 
and Teaching in Nanoscale Science and Engineering, hosted by 
Northwestern University, has a stated goal of reaching one million 
students in grades 7-16 over ten years. It is the largest of many NSF-
sponsored nanotechnology projects in the formal education area. 
University-based centers and networks funded by NSF, NCI, and all the 
Department of Energy (DOE) Nanoscale Science and Research Centers have 
some component of community outreach or public engagement in their 
activities, and NNI-funded researchers have held panels, seminars, and 
other events to discuss nanotechnology issues with the public in cities 
including Madison, Wisconsin; Tacoma, Washington; Columbia, South 
Carolina; Cleveland, Ohio; and Raleigh, North Carolina; among others.
    These are just a few of the existing NNI's rapidly expanding 
efforts at education and public outreach. This approach by the NNI 
agencies to use primarily locally-based forms of public engagement, 
utilizing research centers and scientists as experts, is proving to be 
both economical and effective.

Q6.  Do federal agencies currently support research on identifying ways 
to mitigate the undesirable effects of nanoparticles? If so, please 
describe such programs and how they are coordinated with programs 
identifying the risks associated with nanoparticles.

A6. In considering this question, the distinction between engineered 
nanomaterials and other nanoscale particles provided in the preface 
should be recalled. Determining and mitigating the undesirable effects 
of natural and incidental nanoscale particles is an ongoing and major 
area of research by federal agencies. The parallels and differences in 
behavior between engineered nanomaterials and these other nanoscale 
particles are as yet not fully known. In the absence of broad knowledge 
at this time regarding toxicity and uptake mechanisms, we must first 
determine what, if any, undesirable effects are associated with 
engineered nanomaterials. This is an important element of the NNI's 
environmental, health, and safety (EHS) research agenda, and is a 
necessary precursor to mitigating any undesirable effects that are 
identified. Concurrently, the NNI is funding basic research that will 
provide the foundation for future work in this area, including studies 
on the fundamental principles that govern behavior of nanostructured 
materials, which will in turn help us understand and mitigate any 
possible negative effects.
    In addition to this research, there is significant research already 
being funded under the NNI aimed at mitigating possible undesirable 
effects of engineered nanomaterials. For example, NSF, the National 
Institutes of Health, and other NNI agencies have supported research on 
novel methods for rendering engineered nanomaterials more benign. Rice 
University researchers have found that they can make carbon nanotubes 
less toxic by engineering them to be soluble.\2\ Additional work, also 
at Rice University, has found ways of modifying the surfaces of 
buckyballs to make them less toxic.\3\ University of Michigan 
researchers have found that the cytotoxicity (cell damaging) properties 
of dendrimers--which have been found to have great promise for 
destroying cancer cells--can be controlled by engineering dendrimers in 
particular ways, such as modifying their surfaces to make them neutral 
instead of charged.
---------------------------------------------------------------------------
    \2\ ``They were so safe, in fact, that no more of the cells exposed 
to these tubes died than those that died when exposed to a control 
solution without nanotubes.'' http://www.techreview.com/NanoTech/
wtr-15847,318,p1.html
    \3\ http://www.sciencenews.org/articles/20041002/fob1.asp
---------------------------------------------------------------------------
    Not only does engineering them this way make them less harmful, but 
it also makes them better at what they were designed to do in the first 
place.\4\ Many of the nanotechnology development projects supported 
across NCI's eight Centers of Cancer Nanotechnology Excellence include 
biocompatibility and toxicity studies relevant to risk identification 
and mitigation. For example, studies on cadmium-based quantum dots for 
biomedical imaging and therapeutic applications include research on 
effectively coating or encapsulating these particles to make them 
biocompatible and prevent toxic effects during in vivo applications. 
These are a few examples of what we view as one of the principal 
advantages of the ``control at the nanoscale'' that nanotechnology 
entails: tailoring (controlling) the properties of these materials to 
optimize their beneficial properties, while engineering out any 
possible undesirable properties.
---------------------------------------------------------------------------
    \4\ http://www.physorg.com/news3420.html
---------------------------------------------------------------------------
    The results of such research are coordinated with risks 
identification and assessment through dissemination among the 
scientific and technological communities as they become available 
through publications and presentations at conferences and workshops and 
by sharing the results among the members of the interagency NSET 
Subcommittee and its Nanotechnology Environmental and Health 
Implications Working Group.

Question submitted by Representative Michael M. Honda

Q1.  What portion of the EHS budget within NNI is currently addressing 
``end of life'' and bioaccumulation aspects of nanomaterials? Describe 
the characteristics and goals of the research now underway?

A1. As indicated in the answers to Chairman Boehlert's Question 6 
above, a significant thrust of the NNI from its inception has been to 
find ways to engineer nanomaterials from the start with such a degree 
of control that desirable properties are engineered in and undesirable 
properties are engineered out. The true long-term promise of nanoscale 
manufacturing technology is that it will yield new products and 
processes that are ``green'' from the start, minimizing waste (hence 
landfill use) and energy consumption during the manufacturing process 
and throughout the product life cycle. NNI agencies also have funded 
research on use of engineered nanomaterials to remediate toxic waste 
sites and contaminated groundwater. In that broad sense, much of the 
NNI investment in long-term nanomaterials and nanomanufacturing 
research is aimed at addressing the general issue that this question 
refers to.
    Among the functions of NSET's Nanotechnotogy Environmental and 
Health Implications Working Group are to facilitate the identification, 
prioritization, and implementation of research and other activities 
required for the responsible research, development, utilization, and 
oversight of nanotechnology, including research on methods of life-
cycle analysis (LCA).
    Solid waste and LCA issues with respect to engineered nanomaterials 
fall primarily within the purview of the EPA. However, several other 
agencies (NSF, NIOSH, and now NIEHS) have joined with EPA in funding a 
series of joint interagency solicitations for research on 
environmental, health, and safety (EHS) impacts of nanotechnology. 
``Environmental and biological fate, transport, and transformation of 
manufactured nanomaterials'' is one of three topics covered by this 
solicitation, funded at approx. $7 million in FY 2005 and expected to 
grow to $8 million in FY 2006.\5\ The solicitation is broad, and covers 
many EHS-related topics. So far under this solicitation, EPA has funded 
three grants totaling $0.5 million on life cycle assessment 
specifically. Research under these grants includes the development of a 
screening methodology that can be applied to assess the relative 
magnitudes of potential impacts of future applications of engineered 
nanomaterials particularly in the areas of membranes, catalysis, and 
nanotechnology-enabled sensors; developing methods for examining the 
economic and environmental implications of specific nanotechnology 
products, processes, and markets; and developing original life cycle 
inventory data for the manufacture of polymer nanocomposites. Sponsored 
research in the area of bioaccumulation of engineered nanomaterials 
includes: quantifying biological effects of quantum dots and monitoring 
the process of quantum dot uptake and breakdown that result from 
bacterial metabolism of these particles. The forthcoming EPA White 
Paper\6\ (draft is available for public comment) on nanotechnology will 
include recommendations for future EPA activities in several areas 
related to nanotechnology, including environmental fate.
---------------------------------------------------------------------------
    \5\ http://es.epa.gov/ncer/rfa/2004/
2004-manufactured-nano.html
    \6\ http://www.epa.gov/osa/nanotech.htm
---------------------------------------------------------------------------
    NIEHS and NIEHS/National Toxicology Program are developing 
systematic methods to determine biological responses to engineered 
nanomaterials. Acute and chronic exposures and in vivo studies are 
proposed to address questions of systemic distribution of materials, 
biotransformation and bioaccumulation. As research implementing these 
criteria proceeds, it should be possible to focus future studies on 
those characteristics most directly correlated with toxicological 
effects that may be discovered, and to mitigate them through control of 
the materials.
    There is considerable work ongoing within other NNI agencies (e.g., 
DOE, DOD) aimed at determining how (and in what quantities and forms) 
engineered nanomaterials enter organisms and the environment. This 
information about fate, transport, and uptake needs to be gathered 
before questions on accumulation can be appropriately addressed.

                   Answers to Post-Hearing Questions

Responses by Krishna C. Doraiswamy, Research Planning Manager, DuPont 
        Central Research and Development

Questions submitted by Representative Michael M. Honda

Q1.  What is the nature and extent of research activities underway that 
are addressing the ``end of life'' and bioaccumulation aspects of 
nanomaterials? Is this area receiving adequate attention within the 
current EHS research effort in nanotechnology?

A1. We would first like to address the second part of the question 
regarding the need for a better defined research strategy in this area. 
We will then summarize how DuPont is approaching such research as well 
as relevant work being done elsewhere that we are aware of.
    As described in my testimony, it is important to understand the 
``end of life'' and bioaccumulation aspects of nanoscale materials 
before they enter widespread commercial use. As with other questions 
relating to the safety, health and environmental impact of nanoscale 
materials, these aspects need a structured, disciplined and broadly 
consistent conceptual framework, which will help to appropriately focus 
research into these important questions, and to prioritize and guide 
the development of the appropriate tools and data. Such a framework 
must recognize and accommodate the essential differences between 
different kinds of nanoscale materials and the variety of application 
scenarios in which they are used. These variables will play a major 
role in determining whether and when a particular material has a 
significant probability of entering the environment in its nano-form 
during or at the end of its life cycle and whether such a release could 
present a significant risk. The answers to these questions will in turn 
determine the nature and scope of information that is needed for that 
particular material and application.
    The development of this kind of framework, as well as the 
development and validation of tests, measurement techniques and 
standards, are of broad relevance. For example, we need to develop 
testing methods and standards for assessing environmental fate and 
bioaccumulation of nanomaterials. Knowledge of this kind should, in our 
view, be actively supported through public funding, and made widely and 
freely available.
    With respect to current research efforts in the public domain, we 
are aware of some ongoing activity funded by government agencies, e.g., 
the work funded by NSF and EPA at Purdue (http://news.uns.purdue.edu/
html4ever/2004/040826.Turco.nanogrants.html), and by the EPA at several 
universities (http://es.epa.gov/ncer/nano/research/
nano-fate-and-transport.html). The 
International Council on Nanotechnology (of which DuPont is a founding 
member) has recently posted on its website a more complete list of 
already published work relevant to EHS (http://icon.rice.edu/
research.cfm), with the intention of keeping this list updated as new 
information becomes available. While DuPont supports such endeavors, we 
believe that this work would have greater utility, if it were carried 
out in the context of a strategic framework as described previously.
    With respect to our own efforts, DuPont is evaluating novel 
nanoparticles, each of which has potential interest for a range of 
applications. Our current experiments with such materials typically 
involve relatively small quantities in a controlled research 
environment. Our immediate objective is to demonstrate the feasibility 
of particular inventions or innovation concepts, while we continue to 
focus on addressing lab safety and workplace safety questions that 
apply to all such materials. Questions regarding ``end of life'' and 
bioaccumulation will take on a higher priority for these materials as 
practical applications emerge and their probability of 
commercialization increases. Our internal Product Stewardship process, 
as described in the attached background statement, will then require an 
appropriate level of attention to questions relating to environmental 
fate, before a decision is made to scale up to manufacturing volumes. 
Where our internal process reveals serious concerns about environmental 
fate issues, such concerns will be addressed prior to 
commercialization.
    Questions relating to ``end of life'' and bioaccumulation are of 
immediate relevance to the large number of companies that are 
developing and marketing proprietary nanoscale materials as primary 
materials suppliers. Customers for such materials (including DuPont) 
will usually look to these suppliers for adequate SHE related data. 
Many of these suppliers are early stage start-ups, who will face 
obvious practical challenges in carrying out such investigations on 
their own. Access to public domain information will clearly help these 
entities and encourage applications-focused innovation with the 
materials that they seek to provide.

Q2.  Should there be a greater partnership between business and 
government in carrying out research in this area? Do you have 
recommendations on how to institute such cooperative R&D activities?

A2. DuPont believes that progress in all areas relating to the SHE 
aspects of nanoscale materials will be greatly accelerated through 
active collaborations between all of the stakeholders, including 
industry, government, academic institutions and NGOs. We believe that 
government, industry and other stakeholders should work together to 
define what kinds of data and measurement methods will have the 
greatest value for different materials in different application 
scenarios, and should collaborate to develop and validate methods that 
could set the foundation for future industry standards.
    In particular, we would recommend that a multi-stakeholder task 
force should be established to develop broadly accepted research 
priorities and a roadmap.
    We believe our strongest need is for joint work on establishing 
basic understanding of how to assess physical-chemical properties, 
environmental fate, bioaccumulation, and toxicity of nanomaterials. 
This would include developing methods for tests and gathering baseline 
information on common materials presently in wide use.
    While the private sector needs to contribute expertise and 
resources to this effort, there is a clear role for public cost sharing 
recognizing that the data that is generated will not be proprietary. 
The nature of the research that is needed at this early stage is pre-
commercial; the resulting knowledge will ideally benefit all the 
players.
    Research goals that are clearly defined and targeted could be 
pursued through the formation of consortia, made up of stakeholders 
with a particular interest in those goals. For example, the 
Nanoparticle Occupational Safety and Health (NOSH) consortium is a 
multi-stakeholder group that sharing the cost of R&D to investigate 
nanoparticle aerosols in the workplace and may provide a benchmark for 
the formation of similar consortia to address other questions.
    Excellent models for collaboration are also offered by the joint 
efforts in the AIChE's Center for Chemical Process Safety and their 
Design Institute for Physical Property Data (DIPPR), as well as by the 
American Chemistry Council's program to share chemical toxicity data.

                   Answers to Post-Hearing Questions

Responses by David Rejeski, Director, Project on Emerging 
        Nanotechnologies, Woodrow Wilson International Center for 
        Scholars

Questions submitted by Representative Michael M. Honda

Q1.  What is the nature and extent of research activities underway that 
are addressing the ``end of life'' and bioaccumulation aspects of 
nanomaterials? Is this area receiving adequate attention within the 
current EHS research effort in nanotechnology?

A1. Thus far, only a handful LCAs on nanotechnologies have been 
completed. A summary of the LCAs identified through work done with Yale 
University is provided in Table 2 (see attachment). For each LCA, the 
table lists the study year and location, the nanotech sector and 
product assessed, the focus of the study, and the specific approach 
used. Also identified are the life cycle phases addressed during each 
LCA, the technological benefits of the nanomaterial, the environmental 
benefits and costs, and life stages with the greatest and least 
benefits compared to traditional products.
    The completed LCAs have focused on the automotive, electronic, 
chemical, and lighting sectors. Performing a LCA of a product is a 
laborious and potentially costly endeavor. One would not expect that 
each LCA would include all life stages and quantify all potential 
impacts. However, we have preliminarily identified the following gaps 
that need to be addressed in future research.

          Evaluation of a greater variety of products across 
        multiple sectors (Table 4 in the enclosed report highlights 
        these gaps).

          Assessment of impacts associated with transportation 
        and end-of-life.

          Inclusion in the analyses of all material inputs, 
        including those related to energy use.

          Development of nanoscale-relevant metrics to better 
        quantify impacts across the life cycle.

          Consideration of the fate of material outputs and 
        possible exposure routes.

          Consideration and explicit evaluation of health and 
        environmental risks.

          Modeling of nano-specific effects, which appear to be 
        ignored in most of the existing LCAs, i.e., normal hazardous 
        waste versus waste considered ``hazardous'' because it contains 
        nanomaterials.

    A search of our recently released environmental, health, and safety 
(EHS) inventory indicates that there are not many LCAs currently 
underway or being funded in the United States. A search for the 
keywords ``life cycle analysis'' returned five (5) projects with an 
annual funding of $418,069. The ongoing projects include:

          ``A Life Cycle Analysis Approach for Evaluating 
        Future Nanotechnology Applications,'' funded by the 
        Environmental Protection Agency (EPA) for a total of $100,000 
        over two years and the continuation of one of the completed 
        projects presented in Table 2.

          ``Carbon Nanotube Synthesis: Assessing Economic and 
        Environmental Tradeoffs in Process Design,'' funded by the 
        National Science Foundation (NSF) for $129,989 over two years.

          ``Identifying and Regulating Environmental Impacts of 
        Nanomaterials,'' funded by NSF for $130,000 for one year.

          ``Implications of Nanomaterials Manufacture and Use: 
        Development of a Methodology for Screening Sustainability,'' 
        funded by EPA for $99,740 for two years.

          ``Sustainable Biodegradable Green Nanocomposites From 
        Bacterial Bioplastic for Automotive Applications,'' funded by 
        EPA for $369,613 over three years.

          EPA has added one additional LCA project for FY 2006 
        that is not contained in our inventory: ``Evaluating the 
        Impacts of Nanomanufacturing via Thermodynamic and Life Cycle 
        Analysis,'' for $375,000 over two years.

    On the international level, our inventory contains one project 
being funded by the European Union, entitled ``SHAPE-RISK: Sharing 
Experience on Risk Management (Health, Safety, and Environment) to 
Design Future Industrial Systems,'' for approximately $544,624 USD over 
three years. Please note that although we tried to identify all ongoing 
and completed LCAs on nanotechnologies, there may be some that were 
inadvertently missed through this research effort.
    The results provided by the LCA inventory paper and the search of 
our EHS inventory indicate that more attention is needed, especially 
since nano-based products are already on the market and many more are 
sure to follow. Few LCAs have been completed that are publicly 
available. The existing LCAs do not assess nano-specific impacts, such 
as those related to the hazard potential of nanoparticles. The 
performed LCAs also assess too few products and life cycle stages to 
provide a clear picture of the life cycle impacts of nanomaterials. 
Future LCAs should focus on evaluating human health and environmental 
impacts and risks associated specifically with nano-based inputs and 
products during pre-manufacture activities, product manufacture, 
packaging and transport, use, and recycling and disposal. These efforts 
will help inform and improve safe development, management, and use of 
nanotechnology as this field moves forward.

Q2.  Should there be a greater partnership between business and 
government in carrying out research in this area? Do you have 
recommendations on how to institute such cooperative R&D activities?

A2. As I stated in my testimony before your committee, it is unlikely 
that the United States, or any individual country, will have adequate 
funds to address all the major existing and emerging risks associated 
with nanotechnologies, especially across all the potential products and 
their life cycles. It is therefore necessary to look towards 
international cooperation and partnerships with industry to fill 
important gaps and stay in front of any potential risks. In terms of 
life cycle impacts, industry cooperation is critical because businesses 
have information that is necessary in assessing impacts during the 
manufacturing stage. In addition, firms involved in waste management 
need to become involved to properly assess end-of-life impacts 
associated with disposal, incineration, recycling, etc.
    To initiate and sustain the needed partnerships, it is important 
that one government agency be designated as the lead. We would 
recommend that EPA be given the lead in LCA work in the Federal 
Government. Because EPA regulations and voluntary programs affect most 
points in the product life cycle, this approach represents the best 
opportunity to have the science inform our public policies as 
nanotechnology moves forward.
    EPA's share of the EH&S research funding under the NNI needs to be 
increased significantly because of their key, and increasingly 
important, role in regulation (we believe they should receive at least 
$10 million, double their current funding level). $2-3 million of an 
expanded EPA nano research fund should be dedicated to LCA analyses. 
LCAs are needed now for products in the market such as cosmetics and 
composite materials used in automobiles, sporting goods, etc.
    We hope that this information will be useful for the Committee. We 
would be glad to meet with you, other Committee Members, and staff to 
discuss these important issues. The inventory can be found on our 
website: www.nanotechproject.org.



                   Answers to Post-Hearing Questions

Responses by Richard A. Denison, Senior Scientist, Environmental Health 
        Program, Environmental Defense, Washington, D.C.

Questions submitted by Representative Michael M. Honda

Q1.  What is the nature and extent of research activities underway that 
are addressing the ``end of life'' and bioaccumulation aspects of 
nanomaterials? Is this area receiving adequate attention within the 
current EHS research effort in nanotechnology?

A1. Very little research now underway directly addresses these critical 
questions related to the longer-term risks of nanomaterials. Searches 
of the databases of current research projects maintained by the 
USEPA\1\ and the Woodrow Wilson Center's Project on Emerging 
Nanotechnologies\2\ yielded only a handful of studies relevant to these 
two topics--even taking an expansive view of which studies could be 
considered directly relevant. (The identified studies, all funded by 
EPA, are summarized in the Appendix.) Total funding for the work 
ongoing in these areas is less than $1 million annually, truly a drop 
in the bucket in terms of what is needed.
---------------------------------------------------------------------------
    \1\ See http//es.epa.gov/ncer/nano/research/
nano-industrial-ecology.html; and http://
es.epa.gov/ncer/nano/research/
nano-fate-and-transport.html.
    \2\ See http://www.nanotechproject.org/index.php?id=18.
---------------------------------------------------------------------------

Areas of needed research

    Issue related to end-of-life impacts and the potential for 
bioaccumulation have been identified by the USEPA as research 
priorities in its recent Nanotechnology White Paper\3\ As EPA states: 
``Research on the transport and potential transformation of 
nanomaterials in soil, subsurface, surface waters, waste water, 
drinking water, and the atmosphere is essential as nanomaterials are 
used increasingly in products.''
---------------------------------------------------------------------------
    \3\ Science Policy Council, U.S. Environmental Protection Agency, 
Nanotechnology White Paper, External review draft dated 2 December, 
2005, available at http://www.epa.gov/osa/nanotech.htm.
---------------------------------------------------------------------------
    To illustrate the range and depth of research questions needing to 
be addressed, consider this sampling of ``high-priority'' research 
questions identified by EPA in its draft white paper:

Transport

          What is the potential for these materials, if 
        released to soil or landfills, to migrate to groundwater and 
        within aquifers, with potential exposure to general populations 
        via groundwater ingestion?

          How do nanomaterials bioaccumulate? Do their unique 
        characteristics affect their bioavailability? Do nanomaterials 
        bioaccumulate to a greater or lesser extent than macroscale or 
        bulk materials?

Transformation

          What are the physicochemical factors that affect the 
        persistence of intentionally produced nanomaterials in the 
        environment?

          Do particular nanomaterials persist in the 
        environment, or undergo degradation via biotic or abiotic 
        processes? If they degrade, what are the byproducts and their 
        characteristics? Is the nanomaterial likely to be in the 
        environment, and thus be available for bioaccumulation/
        biomagnification?

Treatment

          What is the potential for these materials to bind to 
        soil, subsurface materials, sediment or sludge in waste water 
        treatment plants?

          Are these materials effectively removed from waste 
        water using conventional waste water treatment methods and, if 
        so, by what mechanism?

          Do these materials have an impact on the treatability 
        of other substances in waste water, or on treatment plant 
        performance?

          Are these materials effectively removed in drinking 
        water treatment and, if so, by what mechanism?

          Do these materials have an impact on the removal of 
        other substances during drinking water treatment, or on 
        drinking water treatment plant performance?

          When nanomaterials are placed in groundwater 
        treatment, how do they behave over time? Do they move in 
        groundwater? What is their potential for migrating to drinking 
        water wells?

          How effective are existing treatment methods such as 
        carbon adsorption, filtration, and coagulation and settling for 
        treating nanomaterials?

New Methods and Technologies

          What low-cost, portable, and easy-to-use technologies 
        can detect, characterize, and quantify nanomaterials of 
        interest in environmental media?

Release and Exposure

          What tools/resources currently exist for assessing 
        releases and exposures within EPA (chemical release 
        information/monitoring systems (e.g., TRI), measurement tools, 
        models, etc.)? Are these tools/resources adequate to measure, 
        estimate, and assess releases and exposures to nanomaterials? 
        Is degradation of nanomaterials accounted for?

          What research is needed to develop sensors that can 
        detect nanomaterials?

Why worry about the end-of-life of nanomaterial-containing products?

    In my testimony, I argued that taking a life cycle view is critical 
to understanding the potential risks of nanomaterials. It is also 
critical to identifying opportunities during the process of developing 
nanomaterials and associated applications to ``design out'' potential 
downstream impacts. Let me discuss two real-world examples of 
bioaccumulation and end-of-life concerns related to products that in 
the future may well routinely contain nanomaterials, examples that 
vividly illustrate the need to adopt a life cycle view.

Sunscreens: In my testimony, I made the point that nanomaterials 
present in products like cosmetics and sunscreens will be washed off 
and enter water supplies, with ``end-of-life'' impacts as yet 
uninvestigated. Quite recently, researchers in Southern California and 
Switzerland appear to have found direct evidence of ingredients from 
sunscreens and related products entering surface waters, though the 
ingredients in question were not nanomaterials.\4\ The Southern 
California researchers found that male fish living near a sewage 
outfall are accumulating a chemical, oxybenzone, used in sunscreens to 
protect the skin from the ultraviolet component of sunlight. The 
chemical appears to be washed off of bodies in the shower, passes 
through sewage treatment plants unchanged and settles on the sea floor, 
where bottom-feeding fish eat it. The Swiss research has identified two 
other substances used in sunscreen and lip balm--octocrylene and 4-
methylbenzylidene camphor--that are also building up in fish. The 
salient point here is that we don't know--but need to determine--
whether nanomaterials present in products like sunscreens can 
potentially survive sewage treatment to enter surface waters, and if 
they are also bioaccumulative, have the potential to build up in 
aquatic organisms.
---------------------------------------------------------------------------
    \4\ Geoffrey Lean, ``If your suntan oil can change the sex of fish, 
what can do it to you?'' The Independent Online, 22 January, 2006, 
available at http://news.independent.co.uk/environment/
article340237.ece.

Electronics ``recycling'': A prime area of application for 
nanomaterials is in the fabrication of components used in electronics. 
In my testimony, I noted that the use of nanomaterials in such 
applications may be unlikely to lead to exposures during product use, 
but that subsequent disposal or recycling might well pose increased 
risks. As described below, this potential is more than just 
theoretical.
    In many developed countries, including the U.S., programs are being 
put in place to collect discarded electronics products such as 
computers for recycling, motivated by the desire to keep such used 
products, which can contain a variety of toxic materials, out of 
landfills and incinerators, as well as to recover any valuable 
materials. While these programs are well-intentioned, in practice they 
have led to what many consider an epidemic of so-called ``e-waste''--
the export to developing countries of our electronics discards. What 
happens to these materials?
    A recent article in Chemical & Engineering News describes the end-
of-life reality of much of today's electronics recycling programs.\5\ 
Because such recycling is generally not economical in the U.S.,
---------------------------------------------------------------------------
    \5\ Bette Hileman, ``Electronic Waste: States strive to solve 
burgeoning disposal problem as more waste ends up in developing 
countries,'' Chemical & Engineering News, January 2, 2006, pp. 18-21, 
available at www.cen-online.com.

         ``. . .more and more of the used electronic equipment 
        collected for recycling is being shipped to China, India, 
        Pakistan, and Africa, where most of it is disposed of 
        inappropriately. The Government Accountability Office (GAO) 
        estimates that 50-80 percent of the devices collected for 
        recycling in the U.S. end up in Asia or Africa. Although a 
        small percentage of the devices are refurbished and reused 
        abroad, most are disassembled and disposed of in a way that 
---------------------------------------------------------------------------
        poses risks to workers and the environment.''

    The photos and captions that follow, taken from the C&E News 
article, tell the end-of-life story:




Q2.  Should there be a greater partnership between business and 
government in carrying out research in this area? Do you have 
recommendations on how to institute such cooperative R&D activities?

A2. As discussed above, there is a tremendous, and currently poorly 
met, need to identify and address potential health and environmental 
risks of nanomaterials, including those associated with ``end-of-life'' 
impacts and bioaccumulation. As illustrated by the expensive and 
contentious battles waged over clean-up of toxic ``legacy'' materials 
(e.g., lead-based paint, asbestos, hazardous waste sites), failing to 
consider in advance ``end of life'' issues and the potential for 
materials to build up in the environment over time can be very costly 
for both the government and private industry. Given the anticipated 
pervasiveness of nanomaterials in a wide range of applications, it is 
critical to address these issues at the front end, where solutions can 
most efficiently and cost-effectively be implemented to prevent 
widespread and costly environmental and health problems down the road.
    Joint funding by government and industry should be one means used 
to conduct critical health and environmental research in these areas. 
Initially, government should play the lead role in initiating and 
coordinating this kind of research. At this early stage, we lack many 
of the basic tools, methods and instrumentation needed to detect, 
measure and monitor for nanomaterials in the environment and in living 
organisms--critical to assessing both end-of-life and bioaccumulation 
concerns. Because this research cuts across all industries and 
applications, and given the major investment of the Federal Government 
in funding nanotechnology development, government needs to play a lead 
role in developing this ``enabling infrastructure,'' which companies 
can then use to assess the safety of their own products prior to 
commercialization.
    Government also has an essential role to play in collecting from 
companies the information needed to best target this research. Private 
companies are in the best position to identify those materials and 
applications most likely to be widely commercialized, and they should 
also be expected to provide the actual materials to be tested. 
Information on the volume of different materials produced, current and 
expected uses for those materials, and practices and activities 
associated with the management of these materials after use (disposal, 
recovery for recycling, etc.) is key to determining which materials are 
most important to investigate first. Companies may well be reluctant to 
share this type of information publicly for fear of exposing 
competitive information. Government therefore needs to identify 
mechanisms to obtain the information it needs, while balancing the need 
to protect legitimate confidential information and to make publicly 
available as much information as possible to ensure public trust in the 
process. (Government can, for example, provide information in 
aggregated forms that do not disclose individual companies' 
confidential information.) It is essential that a range of stakeholders 
be informed and involved from the start in the debate over how best to 
focus such health and environmental research.
    Once the needed ``infrastructure'' is in place, companies should 
bear the primary responsibility to conduct the needed research on their 
own nanomaterials and applications, to ensure that they are able to be 
safely managed throughout their life cycles and will not build up in 
the environment.



                              Appendix 2:

                              ----------                              


                   Additional Material for the Record



                      Statement by Keith Blakely,
                        Chief Executive Officer
                           NanoDynamics, Inc.

    As CEO of NanoDynamics and a member of the advisory board of the 
NanoBusiness Alliance, I would like to thank Chairman Boehlert and the 
Committee for giving me the opportunity to submit this testimony for 
the hearing on nanotechnology environment, health and safety issues. I 
hope that these hearings lead to greater understanding of the true 
environmental, health, and safety (``EHS'') issues of nanotechnology, 
and that they help to dispel the many myths and misperceptions that are 
already developing about this new and dynamic field. And most 
importantly, I hope these hearings lead to an understanding of why it 
is crucial to support EHS research in nanotechnology at an early stage.
    Twenty years ago I founded ART, Inc., widely regarded as one of the 
leading innovators in advanced materials. The company developed and 
commercialized dozens of new products, entered into joint development 
agreements with numerous Fortune 100 organizations, and funded programs 
at more than 15 universities and national laboratories. In the process, 
I grew the business to over three hundred employees and tens of 
millions in revenues. The key to our success was developing good, 
innovative products that were safe: safe for my employees who 
manufactured them, safe for my customers who bought them, and safe for 
the environment long after they were used.
    I have brought that same ethos with me to NanoDynamics. 
NanoDynamics is a fully integrated technology and manufacturing company 
using nanoscale engineering to improve the lives, health, and safety of 
our customers. With nanotechnology solutions addressing issues in 
energy, homeland defense, water, electronics, advanced materials and 
consumer products, NanoDynamics is committed to delivering the Power of 
Nanotechnology to the global marketplace. We already have numerous 
products ready for the marketplace, from nanoscale metals and other 
materials to our NDMX golf ball and Rev 50 portable solid oxide fuel 
cell and are working on everything from printable electronics to black 
mold combating paint.
    We have always taken our environmental responsibilities seriously. 
NanoDynamics hired as one of its first 10 employees an EHS officer and 
we have been involved in EHS discussions at the NanoBusiness Alliance, 
the nanotechnology industry association, NIOSH, and several trade 
organizations. We have also sent staff to participate in EPA meetings 
discussing nanotechnology regulation. As a father whose children will 
be using nanotech products, as the CEO of a company that is on the 
forefront of their production and as a researcher in the field, the 
development of responsible and fair EHS guidelines for nanotechnology 
is a matter of great importance in my life.
    The National Nanotechnology Initiative defines nanotechnology as 
the understanding and control of matter at dimensions of roughly one to 
100 nanometers (for comparison, a sheet of notebook paper is about 
100,000 nanometers thick) and exploiting the unique phenomena that 
occur at that scale to enable novel applications. Today, nanotech 
research holds the promise of significant breakthroughs in nearly every 
industry, through thousands of products and multiple methods of 
production. Nanosys is working toward high-volume manufacturing of its 
thin-film solar panels, Nano-Tex is developing wrinkle- and stain-
resistant pants that may revitalize the U.S. textile industry, Intel 
and others are looking at carbon nanotubes as a way to break the next 
barrier in Moore's law of ever smaller and denser computer memory and 
companies like Nanosphere and American Pharmaceutical Partners are 
developing medical applications that promise dramatic improvements in 
treatment for cancer, Parkinson's disease and Alzheimer's. This breadth 
of application and the fact that the same nanomaterial may behave very 
differently based on its size and use is the primary challenge in 
creating a unified system at the corporate and government level for 
ensuring EHS safety. For example, aluminum particles at 500nm work well 
for soda cans while aluminum particles at 5nm make a great explosive.
    Another complication is that nanoscale products have been with us 
for a thousand years, starting with the nano particles of gold that 
give Venetian stained glass its color to carbon black in inks and 
pigments to silvers used in the early photographic processes. Even the 
combustion of gasoline in vehicles produces carbon based nanoparticles. 
This means that any policy governing nanoparticles and materials may 
have far-reaching implications that will impact existing and 
established industries.
    Nanotechnology holds the potential for a safer, cleaner and better 
world. Our goal should be to provide EHS guidelines that will allow us 
to reap the benefits of that technology in an environmentally 
responsible fashion.
    In looking at the Nanotech space from an EHS perspective it is 
clear that we must drastically reduce uncertainty surrounding 
environmental, health, and safety issues of nanomaterials. This is 
important not only for the safety of the public but also for the 
success of nanotech industries that depend on consumers not harboring 
unfounded or ill-informed fears that will keep them from buying 
nanotech products. Today, not enough fundamental toxicity research has 
been done on nanoparticles to decisively determine what hazards they 
may pose to workers, the public, and the environment--or how such 
hazards, should they exist, might be mitigated. The EHS guidelines we 
produce to address this must cover all the different aspects of dealing 
with nanomaterials including:

          Safe Manufacturing;

          Storage and Packaging; and

          Disposal and Recycling

    The steps we anticipate must take place to develop these guidelines 
are as follows:

1.  Increase Overall Federal Support for EHS-Focused Research in 
Nanotech

    A massive level of investment is going into nanotech development--
$8.6 billion combined in government spending, corporate R&D, and 
venture capital worldwide in 2004, up 10 percent from 2003. By most 
measures, the U.S. leads in nanotechnology today, including: absolute 
public sector spending; patents issued, corporate R&D spending; and 
scientific publications. In contrast, approximately $40 million or 3.7 
percent of the 2006 NNI budget is allocated to researching the health 
and environmental implications of the technology. This is clearly not 
sufficient to keep pace with the rate at which the technology is 
progressing.
    While the optimal amount of EHS funding could be the subject of a 
study unto itself, we believe that a significant increase to the level 
of approximately 10 percent of NNI funding is well founded. This 
reflects the view that potential future costs associated with 
litigation, health care, and lost productivity can be avoided with 
sufficient investment at this juncture.

2.  Support EHS Compliance Efforts in Emerging Businesses

    The majority of the research being performed with government 
funding tends to focus on supporting basic research at academic 
institutions (i.e., labs and universities). Since this basic research 
is not focused on producing publicly consumable products, there is no 
impetus to examine all the EHS implications of the technology--
particularly those around manufacturing, disposal and recycling. 
Private corporations like NanoDynamics, on the other hand, have taken a 
voluntary approach and invested their own capital in being responsible 
corporate citizens. However, the costs of characterizing new 
nanomaterials and maintaining compliance can be prohibitive for 
emerging companies.
    We recommend that the government provide incentives for EHS 
research in the private sector and in particular, focus on helping 
emerging nanotech businesses perform the work required to examine the 
EHS implications of their innovations and make them compliant with EHS 
guidelines. These incentives can take the form of more or better-funded 
federal centers that provide equipment and services required to 
investigate the properties of nanomaterials and particles or grants 
that emerging businesses can acquire to fund research into reducing the 
toxicity of their products.

3.  Coordinate Individual Agencies to Develop EHS Policies for Nanotech

    Since nanotechnology spans various industries, we do not recommend 
that there be a separate or central agency that oversees EHS concerns 
in this area. Rather, existing agencies concerned with EHS in the 
industries they regulate develop their own policies and guidelines (for 
example, the FDA for pharmaceutical and agricultural nanotech 
applications). This will allow EHS guidelines for a particular 
nanomaterial or nanoparticle to be appropriately placed in the context 
of the application in which they are used.
    We recommend that a central interagency coordinating program be 
implemented that coordinates the efforts of the various agencies as 
they develop their policies and ensures that there is communication 
between the agencies and consistency in the policies they develop.

4.  Promote Public Education around EHS and Nanotech

    The public's primary source of education on EHS and Nanotech today 
is Hollywood movies and science fiction novels. Unsurprisingly, the 
viewpoint they present is entertaining but fundamentally alarmist and 
not based in fact. The impact however is that U.S. consumers are being 
educated to view nanotech products as harmful without having a clear 
understanding of their actual behavior. This bias will make it 
difficult for corporations with nanotech products to succeed in the 
U.S. marketplace and will eventually force U.S. companies to go abroad 
to succeed. This is in addition to disadvantaging the American public 
by denying them the quality of life they could enjoy through the use of 
nanotech products.
    We recommend allocating funding to public education projects that 
provide a correct and rational evaluation of the risks and benefits of 
nanotechnology.

    In the process of following these recommendations, it is important 
that we keep in mind the implications EHS policy may have on the U.S. 
economic climate for nanotech innovation. In this global economy, the 
U.S. is competing not only to attract innovation and investment from 
abroad, but also to prevent that same innovation and investment from 
leaving the country. As we develop our policies we must attempt to not 
unduly burden innovators, researchers and corporations that are 
involved in nanotechnology development. Japan, Singapore, Germany and 
the U.K. have all invested significantly in nanotech development and 
are actively attempting to attract the innovations and technologies 
being developed in U.S. institutions and funded by U.S. taxpayers. 
Losing companies to these foreign territories because of cost of 
compliance issues would mean we would be foregoing the job creation and 
economic benefits of our investment in nanotech.
    Precedent shows us that a wise investment in research today could 
save a far greater cost in the future. Asbestos, an extremely effective 
fire retardant, was installed in millions of homes, businesses, and 
schools. And while asbestos was an important innovation that allowed us 
to save lives and make industrial progress, it came at a high cost that 
could have been avoided by paying attention to and investing in EHS 
research early in its development. When considering the health care, 
legal, social and quality of life costs that were incurred as a result 
of not making this investment, it becomes evident that investing in 
early EHS studies pays for itself many times over and is in the 
economic best interests of the public, industry and government. Today, 
the federal government is the largest single investor in nanotechnology 
research. As such it must take the lead in identifying the appropriate 
gaps in EHS knowledge and organize appropriate, objective, and 
economically sound research studies to assess the risks and rewards of 
nanomaterials processes and applications. As I mentioned earlier, less 
than four percent of the National Nanotechnology Initiative budget is 
devoted to researching health and environmental implications. Given 
what's at stake, that investment is insufficient. Nanotechnology is new 
and has the potential to end up, in some form, in the majority of 
American households. Given this, we should consider spending as much as 
10 percent of our research budget, or $100 million annually, during the 
first several years to learn about the potential impact of these 
materials. To put the investment in perspective, note that Standard and 
Poor's has estimated that the cost of liability for asbestos alone 
could reach $200 billion.
    EHS research is equally important to realizing the economic 
development benefits expected from the government's support of 
nanotechnology. U.S. companies are in the forefront of this revolution, 
leveraging our technological prowess to create a new and vibrant 
manufacturing sector that promises to stimulate job growth at all 
levels. An investment in EHS will engender the same level of trust from 
the global market that American pharmaceuticals enjoy and give us 
access to international export markets and foreign investment. The 
innovation sparked by this boom will lead to a cleaner environment, 
higher quality of life and economic development for all.
    Today, our technological competencies can be leveraged to both 
understand the risks of nanotechnology and harness the potential of 
these exciting materials and processes. It only requires us to make 
appropriate, informed, and timely investments in the right areas to 
reap the maximum benefit. I greatly appreciate the opportunity to share 
my thoughts on this critically important subject.

 Approaches to Safe Nanotechnology: An Information Exchange With NIOSH

   National Institute for Occupational Safety and Health Centers for 
                     Disease Control and Prevention
                            October 1, 2005

Director's Message

    The field of nanotechnology is advancing rapidly and will likely 
revolutionize the global industry. As with any new technology, we are 
faced with many unknowns; all of which raise questions concerning 
occupational safety and health. The National Institute for Occupational 
Safety and Health (NIOSH) is committed to ensuring worker protection as 
nanotechnology develops.
    NIOSH has developed the document Approaches to Safe Nanotechnology: 
An Information Exchange With NIOSH to raise awareness of potential 
safety and health concerns from exposure to nanomaterials. The document 
also addresses current and future research needs essential to 
understanding the potential risks that nanotechnology may have to 
workers.
    It is imperative that the scientific community come together to 
advance our understanding of nanotechnology and its implications in the 
workplace. I invite you to participate in this process and encourage 
you to provide feedback, comments, or suggestions regarding the 
Approaches to Safe Nanotechnology document. I also encourage you to 
share any relevant information or experience pertaining to the field of 
nanotechnology.
    As our knowledge grows, NIOSH plans to provide valuable guidance to 
the safe handling of nanoparticles and other safe approaches to 
nanotechnology. This will be an effort that evolves as the technology 
advances and our knowledge and experience grows.
    Thank you.

John Howard, M.D.
Director, National Institute for Occupational Safety and Health Centers 
        for Disease Control and Prevention

                            DRAFT (9-30-05)

 Approaches to Safe Nanotechnology: An Information Exchange With NIOSH

    This information is distributed solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. It has not been formally disseminated by CDC/NIOSH and 
should not be construed to represent any agency determination or 
policy.

Summary

    Safety and health practitioners recognize a lack of consistent 
guidance for the safe handling of nanomaterials. This information gap 
is critical because of the unknown risk that nanomaterials pose to 
workers. Experimental studies in rats have shown that at equivalent 
mass doses, insoluble ultrafine particles (smaller than 100nm) are more 
potent than large particles of similar composition in causing pulmonary 
inflammation and lung tumors. Whether these effects would occur in 
exposed workers is not known. If engineered nanoparticles involve the 
same characteristics that seem to be associated with ultrafine 
particles, they may raise the same concerns. The greater hazard may 
relate to the larger number and total surface area of nanoparticles 
compared with that of the larger particles at the same mass 
concentration. Until these preliminary findings and hypotheses are 
confirmed, we can have no firm knowledge about the health risks that 
nanoparticles pose to exposed workers. However, to increase the 
likelihood of safe work with nanomaterials, we should consider using 
control measures that are known to work for larger particles. In terms 
of control measures, nanoparticles appear to have no major physical 
features that would make them behave differently from larger particles 
in a control system. Therefore, it may be useful for those working with 
nanomaterials to employ the range of control technologies, work 
practices, and personal protective equipment demonstrated to be 
effective with other fine and ultrafine particles.
    This document reviews what is currently known about nanoparticle 
toxicity and control, but it is only a starting point. The document 
serves as a request from NIOSH to occupational safety and health 
practitioners, researchers, product innovators and manufacturers, 
employers, workers, interest group members, and the general public to 
exchange information that will ensure that no worker suffers material 
impairment of safety or health as nanotechnology develops. 
Opportunities to provide feedback and information are available 
throughout this document.

Introduction

    Nanotechnology is the manipulation of matter on a near-atomic scale 
to produce new structures, materials, and devices. This technology has 
the ability to transform many industries and to be applied in many ways 
to areas ranging from medicine to manufacturing. Research in nanoscale 
technologies is growing rapidly worldwide. By 2015, the National 
Science Foundation estimates that nanotechnology will have a $1 
trillion impact on the global economy and will employ two million 
workers, one million of which may be in the United States [Roco and 
Bainbridge, 2001].
    Nanomaterials present new challenges to understanding, predicting, 
and managing potential health risks to workers. As with any new 
material being developed, scientific data on the health effects in 
exposed workers are largely unavailable. In the case of nanomaterials, 
the uncertainties are great because the characteristics of 
nanomaterials may be different from those of the larger particles with 
the same chemical composition. Safety and hearth practitioners 
recognize the critical lack of guidance on the safe handling of 
nanorilaterials--especially now, when the degree of risk to exposed 
workers is unknown.
    The National Institute for Occupational Safety and Health (NIOSH) 
is working in parallel with the development and implementation of 
commercial nanotechnology through (1) conducting strategic planning and 
research, (2) partnering with public- and private-sector colleagues 
from the United States and abroad, and (3) making information widely 
available. The NIOSH goal is to provide national and world leadership 
for incorporating research findings about the applications and 
implications of nanotechnology into good occupational safety and health 
practice for the benefit of all nanotechnology workers.

Intent and Purpose

    With the launch of the Approaches to Safe Nanotechnology Web page, 
NIOSH hopes to do the following:

          Raise awareness of the occupational safety and health 
        issues being identified in the rapidly moving and changing 
        science and applications and implications of nanotechnology.

          Use the best information available to make interim 
        recommendations on occupational safety and health practices in 
        the production and use of nanomaterials. These interim 
        recommendations will be updated as appropriate to reflect new 
        information. They will address key components of occupational 
        safety and health, including monitoring, engineering controls, 
        personal protective equipment, occupational exposure limits, 
        and administrative controls. They will draw from the ongoing 
        NIOSH assessment of current best practices, technical 
        knowledge, and professional judgment. Throughout the 
        development of these guidelines, the utility of a hazard-based 
        approach to risk assessment and control will be evaluated and, 
        where appropriate, recommended.

          Facilitate an exchange of information between NIOSH 
        and its external partners from ongoing research, including 
        success stories, applications, and case studies.

          Respond to requests from industry, labor, academia, 
        and other partners who are seeking science-based, authoritative 
        guidelines.

          Identify information gaps where few or no data exist 
        and where research is needed.

    The NIOSH Web site will serve as a starting point for developing 
good work practices and will set a foundation for developing proactive 
strategies for responsible development of nanotechnologies in the U.S. 
workplace. This site will be dynamic in soliciting stakeholder input 
and featuring regular updates.

Scope

    This document has been developed to provide a resource for 
stakeholders who wish to understand more about the safety and health 
applications and implications of nanotechnology in the workplace. The 
information and guidelines presented here are intended to aid in risk 
assessments for engineered nanomaterials and to set the stage for the 
development of more comprehensive guidelines for reducing potential 
workplace exposures in the wide range of tasks and processes that use 
nanomaterials. The information in this document will be of specific 
interest to the following:

          Occupational safety and health professionals who must 
        (1) understand how nanotechnology may affect occupational 
        health and (2) devise strategies for working safely with 
        nanomaterials.

          Researchers working with or planning to work with 
        engineered nanomaterials and studying the potential 
        occupational safety and health impacts of nanomaterials.

          Policy and decision-makers in government agencies and 
        industry.

          Risk evaluation professionals.

          People working with or potentially exposed to 
        engineered nanomaterials in the workplace.

    In addition to presenting this document, NIOSH is requesting data 
and information from key stakeholders that is relevant to the 
development of occupational safety and health guidelines. The purpose 
will be to develop a complete resource of occupational safety and 
health information and recommendations for working safely with 
nanomaterials based on the best available science. Particular attention 
will be given to questions about the potential health risks associated 
with exposure to nanoparticles and to the steps that can be taken to 
protect worker health. The information provided in this document has 
been abstracted from peer-reviewed literature currently available. This 
document and resulting guidelines will be systematically updated by 
NIOSH as new information becomes available from NIOSH research or 
others in the scientific community.
    Established safe work practices are generally based on an 
understanding of the hazards associated with the chemical composition 
of a material. Engineered nanomaterials exhibit unique properties that 
are related to their physical size and structure as well as chemical 
composition. Considerable uncertainty still exists as to whether these 
unique properties involve occupational health risks. However, the large 
body of scientific literature that exists on exposures and responses to 
ultrafine and other airborne particles in animals and humans will be 
useful. Current information about the potential health effects of 
nanomaterials, exposure assessment, and exposure control is limited. 
Until further information is available, interim safe Working practices 
should be developed based on the best available information. The 
information and guidelines in this document are intended to aid in risk 
assessments for engineered nanomaterials and to set the stage for 
development of more comprehensive guidelines for reducing potential 
workplace exposures in the wide range of tasks and processes using 
nanomaterials.

Descriptions and Definitions

    Nanotechnology involves the manipulation of matter at nanometer-
length\1\ scales to produce new materials, structures, and devices. The 
U.S. National Nanotechnology Initiative (NNI) (see nano.gov/html/facts/
whatIsNano.html) defines a technology as nanotechnology only if it 
involves all of the following:
---------------------------------------------------------------------------
    \1\ one nanometer (nm) = one billionth of a meter 
(10-9).

        1.  Research and technology development involving structures 
        with at least one dimension in the range of one to 100 
---------------------------------------------------------------------------
        nanometers (nm), frequently with atomic/molecular precision.

        2.  Creating and using structures, devices, and systems that 
        have unique properties and functions because of their 
        nanometer-scale dimensions.

        3.  The ability to control or manipulate on the atomic scale.

    Nanotechnology is an enabling technology that offers the potential 
for unprecedented advances in many diverse fields. The ability to 
manipulate matter at the atomic or molecular scale makes it possible to 
form new materials, structures, and devices that exploit the unique 
physical and chemical properties associated with nanometer-scale 
structures. The promise of nanotechnology goes far beyond extending the 
use of current materials. New materials and devices with intricate and 
closely engineered structures will allow for (1) new directions in 
optics, electronics, and optoelectronics; (2) development of new 
medical imaging and treatment technologies; and (3) production of 
advanced materials with unique properties and high-efficiency energy 
storage and generation.
    Although nanotechnology-based products are generally thought to be 
at the pre-competitive stage, an increasing number of products and 
materials are becoming commercially available. These include nanoscale 
powders, solutions, and suspensions of nanoscale materials as well as 
composite materials and devices having a nanostructure.
    Nanoscale titanium dioxide, for instance; is finding uses in 
cosmetics, sun-block creams, and self-cleaning windows. And nanoscale 
silica is being used as filler in a range of products, including dental 
fillings. Recently, a number of new or ``improved'' consumer products 
using nanotechnology have entered the market--for example, stain and 
wrinkle-free fabrics incorporating ``nanowhiskers,'' and longer-lasting 
tennis balls using butyl-rubber/nanoclay composites. Further details on 
anticipated products can be found at www.nano.gov/html/facts/
appsprod.html.
A. Nanoparticles
    Nanoparticles are particles with diameters between one and 100nm. 
Nanoparticles may be suspended in a gas (as a nanoaerosol), suspended 
in a liquid (as a colloid or nanohydrosol),or embedded in a matrix (as 
a nanocomposite). Nanoparticles are commonly incorporated in a larger 
matrix or substrate referred to as a nanomaterial. The precise 
definition of ``particle diameter'' depends on particle shape as well 
as how the diameter is measured. Particle morphologies may vary widely 
at the nanoscale. For instance, carbon fullerenes represent 
nanoparticles with identical lengths in all directions, whereas single-
walled carbon nanotubes (SWCNTs) typically form convoluted, fiber-like 
nanoparticles with only two dimensions below 100nm. Many regular but 
nonspherical particle morphologies can be engineered at the nanoscale, 
including ``flower'' and ``belt''-like structures. For examples of some 
nanoscale structures, see www.nanoscience.gatech.edu/zlwang/
research.html.
B. Ultrafine particles
    The term ``ultrafine particle'' has traditionally been used by the 
aerosol research and occupational and environmental health communities 
to describe airborne particles typically smaller than 100nm in 
diameter. Although no formal distinction exists between ultrafine 
particles and nanoparticles, the term ``ultrafine'' is frequently used 
in the context of manometer-diameter particles that have not been 
intentionally produced but are the incidental products of processes 
involving combustion, welding fume, or diesel exhaust. Likewise, the 
term ``nanoparticle'' is frequently used with respect to particles 
demonstrating size-dependent physicochemical properties, particularly 
from a materials science perspective, although no formal definition 
exists. As a result, the two terms are sometimes used to differentiate 
between engineered (nanoparticle) and incidental (ultrafine) manometer-
scale particles.
    It is currently unclear whether the use of source-based definitions 
of nanoparticles and ultrafine particles is justified from a safety and 
health perspective. This is particularly the case where data on non-
engineered, manometer-diameter particles are of direct relevance to the 
impact of engineered particles. An attempt has been made in this 
document to preferentially use the term ``nanoparticle'' where the 
material or data pertaining to it has some relevance to understanding a 
particular issue associated with nanotechnology.
C. Engineered nanoparticles

    Engineered nanoparticles are intentionally produced, whereas 
incidental nanoparticles or ultrafine particles are byproducts of 
processes such as combustion and vaporization. Engineered nanoparticles 
are designed with very specific properties (including shape, size, 
surface properties, and chemistry), and collections of the particles in 
an aerosol, colloid, or powder will reflect these properties. 
Incidental nanoparticles are generated in a relatively uncontrolled 
manner and are usually physically and chemically heterogeneous compared 
with engineered nanoparticles.
D. Nanoaerosol

    A nanoaerosol is a collection of nanoparticles suspended in a gas. 
The particles may be present as discrete nanoparticles, or as 
agglomerates of nanoparticles. These agglomerates may have diameters 
larger than 100nm. In the case of an aerosol consisting of micrometer-
diameter particles formed as agglomerates of nanoparticles, the 
definition of nanoaerosol is open to interpretation. It is generally 
accepted that if the nanostructure associated with the nanoparticles is 
accessible (through the component nanoparticles being available for 
either physical, chemical, or biological interactions), then the 
aerosol may be considered a nanoaerosol. However, if the nanostructure 
within individual micrometer-diameter particles does not directly 
influence particle behavior (for instance, if the nanoparticles were 
inaccessibly embedded in a solid matrix), the aerosol would not be 
described as a nanoaerosol.

Potential Health Concerns

    Nanotechnology is an emerging field: As such, there are many 
uncertainties as to whether the unique properties of engineered 
nanomaterials (which underpin their commercial potential) also pose 
occupational health risks. These uncertainties arise because of gaps in 
knowledge about the factors that are essential for predicting health 
risks--factors such as routes of exposure, movement of materials once 
they enter the body, and interaction of the materials with the body's 
biological systems. The potential health risk following exposure to a 
substance is generally associated with the magnitude and duration of 
the exposure, the persistence of the material in the body, the inherent 
toxicity of the material, and the susceptibility or health status of 
the person. More data are needed on the health risks associated with 
exposure to engineered nanomaterials. Results of existing studies in 
animals or humans on exposure and response to ultrafine or other 
respirable particles may provide a basis for preliminary estimates of 
the possible adverse health effects from exposures to similar materials 
on the nanoscale. It must be recognized that the influence of particle 
properties, including size and surface area, are not fully understood. 
Existing toxicity information about a given material can provide a 
baseline for anticipating the possible adverse health effects that may 
occur from exposure to that same material on the nanoscale (see 
www.cdc.gov/niosh/homepage.html for listing).
A. Exposure routes

    The most common route of exposure to airborne particles in the 
workplace is by inhalation. Like deposition of other types of airborne 
particles, discrete nanoparticle deposition in the respiratory tract is 
determined by particle diameter. Agglomerates of nanoparticles will 
deposit according to the diameter of the agglomerate, not constituent 
nanoparticles. Research is still ongoing to determine the physical 
factors that contribute to the agglomeration and de-agglomeration of 
nanoparticles, and the role of these structures in the toxicity of 
inhaled nanoparticles.
    Discrete nanoparticles are deposited in the lungs to a greater 
extent than larger respirable particles [ICRP, 1994], and deposition 
may increase during strenuous physical activity [Jaques and Kim, 2000; 
Daigle et al., 2003] and among persons with existing lung diseases or 
conditions [Brown et al., 2002]. On the basis of studies reported from 
animal model studies, discrete nanoparticles may enter the bloodstream 
and translocate to other organs. [Nemmar et al., 2002; Oberdorster et 
al., 2002].
    Discrete nanoparticles that deposit in the nasal region may be able 
to enter the brain by translocation along the olfactory nerve, as was 
recently observed in rats [Oberdorster et al., 2004]. The axonol 
transport of insoluble particles of 50, 200, and possibly 500nm was 
also reported in the same research. This exposure route has not been 
studied in humans, and research is continuing to evaluate its 
relevance.
    Ingestion is another route whereby nanoparticles may enter the 
body. Ingestion can occur from unintentional hand to mouth transfer of 
materials; this can occur with traditional materials, and it is 
scientifically reasonable to assume that it also could happen during 
handling of materials that contain nanoparticles. Ingestion may also 
accompany inhalation exposure because particles that are cleared from 
the respiratory tract via the mucociliary escalator may be swallowed 
[ICRP, 1994]. Little is known about possible adverse effects from the 
ingestion of nanoparticles.
    Some studies suggest that nanoparticles also could enter the body 
through the skin during occupational exposure. The U.K. Royal Society 
and Royal Academy of Engineers have reported that unpublished studies 
indicate nanoparticles of titanium dioxide used in sunscreens do not 
penetrate beyond the epidermis [The Royal Society and The Royal Academy 
of Engineering, 2004]. However, the report also makes a number of 
recommendations addressing the need for further and more transparent 
information in the area of nanoparticle dermal penetration. Tinkle et 
al. [2003] have shown that particles smaller than 1 mm in diameter may 
penetrate into mechanically flexed skin samples. Research is ongoing to 
determine whether this is a viable exposure route for nanoparticles 
[www.uni-leipzig.de/nanoderm/]. Some laboratory studies conducted in 
vitro using cultured cells have suggested that carbon nanotubes can be 
absorbed and deposited in skin cells and potentially induce cellular 
toxicity [Monteiro-Riviere et al., 2005; Shvedova et al., 2003]. It 
remains Unclear, however, how these findings may be extrapolated to a 
potential occupational risk, given that additional data are not yet 
available for comparing the cell model studies with actual conditions 
of occupational exposure.
B. Effects seen in animal studies

    Experimental studies in rats have shown that at equivalent mass 
doses, tested insoluble ultrafine particles are more potent than larger 
particles of similar composition in causing pulmonary inflammation, 
tissue damage, and lung tumors [Lee et al., 1985; Oberdorster and Yu, 
1990; Oberdorster et al., 1994; Heinrich et al., 1995; Driscoll. 1996; 
Renwick et al., 2004].
    Specialized forms of engineered nanoparticles may differ in their 
toxicity from other nanoparticles. SWCNTs have been evaluated in recent 
studies of mice and rats exposed via intratracheal instillation. SWCNTs 
instilled into the lungs of mice and rats produced increased early 
fibrosis, granulomas, and toxicity in the pulmonary interstitium of the 
lungs compared with carbon black and quartz [Lam et al., 2004; Warheit 
et al., 2004]. One study suggested that the SWCNTs may act through a 
different mechanism than other inhaled contaminants because of the 
absence of pulmonary inflammation or cellular proliferation [Warheit et 
al., 2004].
    NIOSH researchers recently reported adverse lung effects in mice 
following exposure to SWCNTs using a dosing technique that correlated 
with the OSHA Permissible Exposure Limit (PEL) for graphite (5 mg/
m3) [Shvedova et al., 2005]. The study included a dose that 
was correlated with the dose that would be deposited in a person 
exposed at the graphite PEL for approximately twenty eight-hour work 
days. The findings suggest that exposure to SWCNTs in mice leads to 
pulmonary inflammation, oxidative stress, development of multi-focal 
granulomatous pneumonia and fibrosis.
C. Observations from epidemiological studies involving fine and 
        ultrafine particles
    Epidemiological studies in workers exposed to aerosols including 
fine and ultrafine particles have reported lung function decrements, 
adverse respiratory symptoms, chronic obstructive pulmonary disease, 
and fibrosis [Kreiss et al., 1997; Gardiner et al., 2001; Antonini, 
2003]. In addition, some studies have found elevated lung cancer among 
workers exposed to certain ultrafine particles, e.g., diesel exhaust 
particulate [Steenland et al., 1998; Garshick et al., 2004] or welding 
fumes [Antonini, 2003]. The implications of these studies, however, are 
uncertain because other studies have not found elevated lung cancer, 
and the precise contribution of the ultrafine particle fraction in 
workplace aerosols to the observed adverse health effects is still open 
to question and a matter of active research.
    Epidemiological studies in the general population have shown 
associations between particulate air pollution and increased morbidity 
and mortality from respiratory and cardiovascular diseases [Dockery et 
al., 1993; HEI, 2000; Pope et al., 2002; Pope et al., 2004]. Although 
some epidemiological studies have shown adverse health effects 
associated with exposure to the ultrafine particulate fraction of air 
pollution [Peters et al., 1997; Penttinen et al., 2001; Ibald-Mulli et 
al., 2002], uncertainty exists about the role of ultrafine particles 
relative to the other air pollutants in causing the observed adverse 
health effects.
D. Hypotheses from animal and epidemiological studies
    Research reported from laboratory animal studies and from human 
epidemiological studies lead to several hypotheses regarding the 
potential health effects of engineered nanoparticles. As this research 
continues, more data will become available to support or refute these 
hypotheses.

1.  Engineered nanoparticles are likely to have health effects similar 
to well characterized ultrafine particles with similar physical and 
chemical characteristics.

    Studies in rodents and humans support the hypothesis that 
incidental ultrafine particles nanoparticles may pose a greater 
respiratory hazard than the same mass of larger particles with similar 
chemical composition. Studies of existing particles have shown adverse 
health effects in workers exposed to ultrafine particles (e.g., diesel 
exhaust particulate, welding fumes); and animal studies have shown that 
ultrafine particles are more inflammogenic and tumorigenic in the lungs 
of rats than an equal mass of larger particles of similar composition 
[Oberdorster and Yu, 1990; Driscoll, 1996; Tran et al., 1999, 2000]. If 
engineered nanoparticles involve the same characteristics that seem to 
be associated with reported effects from ultrafine particles, they may 
also involve the same concerns.
    Although the characteristics of existing ultrafine particles and 
engineered nanoparticles may differ substantially, the toxicological 
and dosimetric principles derived from these studies may be relevant to 
engineered particles. The biological mechanisms of particle-related 
lung diseases (e.g., oxidative stress, inflammation, and production of 
cytokines, chemokines, and cell growth factors) [Mossman and Churg, 
1998; Castranova, 2000] also appear to be involved in the lung 
responses to ultrafine or nanoparticles [Donaldson et al., 1998; 
Donaldson and Stone, 2003; Oberdorster et al., 2005]. Toxicological 
studies have shown that the chemical and physical properties that are 
important factors influencing the fate and toxicity of ultrafine 
particles may also be significant for nanoparticles [Duffin et al., 
2002; Kreyling et al., 2002; Oberdorstor et al., 2002].

2.  Surface area and activity, particle number, and solubility may be 
better predictors of potential hazard than mass.

    The greater potential hazard may relate to the greater number or 
surface area of nanoparticles compared with that for the same mass 
concentration of larger particles [Oberdorster et al., 1992; 
Oberdorster et al., 1994; Peters et al., 1997; Moshammer and Neuberger, 
2003]. This hypothesis is based primarily on the pulmonary effects 
observed in studies of rodents exposed to various types of ultrafine or 
fine particles (e.g., titanium dioxide, carbon black, barium sulfate, 
carbon black, diesel soot, coal fly ash, and toner) and in humans 
exposed to aerosols including nanoparticles (e.g., diesel exhaust and 
welding fumes). These studies indicate that for a given mass of 
particles, relatively insoluble nanoparticles are more toxic than 
larger particles of similar chemical composition and surface 
properties. Studies of fine and ultrafine particles have shown that 
particles with less reactive surfaces are less toxic [Tran et al., 
1999; Duffin et al., 2002]. However, even particles with low inherent 
toxicity (e.g., titanium dioxide) have been shown to cause pulmonary 
inflammation, tissue damage, and fibrosis at sufficiently high particle 
surface area doses [Oberdorster et al., 1992, 1994; Tran et al., 1999, 
2000].
    Through engineering, nanomaterials can be generated with specific 
properties. For example, a recent study has shown the cytotoxicity of 
water-soluble fullerenes can be reduced by several orders of magnitude 
by modifying the structure of the fullerene molecules (e.g., by 
hydroxylation) [Sages et al., 2004]. These structural modifications 
were shown to reduce the cytotoxicity by reducing the generation of 
oxygen radicals--which is the probable mechanism by which the cell 
membrane damage and cell death occurred in laboratory animals.
    The studies of ultrafine particles may provide useful data to 
develop preliminary hazard or risk assessments and to generate 
hypotheses for further testing. More research is needed of the specific 
particle properties and other factors that influence the toxicity and 
disease development associated with airborne particles, including those 
characteristics that may be most predictive of the potential safety or 
toxicity of new engineered nanoparticles.

Potential Safety Hazards

    Very little is known about the safety risks that engineered 
nanomaterials might pose, beyond some data indicating that they possess 
certain properties associated with safety hazards in traditional 
materials. From currently available information, the potential safety 
concerns most likely would involve catalytic effects or fire and 
explosion hazards if nanomaterials are found to behave similarly to 
traditional materials in key respects.
A. Fire and explosion
    Although insufficient information exists to predict the fire and 
explosion risk associated with nanoscale powders, nanoscale combustible 
material could present a higher risk than a similar quantity of coarser 
material, given its unique properties [HSE, 2004]. Decreasing the 
particle size of combustible materials can increase combustion 
potential and combustion rate, leading to the possibility of relatively 
inert materials becoming as highly reactive as nanomaterials. 
Dispersions of combustible nanomaterial in air may present a greater 
safety risk than dispersions of non-nanomaterials with similar 
compositions. Some nanomaterials are designed to generate heat through 
the progression of reactions at the nanoscale. Such materials may 
present a fire hazard that is unique to engineered nanomaterials. In 
the case of some metals, explosion risk can increase significantly as 
particle size decreases.
    The greater activity of nanoscale materials forms a basis for 
research into nanoenergetics. For instance, nanoscale Al/MoO3 
thermites ignite more than 300 times faster than corresponding 
micrometer-scale material [Granier and Pantoya, 2004].
B. Catalytic reaction
    Nanometer-diameter particles and nanostructured porous materials 
have been used for many years as effective catalysts for increasing the 
rate of reactions or decreasing the necessary temperature for reactions 
to occur in liquids and gases. Depending on their composition and 
structure, some nanomaterials may initiate catalytic reactions that 
would not otherwise be anticipated from their chemical composition 
alone [Pritchard, 2004].

Working With Engineered Nanomaterials

    Engineered nanomaterials are diverse in their physical, chemical, 
and biological nature. The processes used in research, material 
development, production, and use or introduction of nanomaterials have 
the potential to vary greatly. Until further information on the 
possible health risks and extent of occupational exposure to 
nanomaterials becomes available, interim precautionary measures should 
be developed and implemented. These measures should focus on the 
development of safe working practices tailored to specific processes 
and materials where workers might be exposed. Hazard information that 
is available about common materials that are being manufactured in the 
nanometer range (for example, TiO2) should be considered as 
a starting point in developing any work practices. The following 
guidelines are designed to aid in risk assessments for engineered 
nanomaterials, and for reducing the risk of exposure in the workplace. 
Using a risk-based approach to assess a given process and develop 
precautionary measures is consistent with good professional 
occupational safety and health practice and with those recommended by 
the U.K. Royal Society and Royal Academy of Engineers [The Royal 
Society and The Royal Academy of Engineering, 2004].
A. Potential for occupational exposure
    Very few studies have been measured exposure to nanoparticles that 
are purposely produced and not incidental to an industrial process. In 
general, it is likely that processes generating nanomaterials in the 
gas phase, or using or producing nanomaterials as powders or slurries/
suspensions/solutions (i.e., in liquid media) pose the greatest risk 
for releasing nanoparticles. In addition, maintenance on production 
systems (including cleaning and disposal of materials from dust 
collection systems) is likely to result in exposure to nanoparticles if 
it involves disturbing deposited nanomaterial. Exposures associated 
with waste streams containing nanomaterials may also occur.
    The magnitude of exposure to nanoparticles when working with 
nanopowders depends on the likelihood of particles being released from 
the powders during handling. Studies on exposure to SWCNTs have 
indicated that although the raw material may release visible particles 
a few millimeters in diameter into the air when handled, the release 
rate of inhalable and respirable particles is relatively low (on a mass 
or number basis) compared with other nanopowders [Maynard et al., 
2004]. Since data are generally lacking with regard to the generation 
of inhalable/respirable particles during the production and use of 
engineered nanomaterials, further research is required to determine 
exposures under various conditions.
    Devices comprised of nanostructures, such as integrated circuits, 
pose a minimal risk of exposure to nanoparticles during handling. 
However, some of the processes used in their production may lead to 
exposure to nanoparticles (for example, exposure to commercial 
polishing compounds that contain nanoscale particles, or exposure to 
nanoscale particles that are inadvertently dispersed or created during 
the manufacturing and handling processes). Likewise, large-scale 
components formed from nanocomposites will most likely not present 
significant exposure potential. However, if such materials are used or 
handled in such a manner that can generate nanostructured particles 
(e.g., cutting, grinding), or undergo degradation processes that lead 
to the release of nanostructured material, then a potential exposure 
may occur by the inhalation, ingestion, and/or dermal penetration of 
these particles.
B. Factors affecting exposure to nanoparticles
    Factors affecting exposure to engineered nanoparticles will include 
the amount of material being used and whether the material can be 
easily dispersed (in the case of a powder) or form airborne sprays or 
droplets (in the case of suspensions). The degree of containment and 
duration of use will also influence exposure. In the case of airborne 
material, particle or droplet size will determine whether the material 
can enter the respiratory tract and where it is most likely to deposit. 
Inhaled particles smaller than 10 mm in diameter have some probability 
of penetrating to and being deposited in the gas exchange (alveolar) 
region of the lungs, but there is at least a 50 percent probability 
that particles smaller than 4 mm in diameter will reach the gas-
exchange region [Lippmann, 1977; ICRP, 1994; ISO, 1995]. Particles that 
are capable of being deposited in the gas exchange region of the lungs 
are considered respirable particles. The mass deposition fraction of 
discrete nanoparticles (i.e., <100nm) is greater in the human 
respiratory tract than that for larger respirable particles. Up to 50 
percent of inhaled nanoparticles may deposit in the gas-exchange region 
[ICRP, 1994]. For inhaled nanoparticles smaller than approximately 
30nm, an increasing mass fraction of particles is predicted to deposit 
in the upper airways of the human respiratory tract [ICRP, 1994]. At 
present there is insufficient information to predict situations and 
scenarios that are likely to lead to exposure to nanomaterials. 
However, some of those workplace factors that can increase the 
potential for exposure include the following:

          Working with nanomaterials in liquid media without 
        adequate protection (e.g., gloves) will increase the risk of 
        skin exposure.

          Working with nanomaterials in liquid media during 
        pouring or mixing operations, or where a high degree of 
        agitation is involved, will lead to an increased likelihood of 
        inhalable and respirable droplets being formed.

          Generating nanoparticles in the gas phase in non-
        enclosed systems will increase the chances of aerosol release 
        to the workplace.

          Handling nanostructured powders will lead to the 
        possibility of aerosolization.

          Maintenance on equipment and processes used to 
        produce or fabricate nanomaterials will pose a potential for 
        exposure to workers performing these tasks.

          Cleaning of dust collection systems used to capture 
        nanoparticles can pose a potential for both skin and inhalation 
        exposure.

Exposure Assessment and Characterization

    Until more information is available on the mechanisms underlying 
nanoparticle toxicity, it is uncertain as to what measurement 
techniques should be used to monitor exposures in the workplace. If the 
qualitative assessment of a process has identified potential exposure 
points and leads to the decision to measure nanoparticles, several 
factors must be kept in mind. Current research indicates that mass and 
bulk chemistry may be less important than particle size, surface area, 
and surface chemistry (or activity) for nanostructured materials 
[Oberdorster et al., 1992, 1994]. Research is still ongoing into the 
relative importance of these different exposure metrics, and how to 
best characterize exposures against them. Once the decision has been 
made to measure exposure, the metric to be used will depend on 
availability of sampling equipment or instruments and experience with 
those methods or instruments. Regardless of the metric and method 
selected, it is critical that measurements be conducted before 
production or processing of a nanoparticle to obtain background data. 
Measurements made during production or processing can then be evaluated 
to determine if there has been an increase in the metric selected. 
NIOSH intends to release the results of its research on this site and 
invites additional information and comments to be submitted.
A. Monitoring workplace exposures
    Although research continues to address questions of nanoparticle 
toxicity, a number of exposure assessment approaches can be instituted 
to determine worker exposures. These assessments can often be performed 
using traditional industrial hygiene sampling methods that include the 
use of samplers placed at static locations (area sampling), samples 
collected in the breathing zone of the worker (personal sampling), or 
real-time measurements of exposure that can be personal or static. In 
general, personal sampling is preferred to ensure an accurate 
representation of the worker's exposure, whereas area samples (e.g., 
size-fractionated aerosol samples) and real-time (direct-reading) 
exposure measurements may be more useful for evaluating the need for 
improvement of engineering controls and work practices.
    Many of the sampling techniques that are available for measuring 
airborne nanoaerosols vary in complexity but can provide useful 
information for evaluating occupational exposures with respect to 
particle size, mass, surface area, number concentration, composition, 
and surface chemistry. Unfortunately, relatively few of these 
techniques are readily applicable to routine exposure monitoring. These 
measurement techniques are described below along with their 
applicability for monitoring nanometer aerosols.
    For each measurement technique used, it is vital that the key 
parameters associated with the technique and sampling methodology be 
recorded when measuring exposure to nanoaerosols. This should include 
the response range of the instrumentation, whether personal or static 
measurements are made, and the location of all potential aerosol 
sources. Comprehensive documentation will facilitate comparison of 
exposure measurements and aid the re-interpretation of historic data as 
further information is developed on appropriate exposure metrics.
            Size-fractionated aerosol sampling
    Studies have indicated that particle size plays an important role 
in determining the potential effects of nanoparticles in the 
respiratory system, either by influencing the physical, chemical, and 
biological nature of the material, affecting the surface area of 
deposited particles, or enabling deposited particles to move to other 
parts of the body. Animal studies indicate that the toxicity of 
nanometer aerosols is more closely associated with aerosol surface area 
and particle number than the mass concentrations of the aerosol. 
However, mass concentration measurements may be applicable for 
evaluating occupational exposure to nanometer aerosols where a good 
correlation between the surface area of the aerosol and mass 
concentration can be determined.
    Aerosol samples can be collected using inhalable, thoracic, or 
respirable samplers, depending on the region of the respiratory system 
most susceptible to the inhaled particles. Current information suggests 
that the gas-exchange region of the lungs is particularly susceptible 
to nanomaterials [ICRP, 1994], suggesting the use of respirable 
samplers. Respirable fraction samplers will also collect a nominal 
amount of nanometer-diameter particles that can deposit in the upper 
airways and ultimately cleared or transported to other parts of the 
body.
    Respirable fraction samplers allow mass-based exposure measurements 
to be made using gravimetric and/or chemical analysis [NIOSH, 1994a]. 
However, they do not provide information on aerosol number, size, or 
surface area concentration, unless the relationship between different 
exposure metrics for the aerosol (e.g., density, particle shape) has 
been previously characterized. Currently, no commercially available 
personal samplers are designed to measure the particle number, surface 
area, or mass concentration of nanometer aerosols. However, several 
methods are available that can be used to estimate surface area, 
number, or mass concentration for particles smaller than 100nm.
    In the absence of specific exposure limits or guidelines for 
engineered nanoparticles, exposure data gathered from the use of 
respirable samplers [NIOSH, 1994b] can be used to determine the need 
for engineering controls or work practices and for routine exposure 
monitoring of processes and job tasks. When chemical components of the 
sample need to be identified, chemical analysis of the filter samples 
can permit smaller quantities of material to be quantified, with the 
limits of quantification depending on the technique selected [NIOSH, 
1994a]. The use of conventional impactor designs to assess nanoparticle 
exposure is limited, since practical impaction limits are 200 to 300nm. 
Low-pressure cascade impactors that can measure particles to 50nm may 
be used for static sampling, since their size and complexity preclude 
their use as personal samplers [Marple et al., 2001, Hinds, 1999]. A 
personal cascade impactor is available with a lower aerosol cut point 
of 250nm [Misra et al., 2002], allowing an approximation of nanometer 
particle mass concentration in the worker's breathing zone. For each 
method, the detection limits are of the order of a few micrograms of 
material on a filter or collection substrate [Vaughan et al., 1989]. 
Cascade impactor exposure data gathered from worksites where 
nanomaterials are being processed or handled can be used to make 
assessments as to the efficacy of exposure control measures.
            Real-time aerosol sampling

    The real-time (direct-reading) measurement of nanometer aerosol 
concentrations is limited by the sensitivity of the instrument to 
detect small particles. Many real-time aerosol mass monitors used in 
the workplace rely on light scattering from groups of particles 
(photometers). This methodology is generally insensitive to particles 
smaller than 300nm [Hinds, 1999]. Optical instruments that size 
individual particles and convert the measured distribution to a mass 
concentration are similarly limited to particles larger than 100 to 
300nm.
    The Scanning Mobility Particle Sizer (S14IPS) is widely used as a 
research tool for characterizing nanometer aerosols, although its 
applicability for use in the workplace may be limited because of its 
size, cost, and the inclusion of a radioactive source. The Electrical 
Low Pressure Impactor (ELPI) is an alternative instrument that combines 
a cascade impactor with real-time aerosol charge measurements to 
measure size distributions [Keskinen et al., 1992].
            Surface area measurements

    Relatively few techniques exist to monitor exposures with respect 
to aerosol surface area. Isothermal adsorption is a standard off-line 
technique used to measure the specific surface area of powders that 
could be adapted to measure the specific surface area of collected 
aerosol samples. For example, the surface area of particulate material 
(e.g., using either a bulk or an aerosol sample) can be measured in the 
laboratory using a gas adsorption method (e.g., Brunauer, Emmett, and 
Teller, BET) [Brunauer et al., 1938]. However, the BET method requires 
relatively large quantities of material, and measurements are 
influenced by particle porosity and adsorption gas characteristics.
    The first instrument designed to measure aerosol surface-area was 
the epiphaniometer [Baltensperger et al., 1988]. This device measures 
the Fuchs or active surface-area of the aerosols by measuring the 
attachment rate of radioactive ions. For aerosols less than 
approximately 100nm in size, measurement of the Fuchs surface area is 
probably a good indicator of external surface-area (or geometric 
surface area). However, for aerosols greater than approximately 1 mm 
the relationship with geometric particle surface-area is lost [Fuchs, 
1964]. Measurements of active surface-area are generally insensitive to 
particle porosity. The epiphaniometer is well suited to widespread use 
in the workplace because of the inclusion of a radioactive source and 
the lack of effective temporal resolution.
    This same measurement principle can be applied with the use of a 
portable aerosol diffusion charger. Studies have shown that these 
devices provide a good estimate of aerosol surface area when the 
airborne particles are smaller than 100nm in diameter. For larger 
particles, diffusion chargers underestimate aerosol surface area. 
However, further research is needed to evaluate the degree of 
underestimation. Extensive field evaluations of commercial instruments 
are yet to be reported. However, laboratory evaluations with 
monodisperse silver particles have shown that two commercially 
available diffusion chargers can provide good measurement data on 
aerosol surface area for particles smaller than 100nm in diameter but 
underestimate the aerosol surface area for particles larger than 100nm 
in diameter [Ku and Maynard (in press)].
            Particle number concentration measurement

    The importance of a particle number concentration as an exposure 
metric is not clear from the toxicity data. In many cases, health end 
points appear to be more closely related with particle surface area 
rather than particle number. However, the number of particles deposited 
in the respiratory tract or other organ systems may play an important 
role.
    Aerosol particle number concentration can be measured relatively 
easily using Condensation Particle Counters (CPCs). These are available 
as hand-held static instruments, and they are generally sensitive to 
particles greater than 10 to 20nm in diameter. CPCs designed for the 
workplace do not have discrete size-selective inputs, and so they are 
typically sensitive to particles up to micrometers in diameter. 
Commercial size-selective inlets are not available to restrict CPCs to 
the nanoparticle size range; however, the technology exists to 
construct size-selective inlets based on particle mobility, or possibly 
inertial pre-separation. An alternative approach to estimating 
nanoparticle concentrations using a CPC is to use the instrument in 
parallel with an optical particle counter. The difference in particle 
count between the instruments will provide an indication of particle 
number concentration between the lower CPC detectable particle diameter 
and the lower optical particle diameter detectable (typically 300 to 
500nm).
    A critical issue when characterizing exposure using particle number 
concentration is selectivity. Nanoparticles are ubiquitous in many 
workplaces, from sources such as combustion, vehicle emissions, and 
infiltration of outside air. Particle counters are generally 
insensitive to particle source or composition making it difficult to 
differentiate between incidental and process-related nanoparticles 
using number concentration alone. In a study of aerosol exposures while 
bagging carbon black, Kuhlbusch et al. [2004] found that peaks in 
number concentration measurements were associated with emissions from 
fork lift trucks and gas burners in the vicinity, rather than the 
process under investigation. Although this issue is not unique to 
particle number concentration measurements, orders of magnitude 
difference can exist in aerosol number concentrations depending on 
concomitant sources of particle emissions.
    Although using nanoparticle number concentration as an exposure 
measurement may not be consistent with exposure metrics being used in 
animal toxicity studies, such measurements may be a useful indicator 
for identifying nanoparticle emissions and determining the efficacy of 
control measures. Portable CPCs are capable of measuring localized 
aerosol concentrations, allowing the assessment of particle releases 
occurring at various processes and job tasks [Brouwer et al., 2004].
            Surface Area Estimation
    Information about the relationship between different measurement 
metrics can be used for estimating aerosol surface area. If the size 
distribution of an aerosol remains consistent, the relationship between 
number, surface area, and mass metrics will be constant. In particular, 
mass concentration measurements can be used for deriving surface area 
concentrations, assuming the constant of proportionality is known. This 
constant is the specific surface area (surface to mass ratio).
    Size distribution measurements obtained through sample analysis by 
transmission electron microscopy may also be used to estimate aerosol 
surface area. If the measurements are weighted by particle number, 
information about particle geometry will be needed to estimate the 
surface area of particles with a given diameter. If the measurements 
are weighted by mass, additional information about particle density 
will be required.
    If the airborne aerosol has a lognormal size distribution, the 
surface-area concentration can be derived using three independent 
measurements. An approach has been proposed using three simultaneous 
measurements of aerosol that included mass concentration, number 
concentration, and charge [Woo et al., 2001]. With knowledge of the 
response function of each instrument, minimization techniques can be 
used to estimate the parameters of the lognormal distribution leading 
to the three measurements used in estimating the aerosol surface area.
    An alternative approach has been proposed whereby independent 
measurements of aerosol number and mass concentration are made, and the 
surface area is estimated by assuming the geometric standard deviation 
of the (assumed) lognormal distribution [Maynard, 2003]. This method 
has the advantage of simplicity by relying on portable instruments that 
are finding increasing application in the workplace. Theoretical 
calculations have shown that estimates may be up to a factor of ten 
different from the actual aerosol surface-area, particularly when the 
aerosol has a bimodal distribution. Field measurements indicate that 
estimates are within a factor of three of the active surface-area, 
particularly at higher concentrations. In workplace environments, 
aerosol surface-area concentrations can be expected to span up to five 
orders of magnitude; thus, surface-area estimates may be suited to 
initial or preliminary appraisals of occupational exposure 
concentrations.
    Although such estimation methods are unlikely to become a long-term 
alternative to more accurate methods, they may provide a viable interim 
approach to estimating the surface area of nanometer aerosols in the 
absence of precise measurement data. Additional research is needed on 
comparing methods used for estimating aerosol surface area with a more 
accurate aerosol surface area measurement method. NIOSH is conducting 
research in this area and will communicate results as they become 
available. In the interim, NIOSH welcomes additional information and 
input on this topic.
B. Proposed sampling strategy

    Currently, there is not one sampling method that can be used to 
characterize exposure to nanosized aerosols. Therefore, any attempt to 
characterize workplace exposure to nanoparticles must involve a 
multifaceted approach incorporating many of the sampling techniques 
mentioned above. Brouwer et al. [2004] recommend that all relevant 
characteristics of nanoparticle exposure be measured and a sampling 
strategy similar to theirs would provide a reasonable approach to 
characterizing workplace exposure.
    The first step would involve identifying the source of nanoparticle 
emissions. A CPC provides acceptable capability for this purpose. It is 
critical to determine ambient or background particle counts before 
measuring particle counts during the manufacture or processing of the 
nanoparticles involved. If a specific nanoparticle is of interest 
(e.g., TiO2), then area sampling with a filter suitable for 
analysis by electron microscopy should also be employed. Transmission 
electron microscopy (TEM) can identify specific particles and can 
estimate the size distribution of the particles.
    Once the source of emissions is identified, aerosol surface area 
measurements should be conducted with a portable diffusion charger and 
aerosol size distributions should be determined with an SMPS or ELPI 
using static (area) monitoring. A small portable surface area 
instrument could be adapted to be worn by a worker, although depending 
on the nature of the work, this may be cumbersome. Further, losses of 
aerosol with the addition of a sampling tube would need to be 
calculated. The location of these instruments should be considered 
carefully. Ideally they would be placed close to the work areas of the 
workers of interest, but other factors such as size of the 
instrumentation, power source, etc., should be considered.
    Lastly, personal sampling using filters suitable for analysis by 
electron microscopy should be employed, particularly if measuring 
exposures to specific nanoparticles is of interest. Electron microscopy 
can be used to identify the particles, and can provide an estimate of 
the size distribution of the particle of interest. The use of a 
personal cascade impactor or a respirable cyclone sampler with a 
filter, though limited, will help to remove larger particles that are 
not of interest, allowing for a more definitive determination of 
particle size.
    Using a combination of these techniques, an assessment of worker 
exposure to nanoparticles can be conducted. This approach will allow a 
determination of the presence and identification of nanoparticles, and 
the characterization of the important aerosol metrics, providing a 
reasonable estimate of exposure can be achieved. This approach is not 
without limitations, however. It largely relies on static or area 
sampling, which will hamper interpretation and increase the inaccuracy 
of the exposure estimate.

Exposure Control Procedures

    Given the limited information about the health risks associated 
with occupational exposure to engineered nanoparticles, precautionary 
work practices should be tailored to the processes and job tasks in 
which exposure might occur. For most processes and job tasks, the 
control of airborne exposure to nanoparticles can most likely be 
accomplished using a wide variety of engineering control techniques 
similar to those used in reducing exposures to general aerosols 
[Ratherman, 1996; Burton, 1997]. To ensure that the appropriate steps 
are taken to minimize the risk of exposure, a risk management program 
should be implemented. Elements of such a program should include the 
education and training of workers in the proper handling of 
nanomaterials, the criteria and procedures for installing engineering 
controls (e.g., exhaust ventilation) at process locations where 
exposure might occur, and the development of procedures describing the 
types of personal protective equipment (e.g., clothing, respirators) 
that should be used and when it should be worn.
A. Engineering controls
    In general, control techniques such as source enclosure (i.e., 
isolating the generation source from the worker) and local exhaust 
ventilation systems should be effective for capturing airborne 
nanoparticles, based on what is known of nanoparticle motion and 
behavior in air. Ventilation systems should be designed, tested, and 
maintained using approaches recommended by the American Conference of 
Governmental Industrial Hygienists [ACGIH, 2001]. In light of current 
scientific knowledge regarding the generation, transport, and capture 
of aerosols, these control techniques should be effective for 
controlling airborne exposures to manometer-scale particles [Seinfeld 
and Pandis, 1998; Hinds, 1999].
            Dust collection efficiency of filters
    Current knowledge indicates that a well-designed exhaust 
ventilation system with a high-efficiency particulate air (HEPA) filter 
should effectively remove nanoparticles [Hinds, 1999]. NIOSH is 
conducting research to validate the efficiency of HEPA filter media 
used in environmental control systems and in respirators in removing 
nanoparticles. As results of this research become available, they will 
be posted on the NIOSH web site. Filters are tested using particles 
that have the lowest probability of being captured (typically around 
300nm in diameter). Collection efficiencies for smaller particles 
should exceed the measured collection efficiency at this particle 
diameter [Lee and Liu, 1982]. The use of a HEPA filter must also be 
coupled to well-designed filter housing. For example, if the filter is 
improperly seated, nanoparticles have the potential to bypass the 
filter, leading to filter efficiencies much less than predicted [NIOSH, 
2003]. An unventilated process enclosure that is effective in 
controlling the emission of larger particles may not be effective in 
controlling nanoparticles because of their greater ability to penetrate 
small gaps and the nontraditional measurements needed to evaluate 
effectiveness of control.
B. Work practices

    The incorporation of good work practices in a risk management 
program can help to minimize worker exposure to nanomaterials. Examples 
of good practices include the following:

          Cleaning work areas at the end of each work shift (at 
        a minimum) using HEPA vacuum pickup and wet wiping methods. Dry 
        sweeping or air hoses should not be used to clean work areas. 
        Cleanup and disposal should be conducted in a manner that 
        prevents worker contact with wastes and complies with all 
        applicable federal and State, and local regulations.

          Preventing the storage and consumption of food or 
        beverages in workplaces where nanomaterials are handled.

          Providing hand-washing facilities and encouraging 
        workers to use them before eating, smoking, or leaving the 
        worksite.

          Providing facilities for showering and changing 
        clothes to prevent the inadvertent contamination of other areas 
        (including take-home) caused by the transfer of nanoparticles 
        on clothing and skin.

C. Personal protective clothing

    Currently, no guidelines are available on the selection of clothing 
or other apparel for the prevention of dermal exposure to 
nanoparticles. Published research has shown that penetration 
efficiencies for eight widely different fabrics (including woven, non-
woven, and laminated fabrics) against 0.477 mm particles range from 0.0 
percent to 31 percent, with an average of 12 percent [Shalev et al., 
2000]. Penetration efficiencies for nanoparticles have not been 
studied. However, even for powders in the macro scale, it is recognized 
that skin protective equipment (i.e., suits, gloves acid other items of 
protective clothing) is very limited in its effectiveness to reduce or 
control dermal exposure [Schneider et al., 2000]. In any case, although 
nanoparticles may penetrate the epidermis, there has been little work 
to suggest that penetration leads to disease, and no dermal exposure 
standards have been generated.
    Existing clothing standards already incorporate testing with 
nanometer-sized particles and therefore provide some indication of the 
effectiveness of protective clothing with regard to nanoparticles. For 
instance, ASTM standard F1671-03 specifies the use of a 27nm 
bacteriophage to evaluate the resistance of materials used in 
protective clothing to penetration by blood-borne pathogens [ASTM 
Subcommittee F23.40, 2003].
D. Respirators
    In the hierarchy of controls, respirators may be necessary when 
engineering and administrative controls do not adequately keep worker 
exposures to an airborne contaminant below a regulatory limit of an 
internal control target. Currently, there are no specific exposure 
limits for airborne exposures to engineered nanoparticles although 
occupational exposure limits (e.g., OSHA, NIOSH, ACGIH) exist for 
larger particles of similar chemical composition. Preliminary 
scientific evidence indicates that nanoparticles may be more 
biologically reactive than larger particles of similar chemical 
composition and thus may pose a greater health risk when inhaled.
    The decision to institute respiratory protection recommended in 
this document should be based on a combination of professional judgment 
and the results of the risk assessment and risk management approach 
recommended in the document. The effectiveness of administrative, work 
practice, and engineering controls can be evaluated using the 
measurement techniques described in Exposure Assessment and 
Characterization. If worker exposure to nanoparticles remains a concern 
after instituting measures to control exposure, the use of respirators 
can further reduce worker exposures. Several classes of respirators 
exist that can provide different levels of protection when properly fit 
tested on the worker. Table 1 lists various types of particulate 
respirators that can be used along with information on the level of 
exposure reduction that can be expected from each and the advantages 
and disadvantages of each respirator type. To assist respirator users, 
NIOSH has published the document NIOSH Respirator Selection Logic (RSL) 
that provides a process that respirator program administrators can use 
to select appropriate respirators for agents with exposure limits (see 
www.cdc.gov/niosh/docs/2005-100/default.html). As new toxicity data for 
individual nanomaterials become available, NIOSH will review the data 
and make recommendations for respirator protection.
    When respirators are required to be used in the workplace, the 
Occupational Safety and Health Administration (OSHA) respiratory 
protection standard (29 CFR 1910.134) requires that a respiratory 
program be established that includes the following program elements: 
(1) an evaluation of the worker's ability to perform the work while 
wearing a respirator, (2) regular training of personnel, (3) periodic 
environmental monitoring, (4) respirator fit testing, and (5) 
respirator maintenance, inspection, cleaning, and storage. The standard 
also requires that the selection of respirators be made by a person 
knowledgeable about the workplace and the limitations associated with 
each type of respirator. OSHA has also issued guidelines for employers 
who choose to establish the voluntary use of respirators [29 CFR 
1910.134 Appendix D].
    NIOSH tests and certifies respirator filters using solid (NaCl) or 
liquid (DOP) particles that are nominally 0.3 mm in diameter to 
determine the filter's collection efficiency at 95 percent to at least 
99.97 percent. Particles of this size are considered to be the most 
penetrating particle size [TSI, 2005; NIOSH, 1996]. Particles larger 
than 0.3 mm are collected most efficiently by impaction, interception, 
and settling. Particles smaller than 0.3 mm are collected most 
efficiently by diffusion or electrostatic attraction. Current data 
indicate that the penetration of approximately 0.3 mm particles 
represents the worst case [Martin and Moyer, 2000]. Since nanoparticles 
are typically smaller than 100 nanometers they are theoretically 
collected more efficiently than the 0.3 mm test aerosols [Hinds, 1999]. 
NIOSH is conducting research to validate the efficiency of HEPA filter 
media used in environmental control systems and in respirators in 
removing nanoparticles. As results from this research become available, 
they will be posted on the NIOSH Web site.




E. Cleanup of nanomaterial spills
    No specific guidance is currently available on cleaning up 
nanomaterial spills. Until relevant information is available, it would 
be prudent to base strategies for dealing with spills on current good 
practices, together with available information on exposure risks and 
the relative importance of different exposure routes. Standard 
approaches to cleaning up powder and liquid spills include the use of 
HEPA-filtered vacuum cleaners, wetting powders down, using dampened 
cloths to wipe up powders and applying absorbent materials/liquid 
traps. As in the case of any material spill, handling and disposal of 
the waste material should follow any exiting federal, State, or local 
regulations.
    When developing procedures for cleaning up nanomaterial spills, 
consideration should be given to the potential for exposure during 
cleanup. Inhalation exposure and dermal exposure will likely present 
the greatest risks. Consideration will therefore need to be given to 
appropriate levels of personal protective equipment. Inhalation 
exposure in particular will be influenced by the likelihood of material 
re-aerosolization. In this context, it is likely that a hierarchy of 
potential exposures will exist, with dusts presenting a greater 
inhalation exposure potential than liquids, and liquids in turn 
presenting a greater potential risk than encapsulated or immobilized 
nanomaterials and structures.

Research

    NIOSH has developed a strategic plan for research on several 
occupational safety and health aspects of nanotechnology. The plan is 
available at www.cdc.gov/niosh/topics/nanotech/
strat-plan.html. Review and feedback on the plan is 
welcomed.

    * Code of Federal Regulations. See CFR in references.

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