[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
                     RESEARCH ON ENVIRONMENTAL AND 
                   SAFETY IMPACTS OF NANOTECHNOLOGY: 
                     CURRENT STATUS OF PLANNING AND 
                   IMPLEMENTATION UNDER THE NATIONAL 
                       NANOTECHNOLOGY INITIATIVE 

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

                                HEARING

                               BEFORE THE

             SUBCOMMITTEE ON RESEARCH AND SCIENCE EDUCATION

                  COMMITTEE ON SCIENCE AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 31, 2007

                               __________

                           Serial No. 110-69

                               __________

     Printed for the use of the Committee on Science and Technology


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

                                 ______

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                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                 HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois          RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas         F. JAMES SENSENBRENNER JR., 
LYNN C. WOOLSEY, California              Wisconsin
MARK UDALL, Colorado                 LAMAR S. SMITH, Texas
DAVID WU, Oregon                     DANA ROHRABACHER, California
BRIAN BAIRD, Washington              ROSCOE G. BARTLETT, Maryland
BRAD MILLER, North Carolina          VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois            FRANK D. LUCAS, Oklahoma
NICK LAMPSON, Texas                  JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona          W. TODD AKIN, Missouri
JERRY MCNERNEY, California           JO BONNER, Alabama
LAURA RICHARDSON, California         TOM FEENEY, Florida
PAUL KANJORSKI, Pennsylvania         RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon               BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey        DAVID G. REICHERT, Washington
JIM MATHESON, Utah                   MICHAEL T. MCCAUL, Texas
MIKE ROSS, Arkansas                  MARIO DIAZ-BALART, Florida
BEN CHANDLER, Kentucky               PHIL GINGREY, Georgia
RUSS CARNAHAN, Missouri              BRIAN P. BILBRAY, California
CHARLIE MELANCON, Louisiana          ADRIAN SMITH, Nebraska
BARON P. HILL, Indiana               PAUL C. BROUN, Georgia
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
                                 ------                                

             Subcommittee on Research and Science Education

                 HON. BRIAN BAIRD, Washington, Chairman
EDDIE BERNICE JOHNSON, Texas         VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois            ROSCOE G. BARTLETT, Maryland
JERRY MCNERNEY, California           RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon               DAVID G. REICHERT, Washington
RUSS CARNAHAN, Missouri              BRIAN P. BILBRAY, California
BARON P. HILL, Indiana                   
BART GORDON, Tennessee               RALPH M. HALL, Texas
                 JIM WILSON Subcommittee Staff Director
          DAHLIA SOKOLOV Democratic Professional Staff Member
           MELE WILLIAMS Republican Professional Staff Member
                 MEGHAN HOUSEWRIGHT Research Assistant






















                            C O N T E N T S

                            October 31, 2007

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

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

                           Opening Statements

Statement by Representative Brian Baird, Chairman, Subcommittee 
  on Research and Science Education, Committee on Science and 
  Technology, U.S. House of Representatives......................     8
    Written Statement............................................     9

Statement by Representative Vernon J. Ehlers, Ranking Minority 
  Member, Subcommittee on Research and Science Education, 
  Committee on Science and Technology, U.S. House of 
  Representatives................................................    10
    Written Statement............................................    11

Prepared Statement by Representative Daniel Lipinski, Member, 
  Subcommittee on Research and Science Education, Committee on 
  Science and Technology, U.S. House of Representatives..........    12

                               Witnesses:

Dr. E. Clayton Teague, Director, National Nanotechnology 
  Coordination Office (NNCO)
    Oral Statement...............................................    12
    Written Statement............................................    14
    Biography....................................................    24

Mr. E. Floyd Kvamme, Co-Chair, President's Council of Advisors on 
  Science and Technology
    Oral Statement...............................................    25
    Written Statement............................................    27
    Biography....................................................    28

Dr. Vicki L. Colvin, Professor of Chemistry and Chemical 
  Engineering; Executive Director, International Council on 
  Nanotechnology; Director, Center for Biological and 
  Environmental Nanotechnology, Rice University
    Oral Statement...............................................    29
    Written Statement............................................    31
    Biography....................................................    35

Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging 
  Nanotechnologies, Woodrow Wilson International Center for 
  Scholars, Washington, D.C.
    Oral Statement...............................................    36
    Written Statement............................................    37
    Biography....................................................    57

Dr. Richard A. Denison, Senior Scientist, Environmental Defense
    Oral Statement...............................................    57
    Written Statement............................................    59
    Biography....................................................    66

Mr. Paul D. Ziegler, Chairman, American Chemistry Council 
  Nanotechnology Panel
    Oral Statement...............................................    71
    Written Statement............................................    73
    Biography....................................................    77

Discussion.......................................................    78

              Appendix: Answers to Post-Hearing Questions

Dr. E. Clayton Teague, Director, National Nanotechnology 
  Coordination Office (NNCO).....................................    96

Mr. E. Floyd Kvamme, Co-Chair, President's Council of Advisors on 
  Science and Technology.........................................   104

Dr. Vicki L. Colvin, Professor of Chemistry and Chemical 
  Engineering; Executive Director, International Council on 
  Nanotechnology; Director, Center for Biological and 
  Environmental Nanotechnology, Rice University..................   108

Dr. Andrew D. Maynard, Chief Science Advisor, Project on Emerging 
  Nanotechnologies, Woodrow Wilson International Center for 
  Scholars, Washington, D.C......................................   110

Dr. Richard A. Denison, Senior Scientist, Environmental Defense..   117

Mr. Paul D. Ziegler, Chairman, American Chemistry Council 
  Nanotechnology Panel...........................................   136

 
RESEARCH ON ENVIRONMENTAL AND SAFETY IMPACTS OF NANOTECHNOLOGY: CURRENT 
STATUS OF PLANNING AND IMPLEMENTATION UNDER THE NATIONAL NANOTECHNOLOGY 
                               INITIATIVE

                              ----------                              


                      WEDNESDAY, OCTOBER 31, 2007

                  House of Representatives,
    Subcommittee on Research and Science Education,
                       Committee on Science and Technology,
                                                    Washington, DC.

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

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                            hearing charter

             SUBCOMMITTEE ON RESEARCH AND SCIENCE EDUCATION

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                     U.S. HOUSE OF REPRESENTATIVES

                     Research on Environmental and

                   Safety Impacts of Nanotechnology:

                     Current Status of Planning and

                   Implementation Under the National

                       Nanotechnology Initiative

                      wednesday, october 31, 2007
                         10:00 a.m.-12:00 p.m.
                   2318 rayburn house office building

1. Purpose

    On Wednesday, October 31, 2007, the Subcommittee on Research and 
Science Education of the Committee on Science and Technology will hold 
a hearing to review the need and motivation for research on the 
environmental, health and safety (EHS) aspects of nanotechnology, 
determine the current state of planning and implementation of EHS 
research under the National Nanotechnology Initiative (NNI), and 
explore whether changes are needed to the current mechanisms for 
planning and implementing EHS research. This hearing is one in a series 
the Committee will hold to review the administration and content of the 
NNI as part of the process for developing legislation to reauthorize 
the 21st Century Nanotechnology Research and Development Act of 2003 
(P.L. 108-153) during the next session of Congress.

2. Witnesses

Dr. Clayton Teague, Director of the National Nanotechnology 
Coordination Office (NNCO). The NNCO serves as the focal point for and 
provides staff support to the Nanoscale Science, Engineering, and 
Technology (NSET) Subcommittee of the National Science and Technology 
Council. The NSET Subcommittee is responsible for the planning and 
coordination of the interagency NNI.

Mr. Floyd Kvamme, Co-Chair of the President's Council of Advisors on 
Science and Technology (PCAST). PCAST was designated by the President 
to act as the National Nanotechnology Advisory Panel (NNAP) in 
accordance with the 21st Century Nanotechnology Research and 
Development Act of 2003 (P.L. 108-153).

Dr. Vicki L. Colvin, Executive Director, International Council on 
Nanotechnology and Professor of Chemistry and Chemical Engineering, 
Rice University.

Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging 
Nanotechnologies, Woodrow Wilson International Center for Scholars.

Dr. Richard Denison, Senior Scientist, Environmental Defense.

Mr. Paul D. Ziegler, Chairman of the Nanotechnology Panel, American 
Chemistry Council, and Global Director, PPG Industries, Inc.

3. Overarching Questions

          How important for the advancement of nanotechnology 
        is developing greater understanding of potential risks that the 
        technology may introduce to the environment and human health? 
        What impacts are environmental and safety concerns having on 
        the development of nanotechnology-related products and their 
        entry into the marketplace? What impact might these concerns 
        have in the future?

          Are current federal research efforts adequate to 
        address concerns about environmental and safety ramifications 
        of nanotechnology? Is the EHS research funding properly aligned 
        with the agencies' roles and responsibilities for environmental 
        and safety matters; is the overall level of funding adequate; 
        have the most important research priorities been identified; 
        and is the funding aligned satisfactorily to address those 
        research priorities?

          What is the status of the development of a 
        prioritized, detailed implementation plan for EHS research 
        under the NNI? Will the plan now under development provide 
        specific goals and timelines for achieving those goals; will it 
        have a description of the roles and responsibilities of the 
        participating agencies; and will it specify funding, by agency, 
        required to reach the goals? Are the research priorities in the 
        interim planning document appropriate?

          How can the current planning, coordination and 
        implementation of EHS research under NNI be improved? Are 
        alternative mechanisms needed to ensure EHS research is carried 
        out expeditiously and on topics that will support the research 
        needs of the agencies charged with environmental and safety 
        regulation?

4. Brief Overview

          Nanotechnology, the science of materials and devices 
        of the scale of atoms and molecules, has entered the consumer 
        marketplace. Today, there are over 300\1\ products on the 
        market claiming to contain nanomaterials (materials engineered 
        using nanotechnology or containing nano-sized particles), 
        generating an estimated $32 billion in revenue.\2\ By 2014, 
        according to Lux Research,\3\ a private research firm that 
        focuses on nanotechnology, there could be $2.6 trillion worth 
        of products in the global marketplace which have incorporated 
        nanotechnology.
---------------------------------------------------------------------------
    \1\ Wilson Center, Project on Emerging Nanotechnologies, 
``Nanotechnology: A Research Strategy for Addressing Risk'' July, 2006. 
p. 4.
    \2\ Lux Research, ``Taking Action on Nanotech Environmental, 
Health, and Safety Risks,'' Advisory, May 2006 (NTS-R-06-003) 
(hereafter cited as ``Taking Action'').
    \3\ Lux Research, ``Sizing Nanotechnology's Value Chain,'' October 
2004.

          There is significant concern in industry that the 
        projected economic growth of nanotechnology could be undermined 
        by either real environmental and safety risks of nanotechnology 
        or the public's perception that such risks exist. Recently, 
        some reports have indicated that these concerns are causing 
        some companies to shy away from nanotechnology-related products 
        and downplay nanotechnology when they talk about or advertise 
        their products.\4\ There is an unusual level of agreement among 
        researchers, and business and environmental organizations that 
        the basic scientific information needed to assess and protect 
        against potential risks does not yet exist.
---------------------------------------------------------------------------
    \4\ Matthew Nordan testimony, Science Committee hearing, September 
21, 2006, Serial No. 109-63.

          The President's fiscal year 2008 (FY08) budget 
        requests $1.4 billion for the NNI, the interagency 
        nanotechnology research and development program. Of this 
        amount, the budget proposes $58.6 million (4.1 percent of the 
        overall program) for research on EHS research. This is $10.8 
        million above the FY07 funding level. Nearly 50 percent of this 
---------------------------------------------------------------------------
        funding would go to NSF.

          In October 2003, the NSET organized an interagency 
        Nanotechnology Environmental and Health Implications (NEHI) 
        Working Group to coordinate environmental and safety research 
        carried out under the NNI. The NEHI Working Group is charged 
        with ``facilitate[ing] the identification, prioritization, and 
        implementation of research. . .required for the responsible'' 
        development and use of nanotechnology.\5\
---------------------------------------------------------------------------
    \5\ Terms of Reference, Nanotechnology Environmental and Health 
Implications Working Group Nanoscale Science, Engineering, and 
Technology Subcommittee Committee on Technology; March, 2005.

          One of the NEHI Working Group's initial tasks was 
        developing a prioritized plan for EHS research under the NNI. 
        In March 2006, the Administration informed the Science 
        Committee that this report would be completed that spring, but 
        the document that was finally released in September 2006 was a 
        non-prioritized list of EHS research areas. At a Science 
        Committee hearing organized at the time of the report's 
        release, the Chairman and Ranking Member stressed the urgency 
---------------------------------------------------------------------------
        of developing the prioritized research plan.

          The latest iteration of the EHS research plan, which 
        was released for public comment in August 2007, presents a 
        rationale for the process of defining EHS research priorities 
        and provides a reduced set of priorities based on the previous 
        report. It also indicates that the ``next steps'' (with no 
        indication of timing) include NEHI evaluating the NNI EHS 
        research portfolio to carry out a gap analysis to compare 
        current work to the priorities list and then develop ``a 
        strategy to address EHS research priorities'', which is 
        essentially what was promised in the plan expected in the 
        spring of 2006.

5. Previous Hearings

    The Committee held a hearing on this topic, Environmental and 
Safety Impacts of Nanotechnology: What Research Is Needed? [Serial No. 
109-34], on November 17, 2005. At that hearing, witnesses from the 
Federal Government, industry, and environmental organizations agreed 
that relatively little is understood about the environmental and safety 
implications of nanotechnology. The non-governmental witnesses 
emphasized that, for the emerging field of nanotechnology to reach its 
full economic potential, the Federal Government must significantly 
increase funding for research in this area. The hearing also raised 
questions about the effectiveness of the coordination and 
prioritization of EHS research being carried out under the NNI, as well 
as whether the key agencies having responsibilities for regulating 
exposure of people and the environment to nanomaterials were fully 
engaged in setting the priorities and funding appropriate activities.
    A second, related hearing was held by the Committee on September 
21, 2006, Research on Environmental and Safety Impacts of 
Nanotechnology: What Are the Federal Agencies Doing? [Serial No. 109-
63]. The witnesses were from the agencies sponsoring EHS research and 
participants in the NEHI Working Group, along with representatives from 
an industry association and an NGO. The hearing was intended to review 
the NEHI EHS research plan that the Committee had expected to receive 
earlier that year (see following section). The agency witnesses were 
unable to explain why the prioritized research plan had not been 
completed. The non-government witnesses reiterated the urgency of 
developing and implementing such a plan without further delay and 
indicated that there were deficiencies in the scale and content of the 
current EHS research portfolio. The hearing also raised, but did not 
resolve, the issue of whether the current process for planning and 
carrying out EHS research under NNI is viable.

6. National Nanotechnology Initiative

Fiscal Year 2008 Budget
    The National Nanotechnology Initiative (NNI) is a multi-agency 
research and development (R&D) program authorized by the 21st Century 
Nanotechnology Research and Development Act (P.L. 108-153). Currently, 
13 federal agencies participate in the coordination, planning, and 
implementation of the research and development activities carried out 
under the NNI. The primary goals of the NNI are to foster the 
development of nanotechnology and coordinate federal R&D activities. 
The total NNI funding for FY 2007 is $1.35 billion and the FY 2008 
request is $1.44 billion. More information on agency roles and 
activities under the NNI is available at http://www.nano.gov/.
    The following table provides the FY 2008 funding proposal for each 
participating agency and the amount the agency has identified as 
supporting EHS activities:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


Research Plan for Environmental and Safety Implications of 
        Nanotechnology
    At the Science Committee's November 17, 2005 hearing on EHS 
research related to nanotechnology, Dr. Clayton Teague, Director of the 
National Nanotechnology Coordination Office, testified that the NEHI 
Working Group was ``preparing a document that identifies and 
prioritizes information and research needs in this area. The document 
will serve as a guide to the NNI agencies as they develop budgets and 
programs and will inform individual investigators as they consider 
their research directions.'' \6\ In his responses to questions for the 
record, Dr. Teague said the report was expected to be completed by 
``Spring 2006'' and ``is intended to be sufficiently detailed to guide 
investigators and managers in making project-level decisions, yet broad 
enough to provide a framework for the next five to ten years.'' The 
report was finally released at the time of the September 21, 2006 
Committee hearing, but it was merely a listing of research topics, not 
a prioritized research plan with agency roles and funding levels 
delineated.
---------------------------------------------------------------------------
    \6\ Clayton Teague testimony, Science Committee hearing, November 
17, 2005, Serial No. 109-34.
---------------------------------------------------------------------------
    In August 2007, a new report was released, ``Prioritization of 
Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale Materials: An Interim Document for Public Comment.'' \7\ This 
report, once again, is not the prioritized research plan originally 
anticipated for release in the Spring of 2006. It is a refined list of 
research priorities along with a description of a process for updating 
the priorities list. The document includes a ``next steps'' section 
that indicates NEHI will evaluate the NNI EHS research portfolio to 
carry out a gap analysis to compare current work to the priorities list 
and then develop ``a strategy to address EHS research priorities.'' No 
estimate is given for a date for completion of this EHS research 
program assessment and strategy document.
---------------------------------------------------------------------------
    \7\ http://www.nano.gov/
Prioritization-EHS-Research-Needs-
Engineered-Nanoscale-Materials.pdf

7. Witness Questions

    Dr. Teague was asked to provide an overview of the current scope of 
EHS research being conducted under the NNI, including how it relates to 
international and private sector EHS research efforts, and to provide 
an update on the development of a detailed implementation plan for EHS 
research. He was asked to include in his testimony:

          a description of the process that is underway to 
        develop the EHS research plan;

          a description of the tenor of the responses received 
        during the period the NEHI Working Group report referenced 
        above was open for public comment; and

          recommendations for ways to improve the planning, 
        prioritization, and implementation of EHS research under the 
        NNI.

    Mr. Kvamme was asked to provide the views of the NNAP on the 
effectiveness, scope, and content of the current EHS research efforts 
under the NNI and any recommendations the NNAP may have on ways to 
improve the process for planning, prioritization, and implementation of 
EHS research under NNI. He was asked to answer the following questions:

          Has the NNAP reviewed the recent report of the 
        Nanotechnology Environmental and Health Implications Working 
        Group, ``Prioritization of Environmental, Health, and Safety 
        Research Needs for Engineered Nanoscale Materials''? If so, are 
        the priorities listed in the report the right ones, and will 
        carrying out the ``next steps'' described in the report result 
        in a satisfactory detailed implementation plan for EHS 
        research?

          Has the NNI assigned a sufficiently high priority to 
        EHS research and are there gaps in the portfolio of NNI 
        research now underway? What level of funding over what time 
        period is needed to make acceptable progress in understanding 
        the potential environmental and health risks associated with 
        the development of nanotechnology?

          What are the optimum roles for the agencies in 
        sponsoring or conducting EHS research? Are responsibilities and 
        available resources currently in balance?

          Does the NNAP believe the current process is working 
        for developing an EHS research plan under the NNI, and if not, 
        what changes are needed?

    The other witnesses were asked to provide their views on the 
effectiveness, scope, and content of the current EHS research efforts 
under the NNI and recommendations on ways to improve the process for 
planning, prioritization, and implementation of EHS research under NNI. 
They were asked to answer the following questions:

          What is your reaction to the recent report of the 
        Nanotechnology Environmental and Health Implications Working 
        Group, ``Prioritization of Environmental, Health, and Safety 
        Research Needs for Engineered Nanoscale Materials''? Do outside 
        groups have a way to influence this planning process? Are the 
        priorities listed in the report the right ones, and do you 
        believe that carrying out the ``next steps'' described in the 
        report will achieve the detailed implementation plan for EHS 
        research that is needed?

          Has the NNI assigned a sufficiently high priority to 
        EHS research and are there gaps in the portfolio of NNI 
        research now underway? What level of funding over what time 
        period is needed to make acceptable progress in understanding 
        the potential environmental and health risks associated with 
        the development of nanotechnology?

          What are the optimum roles for the agencies in 
        sponsoring or conducting EHS research? Are responsibilities and 
        available resources currently in balance?

          Can the current process for developing the EHS 
        research plan under the NNI be made to work, and if so, what 
        changes are needed? If not, do you have recommendations for a 
        different approach for developing and implementing a 
        prioritized, appropriately funded EHS research plan with well 
        defined goals, agency roles, and milestones?
    Chairman Baird. This morning's hearing is the third one in 
three years the Science Committee has held on federally 
sponsored research on the health and environmental risks that 
may arise from applications of nanotechnology. The Committee's 
attention to the issue reflects our view of its importance to 
the development of nanotechnology and to capturing the enormous 
promise of this technology.
    The previous hearings have shown that there is wide 
agreement on two main points: first, nanotechnology will 
advance faster and receive public support if environmental, 
health, and safety implications of the technology are fully 
understood. Secondly, the interagency National Nanotechnology 
Initiative must include a prioritized and adequately funded 
research component focused on environmental, health, and safety 
issues, or as they are sometimes known, EHS issues.
    So the question before us today is not whether EHS research 
is important nor whether the NNI should fund research on 
environment and health risks. The question is how effectively 
is the NNI carrying out the planning and implementation of the 
EHS research component of the interagency program.
    With regard to the adequacy of the funding, the outside 
witnesses at the previous hearings either recommended that the 
NNI substantially increase funding for EHS research or they 
expressed frustration that they were unable to determine 
exactly what EHS research was being supported by the NNI. The 
basic position of most outside observers from industry and non-
governmental organizations is that the funding level should be 
on the order of 10 percent of the total funding, rather than 
the current four percent.
    More important than funding level is the concern that the 
EHS research component has not been well-planned and executed. 
At the Committee's November 2005 hearing, the Administration's 
witness indicated that an interagency working group was 
developing a coordinated approach to nanotech research on EHS 
that included input from industry and other non-governmental 
entities. That was back in '05 I should emphasize.
    We were told that the working group was in process of 
producing a document that would identify and prioritize 
research needs to assess the risks associated with engineered 
nanomaterials and would be sufficiently detailed to guide 
researchers and research managers in making project-level 
decisions.
    The estimated completion date for the document back in '05 
was Spring of 2006. The fact that I have alluded to Halloween 
in 2007 suggests we have missed that date. Unfortunately, we 
are still waiting for that detailed implementation plan for 
EHS.
    At the Committee's hearing last September, then-Chairman 
Boehlert and Ranking Member Gordon both expressed frustration 
at the slow pace in developing this research plan. But they 
were assured that the agencies were hard at work and that the 
plan would soon be forthcoming.
    Nearly a year later, this past August, an interim report 
was released for public comment. Although the report makes some 
progress in defining research goals, once again it is not a 
research plan laying out goals and timelines, funding levels, 
and defined agency roles and responsibilities for achieving 
these goals. The report suggests this is all coming in the 
``next steps,'' although it does not provide a target date for 
completion of those next steps.
    Meanwhile, more and more engineered nanoparticles continue 
to enter the marketplace. The number of such products has 
doubled to 500 over the past year according to surveys by the 
Wilson Center's Project on Engineering Nanotechnologies. Simple 
prudence suggests the need for urgency in having the science of 
health and environmental implications catch up to or even 
better surpass the pace of commercialization.
    The bottom line is that this is simply not an acceptable 
situation. We are basically still waiting for the EHS research 
strategy and detailed implementation plan that we were told 
would be available 18 months ago.
    I am genuinely puzzled why more progress has not been made, 
hence today's hearing, to develop this research strategy and 
plan that everyone believes is necessary for the successful 
development of nanotech.
    Today, I want to determine how the mechanisms in place for 
planning and implementing the interagency EHS research 
component of the NNI can be made to work better and what steps 
are needed to accomplish that outcome.
    On the other hand, if the process is flawed or is 
intrinsically unable to function satisfactorily, I would invite 
our witnesses to suggest alternative approaches and mechanisms. 
I am looking for concrete suggestions that the Committee can 
use as it develops legislation to reauthorize NNI over the next 
few months. I will just interject as we look towards that 
reauthorization, I will keep in mind closely whether or not we 
have actually been able to meet some of the goals that we are 
now 16 months past achieving. For me it seems difficult to 
promote reauthorizing the program when fundamental elements of 
environmental health and human safety are not being well-
addressed.
    So I want to thank our witnesses for their attendance at 
today's hearing, and I look forward to our discussion of this 
important set of issues.
    I now recognize the Ranking Member, Mr. Ehlers for an 
opening comment.
    [The prepared statement of Chairman Baird follows:]
               Prepared Statement of Chairman Brian Baird
    This morning's hearing is the third one in three years the Science 
Committee has held on federally sponsored research on the health and 
environmental risks that may arise from applications of nanotechnology. 
The Committee's attention to this issue reflects our view of its 
importance to the development of nanotechnology and to capturing the 
enormous promise of this technology.
    The previous hearings have shown that there is wide agreement on 
two main points:

          First, nanotechnology will advance faster and receive 
        public support if the environmental, health, and safety 
        implications of the technology are understood.

          Secondly, the interagency National Nanotechnology 
        Initiative must include a prioritized and adequately funded 
        research component focused on environmental, health, and safety 
        issues--or EHS issues.
    So the question before us today is not whether EHS research is 
important nor whether the NNI should fund research on environmental and 
health risks. The question is how effectively is the NNI carrying out 
the planning and implementation of the EHS research component of the 
interagency program.
    With regard to the adequacy of funding, the outside witnesses at 
the previous hearings either recommended that the NNI substantially 
increase funding for EHS research or expressed frustration that they 
were unable to determine exactly what EHS research was being supported 
by the NNI. The basic position of most outside observers from industry 
and non-governmental organizations is that the funding level should be 
on the order of 10 percent of the initiative's total funding, rather 
than the current four percent.
    More important than funding level is the concern that the EHS 
research component has not been well planned and executed. At the 
Committee's November 2005 hearing, the Administration's witness 
indicated that an interagency working group was developing a 
coordinated approach to nanotechnology research on EHS that included 
input from industry and other non-governmental entities.
    We were told the working group was in process of producing a 
document that would identify and prioritize research needs to assess 
the risks associated with engineered nanomaterials and be sufficiently 
detailed to guide researchers and research managers in making project-
level decisions.
    The estimated completion date for the document was the spring of 
2006. Unfortunately, we are still waiting for that detailed 
implementation plan for EHS research.
    At the Committee's hearing last September, then Chairman Boehlert 
and Ranking Member Gordon both expressed frustration at the slow pace 
in developing this research plan. But they were assured that the 
agencies were hard at work and that the plan would soon be forthcoming.
    Nearly a year later--this past August--an ``interim report'' was 
released for public comment. Although this report makes some progress 
in defining research goals, once again it is not a research plan laying 
out goals and timelines, funding levels, and defined agency roles and 
responsibilities for achieving those goals. The report suggests this is 
all coming in the ``next steps,'' although it does not provide a target 
date for completion of these next steps.
    Meanwhile, more and more products containing engineered 
nanoparticles continue to enter the marketplace--the number of such 
products has doubled to 500 over the past year according to surveys by 
the Wilson Center's Project on Emerging Nanotechnologies. Simple 
prudence suggests the need for urgency in having the science of health 
and environmental implications catch up to, or even better surpass, the 
pace of commercialization.
    The bottom line is that this is simply not an acceptable situation. 
We are basically still waiting for the EHS research strategy and 
detailed implementation plan that we were told would be available 18 
months ago.
    I am genuinely puzzled why more progress has not been made to 
develop this research strategy and plan that everyone believes is 
necessary for the successful development of nanotechnology.
    Today, I want to determine how the mechanisms in place for planning 
and implementing the interagency EHS research component of the NNI can 
be made to work better, and what steps are needed to accomplish that 
outcome.
    On the other hand, if the process is flawed or is intrinsically 
unable to function satisfactorily, I invite our witnesses to suggest 
alternative approaches and mechanisms. I am looking for concrete 
suggestions that the Committee can use as it develops legislation to 
reauthorize the NNI over the next few months.
    I want to thank our witnesses for their attendance at today's 
hearing, and I look forward to our discussion of this important set of 
issues.
    I now recognize the Ranking Member for an opening statement.

    Mr. Ehlers. Thank you, Mr. Chairman. I am pleased the 
Committee is holding this important hearing today, but I also 
hope that the scary reputation of this day doesn't somehow 
impinge on the seriousness of the topic we're engaged in.
    The promises of technology often compete for media 
attention with coverage of the unknown pitfalls nanotechnology 
products may have on human health and the environment. The 
nanoscale is so unexplored that we know very little about the 
short- and long-term environmental effects of nanomaterials in 
our ecosystem, and having lived through some periods of life 
where we did the wrong thing, for example, with pesticides and 
DDT and so forth, I can certainly understand the concern and 
perhaps even paranoia of society. At the same time, I am not 
sure very many people appreciate the difficulty of the work 
that has to be done. It is quite easy when you conduct a human-
scale, large-scale experiment such as using pesticides 
throughout the entire world and now observe the effects. It is 
quite a different matter to take an unknown effect and a 
relatively new scientific development and try to project what 
the problems might be. And I think very few people realize how 
difficult the work is and trying to identify the environmental 
effects of nanomaterials. The calm prevailing force here, of 
course, is the incredible benefits of nanoscale. I just read a 
fascinating article last week, and I am a would-be pilot and so 
I read a lot of aviation literature. And I found this 
fascinating article about nanotubes used in composite airplane 
construction. If you put a wire grid in, you also have the 
great advantage of using the nanotubes to detect cracks; but at 
the same time, by applying heat through the grid, you have a 
self-healing composite. This is a marvelous development for 
aviation and many other areas.
    What are the bad effects? We do not yet know, but as our 
country invests in innovative research in nanotechnology, we 
must ensure that accurate risk assessments are conducted and 
communicated to all stakeholders. An atmosphere of trust 
between the nanotechnology industry and the public is necessary 
to allow benign products to benefit our nation and to ensure 
that dangerous products and byproducts never enter the market 
or ecosystem, a very demanding agenda.
    Congress must continually assess whether nanotechnology 
research priorities to address unintended public health 
consequences of nanotechnology have been established and are 
being effectively implemented. As this committee prepares to 
reauthorize the National Nanotechnology Initiative, today's 
witnesses will provide valuable insights on both conducting 
research and sharing its results with the public.
    I look forward to hearing an update from our witnesses on 
this most important topic, and thank you all very much for 
taking the time to be here.
    I yield back.
    [The prepared statement of Mr. Ehlers follows:]
         Prepared Statement of Representative Vernon J. Ehlers
    Thank you Chairman Baird. I am pleased that the Committee is 
holding this important hearing today, but I also hope that the 
``scary'' reputation of today is not in any way linked with the topic 
at hand.
    Nonetheless, the promises of nanotechnology often compete for media 
attention with coverage of the unknown pitfalls nanotechnology products 
may have on human health and the environment. The nanoscale is so 
under-explored that we know very little about the short- and long-term 
environmental effects of nanomaterials in our ecosystem.
    As our country invests in innovative research in nanotechnology, we 
must ensure that accurate risk assessments are conducted and 
communicated to all stakeholders. An atmosphere of trust between the 
nanotechnology industry and the public is necessary to allow benign 
products to benefit our nation, and to ensure that dangerous products 
and byproducts never enter the market or ecosystem. Congress must 
continually assess whether nanotechnology research priorities to 
address unintended public health consequences of nanotechnology have 
been established and are being effectively implemented. As this 
committee prepares to reauthorize the National Nanotechnology 
Initiative, today's witnesses will provide valuable insights on both 
conducting research and sharing its results with the public.
    I look forward to hearing an update from our witnesses on this 
important topic.

    Chairman Baird. Thank you, Dr. Ehlers. We also are joined 
today by Mr. Rothman from New Jersey, and Dr. McNerney from 
California; and others will be joining us. As you know, we 
often have multiple hearings at the same time.
    [The prepared statement of Mr. Lipinski follows:]
          Prepared Statement of Representative Daniel Lipinski
    Thank you, Mr. Chairman.
    I am proud to note that the State of Illinois was ranked 8th in the 
Nation this year by Small Times magazine of leading nanotechnology 
states. However, with success comes responsibility and nanotechnology 
certainly is no different as we examine potential environmental, health 
and safety implications.
    This week's copy of BusinessWeek contains an article about how new 
nanotechnologies are helping to save vast amounts of energy simply by 
reducing the amount of friction in pipes throughout our economy. 
Innovative thin coatings and ball bearings in pipelines, as well as 
nanotech additives to motor oils, are helping to reduce friction by 50 
percent and promote much more efficient processes. Every day, new 
products such as these are being introduced into the marketplace. As 
nanotechnology moves from a multi-billion to a multi-trillion dollar 
industry in just the next few years, now more than ever we must take 
action to identify, assess and manage potential environmental, health 
and safety risks.

    Chairman Baird. In the interest of hearing what you all 
have to say, I will be very brief in the introductions and then 
we will have the panel have five minutes to speak. Dr. Ehlers 
and I have agreed that there are buttons we press when people 
go about five and one-half minutes. The chairs drop out from 
underneath you and you disappear into an oblivion that we will 
try to rescue you from at some future date.
    Dr. Clayton Teague is Director of the National 
Nanotechnology Coordination Office. Mr. Floyd Kvamme is Co-
Chair of the President's Council of Advisors on Science and 
Technology; Dr. Vicki Colvin, Executive Director of the 
International Council on Nanotechnology and Professor of 
Chemistry and Chemical Engineering at Rice University; Dr. 
Andrew Maynard, Chief Science Advisor for the Project on 
Emerging Nanotechnologies, Woodrow Wilson International Center 
for Scholars; Dr. Richard Denison, Senior Scientist, 
Environmental Defense; and Mr. Paul D. Ziegler, Chairman, 
Nanotechnology Panel, American Chemistry Council.
    So a very, very distinguished and accomplished panel of 
experts. We look forward to your comments, and with that we 
will begin our testimony with Dr. Teague.

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

    Dr. Teague. Good morning, and thank you, Mr. Chairman, and 
other Members of the Subcommittee. Thank you for inviting me to 
testify at this hearing. I am pleased to have the opportunity 
to update the Subcommittee on the extensive efforts of the NNI 
to address the needs for research on the environmental, health, 
and safety, or EHS, aspects of nanotechnology.
    Since its inception, the NNI has supported research along 
two paths: research toward beneficial uses of nanotechnology 
for society and research to protect public health and the 
environment. By integrating results from these two paths of 
research, the NNI aims to maximize the benefits of this new 
technology at the same time it is developing an understanding 
of any potential risk and means to manage such risk.
    EHS research is and has been a top priority of the 
Administration and the NNI. During fiscal years 2005 through 
2008, the NNI agencies will have invested nearly $180 million 
in what we call primary purpose EHS research. This U.S. 
investment in such research leads all other countries by a wide 
margin. For 2008, the NNI agency request totaled about $59 
million, an increase of 55 percent over that that was invested 
in 2006. We expect this trend to continue as increased 
knowledge informs our path forward.
    Our strategic approach to prioritizing and addressing 
nanotechnology-related EHS research consists of four major 
elements: successful coordination, comprehensive planning and 
guidance, leveraging forefront science and collaboration, and 
periodic review. This four-element strategy for nanotechnology 
EHS research enables the NNI to identify new research needs and 
to pursue paths to meet those needs. By continuing to iterate 
these elements over the long-term, the NNI will accelerate the 
pace at which EHS information is developed and made available 
to government regulators and to industry; helping to ensure 
that nanotechnology enabled products are brought to the market 
responsibly.
    The NNI is effectively coordinating government-funded 
research and the agency's multi-disciplinary expertise on the 
EHS aspects of nanotechnology. NNI agencies have expressed 
strong satisfaction with the coordination and collaboration 
opportunities stimulated by their participation in the 
Nanotechnology Environmental and Health Implications Working 
Group, or NEHI, as shown in some exemplary endorsements of the 
NEHI by the NNI agencies that I have provided in my written 
testimony. This group's outputs are developed by consensus, a 
process which is time consuming but ensures that the results 
receive strong support from all the member agencies. To provide 
guidance for investments in nanotechnology EHS research, we 
started by identifying the breadth of research necessary to 
support the risk assessment and risk management decision-making 
to inform the safe use and commercialization of nanomaterials. 
We narrowed the list to a set of high priority needs. We 
obtained a snapshot of the government portfolio of 
nanotechnology EHS research in 2006, and we are now comparing 
this list of research projects to the priority research needs 
in order to determine what research topics may need increased 
emphasis.
    The important outcome of this process will be the creation 
of a science-based nanotechnology EHS research strategy 
document that provides comprehensive guidance for the planning, 
management, and coordination of nanotechnology-related EHS 
research. We hope this document's recommendations will inform 
and influence you in Congress, the Administration, and the 
agencies as they develop their annual budgets and make 
decisions on funding and program support. Publication of our 
EHS research strategy document will complete the first cycle of 
a long-term process. Ongoing evaluation of research needs will 
continue and priorities may change as new materials become 
candidates for use in products or as funded research yields 
important new results.
    NNI's growing portfolio of EHS research is leveraged 
through collaborations among multi-disciplinary research 
groups, with industries, NGO's, and other governments 
worldwide. Significant inputs to our research strategy document 
have come from consultations, national and international 
workshops, hearings, and subsequent highly constructive public 
comment periods. Some 100 experts within the NNI agencies 
contributed to this planning process. I am confident that the 
EHS strategy document will facilitate the research necessary to 
generate the knowledge for the risk assessment, risk 
management, and regulatory decision-making.
    Extraordinary level of multiagency coordination occurring 
within the NNI with respect to nanotechnology is rare, and in 
my own experience, unique. The NNI approach has been endorsed 
by reviews by the National Research Council and the President's 
Council of Advisors on Science and Technology. Let me assure 
you that we at the NNI share the importance that you, the 
Members of Congress, the Administration, and the research 
community place on nanotechnology-related EHS research. We 
share that view and will continue to make responsible 
development of nanotechnology a top priority of our research 
efforts.
    Thank you for the attention and I am sure the extra time.
    [The prepared statement of Dr. Teague follows:]
                Prepared Statement of E. Clayton Teague

Introduction

    Mr. Chairman and Members of the Subcommittee, thank you for 
inviting me to testify at this hearing. My name is Clayton Teague and I 
am the Director of the National Nanotechnology Coordination Office 
(NNCO). The NNCO supports the efforts of the multi-agency National 
Nanotechnology Initiative (NNI). I am pleased to have the opportunity 
to update this subcommittee on the extensive efforts underway in the 
NNI to address the needs for research on the environmental, health and 
safety (EHS) aspects of nanotechnology.
    Since its inception, the NNI has supported research along two 
fundamental paths: research toward promising, highly beneficial uses of 
nanotechnology for our society and our nation's economic growth and 
research to protect public health and the environment. By integrating 
the results and new knowledge from these two paths of research, the NNI 
can expedite progress toward maximizing the benefit-to-risk ratio in 
the development of nanotechnology.
    Further, EHS research is and has been a top priority of the 
Administration and the NNI. The Directors of the Office of Science and 
Technology Policy (OSTP) and Office of Management and Budget (OMB) have 
highlighted EHS research in each of the annual Research and Development 
Budget Priorities memoranda issued since 2004. During fiscal years 2005 
through 2008, it is estimated that NNI agencies will have invested 
nearly $180 million in research whose primary purpose is to address the 
EHS implications of nanomaterials. With these investments, the United 
States leads all other countries in the world by a wide margin in 
support for such research. The 2008 request for this area is $58.6 
million, an increase of 55 percent over 2006,\1\ the last year for 
which we have estimates of actual funding. This growth reflects 
intentional and systematic program development by the NNI for 
nanotechnology-related EHS research.
---------------------------------------------------------------------------
    \1\ See Table 6 in the NNI Supplement to the President's FY 2008 
Budget, http://www.nano.gov/NNI-08Budget.pdf, p. 11, which 
shows an estimated actual R&D investment for FY 2006 of $37.7 million 
and the amount stated for the FY 2008 request in the PCA for research 
whose primary purpose was EHS implications of nanotechnology.
---------------------------------------------------------------------------
    I have been asked to describe the NNI's approach to prioritizing 
and addressing EHS research related to nanotechnology. Our approach--
our strategy--consists of four major elements. 1) Successful 
coordination: The NNI is effectively coordinating Government-funded 
research and the multi-disciplinary expertise of participating agencies 
on the EHS aspects of nanotechnology; 2) Comprehensive planning and 
guidance: Through ongoing analysis of available research results by 
government subject matter experts, along with inputs from program 
managers, funding decision-makers, and the public, the NNI has 
published and is drafting further planning documents to provide 
guidance for agencies, industry, and academia on EHS research needs; 3) 
Leveraging forefront science through collaboration: The NNI is 
supporting a growing portfolio of EHS research and is leveraging its 
investment through collaborations among multi-disciplinary research 
groups, with industry, and with other governments worldwide; 4) 
Periodic review: The NNI plans to conduct periodic reviews of the state 
of EHS research to determine new developments or discoveries that would 
require changes in emphases or directions of research.
    This four-element strategy for planning and implementing 
nanotechnology EHS research enables the NNI to adapt to the dynamic 
aspects of research and to pursue appropriate paths that address 
identified research needs. Equally, practicing these elements in an 
iterative long-range fashion accelerates progress toward producing the 
information necessary to assess safety of nanomaterials and to 
responsibly develop products enabled by nanotechnology.

Successful Coordination

    The Nanoscale Science, Engineering, and Technology (NSET) 
Subcommittee's Nanotechnology Environmental Health Implications (NEHI) 
Working Group serves centrally and effectively to coordinate the 
planning and implementation of the U.S. Government's EHS 
nanotechnology-related research and activities. This interagency 
approach aligns the agencies' mandates, missions, authorities, and 
resident expertise with EHS research planning and implementation.
    Twenty of the 26 NNI agencies participate in the NEHI Working 
Group. Thirteen of the agencies fund safety-related research in the 
field and/or have regulatory authorities to guide the safe use of 
nanomaterials.
    The NEHI Working Group is co-chaired by Dr. Norris Alderson, 
Associate Commissioner for Science in the U.S. Food and Drug 
Administration, and Dr. George Gray, Assistant Administrator for the 
Office of Research and Development in the Environmental Protection 
Agency. Under their combined leadership, NEHI creates the framework 
that supports a robust, proactive process for identifying and 
addressing EHS research related to nanotechnology.
    Starting with initial, informal meetings beginning in 2003 and 
formally established by the NSET Subcommittee in 2005, the NEHI Working 
Group has the following objectives:

          provide for the exchange of information among 
        agencies and non-government parties that support nanotechnology 
        research and those responsible for regulation and guidelines 
        related to nanoproducts

          facilitate the identification, prioritization, and 
        implementation of research and other activities required for 
        the responsible research, development, utilization, and 
        oversight of nanotechnology

          promote communication of information related to 
        research on environmental and health implications of 
        nanotechnology to other government agencies and non-government 
        parties.

    The NEHI Working Group operates on a consensus basis, thereby 
leading to reports and other documents that have broad approval from 
all member agencies. Moreover, representatives to the working group 
involve appropriate experts within their agencies in the development 
and review of any working group product. Such involvement can be time 
consuming, however the result is strong awareness of and support for 
the ultimate output. Consensus-building among key decision makers 
produces agency commitments to carry out their parts in generating 
needed information through research activity.
    With this support, the NNI, through its multi-agency participation 
and access to the wide range of subject matter expertise, is 
successfully coordinating EHS research among the NNI agencies, with 
industry and academia, and with other nations. Doing so enables us to 
leverage all available resources and to accelerate the pace of progress 
toward generating safety-related information.
    The NEHI Working Group is the most active working group of the NNI 
and has been described by agency representatives as the most effective 
interagency collaboration they have witnessed or in which they have 
participated. This is a clear indication of the NEHI Working Group's 
success.
    NNI agencies have expressed strong satisfaction with the 
coordination and collaboration opportunities stimulated by their 
participation in the NNI. Some example endorsements are presented in 
Appendix A: How the Interagency Process Helps Individual Agencies. The 
Administration through its Budget Priorities memoranda and Congress 
through the 21st Century Nanotechnology Research and Development Act 
also have emphasized coordination of EHS research.
    Nonetheless, some have called for a centralized office with 
budgetary authority to oversee the NNI's EHS research program. It is 
the consensus of NEHI Working Group members that such an approach would 
have significant detrimental effects:

          No one agency or centralized organization would have 
        the breadth of scientific expertise and knowledge of regulatory 
        authorities and needs currently represented by the 20 agencies 
        participating in the NEHI Working Group.

          Creation of a new central authority would undermine 
        the existing successful interagency coordination.

          Moving the management of all nanotechnology EHS 
        research into a single office would likely decouple such 
        research from related efforts within NNI agencies and from the 
        knowledge base in the agencies that is currently networked into 
        the NNI's EHS research effort.

          Creating a separate office would, on the one hand, 
        give mission agencies a disincentive for doing nanotechnology-
        related EHS research. They would reasonably assume that another 
        agency is responsible, and they therefore could redirect their 
        limited resources to address other priorities. A likely result 
        could be that the level of research would actually decrease. 
        Conversely, creating a separate office could lead to 
        duplicative work being funded, thereby wasting tax dollars and 
        not optimizing progress.

Comprehensive Planning and Guidance

    The NNI strategy for addressing EHS research needs for engineered 
nanoscale materials consist of five steps.

Step one--Identify research needs: In September 2006, the NNI published 
its assessment of the research needed to support risk assessment and 
risk management decision-making. This guidance was contained in the 
document, Environmental, Health, and Safety Research Needs for 
Engineered Nanoscale Materials,\2\ henceforth referred to as the 
Research Needs document. Comments submitted during the public comment 
period acknowledged the comprehensiveness of the document to guide the 
breadth of research needed to inform safety assessment. The research 
needs are organized into five categories: instrumentation, metrology, 
and analytical methods; nanomaterials and human health; nanomaterials 
and the environment; health and environmental exposure assessment; and 
risk management methods.
---------------------------------------------------------------------------
    \2\ http://www.nano.gov/
NNI-EHS-research-needs.pdf

Step two--Prioritize research needs: In August 2007, the NNI published 
a prioritization of the identified research needs on the NNI website 
www.nano.gov as an interim document for public comment. These priority 
needs were identified following extensive dialogue among the subject 
matter experts and careful analysis based on principles outlined in the 
Research Needs document and public comments received.
    It is important to underscore that EHS-research planning and 
implementation have been taking place simultaneously for several years. 
The processes, like those of the research itself, are not linear. The 
NNI agencies have been funding basic research at increasingly higher 
levels and through this research have been producing information 
critical to this field.

Step three--Obtain a snapshot of the government portfolio of EHS 
research in categories identified in Step one: In order to enable a 
more detailed assessment of funded research in this area, OMB collected 
data from the NNI research agencies on all FY 2006 spending for 
research related to the five categories outlined in the Research Needs 
document. Note that this call captures research reported in several 
Program Component Areas (PCAs) as reported in the NNI Supplement to the 
President's 2006 Budget. For example, some research in the PCA for 
Instrumentation Research, Metrology, and Standards was found to be 
highly relevant.

Step four--Analyze data from OMB on EHS research portfolio: The NEHI 
Working Group is analyzing the responses to the OMB data call to 
perform a systematic evaluation of the NNI's EHS research portfolio. 
NEHI experts have retrospectively categorized research funded by NNI 
agencies in FY 2006 according to the priority research needs.
    Preliminary results from the NEHI analysis are summarized in the 
following table.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    NEHI's preliminary analysis indicates strong alignment of ongoing 
research and the priority needs. NEHI members are continuing to analyze 
those data as they complete this step toward drafting the NNI EHS 
research strategy document. While this step is not yet completed, the 
initial analysis indicates that many of the areas identified by experts 
are already receiving significant support. An initial analysis of OMB's 
call for data on research in the five categories of the NNI Research 
Needs Document is provided in Appendix B.

Step five--Provide research strategy document as guidance:

    The single most important outcome of this process is the creation 
of a science-based EHS research strategy document that the NNI 
recommends to individual agencies, the Administration, and Congress for 
use as guidance in their decisions for funding and program support.
    Within the NNI EHS research strategy document, the management of 
R&D programs, as with all other NNI research and funding activities, 
will remain within the agencies that have the appropriate jurisdiction, 
expert staff, and expertise to manage day-to-day research activities 
and funding decisions.
    Agencies whose missions are reflected in a research category of the 
Research Needs document will be noted in the NNI EHS research strategy 
document to be published shortly.
    Agencies will use the NNI EHS research strategy document to:

          Understand where their mission-related research fits 
        into the overall strategy

          Identify opportunities for collaboration or 
        cooperation

          Identify critical needs within their missions which 
        have not gotten sufficient attention

          Understand their relationship to other agencies and 
        their research.

    We understand that some would like to have seen the initial NNI EHS 
research strategy document published yesterday. However, the NNI has 
undertaken thorough, time-consuming activities such as highly specific 
data collection, and the solicitation and synthesis of expert and 
public input to ensure that the strategy would have scientific 
integrity and would reflect real data and information needs and thus 
have the credibility to guide agencies in decisions concerning their 
research funding and activities. And as noted earlier, the lack of a 
published strategy has not delayed getting started on high priority 
research.
    To provide some insight into the complexity of this process, it is 
helpful to note the range of expertise sought through consultations, a 
public hearing, and two highly constructive public-comment periods. 
World-renowned scientists from academia, industry, NGOs, and government 
all have provided input. Within the government alone, some 100 subject 
matter experts across agencies reviewed and contributed to this 
comprehensive document. Among those who informed the development of 
this strategy were experts in:

          quantum mechanical properties of engineered nanoscale 
        materials

          characterization of the physical and biological 
        properties of these nanoscale materials through transmission 
        electron microscopy, dynamic light scattering, and in vitro and 
        in vivo toxicology

          absorption, distribution, metabolism, and elimination 
        of materials in mammalian systems

          environmental toxicology and pharmacokinetic models 
        of toxicity

          interactions of materials with the body at the 
        molecular, cellular, and tissue levels

          metrics for measuring exposure, fate and transport of 
        materials in the environment

          occupational health and exposures; and risk 
        assessment and management practices.

    The road to effectively safeguarding public health is dynamic and 
requires attention to alternative paths for obtaining the necessary 
knowledge and understanding. An ongoing evaluation of the materials 
being considered for use in products and new research findings must 
continue to inform and guide our ongoing strategic planning efforts. In 
the coming six months, for instance, we anticipate the publication of a 
large number of highly informative research papers in the field, 
reflecting the fruits of some of the NNI's earliest investments. These 
research findings could possibly provide information that calls for a 
stronger emphasis on current areas of research or that calls for a 
redirection of resources to another area of inquiry. Science is not 
stagnant and planning for research activity cannot be either.
    The NNI strategic planning process will give the agencies ongoing 
guidance for funding research, and it will continue to inform industry 
of the most important safety issues--something that industry has asked 
us to provide.
    We expect industry-created research plans will address in greater 
detail important industry needs--especially with regard to product-
safety testing. Many of the plans already underway are complementary to 
the Federal Government strategy; indeed, they were input to the 
formulation of the federal strategy. This underscores the fact that 
multiple parties will play significant roles in gaining scientific 
knowledge in this field. But only the NNI process addresses the breadth 
of information needs of the federal agencies and includes the 
deliberations necessary for interagency cooperation. Federal agency 
responsibilities for safeguarding public health cannot be delegated to 
any other agency or group, nor can planning for how those 
responsibilities will be met.

Leveraging Forefront Science Through Collaboration

    The evaluation of research needs through the NNI strategic planning 
process has been guiding agency research efforts since the NNI was 
formed. Implementation of identified research activities also has been 
underway as has the development of partnerships to facilitate research 
collaborations among agencies and with partners from industry, academia 
and non-government organizations (NGOs).
    The 2006 data provide a snapshot of EHS research investments and 
have already helped inform and direct future government research 
funding. Below are a few of the research activities and collaborations 
in priority areas:

          NNI agencies have issued three joint solicitations 
        for research on potential EHS implications of nanotechnology:

                  One led by EPA that is now in its third year focuses 
                on investigating fate, transport, transformation, and 
                exposure of engineered nanomaterials (DOE is joining 
                EPA and NSF in 2008).

                  A second solicitation starting in 2007 is focused on 
                human health implications. It is led by NIH's National 
                Institute of Environmental and Health Sciences and 
                includes participation by five other NIH institutes as 
                well as EPA and NIOSH.

                  Recently NSF and EPA issued a third joint 
                solicitation for proposals to create a national Center 
                for the Environmental Implications of Nanotechnology 
                (CEIN) to conduct fundamental research and education on 
                the implications of nanotechnology on the environment 
                and living systems at all scales. The center will 
                address interactions of naturally derived, incidental 
                and engineered nanoparticles and nanostructured 
                materials, devices and systems with the living world. 
                The award is slated to be up to $5 million annually for 
                up to five years, pending the availability of funds and 
                successful review.

          NIH, FDA, and NIST are collaborating on work at the 
        Nanotechnology Characterization Lab (NCL) of the National 
        Cancer Institute (NCI), where a battery of characterization 
        tests are being developed for pre-clinical evaluation of 
        nanomaterials intended for cancer therapeutics.

          NIH, FDA, and NIOSH are supporting the National 
        Toxicology Program (led by NIEHS) as it develops and carries 
        out research and testing programs addressing health and safety 
        issues. Collaborations are underway with NIOSH, the FDA 
        National Center for Toxicological Research, and the NCI 
        Nanotechnology Characterization Lab.

          NSF and EPA have issued a joint solicitation for 
        proposals to create a national Center for the Environmental 
        Implications of Nanotechnology (CEIN) to conduct fundamental 
        research and education on the implications of nanotechnology on 
        the environment and living systems at all scales. The center 
        will address interactions of naturally derived, incidental and 
        engineered nanoparticles and nanostructured materials, devices 
        and systems with the living world. The award is slated to be up 
        to $5 million annually for up to five years, pending the 
        availability of funds and successful review.

    Identification of detailed research needs within the broader 
strategic framework also is taking place through various other 
activities and partnerships. In January 2007, NSF and NIH supported a 
meeting on International Nanomaterial Environmental Health and Safety 
Research Needs Assessment at the NIH Campus in Bethesda, Maryland. This 
meeting, organized and sponsored by the International Council on 
Nanotechnology (ICON), focused on a piece of the research framework, 
bringing detail to the materials in need of study. NSF supported 
another ICON meeting last summer that focused on research needed to 
inform predictive modeling of biological interactions. In addition to 
providing funds, government agencies sent representatives to plan and 
participate in each of these workshops.
    NIST held a workshop in September 2007 to develop approaches for 
identifying standard materials for critical risk assessment and risk 
management and priority reference materials, among other things.
    Two years ago, NIOSH released its Approaches to Safe 
Nanotechnology, a document that offers guidelines for working with 
nanomaterials, consistent with the best scientific knowledge. That 
document recently has been updated and NIOSH's work has been used as a 
basis in international forums toward drafting international 
recommendations for working with nanomaterials. Furthermore, EPA and 
FDA have developed policy papers guiding their mission-related research 
and information needs. These agencies and NIH each have established 
intra-agency nanotechnology task forces that coordinate across each 
agency and with the other NNI agencies.

International Coordination and Collaboration

    Although the United States is leading the world in the level of 
effort aimed at EHS research, it cannot--and should not--go it alone. 
The U.S. Government conducts many of its planning and implementation 
activities in coordination with other nations and international 
organizations. The NEHI Working Group, with assistance from another 
body of the NSET Subcommittee, the Global Issues in Nanotechnology 
Working Group, coordinates the U.S. position and participation in 
international activities related to environmental, health, and safety 
implications of nanotechnology. For example, NNI representatives are 
leading national and international collaborations that ensure 
coordination of the U.S. strategic priorities with those of the 
International Organization for Standardization (ISO) and the 
Organization for Economic Co-operation and Development (OECD).
    Standards are imperative for accurate and reliable measurement and 
characterization of nanomaterials, which in turn is vital for assessing 
exposure and its effects. NSET Subcommittee members are active 
participants in the ISO Technical Committee on Nanotechnologies (ISO 
TC229). The NSET Subcommittee has provided initial financial support to 
the American National Standards Institute (ANSI) accredited Technical 
Advisory Group (TAG) that represents the United States on the ISO 
TC229. The NNCO Director chairs the TAG and heads the U.S. delegation 
to ISO TC229. The United States holds the convener position for the ISO 
TC229 working group whose charter is the development of science-based 
standards in the areas of health, safety, and environmental aspects of 
nanotechnologies. The U.S. TAG also is participating actively in the 
working group on terminology and nomenclature and the working group on 
metrology and characterization.
    The U.S. Government was instrumental in the formation of two 
nanotechnology-related working parties at the OECD, and U.S. Government 
representatives currently chair the bureaus of each working party. This 
work is not limited to the 30 OECD member countries. Non-OECD countries 
and regions including the European Commission, Argentina, Brazil, 
China, India, Israel, Russia, and Thailand are active participants, as 
well as the nanotechnology and chemicals industries, ISO, and NGOs.
    International efforts to better understand the potential health, 
environmental, and safety implications of manufactured nanomaterials 
are being developed by the Working Party on Manufactured Nanomaterials 
(WPMN) under OECD's Chemicals Committee. Its objective is to promote 
international cooperation in health and environmental safety aspects of 
manufactured nanomaterials, in order to assist in their safe 
development. This will help ensure that approaches to assessment of 
hazard, exposure, and risk are of a high, science-based standard. The 
United States is heavily involved in all the current WPMN activities, 
which include:

          International coordination to assess ongoing EHS 
        research and identify mechanisms to address future research 
        needs

          Testing a representative set of manufactured 
        nanomaterials in collaboration with industrial partners, in 
        order to develop a foundation data set of their physical and 
        chemical properties as well as their fate, safety, and health 
        and environmental effects

          Developing guidelines for EHS-related testing of 
        nanomaterials, building upon already developed methods where 
        possible

          Exchanging information on risk assessment approaches 
        for manufactured nanomaterials and making recommendations to 
        fill gaps in current approaches

          Sharing information on voluntary data collection and 
        regulatory activities.

    The second OECD body is the Working Party on Nanotechnology (WPN) 
under the Committee for Scientific and Technological Policy. The 
objective of the WPN is to promote international cooperation that 
facilitates research, development, and responsible commercialization of 
nanotechnology in member countries and in non-member economies. WPN 
activities relevant to EHS matters include evaluating the regulatory 
concerns of businesses utilizing nanotechnology, and public 
communication issues.

Conclusion

    In closing, the NNI effectively coordinates EHS research planning 
and multi-disciplinary expertise across the 26 participating federal 
agencies. This ensures systematic and comprehensive planning across the 
broad spectrum of research programs needed to support risk assessment 
and risk management and to inform decision-makers.
    The NNI agencies support forefront research, and leverage this 
research through collaborations. These research programs have generated 
and will continue to generate research that informs decision-makers. I 
am highly confident that the forthcoming NNI EHS Research Strategy will 
provide the needed framework for the development and support of 
research programs that provide new knowledge as needed for risk 
assessment and risk management regarding the use of nanomaterials.
    Previous reviews of the NNI by the National Research Council (NRC) 
and the President's Council of Advisors on Science and Technology 
(PCAST) in its capacity as the National Nanotechnology Advisory Panel 
called for by the 21st Century Nanotechnology Research and Development 
Act, confirm the effectiveness of our coordinated, collaborative 
approach. The 2006 NRC review of the NNI\3\ was complimentary of the 
NNI's coordinated interagency approach in addressing EHS research and 
regulatory issues. PCAST is in the process of performing its second 
review of the NNI later this year. The NRC will take a comprehensive 
look at the NNI EHS research strategic process upon its completion.
---------------------------------------------------------------------------
    \3\ ``A Matter of Size: Triennial Review of the National 
Nanotechnology Initiative,'' http://books.nap.edu/
openbook.php?record-id=11752&page=92
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    We will of course welcome any recommendations these outside 
reviewers have as to how to make our strategy even more effective.
    Thank you for the opportunity to speak with you on this important 
subject today.

Appendix A

         How the Interagency Process Helps Individual Agencies

    The effectiveness of the NNI for the participating agencies has 
been described by individual agencies as follows:

The Consumer Product Safety Commission (CPSC): While CPSC does not have 
the resources for research at this point in time, we have benefited 
greatly from the ability to make our research needs known to other 
agencies who have research funding and who share similar needs for 
toxicity and exposure data, etc. The concept of ensuring collaboration/
communication across federal agencies to leverage limited research 
dollars is an important one.

U.S. Food and Drug Administration: The NNI collaboration has provided 
FDA the opportunity to discuss, review, and influence the priority of 
federally funded research organizations in their research programs. 
This has been particularly true in the areas of EHS needs. It is clear 
that the current activities of NCI/NCL, with NIST and FDA as partners, 
has benefited from the collaborative activities under NEHI. As a 
regulatory agency, FDA's research program provides the science support 
for current regulatory issues. Through the activities of NEHI, FDA has 
had the opportunity to assist in developing a research focus for issues 
that are a primary concern for nano-engineered materials as components 
of FDA regulated products. Through NEHI, FDA can leverage the resources 
of the funded research organizations to address those areas of concern 
that are shared with other regulatory agencies.

Department of Energy (DOE): DOE has included funding for new efforts in 
understanding the fate and transport of nanoscale materials in the 
environment in the FY 2008 budget request, and has joined with EPA and 
NSF in issuing a call for proposals in these areas. This interagency 
solicitation has been made possible by the interactions between DOE and 
the other participating agencies in the NSET and NEHI venues.

U.S. Environmental Protection Agency: The EPA is leveraging its 
research and development strengths by partnering with other federal 
agencies such as NIH, NCI, NIEHS, NIOSH, NSF, DOE, and NIST. The NEHI 
Working Group provides the agency with the forum and opportunity to 
engage in fruitful collaborative ventures. Many of our collaborative 
efforts have been enabled through dialogues and cooperation afforded by 
the NEHI Working Group and the NSET Subcommittee member meetings. The 
NEHI venue is especially advantageous for three critical reasons:

        1.  Direct communication of agency-to-agency information on 
        engineered nanomaterial EHS issues is enabled.

        2.  Ways to enhance the understanding of agency-specific EHS 
        issues are discussed.

        3.  Input on complex EHS issues from different agency 
        viewpoints is provided that results in more rapid and tenable 
        solutions.

U.S. Geological Survey: The USGS is in the planning phase of its 
activities with respect to nanotechnology, but has participated in the 
coordination activities of the NEHI Working Group and NSET 
Subcommittee. This involvement has given the USGS the opportunity to 
see where our scientific strengths will be best utilized within the set 
of research priorities, and to avoid duplication of effort. The 
involvement has also enabled us to get to know nanotechnology 
scientists and science leaders in other agencies in order to develop 
collaborative scientific projects that play to our strengths. The 
structure of the interagency interaction fostered by the NNCO provides 
forums for agencies to discuss research facilities that can be shared, 
thus increasing the value of the limited research dollars by enabling 
agencies like USGS to avoid duplicating expensive facilities.

The Nanotechnology Characterization Laboratory (NCL): The NCL at 
Frederick is an example of interagency coordination fostered by the 
NEHI Working Group. The laboratory is the result of a formal 
collaboration between three NEHI participating agencies: the National 
Cancer Institute (NCI) at the National Institutes of Health, the U.S. 
Food and Drug Administration (FDA), and the National Institute of 
Standards and Technology (NIST) within the Department of Commerce. The 
NCL's charter is to conduct safety testing of nanomaterials intended 
for medical applications; it is a resource available to investigators 
in academia, industry, and government laboratories toward facilitating 
the rapid transition of nanotechnology-based drugs and imaging agents 
into commercial products.
    In its three years of operation, the NCL has characterized over 100 
nanoparticle types, including titanium oxide (TiO2), fullerenes, 
dendrimers, gold colloids, polymers, and liposomes. In collaboration 
with FDA and NIST, the lab has developed over 20 ``best practice'' 
protocols for characterizing these particles; several of these are now 
being adopted by formal Standards Developing Organizations such as ASTM 
and ISO.
    Through its association with NEHI Working Group, the NCL also has 
recently engaged the National Toxicology Program (NTP); the NTP now has 
a seat on NCL's Scientific Oversight Committee and utilizes NCL data to 
inform its own nanomaterial characterization strategy and to avoid 
duplication of effort.

National Institute for Occupational, Safety and Health (NIOSH): NIOSH 
has had a good experience working with the NSET Subcommittee and NEHI 
Working Group for sharing information, networking, and identifying 
possible collaborations. This interaction also has helped provide 
feedback on the NIOSH Nanotechnology Program and review of NIOSH 
documents. NIOSH has had a broad range of collaborations with other 
agencies that have evolved as a result of being an early entrant into 
the field. Involvement with the NSET Subcommittee and the NEHI Working 
Group has provided an opportunity to promote and enhance some of those 
collaborations, including:

        1.  An MOU developed with OSHA regarding control banding and 
        hazard communication

        2.  A collaborative arrangement with EPA to work on the 
        Nanoscale Material Stewardship Program

        3.  Collaborations with DOE, DOE, and NASA to develop site-
        specific practices and with NIST to develop reference materials

        4.  Collaborations with OSHA and EPA on international 
        conferences

        5.  Joint Requests for Applications with EPA, NSF, and NIH, 
        since 2004

        6.  NIOSH active participation in OECD's Working Party on 
        Nanotechnology and Working Party on Manufactured Nanomaterials 
        (WPMN), including leadership of the WPMN's activity on 
        Cooperation on Exposure Measurement and Exposure Mitigation.

The National Institute of Standards and Technology (NIST): Interactions 
with the NNI and NEHI Working Group, in particular, have supported the 
establishment of nanotechnology as a research direction for NIST with 
direct emphasis on innovation and traceable measurements, not only to 
advance the development of a measurement-and-standards infrastructure 
for nanotechnology enabled products, but also those standards necessary 
to support the EHS aspects of nanomaterials and products that contain 
them.
    Examples of EHS program developments at NIST as a result of NIST-
NEHI interactions include:

          2005 Advanced Technology Program Project: Development 
        of 2- and 3-Dimensional Analysis Methodology for Determining 
        the Fate of Nanoparticles in Biological Tissues

          2006 Innovative Measurement Science Program: 
        Metrology for the Fate of Nanoparticles in Biosystems

          2008 (if appropriated): Metrology for Nano-EHS

    NIST's interactions with the NEHI Working Group member agencies has 
facilitated advances needed by NIST to leverage nanotechnology 
standards development work among other federal programs, to establish 
direct collaborations with other federal agencies, and to work with 
representatives from the risk assessment and regulatory communities 
representing not only government, but also academia, industry, and the 
international community.

National Institutes of Health (NIH): Through the NIH/National Institute 
of Environmental Health Sciences, active participation in the NEHI 
activities has provided a broad, interagency perspective that has 
enhanced its research program. NIH/NIEHS has worked on teams with 
representatives from CPSC, OSHA, and FDA, as well as funding agencies 
such as NIOSH, EPA and NSF. This interaction enhanced the NIH/NIEHS 
understanding of regulatory issues and informed the development of the 
NIH/NIEHS NanoHealth Initiative, the trans-NIH research strategy for 
environmental health and safety research. Additionally, NEHI was 
instrumental in providing the opportunity for NIH/NIEHS to participate 
in two interagency RFAs that have addressed the interaction of 
engineered nanomaterials with biological systems and in international 
dialogue on nanotechnology health and safety issues.

National Science Foundation (NSF): NSF's mission is focused on 
fundamental research, education, and infrastructure that support 
activities in universities, industry and other agencies. The NNI 
coordination helps in adjusting research directions, informing NSF 
decisions about funding centers, and developing comprehensive 
infrastructure and research and education programs. A few specific 
collaborations that have resulted from this coordination are:

          Three joint solicitations (2005, 2007, 2008) with 
        EPA, NIEHS, NIOSH, and DOE, respectively

          The NSF-EPA MOU and their joint support for the 
        establishment of a Center for Environmental Implications of 
        Nanotechnology.

Appendix B

  Initial Analysis of OMB's Call for FY 2006 Data on Research in Five 
               Categories of NNI Research Needs Document

    In 2006, five agencies performed or supported research on the 
Instrumentation, Metrology and Analytical Methods. This category was 
cited as providing essential tools and methods for several other 
categories, for example to support toxicological research. It is the 
category with the largest 2006 investment, consistent with this 
enabling role. Instruments and methods are being developed to 
characterize a large variety of materials in pure form and in complex 
media, including biological environments. Additional future emphasis 
may be needed on instrumentation specific to the workplace and the 
environment. Since 2006, work has begun to develop reference materials 
for calibration of instruments, examination of analytical processes to 
assess the chemical or physical properties of such materials, and to 
assess the quality or comparability of results from tests designed to 
determine the toxicity of similar health-benefit or drug-related 
materials.
    Six agencies funded Nanomaterials and Human Health research. With 
the most widespread investment, reported research addresses both 
particular nanomaterials and broad classes of materials. Effects of 
exposure through the lung, skin, and gastrointestinal tract are under 
investigation, as well as intravenous injection. Inhalation is the 
exposure route that is the subject of the largest number of projects. 
Translocation out of the exposure organ is also under study, most 
commonly using rodent models. As expected for a new class of materials, 
there is more emphasis on acute exposure than on chronic exposure. 
Analysis of ongoing research in this area reiterated the value that 
could be realized from a comprehensive database for EHS properties of 
nanomaterials, a concept already under development by several agencies 
and through our international collaborations.
    Five agencies funded research in the category Nanomaterials and the 
Environment. Five broad classes of manufactured nanomaterials (metals, 
quantum dots, nanoceramics, carbon-based nanoparticles, and organic 
nanomaterials) are covered by funded projects. Studies of the effects 
of engineered nanomaterials on individuals of a species are underway 
for numerous aquatic organisms. Transport and transportation of 
nanomaterials in the environment are well covered. Numerous studies of 
physical and chemical transformation processes are underway.
    Three agencies funded research on Health and Environmental Exposure 
Assessment. The investment is, in rough terms, evenly split between two 
categories: projects related to collecting general exposure information 
for workers in facilities manufacturing and using nanoscale and micro-
scale titanium dioxide particles, and projects which broadly 
characterize and analyze factors influencing the evolution of 
nanoparticles emitted by production equipment in the workplace 
environment and its effect on the exposure potential. In 2006, this 
category has the smallest budget which mirrors to some extent the 
nascent nature of nanotechnology. Systematic collection of exposure 
information is hindered by the lack of standardized methods, reference 
materials, protocols, and affordable instrumentation for EHS 
measurements. The NNI has already begun to address the need for 
additional research in this priority area, with NIOSH directing 
additional funding in FY 2007 for field evaluations in partnership with 
various enterprises.
    Four agencies funded research into Risk Management Methods. About 
one-third of the funding addresses risk-management control measures for 
airborne particles in the workplace with the rest of the funding 
addressing more general assessment of the application of risk 
management methods to nanomaterials. Inhalation is likely to be the 
most important initial exposure route during development and 
manufacture of particles with nanoscale features or dimensions, and is 
addressed by NIOSH funding for workplace exposures. Research into risk 
management methods for scenarios such as such as environmental 
releases, ecological receptors, and consumer or incidental exposures, 
was not funded in 2006, but the applicability of general (as opposed to 
nanomaterial-specific) risk management methods to these cases has also 
not yet been evaluated.

                    Biography for E. Clayton Teague
    Clayton Teague is Director of the federal National Nanotechnology 
Coordination Office (NNCO) since April 2003. Established in 2001, the 
NNCO is the secretariat to the Nanoscale Science, Engineering and 
Technology Subcommittee of the NSTC. As such, the NNCO provides day-to-
day technical and administrative support to the NSET Subcommittee and 
assists in the preparation of multi-agency planning, budget and 
assessment documents. The NNCO is the point of contact on federal 
nanotechnology activities for government organizations, academia, 
industry, professional societies, foreign organizations, and others to 
exchange technical and programmatic information. In addition, the NNCO 
develops and makes available printed and other materials as directed by 
the NSET Subcommittee as well as maintains the NNI website.
    Dr. Teague was previously Chief of the Manufacturing Metrology 
Division in the Manufacturing Engineering Laboratory of the National 
Institute of Standards and Technology (NIST).
    At NIST since 1972, Dr. Teague has designed, constructed, and used 
precision instrumentation for ultra-high accuracy dimensional metrology 
of surfaces and micrometer to nanometer-scale features. Beginning with 
his metal-vacuum-metal tunneling work in the 1970's, he continued to 
work with such precision instrumentation as scanning tunneling 
microscopes, atomic force microscopes, displacement and phase-measuring 
interferometry, stylus instruments, flexure stages, and light 
scattering apparatus. Because the laboratory and building environments 
were always factors in the ultimate performance of these instruments, 
the subject of this workshop has been an ongoing topic of great 
interest.
    Dr. Teague is a member of the American Society for Precision 
Engineering, has served twice as the Society's President, and is a 
fellow of the UK Institute of Physics. He served as Editor-in-Chief of 
the international journal Nanotechnology for ten years and is currently 
a member of the Editorial Board of the journal. He holds a B.S. and 
M.S. in physics from the Georgia Institute of Technology and a Ph.D. in 
physics from the University of North Texas. He has authored or co-
authored 70 papers, has presented 50 invited talks in the technical 
fields described, and jointly with colleagues, has six patents. Dr. 
Teague has received the Gold Medal, Silver Medal, and Allen V. Astin 
Measurement Science Award from the Department of Commerce, the Kilby 
International Award by the Kilby Awards Foundation, and an IR-100 
Industrial Research and Development Award for his work.

    Chairman Baird. Mr. Kvamme.

STATEMENT OF MR. E. FLOYD KVAMME, CO-CHAIR, PRESIDENT'S COUNCIL 
             OF ADVISORS ON SCIENCE AND TECHNOLOGY

    Mr. Kvamme. Thank you, Mr. Chairman, and Members of the 
Subcommittee. I am pleased to have the opportunity to testify 
before you today.
    My name is Floyd Kvamme, and I am co-chair of the 
President's Council of Advisors on Science and Technology, or 
PCAST. PCAST comprises a group from academia, industry, and 
other entities with experience in leading successful science 
and technology enterprises. My remarks today are my own but 
based on my conversations with fellow PCAST members. I am 
confident that they feel similarly on the issues under 
discussion today.
    As part of its second review, PCAST is taking a close look 
at the environmental, health, and safety, or EHS, aspects of 
the NNI. My Co-Chair for that review is Nancy Dicciani from 
Honeywell Corporation, who brings years of experience in the 
chemical industry and the responsible development of materials. 
The Council has received input from a wide range of 
perspectives, including a technical advisory group, or TAG, 
made up of more than 60 leading academic and industry experts 
including two of my co-witnesses here today.
    The main points I want to make today are, one, the NNI 
approach for identifying and addressing research needed to 
understand and manage the potential risks associated with 
nanotechnology appear sound and appropriate. Secondly, research 
to understand EHS implications should remain integrated with 
the broader portfolio of nanotech R&D.
    It is important to note that the terms nanotechnology and 
nanomaterial do not refer to a single material or class of 
materials. Rather, they refer to a broad spectrum of engineered 
materials with unique size-dependent properties. Each 
individual nanomaterial will have a benefit-to-risk ratio that 
depends on the material's specific characteristics and intended 
application.
    Federal investment in nanoscale science and engineering 
research remains money well spent. PCAST's assessments show 
that the U.S. is a leader in nanotechnology research and 
innovation. Solar cell technology, improved materials, energy 
storage, and medicine are just some of the areas sure to reap 
the benefits, economic and societal, from nano advances. To do 
so, however, there also needs to be investment in research for 
understanding and overcoming, that is, managing or designing 
out, the potential risks. As someone said in a recent PCAST 
discussion, we need to be cautious, not precautious. My own 
experience at the outset of the semiconductor industry taught 
me that EHS risks are part of any new technology, but they are 
risks that can be addressed.
    Our TAG survey shows broad consensus with respect to the 
role of the Federal Government in supporting nanotechnology-
related EHS research. The majority of respondents are eager to 
see the NNI continue its proactive approach and to grow 
research support.
    Secondly, the interagency approach is effective. I reviewed 
the September 2006 report that outlined EHS research needs, as 
well as the more recently released interim document 
prioritizing the needs. These documents cast the wide net 
necessary to address the array of nanotechnology-related EHS 
issues and are good descriptions of the priorities. I believe 
the interagency process will lead to a sound research strategy.
    Funding increases for EHS research across the federal 
agencies are of the right scale and indicate a steady increase 
in the capacity to conduct the necessary research. EHS research 
also fundamentally depends on advances in non-EHS areas such as 
instrumentation development and basic research on 
nanomaterials.
    Development of nanotechnology in a responsible manner, 
especially at the early stages, will be expedited by 
integration of EHS research with broader basic and applied 
research. Applications-oriented research will lead to 
information about EHS. So rather than setting arbitrary funding 
levels or percentages of total spending as a guideline for the 
EHS budget, NNI agency should focus on addressing the 
identified EHS research priorities, while at the same time 
investing in world-class applications research. The NNI's 
strong interagency coordination approach is essential to 
optimize progress in both.
    In summary, I am pleased with the extensive coordination 
and collaboration among the NNI agencies. Their approach 
appears to leverage the expertise and related efforts across 
the government. While there is much to be done, the process is 
not broken. I expect the current planning and coordination 
process will lead to a well-thought-out plan for nanotechnology 
EHS research. In fact, the coordination process used by the 
NNCO and the similar process used to manage networking and 
information technology research and development are so 
effective that they could well be considered models for similar 
coordination in fields such as K-12 education where hundreds of 
programs spread over many agencies without any formal mechanism 
whereby the agencies might coordinate and share information. 
PCAST is, however, anxious to see the nanotechnology EHS 
research strategy document that has been referred to and 
strongly encourages the NEHI Working Group to complete its work 
as expeditiously as possible, hopefully in time for an 
assessment in our upcoming report which we hope to issue in 
January. Thank you.
    [The prepared statement of Mr. Kvamme follows:]
                 Prepared Statement of E. Floyd Kvamme
    Mr. Chairman and Members of the Subcommittee, I am pleased to have 
the opportunity to testify before you today. My name is Floyd Kvamme 
and I am the Co-Chair of the President's Council of Advisors on Science 
and Technology (or PCAST), which was designated by Executive Order as 
the National Nanotechnology Advisory Panel called for by the 21st 
Century Nanotechnology Research and Development Act of 2003.
    PCAST comprises a group from academia, industry, and other entities 
with experience in leading successful science and technology 
enterprises. My remarks today are my own, but based on my conversations 
with fellow PCAST members, I am confident that they feel similarly on 
the issues under discussion today.
    As part of its second review, PCAST is taking a close look at the 
environmental, health, and safety (EHS) aspects of the National 
Nanotechnology Initiative (NMI). I co-chair the PCAST subcommittee 
performing that review, along with Nance Dicciani from Honeywell 
Corporation, who brings years of experience in the chemical industry 
and a personal commitment to the importance of responsible development 
of materials. The Council has received input from a wide range of 
perspectives, including from a technical advisory group (or TAG) made 
up of more than 60 leading academic and industry experts from a broad 
cross-section of disciplines related to nanotechnology, including two 
of my co-witnesses here today.
    Based on PCAST discussions and meetings, input from the TAG, and my 
own talks with researchers at universities and in small and large 
companies, the main points I want to make in response to the 
Subcommittee's questions are:

1. The NMI approach for identifying and addressing research needed to 
understand and manage the potential risks associated with engineered 
nanomaterials appears sound and appropriate.

2. Research to understand EHS implications should remain integrated 
with the broader portfolio of nanotechnology R&D.
    It is important to note that the terms ``nanotechnology'' and 
``nanomaterial'' do not refer to a single material or even class of 
materials. Rather, the terms refer to a broad spectrum of engineered 
materials with unique nanoscale-dependent properties. Each individual 
nanomaterial will have a benefit-to-risk ratio that depends on the 
material's specific characteristics and intended application.

Federal investment in nanoscale science and engineering research 
remains money well spent. PCAST's assessments show that the U.S. is a 
leader in nanotechnology research and innovation. Solar cell 
technology, improved materials, energy storage, and medicine are just 
some of the areas sure to reap the benefits--economic and societal--
from nano advances. To do so, there also needs to be investment in 
research for understanding and overcoming--that is, managing or 
designing out--the potential risks. As someone said in a recent PCAST 
discussion, we need to be ``cautious, not precautious.'' My own 
experience at the outset of the semiconductor industry in the 1960s and 
'70s taught me that EHS risks are part of any new technology. But they 
are risks that can be addressed.
    Already, research is shedding light on some of the questions being 
asked. Specifically, a study at Purdue on the environmental impact of 
manufactured nanoparticles on ordinary soil showed no negative effects; 
Georgia Tech scientists are doing similar work. Researchers at Dayton 
University are working on the health and safety aspects of the use of 
nanodiamonds as drug delivery vehicles with encouraging results. 
University of Oregon chemists are looking at the use of nanomaterials 
to clean up toxic groundwater contaminants that have until now been 
difficult to remove. In vivo tests at Rice University have found no 
immediate adverse health effects from carbon nanotubes injected 
directly into the bloodstream and that the liver seems to collect these 
materials effectively for excretion. These and many other studies are 
increasing the body of knowledge on EHS implications and 
providing,useful information on the responsible use of various 
nanomaterials. The collection and dissemination of this research is an 
important essential function of the NNI, as noted in our first report.
    Our TAG survey shows broad consensus with respect to the role of 
the Federal Government in supporting nanotechnology-related EHS 
research. The majority of respondents are eager to see the NNI continue 
its pro-active approach and expand research support.

The interagency approach is effective. I have reviewed the September 
2006 report (EHS Research Needs for Engineered Nanoscale Materials), as 
well as the more recently released interim document, prioritizing the 
needs. These documents cast the wide net necessary to address the array 
of nanotechnology-related EHS issues and are good descriptions of the 
broad research needs. Thus, I believe the interagency process will lead 
to a sound research strategy. Some have called for there to be a 
separate office established to plan and fund EHS research related to 
nanotechnology. While this might provide a sense of stronger 
management, I do not believe that it is the best way to reduce 
uncertainty about potential risks to health or the environment. As I 
mentioned earlier, the field of ``nano'' is broad and the risk-benefit 
assessment is complex. The best way to address this complexity is by 
utilizing all of the expertise of the federal agencies in a coordinated 
fashion. The National Nanotechnology Coordination Office and the 
interagency NEHI Working Group appear to be the optimal approach at 
this time. Creating a separate office would not just add bureaucracy, 
it would risk losing the collaborative community of experts from 
agencies like EPA, FDA, NIOSH, NIST, and NIH.

Funding increases for EHS research across the federal agencies are of 
the right scale and indicate a steady increase in capacity to conduct 
the necessary research. Funding increases (from $38M in 2006 to $59M 
requested in 2008) are encouraging and indicate a steady increase in 
capacity. In general, increasing funding too rapidly does not lead to 
equivalent increases in high quality research. It is crucial to note 
that EHS research also depends on advances in non-EHS areas, such as 
instrumentation development and basic research on nanomaterials.

Development of nanotechnology in a responsible manner, especially at 
the early stages, will be expedited by integration of EHS research with 
broader basic and applied research. The NNI should continue to fund 
cutting-edge research in all areas, including for EHS. Applications-
oriented research may well lead to information about EHS. Rather than 
setting arbitrary funding levels or percentages of total spending as a 
guideline for the EHS budget, NNI agencies should focus on addressing 
the identified EHS research priorities while at the same time investing 
in world-class applications research. In addition, the NNI agencies 
should continue their efforts to coordinate the entire portfolio of 
applications and implications research to leverage and optimize 
progress in both.
    In summary, at this point in our review, I am pleased with the 
amount of coordination taking place among the agencies through the NNI. 
Their approach appears to leverage the expertise and related efforts 
across the government (e.g., work to assess risks of diesel, exhaust 
and other incidental nanomaterials).
    I expect the current planning and coordination process will lead to 
a well thought out plan for nanotechnology EHS research across NNI 
member agencies. While there is much to be done, the process is not 
broken. In fact, the coordination process used at the NNCO and the 
similar process used to manage Networking and Information Technology 
Research and Development are so effective, they could well be 
considered models for similar coordination in fields such as K-12 
education where spending for hundreds of programs is spread over many 
agencies without any formal mechanism whereby the spending agencies 
might be informed of activities in their sister government departments.
    The Council is eager to see the final nanotechnology EHS research 
strategy, and strongly encourages the Nanotechnology Environmental and 
Health Implications working group (NEHI) to complete its work as 
expeditiously as possible--hopefully in time for an assessment in our 
upcoming report.

                      Biography of E. Floyd Kvamme
    Floyd Kvamme is a Partner at Kleiner Perkins Caufield & Byers, a 
high technology venture capital firm. He is responsible for the 
development of high technology companies from early start-up to 
publicly traded phase. Mr. Kvamme currently serves on the boards of 
Brio Technology, Gemfire, Harmonic, National Semiconductor, Photon 
Dynamics, Power Integrations, and Silicon Genesis. Mr. Kvamme was one 
of five members of the team that began at National Semiconductor in 
1967, serving as its General Manager of Semiconductor Operations and 
building it into a billion-dollar company. He served as President of 
the National Advanced Systems subsidiary, which designed, manufactured 
and marketed large computer systems. In 1982 he became Executive Vice 
President of Sales and Marketing for Apple Computer. While at Apple, 
his responsibilities included worldwide sales, marketing, distribution 
and support. He holds two degrees in Engineering; a BS in Electrical 
Engineering from the University of California at Berkeley and an MSE 
specializing in Semiconductor Electronics from Syracuse University.

    Chairman Baird. Thank you, Mr. Kvamme. I want to 
acknowledge the presence of Ms. Hooley from Oregon who has been 
a strong leader in nanotechnology issues. Also welcome back to 
our Committee Ms. Johnson from Texas. It is good to have you 
back. And also I would like to at this time to ask you now for 
unanimous consent to the gentleman from California, Mr. Honda, 
to join us without objection.
    Thank you. We will return to the witnesses now. Dr. Colvin, 
please.

 STATEMENT OF DR. VICKI L. COLVIN, PROFESSOR OF CHEMISTRY AND 
CHEMICAL ENGINEERING; EXECUTIVE DIRECTOR, INTERNATIONAL COUNCIL 
    ON NANOTECHNOLOGY; DIRECTOR, CENTER FOR BIOLOGICAL AND 
         ENVIRONMENTAL NANOTECHNOLOGY, RICE UNIVERSITY

    Dr. Colvin. Thank you, Mr. Chairman, and Members of the 
Committee for the opportunity to speak today about the 
environmental, health, and safety research needs for 
nanotechnology. Today I am providing my individual opinions, 
but they have been informed by my association with the 
International Council on Nanotechnology, or ICON. This 
organization based at Rice University is a public-private 
partnership founded on the principle that multi-stakeholder, 
international collaboration is an essential ingredient for 
effective risk management of nanotechnology. As its executive 
director, it is my great honor to work with its director, 
Kristen Kulinowski, and our many volunteers from around the 
world on projects ranging from a free, searchable database of 
EHS research papers to a survey of current practices for 
nanoparticle handling in the workplace.
    ICON's most recent activity has been an EHS research needs 
project funded in part by the National Science Foundation. We 
have used the global reach of our volunteers to recruit diverse 
stakeholders to international workshops where we asked them to 
assess the research needs for nano-EHS.
    Given this background and my own experience as a practicing 
scientist and director of NSF Center for Biological and 
Environmental Nanotechnology, I will comment on the latest NNI 
document concerning nano-EHS research.
    I commend the NEHI Working Group for its prioritization of 
the research needs in this area. I know that couldn't have been 
an easy process, and the deliberations were necessary. There is 
an urgency to nano-EHS research that affects the entire NNI 
investment. Innovation in nanotechnology is being threatened by 
the uncertainty about its risks. We need this innovation more 
than ever right now. Nanotechnologies offer new approaches to 
curing cancer and cleaning water and maybe will even enable 
energy independence for our country. But fewer of these 
transformative technologies will make it into commerce if the 
technology transfer pipeline is limited by concerns about 
nanoproduct safety. This problem cannot be solved by increasing 
the inputs to the pipeline, nor should it be addressed by 
relaxing regulatory oversight. The only sure fix is high 
quality and intelligently packaged risk-related information. To 
create such information, researchers must start work soon and 
under the guidance of a federal research strategy that is in 
place no later than 2008.
    Going from a climate of uncertainty to one of confidence in 
managing nanotechnology's risks is a massive undertaking that 
will take years to fully develop. It requires careful planning, 
coordination among agencies, and international cooperation. 
External advisors included as partners in the NNI planning 
process could accelerate the pace as well as make the effort 
more integrated internationally.
    The current NNI document as is clear from its title is not 
a strategic plan but a collection of priority research needs. 
These needs are grouped by not how they connect to some end 
objective but by the relationship to agency missions. The 
cross-cutting issues of nano-EHS do not map well onto single 
agencies, and this presentation left me uncertain that there 
were any shared goals driving the federal investment. I 
recommend that specific research priorities be grouped so as to 
link them to two, maybe three concrete outcomes which have 
clear relevance to developing safe nanotechnology.
    One example of such an outcome is the predictive model for 
nanotechnology risk. During our ICON workshops, we found this 
outcome had broad appeal to everyone, regulators, academics, 
and industry alike. This is because the old ways of managing 
risk are not easily adapted to nanotechnology. Nanomaterials 
can come in millions of different sizes and shapes and surfaces 
and chemical types. Faced with such immense variety, we can't 
just expect to apply new risk assessment for each new flavor of 
nanomaterial. Instead, we have to explore the latest tools of 
21st-Century biology to move from observations of nanoparticles 
hazards to a paradigm that seeks to predict these hazards 
before a material is even created. Such predictive simulations 
are a long-term grand challenge for nanotechnology risk 
research, but to develop them requires near-term, more 
pedestrian activities focused on unifying researchers' 
terminology, methods, data structures, and even materials. I 
loosely refer to these as harmonization tools, and with the 
exception of reference materials, these needs did not make it 
into the top 25 list in the latest NNI analysis. At the ICON 
workshops, these took center stage in our discussion. Most 
participants felt that these tools were a prerequisite for 
nano-EHS research and should receive immediate priority.
    To understand why this issue is so important, consider the 
difference between investing in applications versus risk 
research. In the first case, you might find five different 
teams to build a better battery, each with its own approach; 
but in the end, you help your cause even if only one team 
succeeds. In the second case, if you find five teams to help 
understand nanotube toxicity, for example, and then get five 
different answers, your research investment actually hurts you 
because it creates uncertainty rather than combating it. The 
bad news is that by my count, we have way over five different 
opinions about carbon nanotube toxicity right now. The good 
news is that the U.S. Government can, if it is thoughtful about 
the mechanisms, help researchers solve this problem and for 
relatively low cost.
    In conclusion, I look forward to the rapid development of 
the NNI's strategic plan for nanotech EHS research. Breaking 
down risk research into several concrete outcomes, such as 
predictive simulations, will help to rally the scientific 
community and create an effective strategy. Perhaps the first 
step along the path will be programs that encourage researchers 
to adopt a common set of tools for risk research. These 
developments would create confidence that we are on a path 
towards understanding nanotechnology's risks and spread the 
doors open for safe nanotechnology innovation.
    Thank you.
    [The prepared statement of Dr. Colvin follows:]
                 Prepared Statement of Vicki L. Colvin

Summary

    I am Executive Director of the multi-stakeholder International 
Council on Nanotechnology (ICON), and director of a federal research 
center in nanotechnology, and these roles have informed my opinions of 
the Federal Government's approach to nanotechnology risk research. I 
commend the Nanotechnology Environmental and Health Implications (NEHI) 
working group for its effort to identify and prioritize the research 
needs in this area. The urgency to nano-EHS research affects the entire 
NNI investment. This group should provide a full strategic plan within 
a year, and engage a broader community in authoring this document. The 
apparent agency boundaries that are currently used to classify the 
research needs should be removed, and instead these needs should be 
grouped and linked to larger unifying objectives--such as the 
development of predictive models for nanomaterial's impacts on the 
environment. These organizing goals should be described so that it is 
clear how they help transition us from a climate of uncertainty with 
regards to nanotechnology's risks to one of confidence. Finally, the 
NEHI prioritization misses the critical needs related to uniform 
methods, data structures and languages for nanotechnology risk 
researchers. There should be a clear plan to support the research 
harmonization activities so that the policy-makers can extract--within 
a few years--consensus answers to key questions in this research area. 
These developments would create confidence that we're on a path towards 
understanding nanotechnology's risks, and keep the pipeline for 
nanotechnology wide open for innovations.

    Thank you Mr. Chairman and Members of the Committee for the 
opportunity to speak about the environmental, health and safety (EHS) 
research needs for nanotechnology. Today, I am providing my individual 
opinions, but they have been informed by my association with the 
International Council on Nanotechnology (ICON). ICON was established in 
2004 by a coalition of academics, non-governmental organizations, 
industry and governments. This organization, based at Rice University, 
is a public-private partnership founded on the principle that multi-
stakeholder, international collaboration is an essential ingredient for 
effective risk management of nanotechnology. As its Executive Director, 
it is my great honor to work with its Director, Kristen Kulinowski, and 
our many volunteers from around the world on projects ranging from a 
free, searchable database of EHS research papers to a survey of current 
practices for nanoparticle handling in the workplace.
    ICON's most recent effort is an international research needs 
assessment project--funded in part by the National Science Foundation 
(NSF). We have used the global reach of our volunteers to recruit 
diverse stakeholders to international workshops, where we asked them to 
assess the research needs for nanotechnology EHS. The first step in 
this process is to evaluate known information about these connections 
and identify where resources should be directed to address knowledge 
gaps. The ultimate goal envisioned by this project is the design of 
biocompatible and environmentally benign nanomaterials through the 
development of a framework that enables prediction of interactions 
based on physicochemical properties of engineered nanoparticles. The 
framework contains priorities to enable improved risk assessment over 
time as new nanomaterials or applications are developed. Armed with 
this knowledge, we can work together to develop safe applications of 
nanoscale materials or, in cases where the risks are too great, an 
alternative to their use.
    Given this background, and my own experiences as a practicing 
nanotechnologist and Director of the NSF Center for Biological and 
Environmental Nanotechnology, I will comment on the latest National 
Nanotechnology Initiative (NNI) document concerning nano-EHS research 
needs.
    I commend the Nanotechnology Environmental and Health Implications 
(NEHI) working group for its effort to identify the research needs in 
this area; however, there is an urgency to nano-EHS research that 
affects the entire NNI investment. Innovation in nanotechnology is 
being threatened by the uncertainty about its risks and how government 
will manage them. We need this innovation more than ever right now. 
Nanotechnologies offer new approaches to treating cancer and cleaning 
water, and may enable energy independence for our country; but fewer of 
these transformative technologies will make it into commerce if the 
technology transfer pipeline becomes clogged by concerns about 
nanoproduct safety. This problem cannot be solved by increasing the 
inputs to the pipeline, nor should it be addressed by relaxing 
regulatory oversight. The only sure fix is high quality and 
intelligently packaged risk-related information.
    Going from a climate of uncertainty to one of confidence in 
managing nanotechnology risk is a massive undertaking that will take 
years to fully develop. It will also take careful planning and 
coordination among agencies in this government and abroad. The 2007 
NEHI report is an important first step towards creating a coherent and 
effective strategy for nanotechnology's EHS research, but by summer of 
2008 there should be a full and detailed strategic plan made available. 
As it makes clear in its title, this report is not a strategy. The 
steps proposed to getting to a strategy are reasonable and 
deliberative; however, I would recommend sacrificing some of them (the 
gap analysis for example) because of the urgency of this issue.

Break down barriers between agencies

    The NEHI working group could greatly improve future documents by 
working to break down the apparent agency boundaries that define its 
approach to this area. The needs in this area are all cross-agency, and 
an effective strategic plan cannot look like it was created by agency 
silos. It appears that the various sections of the report were authored 
in large part by agencies working separately from one another. Section 
2, for example, is clearly related to the NIST mission; section 3 to 
the NIH mission and section 4 to the EPA mission; sections 5 and 6 to 
NIOSH. Also, it is not clear that each agency should get five 
priorities; some agency activities need to be greater in scope in the 
beginning and taper towards the end of the program for example.
    A missing agency in this discussion is the Department of Energy 
(DOE). DOE has a large investment in nanotechnology through its network 
of nanotechnology facilities, and is thus an immediate customer for 
information about risk management in a research setting. Moreover, the 
DOE has enormous capability for particulate and molecular contaminant 
transport in air, water and soil, with unparalleled experimental and 
computational capacity. In addition, DOE manages existing programs that 
seek to understand how nature both produces and uses natural 
nanoparticles and this perspective is of great value in risk research. 
For all of these reasons DOE should be a more active participant in the 
planning process. Like any agency, it should not receive any unfunded 
mandates. However, I believe that in the area of environmental exposure 
(fate, transport and modeling) of nanoparticles it is a key partner.
    Also apparently missing is the role of the National Science 
Foundation in nanotechnology risk research. Currently, NSF is the 
single largest funder of nano-EHS research among the agencies; while 
risk research is not as clearly connected to NSF's mission, I would 
argue that this investment is an excellent one for both nanotechnology 
and fundamental science. In particular, the challenge of predicting the 
interactions of nanomaterials with the environment is one that will 
bring together new disciplines in computational biology and 
bioinformatics--disciplines nurtured in large part by the NSF.

A strategic plan needs several unifying objectives

    The prioritization document provides 20,000 foot agency-specific 
views of this problem, but it never brings these together into a 50,000 
foot view of exactly how each research need will transition us from a 
climate of uncertainty to one of confidence. I believe this disconnect 
may exist because of the silo approach to writing this report; this 
division is not a general feature of the NNI and risk research, and I 
note with great appreciation the productive coordination among EPA, 
NSF, NIOSH and NIH already with respect to current funding in the area. 
These agencies know how to work together, they just didn't convey that 
fact very effectively in this current report. As a result of this, the 
overall document left me without a sense of the shared objectives that 
will drive the program. The ultimate strategic plan must be structured 
by two, maybe three, overarching outcomes that stakeholders agree will 
give us more confidence in managing risks.
    During our ICON workshops, we structured debate around the shared 
objective of predictive models for nanotechnology risk. There was great 
enthusiasm for framing the problem this way among scientists with 
research and regulatory missions alike. Nanotechnology throws a curve 
ball at conventional risk assessment, which is designed to evaluate the 
risk of a single substance like DDT. Its basic materials can be created 
with millions of possible variations of different sizes, shapes, 
surfaces and chemical type. Faced with such variety, we can't just 
apply a risk tool over and over again. Instead, we have to predict 
based on measurable properties how nanomaterials might move into 
organisms, and to then use informatics models to link their presence to 
an impact such as toxicity. Such a concrete outcome is the best 
starting point for the NNI's planning process.

Engage external stakeholders in developing Grand Challenges for Nano-
                    EHS Research

    The NEHI's work would benefit greatly from a more open process that 
engaged external advisors not only as commenters on the document, but 
also as authors. This report was made available for public comment for 
one month, and comments were restricted to the `principles used for 
prioritization,' not the actual priorities. The NEHI would benefit 
greatly from convening external advisors for the next stage of the 
process; in the least, this engagement could accelerate the drafting of 
the full plan. I would point to the NNI grand challenge workshops 
(2000-2003) as a model for this activity. These events drew researchers 
from all sectors together to draft the language of `grand challenges' 
in area of nanotechnology related to information sciences, biology, 
materials and manufacturing as well as environment. Reports from these 
meetings often included prioritization of issues and in some cases 
rather detailed plans about how best to proceed with research in the 
area. I think especially for this topic that engagement of multiple 
stakeholder groups is essential. The NNI should hold `Grand Challenge 
for Nanotechnology Risk Research' workshops and structure them in such 
a way as to directly input into their planning--and convey that 
structure to the participants. Engaging external advisors as real 
partners in the planning process should accelerate the pace of this 
activity and ensure the planning document is well integrated with other 
global efforts.

Support harmonization of language, methods and materials

    Finally, there should be a clear plan to support activities devoted 
generally to harmonizing researchers' languages, methods and materials. 
These issues were mentioned in 2006, but this year only a need for 
reference materials made the cut. At the ICON workshops, it was hard to 
get participants to stop complaining about how the lack of standard 
terminology, data structures, methods and reference materials made 
their research slower and less conclusive. Overwhelmingly, participants 
agreed that harmonizing research methods was a critical first step in a 
global nano-EHS research effort.
    To understand why this issue is so important consider the 
difference between funding applications research versus risk research. 
In the first case you might fund five teams to build a better battery, 
each with its own approach, but in the end you get what you want if 
only one team manages to improve the battery. In the second case, if 
you fund five teams to help understand nanotube toxicity and they get 
five different answers you are actually worse off because your research 
creates uncertainty rather than combating it. Unfortunately, such 
dissonance in the technical literature is normal for new types of 
science and what we are trying to measure (nanotechnology's risks) is 
very challenging. We researchers cannot really tackle the problem until 
we have a mechanism to deliberate, argue and ultimately agree on what 
to call nanomaterials and what protocols to follow in doing the risk 
research.
    The harmonization that I envision will not mean that there will be 
consensus among the technical community on elements of nanotechnology's 
hazard and exposure; rather, that we will reach consensus faster 
because we will not be arguing through the slow channels of peer-review 
about methods and language. The most important features of this 
harmonization activity are that it must result in voluntary practices, 
designed by the active researchers in nano-EHS through a collaborative 
and consensus process. Top-down and mandatory instructions about how 
best to collect data, organize it or report would be a disaster. A 
great model, mentioned in the NNI's 2006 report on nano-EHS needs, are 
the MIAME standards for protein arrays; these are driven by researchers 
and NIH had the good sense to fund workshops and a website to keep them 
updated. To get this started for nanotechnology would require a good 
nano-EHS network of researchers; NSF has examples of network funding 
for community building in other areas. This community would convene a 
few workshops, use the electronic data-sharing possible via the web, 
and perhaps contract the services of a technical writer. Round robin 
tests of methods and materials would follow from any uniform practices 
that emerge in a Phase 2 of the harmonization program.
    It is important to realize that the standardization efforts 
underway at ASTM and ISO are not equivalent to what I am referring to a 
research harmonization. I chair the ASTM E56 committee on 
nanotechnology and over the past few years have developed a good 
familiarity with international standardization. I have enormous respect 
for these processes, but they are poorly suited for the task I 
envision. First, academics are not traditionally represented in these 
activities. Indeed, I am one of the few academics actively involved in 
nanotechnology standardization and I cannot see that changing. Second, 
research harmonization could in principle happen over the span of nine 
months and several workshops; even a straightforward ASTM standard 
could take two years. Third, there are real issues with international 
participation in either ASTM or other standard developing 
organizations, including the International Organization for 
Standardization (ISO). U.S. scientists can only write standards by 
being on ASTM (unless they are nominated to the U.S. technical advisory 
group to ISO), and foreign scientists are usually expected to 
participate in their national standards activities--to which ASTM is a 
competitor. Fourth, international standardization is highly politicized 
and any document takes on legal and commercial scrutiny that is out of 
place when researchers are discussing the nitty gritty details of 
evaluating cell death, for example. Finally--and most problematic--
standards documents from ASTM and ISO are copyrighted and expensive. 
The research harmonization documents need to be freely available to 
anyone with a computer--they have to be easy to use and access.
    It may be that the research harmonization documents could serve as 
starting points for more formal standardization in ASTM, ISO or 
elsewhere. In this model, research harmonization activities would be a 
precursor not a competitor for formal standardization processes; in 
this way, they could better serve the immediate needs of the research 
community.

Conclusion

    In conclusion, I hope that the NNI can quickly, with external 
input, develop a detailed strategic plan. Breaking down risk research 
into several concrete outcomes--such as predictive simulations--will 
help to rally the scientific community and create public confidence in 
existing and new nanoproducts. Perhaps the first step will be programs 
that catalyze the research community to develop and adopt common 
practices for nanotechnology risk research. These developments would 
create confidence that we're on a path towards understanding 
nanotechnology's risks, and keep the pipeline for nanotechnology 
innovation flowing.

International Nano-EHS Research Needs Assessment: A Preview of Reports 
                           from Two Workshops

    ICON sponsored two workshops this year to discuss the research 
needed to enable prediction of nanomaterial impacts. The first 
workshop, held at the National Institutes of Health campus in Bethesda, 
MD, in January, tested whether nanomaterial composition was a 
reasonable way to begin classifying nanomaterials for predictive 
purposes and where in the life cycle of a given class of nanoparticle 
there might be high exposure potential. However, the dynamic nature of 
nanomaterials throughout their life cycle presents challenges for using 
physicochemical properties as predictors of biological behavior. 
Workshop participants identified the need for a set of screening tools 
to correlate the functional properties of nanomaterials--i.e., how they 
behave rather than what they are made of--to determine potential for 
bio-interaction. These tools do not exist today.
    The second workshop, held at the Centre for Global Dialogue in 
Ruschlikon, Switzerland in June, focused on the mechanisms by which 
engineered nanomaterials interact with biological organisms--including 
oxidative stress, inflammation and immune response, protein misfolding, 
apoptosis and necrosis, genotoxicity and mutagenicity, and 
developmental effects--and interactions between engineered 
nanomaterials and in vitro and in vivo systems at the level of 
biological molecules, target cells, tissues and whole animals. Workshop 
participants identified a need to understand what happens to a 
nanoparticle when it enters a biological organism and becomes coated 
with biomolecules in a complex and dynamic manner that is still poorly 
understood. Tools for characterizing these coatings, for tracking 
certain types of nanoparticles throughout the body, and for correlating 
cell-culture studies with impacts in whole organisms are all 
outstanding challenges.
    Some themes that cut across both workshops were the need for 
standard terminology, a robust library of standard reference materials 
for use in nano-EHS research, a set of toxicology tools that have been 
validated for use with nanomaterials, and a better understanding of how 
dose and dose rate impact toxicity for nanomaterials. All these needs 
were seen as limiting the research community's ability to develop 
predictive models for the interactions of nanomaterials with humans and 
the environment.
    The workshops were enabled by funding from the National Science 
Foundation (BES-0646107) with generous in-kind support from the 
National Institutes of Health and the Swiss Reinsurance Company. The 
final report is in preparation and will be made available at http://
icon.rice.edu.

                     Biography for Vicki L. Colvin
    Dr. Vicki Colvin received her Bachelor's degree in chemistry and 
physics from Stanford University in 1988, and in 1994 obtained her 
Ph.D. in chemistry from the University of California, Berkeley, where 
she worked under the guidance of Dr. Paul Alivisatos. During her time 
at the University of California, Berkeley, Colvin was awarded the 
American Chemical Society's Victor K. LaMer Award for her work in 
colloid and surface chemistry. Colvin completed her postdoctoral work 
at AT&T Bell Labs.
    In 1996, Colvin was recruited by Rice University to expand its 
nanotechnology program. Today, she serves as Professor of Chemistry and 
Chemical & Biomolecular Engineering at Rice University, as well as 
Director of its Center for Biological and Environmental Nanotechnology 
(CBEN). CBEN was one of the Nation's first Nanoscience and Engineering 
Centers funded by the National Science Foundation. One of CBEN's 
primary areas of interest is the application of nanotechnology to the 
environment.
    Colvin has received numerous accolades for her teaching abilities, 
including Phi Beta Kappa's Teaching Prize for 1998-1999 and the Camille 
Dreyfus Teacher Scholar Award in 2002. In 2002, she was also named one 
of Discover Magazine's ``Top 20 Scientists to Watch'' and received an 
Alfred P. Sloan Fellowship. Her research in low-field magnetic 
separation of nanocrystals was named Top Five (no. 2 of 5) Nanotech 
Breakthroughs of 2006 by Forbes/Wolfe Nanotech Report.
    Colvin is also a frequent contributor to Science, Advanced 
Materials, Physical Review Letters and other peer-reviewed journals, 
having authored/ co-authored over 75 articles, and holds patents to 
four inventions.

    Chairman Baird. We have just now been joined by Dr. 
Bartlett. Dr. Bartlett, thank you for being here with us. Dr. 
Maynard?

  STATEMENT OF DR. ANDREW D. MAYNARD, CHIEF SCIENCE ADVISOR, 
     PROJECT ON EMERGING NANOTECHNOLOGIES, WOODROW WILSON 
      INTERNATIONAL CENTER FOR SCHOLARS, WASHINGTON, D.C.

    Dr. Maynard. Thank you, Mr. Chairman, Ranking Member 
Ehlers, and Members of this committee. My name is Dr. Andrew 
Maynard. I'm the Chief Science Advisor to the Project on 
Emerging Nanotechnologies which is a partnership between the 
Woodrow Wilson International Center for Scholars and the Pew 
Charitable Trusts. But of course, the views I express here are 
my own.
    A few years ago, nanotechnology was little more than the 
stuff of scientists' dreams. Yet now it is being used more and 
more within the products we use every day, and the 
nanomaterials that make up these products are available for 
anyone to buy and use.
    I want to give you an example of that and very topical 
after Vicki's comments. I have here a pouch of single-wall 
carbon nanotubes bought over the Internet. You can see they 
came in a USPS envelope. Anybody with a credit card can buy 
this product, and they can buy it in quantities from a few 
grams up to thousands of kilograms.
    Now, we live in a society where materials like this are 
becoming more and more available, and the question continues to 
arise, are we doing enough to ensure the safety of these 
materials?
    I just want to focus a little bit more on this particular 
example, so take these carbon nanotubes. If you look at the 
safety information which is provided by the company, the 
manufacturer's materials safety data sheet, this material is 
graphite, nothing more than the lead in my pencil. And the 
listed health precautions are really no more than you would 
have for nuisance dust. But under closer examination, these 
carbon nanotubes are as similar to pencil lead as the soot on 
my grill at home is to diamonds. Let me just read you something 
that a group of experts wrote in the journal Nature last year, 
and this was an article where Vicki was one of my co-authors. I 
am quoting here from this article. ``Although it is not clear 
whether fiber-shaped nanoscale particles from carbon 
nanomaterials will behave like asbestos or not, some materials 
are sufficiently similar to cause concern. Any failure to pick 
up asbestos-like behavior as early as possible will be 
potentially devastating to the health of exposed people and to 
the future of the nanotechnology industry.''
    I think you can see, as this particular example eloquently 
demonstrates, there is a yawning knowledge gap between 
nanomaterials entering commerce now and what we know about 
their safety. And this uncertainty over how to develop 
nanotechnology safely is hamstringing regulators, paralyzing 
nanobusinesses, and confusing consumers.
    So how do we bridge this gap? Well, in my written comments, 
I consider what we need to do to move forward and how the 
government's actions match up to this. But in the interest of 
time, let me cut to the chase here and give you the top six 
recommendations arising from this assessment.
    First of all, we need a top-down research strategy by the 
end of this year at the latest, and this must respond to 
oversight challenges and it must be backed up with authority 
and resources to ensure its implementation. As part of this 
strategy, we desperately need a federal advisory committee to 
be established to allow transparent input and review from 
industry, academia, non-government organizations, and other 
stakeholders.
    Secondly, new mechanisms are needed to make a strategic 
plan work. These must overcome both institutional and 
scientific barriers and ensure resources go to where they're 
needed to get the job done. They must empower agencies to do 
what they do best, and they must prevent resources being 
squandered on research which is both ill-conceived and 
irrelevant.
    Third, 10 percent of the Federal Government's 
nanotechnology R&D budget should be dedicated to goal-oriented 
nanotechnology EHS research. And looking at this, a minimum of 
$50 million per year should go to targeted research that 
directly addresses specific strategic challenges. The balance 
of funding should support exploratory or basic research that is 
conducted within the scope of a strategic research program.
    Fourth, a public-private partnership should be established 
to address critical research questions. This should enable 
goal-driven research in support of government and industry 
oversight and a commitment of $10 million per year for the next 
five years sought split evenly between government and industry.
    Fifth, a targeted program of public engagement on 
nanotechnology should be established that ensures two-way 
communication between the developers of these technologies and 
the users.
    And finally, top-level leadership of a single person within 
the Federal Government is needed to ensure appropriate action 
is taken in addressing these issues.
    Members of the National Nanotechnology Initiative have 
great intentions to do the right thing, and I think we have 
already heard that. But considering what is at stake here, the 
quality of our environment, the vitality of the American 
economy, and the health of people like you and people like me, 
good intentions are simply not enough. It is vital that we take 
action now to ensure a world where we cannot only buy 
engineered nanomaterials like these carbon nanotubes, but we 
can also use them without fear of harm.
    Thank you.
    [The prepared statement of Dr. Maynard follows:]
                Prepared Statement of Andrew D. Maynard

Overview

    I would like to thank Chairman Bart Gordon, Ranking Republican 
member Ralph Hall, and the Members of the House Committee on Science 
for holding this hearing on ``Research on Environmental and Safety 
Impacts of Nanotechnology: Current Status of Planning and 
Implementation under the National Nanotechnology Initiative.''
    My name is Dr. Andrew Maynard. I am the Chief Science Advisor to 
the Project on Emerging Nanotechnologies at the Woodrow Wilson 
International Center for Scholars. By way of background, my area of 
expertise is nanomaterials and their environmental and health impacts, 
and I have contributed substantially in the past fifteen years to the 
scientific understanding of how these materials might lead to new or 
different environmental and health risks. I was responsible for 
stimulating government research programs into the occupational health 
impact of nanomaterials in Britain towards the end of the 1990's and 
spent five years developing and coordinating research programs at the 
Centers for Disease Control and Prevention (CDC) National Institute for 
Occupational Safety and Health (NIOSH) that address the safety of 
nanotechnologies in the workplace. While at NIOSH, I represented the 
agency on the Nanoscale Science, Engineering and Technology (NSET) 
Subcommittee of the National Science and Technology Council (NSTC), and 
was Co-Chair of the Nanotechnology Environmental and Health 
Implications (NEHI) Working Group from its inception.
    In my current role as Chief Science Advisor to the Project on 
Emerging Nanotechnologies, I am heavily involved in working with 
government, industry and other groups to find science-based solutions 
to the challenges of developing nanotechnologies safely and 
effectively. The Project on Emerging Nanotechnologies is an initiative 
launched by the Woodrow Wilson International Center for Scholars and 
The Pew Charitable Trusts in 2005.\1\ It is dedicated to helping 
business, government and the public anticipate and manage the possible 
health and environmental implications of nanotechnology. As part of the 
Wilson Center, the Project is a non-partisan, non-advocacy policy 
organization that works with researchers, government, industry, non-
governmental organizations (NGOs), and others to find the best possible 
solutions to developing responsible, beneficial and acceptable 
nanotechnologies. The opinions expressed in this testimony are my own, 
and do not necessarily reflect views of the Wilson Center or The Pew 
Charitable Trusts.
---------------------------------------------------------------------------
    \1\ For further information, see http://www.nanotechproject.org/. 
Accessed October 13, 2007.
---------------------------------------------------------------------------
    In this testimony, I explore why we need to address the 
Environmental, Health and Safety (EHS) aspects of nanotechnology, and 
what in my perspective are key components of an effective research 
strategy. I then look at where current National Nanotechnology 
Initiative (NNI) actions and plans align with or diverge from what is 
needed, and draw clear recommendations on how we can get back on track 
to realizing the promise of nanotechnology. Finally, I draw from this 
assessment to address the questions specifically asked by the House 
Science Committee.

Executive Summary

    Nanotechnology has tremendous potential to create wealth and jobs, 
improve standards of living and provide solutions to some of our 
greatest technological challenges. But this potential will not be 
realized unless strategic action is taken to identify, assess and 
manage potential risks before serious harm is caused. Despite a good 
start, the Federal Government's current approach to ensuring the 
development of responsible and successful nanotechnologies falls short 
of the mark. Action in six areas is recommended to get EHS research 
back on track, in support of sustainable and safe nanotechnologies:

        1.  Strategy. A top-level strategic framework should be 
        established by the end of this year at the latest and updated 
        every two years, that identifies the goals of nanotechnology 
        risk research across the Federal Government, and provides a 
        roadmap for achieving these goals. The strategy should identify 
        information needed to regulate and otherwise oversee the safe 
        development and use of nanotechnologies; which agencies will 
        take a lead in addressing specific research challenges; when 
        critical information is needed; and how the research will be 
        funded. It should reflect evolving oversight challenges, and 
        must be backed up with authority and resources to ensure its 
        implementation.

        2.  Mechanisms. Mechanisms are needed to allow a strategic 
        research framework to be implemented. These must transcend 
        institutional and scientific barriers, and ensure resources get 
        to where they are needed to get the job done. They must empower 
        agencies to do work effectively within their missions, but 
        within an overarching strategic framework. And they must 
        prevent resources from being squandered on research that is 
        ill-conceived and irrelevant. A federal advisory committee 
        should be established to allow transparent input and review 
        from industry, academia, non-government organizations and other 
        stakeholders.

        3.  Funding. Ten percent of the Federal Government's 
        nanotechnology research and development budget should be 
        dedicated to goal-oriented EHS research. A minimum of $50 
        million per year should go to targeted research directly 
        addressing clearly-defined strategic challenges. The balance of 
        funding--an estimated $95 million in fiscal year 2008--should 
        support exploratory research that is conducted within the scope 
        of a strategic research program.

        4.  Public-Private Partnerships. A public-private partnership 
        should be established to address critical industry and 
        government-research questions that fall between the gaps. A 
        partnership model should be developed that enables goal-driven 
        research in support of government and industry oversight, and a 
        commitment to $10 million per year for the next five years 
        sought; split evenly between government and industry sources.

        5.  Communication. A targeted program of public engagement on 
        nanotechnology should be established that ensures two-way 
        communication between the developers and users of these 
        technologies. This should be supported by approximately $1 
        million per year in funding. The program should have the 
        fourfold aims of ensuring transparency, disseminating 
        information, enabling science-based dialogue between 
        stakeholders, and supporting informed decision-making by 
        citizens, businesses, regulators, and other stakeholders.

        6.  Leadership. Top-level leadership is needed to ensure the 
        successful development and implementation of a government-wide 
        strategic research framework addressing nanotechnology EHS 
        risks. One person should be appointed to oversee nanotechnology 
        EHS research and regulation within the Federal Government, and 
        given resources and authority to enable funding allocations and 
        interagency partnerships that will support the implementation 
        of a strategic research plan.

    We cannot afford to drive blind into the nanotechnology future. Not 
only will this prevent us from seeing and navigating around the 
inevitable bends associated with possible risks, but it will also give 
those economies with the foresight to identify and negotiate the bends 
a very real competitive edge. Despite a good start, the U.S. is still 
caught up in developing new technologies within an old mindset. If 
emerging nanotechnologies are to be built on a sound understanding of 
the potential risks--and how to avoid them--new research strategies, 
new mechanisms of execution and new funding are all needed. These 
should be overseen by clear leadership and an interagency group with 
the authority to develop a strategic research framework and ensure its 
execution.

What is needed to make nanotechnology work?

    Nanotechnology has the potential to turn our world upside down. The 
increasing dexterity at the nanoscale it provides gives us the 
opportunity to greatly enhance existing technologies, and to develop 
innovative new technologies. When you couple this capability with the 
unusual and sometimes unique behavior of materials that are engineered 
at near-atomic scales, you have the basis for a transformative 
technology that has the potential to impact virtually every aspect of 
our lives. Some of these emerging technologies will benefit 
individuals. Others will help solve pressing societal challenges like 
climate change, access to clean water and cancer treatment. Many will 
provide companies with the competitive edge they need to succeed. In 
all cases, nanotechnology holds within it the potential to improve the 
quality of life and economic success of America and the world beyond.
    But nanotechnology also is shaking up our understanding of what 
makes something harmful and how we deal with that. New engineered 
nanomaterials are prized for their unconventional properties. But these 
same properties may also lead to new ways of causing harm to people and 
the environment.\2\ Research has already demonstrated that some 
engineered nanomaterials can reach places in the body and the 
environment that are usually inaccessible to conventional materials, 
raising the possibility of unanticipated harm arising from unexpected 
exposures. And studies have shown that the toxicity of engineered 
nanomaterials is not always predictable from conventional knowledge.\3\ 
For instance, we now know that nanometer sized particles can move along 
nerve cells; that the high fraction of atoms on the surface of 
nanomaterials can influence their toxicity; and that nanometer-diameter 
particles can initiate protein mis-folding, possibly leading to 
diseases.
---------------------------------------------------------------------------
    \2\ Maynard, A.D., Aitken, R.J., Butz, T., Colvin, V., Donaldson, 
K., Oberdorster, G., Philbert, M.A., Ryan, J., Seaton, A., Stone, V., 
Tinkle, S.S., Tran, L., Walker, N.J. and Warheit, D.B. (2006). Safe 
handling of nanotechnology. Nature 444:267-269.
    \3\ Oberdorster, G., Stone, V. and Donaldson, K. (2007). Toxicology 
of nanoparticles: A historical perspective. Nanotoxicology 1:2-25.
---------------------------------------------------------------------------
    Moving towards the nanotechnology future without a clear 
understanding of the possible risks, and how to manage them, is like 
driving blindfold. The more we are able to see where the bends in the 
road occur, the better we will be able to navigate round them to 
realize safe, sustainable and successful nanotech applications. But to 
see and navigate the bends, requires the foresight provided by sound 
science, and the ability to apply science-informed lessons.
    Twenty-first century technologies like nanotechnology present new 
challenges to identifying and managing risks, and it would be naive to 
assume that twentieth century assumptions and approaches are up to the 
task of protecting health and the environment in all cases. In the case 
of engineered nanomaterials, the importance of physical structure in 
addition to chemical composition in determining behavior is making a 
mockery of our chemicals-based view of risks and regulation.
    Clearly, action is needed to realign how we oversee the safety of 
engineered nanomaterials with how these new materials might cause harm. 
This is a complex, but not impossible, task. A successful plan for 
realizing the benefits of nanotechnology while minimizing the risks 
depends on acknowledging the possibility of unconventional behavior, 
leadership, a strategic plan, mechanisms to put a research strategy 
into practice and sufficient resources to do this. Each of these five 
components are discussed below.

1.  Acknowledging the possibility of unconventional behavior

    Assuming that new technologies will have conventional, predictable 
and manageable risks is a recipe for disaster. Materials that are 
intentionally engineered to behave in unconventional ways will have the 
potential to cause harm in a manner that is not predictable from 
conventional understanding alone. And as a consequence, we cannot 
assume by default that established ways of evaluating and regulating 
risks will prevent these new materials from causing harm.\4\ There 
undoubtedly will be new engineered nanomaterials and nanotechnology 
applications that do not impact health and the environment in an 
unpredictable way. Yet research has already demonstrated the ability of 
some engineered nanomaterials to defy convention, by getting to places 
inaccessible to larger scale materials, and causing harm that would not 
be predicted from a conventional world-view.\5\
---------------------------------------------------------------------------
    \4\ Davies, J.C. (2006). Managing the effects of nanotechnology. 
Woodrow Wilson International Center for Scholars, Project on Emerging 
Nanotechnologies, Washington, DC.
    \5\ Maynard, A., D. (2007). Nanotechnology: The next big thing, or 
much ado about nothing? Ann. Occup. Hyg. 51:1-12.
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    Denying the potential for engineered nanomaterials to cause harm in 
unconventional ways not only flies in the face of common sense; it also 
prevents effective science-based decision-making. Based on the current 
state of knowledge, ways in which nanomaterials might demonstrate 
unconventional behavior include:

          Adverse reactions to exposure that are not 
        predictable from the material's chemical makeup alone.\6\
---------------------------------------------------------------------------
    \6\ Oberdorster, G., Gelein, R.M., Ferin, J. and Weiss, B. (1995). 
Association of particulate air pollution and acute mortality: 
involvement of ultrafine particles? Inhal. Toxicol. 7:111-124.

          An ability to penetrate to parts of the body and the 
        environment that are inaccessible to non-nanomaterials.\7\
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    \7\ Elder, A., Gelein, R., Silva, V., Feikert, T., Opanashuk, L., 
Carter, J., Potter, R., Maynard, A., Finkelstein, J. and Oberdorster, 
G. (2006). Translocation of inhaled ultrafine manganese oxide particles 
to the central nervous system. Environ. Health Perspect. 114:1172-1178.

          The emergence of physical and chemical properties 
        that are not directly predictable from individual atoms, or the 
        bulk material.\8\
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    \8\ Preining, O. (1998). The physical nature of very, very small 
particles and its impact on their behavior. J. Aerosol Sci. 29:481-495.

          A possible ability to interfere with living systems 
        including DNA and proteins that are naturally nanoscale.\9\
---------------------------------------------------------------------------
    \9\ Colvin, V. and Kulinowski, K. (2007). Nanoparticles as 
catalysts for protein fibrillation. Proc. Natl. Acad. Sci. U.S.A. 
doi:10.1073/pnas.0703194104

          An association with diseases not conventionally 
        associated with exposure to non-nanomaterials.\10\
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    \10\ Mills, N.L., Tornqvist, H., Gonzalez, M.C., Vink, E., 
Robinson, S.D., Soderberg, S., Boon, N.A., Donaldson, K., Sandstrom, 
T., Blomberg, A. and Newby, D.E. (2007). Ischemic and Thrombotic 
Effects of Dilute Diesel-Exhaust Inhalation in Men with Coronary Heart 
Disease. New England J. of Med. 357:1075-1082.
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    This knowledge needs to be tempered by the likelihood of exposure 
(or environmental release) occurring, which could be negligible in the 
case of nano-engineered electronics, but might be substantial for a 
range of products designed to be eaten, put on the body or dispersed in 
the environment.

2.  Leadership in nanotechnology EHS research

    Without clear leadership, the emergence of safe nanotechnologies 
will be a happy accident rather than a foregone conclusion.
    In addressing any difficult task or challenge, progress is likely 
to be slow to non-existent if no one provides vision, direction, 
motivation and encouragement for achieving results, and is not held 
accountable for results. And, ensuring the emergence of safe 
nanotechnologies, where the risks are uncertain and the science 
complex, is a fiendishly difficult challenge when seen from any angle.
    Leadership towards the goal of identifying, assessing and managing 
nanotechnology-specific risks will present many challenges. The 
nanotechnology community includes the Federal Government, State 
government, businesses, researchers, non-government organizations and 
consumers, as well as all their international counterparts. Each set of 
stakeholders brings a different set of issues to the table, and a range 
of abilities and skills to address those issues. Effective leadership 
will enable these groups to work effectively toward addressing a common 
goal of ensuring that emerging nanotechnologies are as safe as 
possible.
    The Federal Government is an acknowledged leader in promoting 
nanotechnology research and development, and is looked to for 
leadership in ensuring the emergence of safe nanotechnologies. Yet the 
diverse makeup of the Federal Government and the different (and 
possibly competing) interests of agencies present real challenges to 
developing effective leadership. Communication and collaboration 
between agencies is essential if the Federal Government as a whole is 
to identify and address critical issues underpinning the development of 
safe nanotechnologies. But committees and networks in and of themselves 
do not constitute leadership.
    Could an internal committee--or working group--provide the 
leadership necessary to ensure safe nanotechnologies? Possibly, if it 
was empowered to establish research directions and allocate resources. 
Yet even working groups are only as good as the person leading them. 
And while it is possible for a good committee to direct, encourage and 
motivate people toward addressing a common set of goals, this is more 
often than not a reflection of the ability of the committee's leader to 
direct, encourage and motivate its members. Certainly, a working group 
without leadership is a very ineffective device!
    In short, there must be one individual within the Federal 
Government who is tasked with leading efforts to ensure the safety of 
emerging nanotechnologies, and has the resources and authority to get 
the job done. A key role of such a person would be to ensure agencies 
are able to work within their missions and competencies toward a common 
set of established goals. But he or she would also provide leadership 
to the broader stakeholder community involved--both national and 
international--in developing safe nanotechnologies.

3.  An effective strategic framework

    We are unlikely to arrive at a future where nanotechnology has been 
developed responsibly without a strategic plan for how to get there. 
Like all good strategies, this should include a clear idea of where we 
want to be, and what needs to be done to get there. And if we are 
currently lost, one of the first steps should be to find out where we 
are now.
    Funding for research and development into nanoscience and 
nanotechnologies serves many purposes, including developing knowledge 
for its own intrinsic value, providing a platform for job and wealth 
creation, and improving quality of life. Research into the potential 
impacts of nanotechnologies supports these goals in that they are 
unlikely to be met if we blindly develop new technologies that might, 
or are perceived to, cause unacceptable harm. Yet strategically, the 
goals of risk-related research must be untwined from those driving 
nanotechnology discovery in general, if an effective research agenda is 
to be developed.
    Later in this testimony, I will explore the goals and elements of a 
viable strategic framework for addressing nanotechnology EHS issues. In 
brief, an overarching goal for federally-funded risk-based 
nanotechnology research should be to develop the information necessary 
to identify (or predict), assess and manage risks associated with 
nanotechnologies. Ultimately, this means research directed towards 
effective oversight. A central principle of this goal is science in the 
service of safety, and not science for its own sake.
    Broad challenges to addressing this goal include:

          Providing answers to pressing questions.

          Developing new tools and knowledge to identify the 
        questions not currently being asked.

          Translating research results into practice, and in 
        particular, developing new ways of predicting and managing 
        risks.

    Many of the recommended research needs identified over the past few 
years by a wide range of organizations fit within these challenges, 
including those published by the NEHI group in 2006\11\ (and the 
shorter list released in 2007).\12\ Addressing these challenges within 
the context of a strategic plan will lead to progress towards the 
overarching goal.
---------------------------------------------------------------------------
    \11\ NSET (2006). Environmental, health and safety research needs 
for engineered nanoscale materials. Subcommittee on Nanoscale Science, 
Engineering and Technology, Committee on Technology, National Science 
and Technology Council, Washington, DC.
    \12\ NEHI (2007). Prioritization of Environmental, Safety and 
Health Research Needs for Engineered Nanoscale Materials. An Interim 
Document for Public Comment, Nanotechnology Environment and Health 
Implications (NEHI) Working Group of the Subcommittee on Nanoscale 
Science, Engineering and Technology, Committee on Technology, National 
Science and Technology Council, Washington, DC.
---------------------------------------------------------------------------
    Developing an effective roadmap to addressing these challenges is 
not as simple as prioritizing research needs. As I discovered while 
developing recommendations on a short-term research strategy in 
2006,\13\ it is necessary to work back from what you want to achieve, 
and map out the research steps needed to get there. This inevitably 
leads to complex and intertwined research threads. Yet if this 
complexity is not acknowledged, the result is simplistic research 
priorities that look good on paper, but are ineffective at addressing 
specific aims. And without a clear sense of context, it is all too easy 
to highlight research efforts that appear to be strategically 
important, but are in reality only marginal to achieving the desired 
goals.
---------------------------------------------------------------------------
    \13\ Maynard, A.D. (2006). Nanotechnology: A research strategy for 
addressing risk. Woodrow Wilson International Center for Scholars, 
Project on Emerging Nanotechnologies, Washington, DC.
---------------------------------------------------------------------------
    In developing the elements of a research strategy in the earlier 
2006 paper, and in a commentary published in the journal Nature with 
thirteen distinguished colleagues,\14\ it became clear that an 
effective research strategy addressing potential nanotechnology risks 
will have a number of key elements. These will include:
---------------------------------------------------------------------------
    \14\ See supra note 2.

---------------------------------------------------------------------------
          Goal-oriented research,

          A balance of targeted and exploratory research,

          Interdisciplinary collaboration,

          Enabling and empowering researchers and research 
        organizations, and

          Communication and translation of information.

    Building a top-down strategic nanotechnology EHS research plan 
around these goals, challenges and elements, is essential to providing 
a framework for generating the information that regulators, industry, 
consumers and others need to develop and use nanotechnologies as safely 
as possible.
    As an example of what is possible, Australia recently announced the 
formation of an AU$36.2 million initiative to develop nanotechnologies 
for niche markets--the Niche Manufacturing Flagship.\15\ What sets this 
initiative apart is an integrated approach to EHS research from the 
start, an approach that will lead to products that have been researched 
and designed with safety in mind. And while the Niche Manufacturing 
Flagship approach represents just one component of an effective 
strategic research framework, in the long run, it is products arising 
from programs like this that are most likely to be embraced by 
consumers and industry alike.
---------------------------------------------------------------------------
    \15\ Niche Manufacturing Flagship. http://www.csiro.au/org/
NicheManufacturingFlagshipOverview.html. Accessed October 19, 2007.

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4.  Mechanisms to get the job done

    A strategic research plan that looks good on paper fails at the 
first hurdle if the mechanisms to implement it effectively are not in 
place.
    Administrative mechanisms necessary to get the job done are largely 
covered by the elements of an effective research strategy already 
discussed, and include responsiveness to new challenges, leadership, 
vision, coordination and communication. But while this list is short, 
the challenges to developing administrative approaches that enable a 
top-level federal research strategy to be implemented are substantial. 
In many ways, it is easier to start by looking at what is not 
effective. Relying on individual agency-driven research plans and 
individual investigators to get the job done, for instance, is not 
effective, as leadership, vision, directed funding, coordination and 
communication are lost. Likewise, establishing mechanisms for 
communication and coordination alone is not effective, as there is no 
vision, no targeted resources and no leadership to apply the resulting 
flow of information.
    Instead, mechanisms need to be implemented at the highest level 
that ensure an environment in which agencies with different but 
complementary competencies and missions can operate most effectively. 
Ideally, administrative structures are needed that: provide leadership 
in addressing research challenges across the Federal Government; 
facilitate the strategic sharing and use of information between 
agencies; enable interdisciplinary and interagency partnerships that 
are goal-oriented rather than mission-driven; simplify resource sharing 
between agencies; and allow for new resources to be allocated 
strategically across agencies to address key issues.
    Mechanisms also are needed that support relevant research that is 
not constrained by bureaucratic and organizational barriers. These 
mechanisms will enable different approaches to supporting research to 
be used in the best possible way to address identified research goals--
including using intramural and extramural research as appropriate, and 
balancing applied and exploratory research. It is vital that mechanisms 
continue to be developed that actively encourage interdisciplinary 
research, and provide frameworks where ill-conceived studies resulting 
from inadequate interdisciplinary collaboration are the exception, 
rather than the norm.
    Where research needs fall between the gap of government and 
industry (because of their different goals), public-private research 
partnerships provide an important mechanism for bridging the gaps. 
Industries investing in nanotechnology have a financial stake in 
preventing harm, manufacturing safe products and avoiding long-term 
liabilities. Yet many of the questions that need answering are too 
general to be dealt with easily by industry alone. Perhaps more 
significantly, the credibility of industry-driven risk research is 
often brought into question by the public and NGOs as not being 
sufficiently independent and transparent. For many nanomaterials and 
nanotechnologies, the current state of knowledge is sufficient to cast 
doubt on their safety but lacks the certainty and credibility for 
industry to plan a clear course of action on how to mitigate potential 
risks. Getting out of this ``information trap'' is a dilemma facing 
large and small nanotechnology industries alike.
    One way out of the ``trap'' is to establish a cooperative science 
organization that is tasked with generating independent, credible data 
that will support nanotechnology oversight and product stewardship. 
Such an organization would leverage federal and industry funding to 
support targeted research into assessing and managing potential 
nanotechnology risks. Its success would depend on five key attributes:

          Independence. The selection, direction and evaluation 
        of funded research would have to be science-based and fully 
        independent of the business and views of partners in the 
        organization.

          Transparency. The research, reviews and the 
        operations of the organization should be fully open to public 
        scrutiny.

          Review. Research supported by the organization should 
        be independently and transparently reviewed.

          Communication. Research results should be made 
        publicly accessible and fully and effectively communicated to 
        all relevant parties.

          Relevance. Funded research should have broad 
        relevance to managing the potential risks of nanotechnologies 
        through regulation, product stewardship and other mechanisms.

    As I discussed in my comments to this committee last September,\16\ 
a number of research organizations have been established over the years 
that comply with some of these criteria. One of these is the Health 
Effects Institute (HEI),\17\ which has been highly successful in 
providing high-quality, impartial, and relevant science around the 
issue of air pollution and its health impacts. The Foundation for the 
National Institutes of Health\18\ also has been successful in 
developing effective public-private partnerships, and the International 
Council on Nanotechnology (ICON)\19\ is a third model for bringing 
government, industry and other stakeholders to the table to address 
common goals. The Wilson Center Project on Emerging Nanotechnologies is 
currently exploring these and other models as possible templates for 
public-private partnerships addressing nanotechnology risks.
---------------------------------------------------------------------------
    \16\ United States House of Representatives Committee on Science 
and Technology. Hearing on Research on Environmental and Safety Impacts 
of Nanotechnology: What are Federal Agencies Doing? Testimony of Andrew 
D. Maynard. September 21, 2006.
    \17\ For further information, see The Health Effects Institute, 
http://www.healtheffects.org. Accessed October 13, 2007.
    \18\ For further information, see The Foundation for the National 
Institutes of Health, http://www.fnih.org. Accessed October 13, 2007.
    \19\ For further information, see the International Council On 
Nanotechnology, http://icon.rice.edu/. Accessed October 13, 2007.
---------------------------------------------------------------------------
    Irrespective of which model is the best suited for nanotechnology, 
the need is urgent to develop such partnerships as part of the 
government's strategy to address nanotechnology risks. Nanotechnologies 
are being commercialized rapidly--going from $50 billion in 
manufactured goods in 2006\20\ to a projected $2.6 trillion in 
nanotechnology-enabled manufactured goods by 2014--or 15 percent of 
total manufactured goods globally.\21\ And knowledge about possible 
risks is simply not keeping pace with consumer and industrial 
applications.
---------------------------------------------------------------------------
    \20\ Lux Research (2007). Profiting from International 
Nanotechnology, Report Press Release: Top nations see their lead erode. 
Lux Research Inc., New York, NY.
    \21\ Lux Research (2006). The Nanotech ReportTM: Investment 
Overview and Market Research for Nanotechnology. 4th edition, volume 1. 
Lux Research Inc., New York, NY.

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5.  Sufficient resources to address critical challenges

    To be effective, a nanotechnology risk-research strategic framework 
needs adequate funding to support proposed research, as well as 
sufficient expert personnel to oversee its development and 
implementation.
    In my testimony to this committee on September 21, 2006,\22\ I made 
the case for a minimum of $50 million per year to be spent on relevant 
nanotechnology risk research. This was based on an assessment of 
critical short-term research needs, and only covered targeted research 
to address these needs.\23\ This estimate still stands. However, I must 
be clear that such an investment would need to be directed towards 
addressing a very specific suite of problems that regulators and 
industry need answers to as soon as possible. This is not envisaged as 
a general pot of money to be assigned to research that does not address 
specific and urgent nanotechnology risk goals. In other words, this is 
an investment that needs to be directed towards the right research.
---------------------------------------------------------------------------
    \22\ See supra note 16.
    \23\ See also: supra note 13.
---------------------------------------------------------------------------
    But beyond the $50 million figure, further investment in 
exploratory research is needed to identify the questions we haven't 
thought of yet. It isn't possible to place a firm figure on how much 
should be spent here, but a useful rule of thumb--and one that others 
have advocated--is to ensure that at least 10 percent of the Federal 
Government's nanotechnology research and development budget is 
dedicated to strategic risk-related research. This would place the 
overall estimated EHS research budget for 2008 at $145 million--
allowing for $50 million in targeted research and $95 million dedicated 
to exploratory research. Given the nature of exploratory research, 
which requires substantial investment to make significant progress, 
this does not seem unreasonable.
    Targeted research primarily would address specific questions where 
answers are urgently needed to make, use and dispose of nanotechnology 
products as safely as possible. I would envisage that much of the 
necessary research would be funded by or conducted within mission-
driven agencies, such as NIOSH and the Environmental Protection Agency 
(EPA). In addition, we must ensure that regulatory agencies, including 
the Food and Drug Administration (FDA) and the Consumer Product Safety 
Commission (CPSC), either have access to resources to fund regulation-
relevant research or input to research that will inform their decision-
making.
    There will also be a role for science-oriented agencies such as the 
National Institutes of Health (NIH) and the National Science Foundation 
(NSF) in funding targeted research, where the missions of these 
agencies coincide with research that informs specific oversight 
questions. For example, these two agencies are ideally positioned to 
investigate the science behind nanomaterial properties, behavior and 
biological interactions in a targeted way, with the aim of predicting 
health and environmental impact. But ensuring that targeted research 
conducted within these agencies is relevant to addressing risk 
identification, assessment and reduction goals will be critical, and 
underscores the need for a robust cross-agency risk research strategy 
and pool of designated funds.
    Exploratory research, on the other hand, primarily would be 
investigator-driven (within determined bounds), and so would 
preferentially lie within the remit of NSF and NIH. However, in 
ensuring effective use of funds, it will be necessary to develop ways 
of supporting interdisciplinary research that crosses the boundary 
separating these agencies, and combines investigations of basic science 
with research into disease endpoints, with the goal of informing 
oversight decisions.
    Exploratory research should not be confined to these two agencies, 
however, as there will be instances where goal-oriented but exploratory 
research will fit best within the scope of mission-driven agencies, and 
will benefit from research expertise within these agencies. For 
example, researchers in NIOSH are currently engaged in exploratory 
research that is directly relevant to identifying and reducing 
potential nanotechnology risks in the workplace.\24\
---------------------------------------------------------------------------
    \24\ NIOSH (2007). Progress towards safe nanotechnology in the 
workplace, National Institute for Occupational Safety and Health, 
Washington, DC.
---------------------------------------------------------------------------
    At present, there is no pot of ``nanotechnology'' money within the 
Federal Government that can be directed to areas of need. Rather, the 
NNI simply reports what individual agencies are spending. Yet if 
strategic nanotechnology risk research is to be funded appropriately, 
mechanisms are required that enable dollars to flow from where they are 
plentiful to where they are needed. Extremely overstretched agencies 
like NIOSH and EPA cannot be expected to shoulder their burden of 
nanotechnology risk research unaided, and regulatory agencies like FDA 
and CPSC currently have no listed budget whatsoever for nanotechnology 
EHS research. If the Federal Government is to fully utilize expertise 
across agencies and enable effective nanotechnology oversight, 
resource-sharing across the NNI will be necessary.
    In addition to adequate funding, development and implementation of 
an effective strategic framework will only be as good as the people who 
develop and implement it. And this means ensuring experts within the 
Federal Government have the time to commit to getting such a strategy 
right. Such a framework is too important to be developed and 
implemented at the margins of peoples' responsibilities. My own 
experiences in co-chairing the NEHI group would suggest that, even with 
some of the best minds in government around the table, little progress 
can be made when those involved do not have the time to dedicate to the 
issues at hand. And nowhere is this need for time more critical than 
with the person charged with leading activities.

How do the Federal Government's actions match up to what is needed?

    While I argue later that the Federal Government's actions on 
nanotechnology have so far been too little too late, it is important to 
recognize that the government has not been deaf to the need to address 
nanotechnology EHS issues. Preliminary discussions on the importance of 
EHS in the development of nanotechnology are evident in some of the 
earliest publications coming out of the NNI. For instance, quoting from 
an early NSET subcommittee of the NSTC document published in 2001:

         ``Although proponents of nanotechnology view it as benign, 
        there are likely to be some unforeseen, undesirable effects.

         Even at the basic research stage, nanotechnology advocates 
        need to inform the public about the prospects and risks. They 
        need to engage and involve the public and the groups that 
        represent them. While this will delay the introduction of new 
        technologies, in the end it is likely to save time.''\25\
---------------------------------------------------------------------------
    \25\ NSET (2001). Societal Implications of Nanoscience and 
Nanotechnology. NSET Workshop Report, M.C. Roco and W.S. Bainbridge, 
eds., National Science and Technology Council Committee on Technology, 
Subcommittee on Nanoscale Science, Engineering and Technology, 
Washington, DC.

    The NEHI working group was established in 2003 as a direct result 
of concerns over possible adverse impacts of technologies under 
development. This early awareness of the need to understand and manage 
risks is reflected in the 21st Century Nanotechnology Research and 
Development act published in 2003,\26\ the NNI strategic plan,\27\ 
annual NNI budget requests and the current efforts within the Federal 
Government to develop a strategic research agenda.
---------------------------------------------------------------------------
    \26\ U.S. Congress (2003). 21st Century Nanotechnology Research and 
Development Act (Public Law 108-153), 108th Congress, 1st session, 
Washington, DC.
    \27\ NSET (2004). The National Nanotechnology Initiative Strategic 
Plan, Nanoscale Science Engineering and Technology Subcommittee 
Committee on Technology National Science and Technology Council, ed., 
National Science and Technology Council, Washington, DC.
---------------------------------------------------------------------------
    Yet talking about the issues is no substitute for progress, and in 
addressing possible harm to people and the environment, good intentions 
are not enough. The Federal Government may have been diligent in 
identifying and discussing issues, but is real progress being made 
towards addressing the challenges, and ensuring businesses, regulators 
and the public have the tools they need to make informed decisions over 
nanotechnology applications?
    Some of the first indications that nanomaterials may present an 
unusual and previously unrecognized health risk came out as far back as 
1990.\28\ Fifteen years ago, the first concerns were raised about the 
potential health impacts of using carbon nanotubes in commercial 
products.\29\ I first wrote about the health and safety challenges 
presented by nanotechnology in 1999, in a report for the UK Health and 
Safety Executive.\30\ In 2004, the UK Royal Society and Royal Academy 
of Engineering stressed the urgency with which action was needed to 
identify and assess the risks presented by nanoparticles,\31\ and the 
past few years have seen an increasing number of research papers 
questioning conventional approaches to understanding health and 
environmental risks. At the same time, uncertainty over potential 
risks, and what is being done to minimize them, has raised barriers to 
businesses hoping to invest in nanotechnology,\32\ and caused consumer 
groups to question whether people should be using nano-products.\33\
---------------------------------------------------------------------------
    \28\ Ferin, J., Oberdorster, G., Penney, D.P., Soderholm, S.C., 
Gelein, R. and Piper, H.C. (1990). Increased Pulmonary Toxicity of 
Ultrafine Particles. 1. Particle Clearance, Translocation, Morphology. 
J. Aerosol. Sci. 21:381-384.
    \29\ Coles, G.V. (1992). Occupational risks. Nature 359:99.
    \30\ Maynard, A.D., Brown, R.C., Crook, B., Curran, A. and Swan, 
D.J. (1999). A scoping study into ultrafine aerosol research and HSL's 
ability to respond to current and future research needs, health and 
Safety Laboratory, UK.
    \31\ RS/RAE (2004). Nanoscience and nanotechnologies: Opportunities 
and uncertainties, The Royal Society and The Royal Academy of 
Engineering, London, UK, 113 pp.
    \32\ Lux Research (2006). Taking action on nanotech environmental, 
health and safety risks, Lux Research Inc., New York, NY.
    \33\ Rock, A. (2007). Nanotechnology. Untold promise, unknown risk, 
Consumer Reports. July.
---------------------------------------------------------------------------
    So how does the Federal Government measure up in terms of 
understanding what is needed to reduce uncertainty and maximize the 
success of nanotechnology?

1.  Acknowledging the possibility of unconventional behavior

    In general, agencies within the Federal Government have made good 
progress in acknowledging the possibility of unconventional behavior in 
nanomaterials. The Office for Research and Development in EPA 
recognized the potential to use unconventional characteristics of 
nanomaterials in remediating environmental pollution some years ago. 
More recently, the agency has been supporting research into addressing 
unconventional behavior in nanomaterials that might lead to adverse 
environment and human health impacts.\34\ NIOSH established a 
nanotechnology research program aimed at workplace exposures in 2004 in 
recognition of nano-specific challenges, and now has a successful--if 
sparsely funded--research portfolio spanning exploratory to applied 
studies.\35\ The NSF recognized the need to develop a science-based 
understanding of nanomaterial-biological interactions early on, which 
led to the establishment of the Center for Biological and Environmental 
Nanotechnology at Rice University, and a number of other risk-relevant 
research initiatives.\36\ NIH has encouraged an integrated approach to 
understanding nano-bio interactions in the development of health-
related applications, and has led in exploring the detailed toxicology 
of select nanomaterials through the National Toxicology Program--a 
collaboration between the National Institute of Environmental Health 
Sciences, NIOSH and FDA.\37\ NIH also is developing an internal 
strategy for developing new knowledge on how nanomaterials interact 
with humans. FDA has recently published a paper clarifying the agency's 
understanding that engineered nanomaterials may take on risk-relevant 
properties due to their nanoscale,\38\ and the CPSC and the 
Occupational Safety and Health Administration have both stated that 
nanotechnology has the potential to present new regulatory challenges. 
In addition, the Department of Energy, the Department of Defense and 
the National Institute of Standards and Technology all have research 
programs related to how engineered nanomaterials represent 
unconventional risks--and how to tackle the resulting challenges.
---------------------------------------------------------------------------
    \34\ EPA (2007). U.S. Environmental Protection Agency 
Nanotechnology White Paper, Environmental Protection Agency, 
Washington, DC. EPA 100/B-07/001. February.
    \35\ See supra note 24.
    \36\ For example, see http://www.nsf.gov/crssprgm/nano/. Accessed 
October 13, 2007.
    \37\ NTP Nanotechnology Safety Initiative. http://
ntp.niehs.nih.gov/files/NanoColor06SRCH.pdf. Accessed October 13, 2007.
    \38\ FDA (2007). Nanotechnology. A report of the U.S. Food and Drug 
Administration Nanotechnology Task Force, Food and Drug Administration, 
Washington, DC.
---------------------------------------------------------------------------
    The reason for this long (and probably incomplete) litany is to 
demonstrate that the relevant agencies within the Federal Government 
are clear that engineered nanomaterials have the potential to behave in 
unconventional ways. This understanding is reflected in the laundry 
list of research needs to address such unconventional behavior 
published by the NNI in September 2006, and the rather shorter list 
published in 2007.
    However, there is not complete accord here. A recent consultation 
paper from EPA on how the Toxic Substances Control Act applies to 
nanoscale substances did not provide a mechanism for addressing 
unconventional behavior in nanoscale materials, but stated that:

         ``a nanoscale substance that has the same molecular identity 
        as a substance listed on the Inventory (whether or not reported 
        to the Agency as being manufactured or processed in nanoscale 
        form) is considered an existing chemical, i.e., the nanoscale 
        and non-nanoscale forms are considered the same chemical 
        substance because they have the same molecular identity 
        [emphasis added]''\39\
---------------------------------------------------------------------------
    \39\ EPA (2007). TSCA Inventory Status of Nanoscale Substances--
General Approach, Environmental Protection Agency, Washington DC.

    EPA's paper led Barnaby Feder--a leading journalist with the New 
York Times--to write an article with the headline ``EPA to Nanotech: 
Size Doesn't Matter.'' \40\ Of course, as I have just laid out, size 
and novel properties at the nanoscale assuredly do matter when it comes 
to potential adverse impacts.
---------------------------------------------------------------------------
    \40\ Feder, B. (2007). EPA to Nanotech: Size Doesn't Matter. Bits, 
New York Times. http://bits.blogs.nytimes.com/2007/07/12/epa-to-
nanotech-size-doesnt-matter/. July 12. Accessed October 13, 2007.
---------------------------------------------------------------------------
    Overall, the Federal Government has made important strides in 
acknowledging the possibility that unconventional behavior in 
engineered nanomaterials could lead to EHS risks. However, as the 
recent EPA paper demonstrates, there is considerable room for 
improvement in linking unconventional behavior to regulatory 
approaches.

2.  Leadership in nanotechnology EHS research

    While it is generally acknowledged that engineered nanomaterials 
potentially present new EHS challenges, the Federal Government has not 
provided strong leadership in addressing these challenges. Despite a 
good start with the formation of NEHI, the overall Federal Government 
response to identifying and managing nanotechnology risks can only be 
described as slow, badly conceptualized, poorly directed, uncoordinated 
and underfunded.
    In a world where unregulated and uncontrolled nanotechnology 
applications are appearing almost daily; where we know that there are 
possibilities in some cases of harm occurring to humans and the 
environment; where industry is calling out for greater certainty in 
managing the potential risks of nanomaterials; and where there are 
concerns that a lack of progress and transparency will undermine public 
confidence in emerging nanotechnologies, the Federal Government took 
eleven months to reduce a laundry list of seventy five research needs 
down to twenty five. To quote Barnaby Feder of the New York Times 
again, ``No one can accuse them [the Federal Government] of acting 
rashly.'' \41\
---------------------------------------------------------------------------
    \41\ Feder, B. (2007). No One Can Accuse Them of Acting Rashly. 
Bits, New York Times. August 17. http://bits.blogs.nytimes.com/2007/08/
17/no-one-can-accuse-them-of-acting-rashly/. Accessed October 13, 2007.
---------------------------------------------------------------------------
    And this latest Federal Government report was not even done as part 
of an overarching strategy, but as a precursor to developing a research 
strategy. By the government's own admission, it does not yet know where 
it is when it comes to addressing risk, and has yet to decide where it 
is going.\42\ Yet for some time now, other countries and organizations 
outside the government have been mapping out what needs to be done and 
how.
---------------------------------------------------------------------------
    \42\ See supra note 12.
---------------------------------------------------------------------------
    Just as striking is the proliferation of agency-based initiatives 
that do not seem to form part of a coordinated interagency strategy. 
With one or two exceptions, there are indications that individual 
agencies are going their own way because of a lack of direction from 
the top. For instance, NIOSH has established an internal nanotechnology 
research program to address the needs of workers and industry 
independent of a coordinated interagency strategy, relying solely on 
internal resources that are not guaranteed to last. The disconnect 
between NIOSH's activities and other agencies' was underlined by the 
agency commenting publicly on EPA plans to regulate engineered 
nanomaterials--rather than rely on internal channels.\43\ A similar 
indication of poor or absent leadership across federal agencies was a 
public submission from NIH on the recently published NEHI research 
priorities document--a document that NIH representatives had 
contributed to!\44\ And the recently announced Center for Environmental 
Implications of Nanotechnology--a joint venture between EPA and NSF--
does not seem to be part of any coordinated cross-agency plan.\45\
---------------------------------------------------------------------------
    \43\ NIOSH (2007). Comments of the National Institute for 
Occupational Safety and Health on the Environmental Protection Agency 
Federal Register Notice Nanoscale Materials Stewardship Program and 
Inventory Status of Nanoscale Substances under the Toxic Substances 
Control Act; Notice of Availability, EPA-HQ-OPPT-2004-0122. September 
7.
    \44\ NIH (2007). National Institutes of Health Comments on 
Prioritization of Environmental, Health, and Safety Research Needs for 
Engineered Nanoscale Materials to the NSET Subcommittee. September 17. 
http://nano.gov/html/society/ehs-priorities/comments/. 
Accessed October 25, 2007.
    \45\ See http://www.nsf.gov/funding/
pgm-summ.jsp?pims-id=503124. Accessed October 25, 
2007.
---------------------------------------------------------------------------
    Current agency-specific initiatives do address key issues and are 
making an important contribution to evaluating and addressing potential 
nanotechnology risks. I do not want to detract in any way from their 
importance, or the leadership being shown by individuals within 
agencies to address specific challenges. But the fractured and 
uncoordinated approach to addressing nanotechnology risks that is 
emerging demonstrates a lack of overall leadership across the Federal 
Government, and challenges the notion that critical issues will be 
addressed in a strategic and timely manner, while using resources most 
effectively.
    Such leadership across many agencies is extremely difficult, which 
perhaps explains NEHI's tardy response to repeated calls for action 
from Congress over the past two years. Yet when economic interests, 
people's health and the environment are on the line, to claim ``it's 
difficult'' is a poor excuse for inaction. If those responsible for the 
NNI have limited ability to lead effectively in ensuring the emergence 
of safe nanotechnologies, then this problem must be fixed if we are to 
find effective approaches to addressing the challenges of 
nanotechnology.

3.  An effective strategic framework

    By its own admission, the Federal Government is working towards 
developing a strategic research framework--and has been doing so since 
the House Science Committee hearing on November 17, 2005. The NEHI 
working group plans to follow a series of steps toward develop such a 
framework, although whether we will have to wait another two years for 
the results is unclear.
    Since publication of its document EHS Research Needs for Engineered 
Nanoscale Materials in September 2006,\46\ the NEHI working group has 
been busy countering criticisms aimed at that report and responding to 
invited comments. NEHI's subsequent document, Prioritization of 
Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale Materials: An Interim Document for Public Comment,\47\ 
further refines the prioritization principles established in the 2006 
report and uses them to identify five research priority areas in each 
of the five categories listed in the initial report, for a total of 
twenty five research priority areas. Yet it remains unclear how this 
report or subsequent planned activities will help to provide the 
scientific information that industry, regulators and the public need to 
ensure the safe development and use of nanotechnology.
---------------------------------------------------------------------------
    \46\ See supra note 11.
    \47\ See supra note 12.
---------------------------------------------------------------------------
    With this report, NEHI has begun to set out a systematic process 
for guiding agency research efforts. But we must not mistake 
methodology for strategy. While the current document focuses on 
prioritization, it does so without a clear understanding of context: 
what the overarching issues are, what is needed to address them, when 
results are needed and how the work will get done. Without this degree 
of vision, the document is in danger of being a bureaucratic reaction 
to criticism, rather than a proactive statement of purpose.
    The stated principles for prioritizing EHS research do provide a 
means for sifting the many research ``wants'' into research ``needs.'' 
But in the absence of a strategic overview, it is hard to see how 
application of these principles will result in an effective research 
plan. And while the principles appear sound individually, it is hard to 
see how as a group they can be used to identify a set of coherent 
research priorities.
    The twenty-five identified research priorities provide little new 
information, but rather reflect many of the recommendations made by 
other organizations over the past few years. Comparing them with the 
strategic research priorities published by the Project on Emerging 
Nanotechnologies in July 2006,\48\ there appears to be substantial 
agreement. But the NEHI priorities are open to broad interpretation in 
many cases. And so, while they reflect repeatedly articulated concerns, 
they present a poor basis for a strategic framework. In contrast, the 
Project on Emerging Nanotechnologies' research priorities are more 
specific and reflect the need to address clear goals.
---------------------------------------------------------------------------
    \48\ See supra note 13.
---------------------------------------------------------------------------
    In short, it is hard to see how following the NEHI priorities will 
provide the information decision-makers need to ensure the safety and 
sustainability of emerging nanotechnologies. Indeed, many of the 
priorities are so broad that they could be adequately addressed without 
any progress being made towards ensuring the safety of 
nanotechnologies!
    On the basis of current evidence, the Federal Government is out of 
touch with reality and seems to be caught in a bureaucratic process 
that lacks the responsiveness and vision to address the questions to 
which nanotechnology stakeholders need answers. There is no sense of 
urgency to address which new research is needed, how it will be funded 
or the extent to which the economic success of emerging 
nanotechnologies will depend on this research.

4.  Mechanisms to get the job done

    Three mechanisms currently exist within the Federal Government to 
enable EHS research on nanotechnology. Firstly, individual agencies are 
able (within their budgetary constraints) to address specific 
challenges that are aligned with their own agendas and missions. 
Secondly, agencies are encouraged to consider priority research areas 
suggested by the Office of Science and Technology Policy (OSTP) and the 
NNI. Thirdly, information is shared between agencies within the NEHI 
working group. But these are weak mechanisms compared to the tasks at 
hand.
    Certainly, these mechanisms have led to some progress--agencies are 
developing their own research agendas (independently of an overarching 
research strategy it would seem), and discussions within NEHI have 
undoubtedly led to a useful exchange of information. Yet taken 
together, they have thus far been ineffective in ensuring that relevant 
and coordinated research is carried out, sufficient resources are 
available to support this research, or that research is translated 
effectively into practical use by regulators, industry and others.
    Clearly, the Federal Government needs a new toolkit if it is to 
provide answers to questions surrounding the safety of 
nanotechnologies. Comparing current Federal Government activities to 
the previously outlined actions needed to support safe and successful 
nanotechnologies, the Federal Government is struggling to develop and 
use:

          Administrative mechanisms that enable federal 
        agencies to participate in an overarching strategic risk 
        research framework, break down institutional barriers 
        preventing collaboration and cooperation and provide leadership 
        within the government and to stakeholders in the U.S. and the 
        rest of the world.

          Mechanisms that ensure the right research funding 
        approaches are used for the job, appropriate agencies take the 
        lead in addressing specific questions and enable effective 
        interdisciplinary and international research collaborations.

          Public-private partnerships that leverage government 
        and industry funding to provide timely and independent answers 
        to critical questions.

          Funding mechanisms that ensure agencies (and, in 
        particular, agencies with regulatory missions) have sufficient 
        funds to participate fully and effectively within an 
        overarching strategic nanotechnology EHS research framework.

    As a result, important research is not being funded because it 
falls between the cracks, because it doesn't fit within a particular 
agency's mandate, or because adequate funding mechanisms do not exist.
    To give one example, research is needed on how atomic-level 
variations in structure at the surface of engineered nanomaterials 
influences biological interactions and potentially causes or 
exacerbates certain diseases. But the necessary interdisciplinary 
research that combines an understanding of materials properties, 
fundamental biological processes and disease is extremely difficult to 
support within the current federal research and development funding 
structure. And where cross-disciplinary proposals are considered (or 
where agencies attempt to fund research in unfamiliar areas), there is 
a danger of applying inappropriate selection criteria.
    This may lead to the perception that there is a lack of competent 
researchers or good research proposals to address a specific challenge, 
whereas the reality is that those judging the proposals do not 
understand them, or their relevance.
    Some progress has been made to correct these failings. The NSF has 
successfully funded a number of interdisciplinary research centers that 
are providing extremely valuable information on the potential risks of 
nanotechnologies--and how to address them. Yet these centers exist 
outside of an overall strategic risk framework, and remain constrained 
in their ability to directly relate engineered nanomaterials to 
potential diseases, or to inform regulation. Another partial success 
story is the EPA Science To Achieve Results (STAR) nanotechnology 
research program that has supported many projects addressing the 
potential health and environmental impacts of engineered nanomaterials. 
Yet funding for individual projects is capped at a level too low for 
many researchers evaluating human and ecological toxicology to consider 
applying. As a result, while the research portfolio looks good on 
paper, in reality it is merely nibbling around the edges of the 
questions that need answering.
    While I do not want to detract from the efforts of individuals 
within agencies to make a difference and develop relevant research 
programs, their research programs could be substantially more effective 
if they were given the support they need to do the job.

5.  Sufficient resources to address critical challenges

    The FY 2008 NNI request for nanotechnology health and safety 
research funding is $58.6 million\49\--less than the estimated $144 
million needed for targeted and exploratory EHS research, but more than 
the estimated $50 million for targeted research alone. However, this 
figure comes with marginal information on how the money will be spent 
and whether it will, in fact, address strategically relevant questions, 
or be squandered on marginally relevant research.
---------------------------------------------------------------------------
    \49\ NSET (2007). The National Nanotechnology Initiative. Research 
and Development Leading to a Revolution in Technology and Industry. 
Supplement to the President's FY 2008 Budget, Subcommittee on Nanoscale 
Science, Engineering and Technology, Committee on Technology, National 
Science and Technology Council, Washington, DC.
---------------------------------------------------------------------------
    Out of this request, 49 percent is to go to NSF, 20 percent to NIH 
and the National Institute of Standards and Technology, 16 percent to 
EPA and eight percent to NIOSH. In other words, despite the need for 
nanotechnology risk research to inform oversight and regulation, the 
vast bulk of the requested funding is associated with agencies that 
have no regulatory mission. Is this an appropriate use of funds, or 
does it merely reflect the spending power of the respective agencies?
    The only way this question can be answered is by understanding how 
each agency's research will feed into an overarching strategic 
framework that is designed to provide answers that decision-makers need 
to oversee the development of safe nanotechnologies.
    Unless the Federal Government is able to give a clear account of 
what is being invested in nanotechnology risk research, and how that 
investment will reduce uncertainty and enable effective risk 
management, there is a danger that current funding will be 
ineffective--no matter how impressive on paper.
    In addition to questions over adequate funding, there is scant 
evidence that the Federal Government is investing in people to develop 
and implement an effective research strategy. Agency personnel 
addressing nanotechnology are frequently doing so at the margins of 
their responsibilities. Despite the acknowledged importance of EHS 
research, there is no single person dedicated to leading and 
coordinating activities across the government.

Conclusions

    We cannot afford to drive blindly into the nanotechnology future. 
Not only will this prevent us from seeing and navigating around the 
inevitable bends associated with possible risks, but it will also give 
those economies with the foresight to identify and negotiate the bends 
a very real competitive edge. Despite a good start, the U.S. is still 
caught up in developing new technologies within an old mindset. If 
emerging nanotechnologies are to be built on a sound understanding of 
the potential risks--and how to avoid them--new research strategies, 
new mechanisms of execution and new funding all are needed. These 
should be overseen by clear, strong leadership and an interagency group 
with the authority to develop a strategic research framework and ensure 
its execution--a NEHI group with teeth.
    At the beginning of this testimony, I recommended six areas where 
action is needed to get nanotechnology EHS research back on track, 
drawing from the assessment above. But the window of opportunity is 
fast closing. In the words of Chairman Boehlert at the September 2006 
House Science Committee hearing addressing nanotechnology EHS research, 
which I believe expressed the sentiment of the entire Committee, 
``time's a wasting.'' \50\ The stakes are too high for the Federal 
Government not to take appropriate action now.
---------------------------------------------------------------------------
    \50\ Congressman Sherwood Boehlert (R-NY) opening statement for 
nanotechnology hearing. September 21, 2006. http://
gop.science.house.gov/hearings/full06/Sept%2021/sbopening.pdf. Accessed 
October 14, 2007.
---------------------------------------------------------------------------

Responses to specific questions

What is your reaction to the recent report of the Nanotechnology 
Environmental and Health Implications Working Group, ``Prioritization 
of Environmental, Health and Safety Research Needs for Engineered 
Nanoscale Materials? Do outside groups have a way to influence this 
planning process? Are the priorities listed in the report the right 
ones, and do you believe that carrying out the ``next steps'' described 
in the report will achieve the detailed implementation plan for EHS 
research that is needed?

Reaction to the recent NEHI report
    With this report, the NEHI working group has begun to set out a 
systematic process for guiding agency research efforts. But the working 
group is in danger of mistaking methodology for strategy. While the 
current document focuses on prioritization, it appears to do so without 
a clear understanding of context: what the overarching issues are, what 
is needed to address them, when results are needed and how the work 
will get done. Without this degree of vision, the resulting document is 
a bureaucratic reaction to criticism, rather than a proactive statement 
of purpose.
    The stated principles for prioritizing EHS research do provide a 
means for sifting the many research ``wants'' into research ``needs.'' 
But in the absence of a strategic overview, it is unclear how 
application of these principles will result in an effective research 
plan. And while the principles appear sound individually, it is 
difficult to understand how they can be applied as a group to identify 
a set of coherent research priorities. In particular, the second and 
third principles (leveraging research funded by other organizations, 
and adaptive management) are critical components of a research 
strategy, but do not help to prioritize research in the absence of such 
a strategy.

Potential for outside groups to influence the planning process
    Public input has been sought on this and the previous NEHI research 
needs document. Responses to the most recent public consultation have 
yet to be published. However, it appears that the public comments on 
the document released in September 2006\51\ led to marginal input to 
the following report. In order to develop a robust research strategy 
that addresses the needs of multiple stakeholders, more effective 
mechanisms are needed for soliciting expert input. Specifically, a 
federal advisory committee should be established to allow transparent 
input and review to an evolving research strategy from industry, 
academia, non-government organizations and other stakeholders.
---------------------------------------------------------------------------
    \51\ See supra note 11.

Are these the right research priorities?
    The research needs listed in the current and previous NEHI 
documents closely match those identified by other groups. Comparing the 
latest set of twenty-five research priorities with the strategic 
research priorities published by the Project on Emerging 
Nanotechnologies in July 2006,\52\ (which draw on recommendations from 
a number of other groups, including the UK Royal Society and Royal 
Academy of Engineering, the American Chemistry Council, and the 
Environmental Protection Agency, EPA) there appears to be substantial 
overlap. But this is because the NEHI priorities are open to broad 
interpretation. While they reflect repeatedly articulated concerns, 
they present a poor basis for a strategic framework. Indeed, many of 
the priorities are so broad that they could be adequately addressed 
without any progress being made towards ensuring the safety of 
nanotechnologies!
---------------------------------------------------------------------------
    \52\ See supra note 13.

Will the ``next steps'' achieve the desired goal
    While the process initiated by NEHI looks logical on paper, it is 
hard to see how following it will provide the information decision-
makers need to ensure the safety and sustainability of emerging 
nanotechnologies. This is a bureaucratic process that is picking at the 
edge of a problem from within the system, rather than starting with a 
clean slate and asking what needs to be done to achieve a well-defined 
end. The current process lacks a clear vision of what is needed to 
prevent people being harmed, the environment being damaged and industry 
being impacted by real and perceived nanotechnology risks. It lacks a 
sense of how research will serve effective science-based decision-
making, and an appreciation for how urgently action is needed.
    As an example, anyone with a credit card can purchase carbon 
nanotubes in powder form from a company called Cheap Tubes Inc. The 
nanotubes come in a sealed bag, and the accompanying safety data 
describes them as graphite--the same substance used to form pencil 
leads. Yet research has shown carbon nanotubes to be potentially 
hazardous in ways we don't fully understand yet if inhaled.\53\ If I 
purchased some of these carbon nanotubes today, how long will it take 
before someone is able to tell me how to open the package, extract the 
material, and use it--safely? Would it be days, months, years or even a 
decade? Researchers, businesses and consumers are facing similar 
questions every day. Yet the currently outlined ``next steps'' hold no 
hope for early answers.
---------------------------------------------------------------------------
    \53\ Cheap Tubes, Inc. http://www.cheaptubesinc.com/. Accessed 
October 19, 2007. Purchased materials are accompanied by detailed--if 
currently out-dated--information on published hazard studies. Yet the 
supplied manufacturer's safety data sheet continues to list the 
material as graphite, in the absence of clear guidance from regulatory 
authorities.

Has the NNI assigned a sufficiently high priority to EHS research and 
are there gaps in the portfolio of NNI research now underway? What 
level of funding over what time period is needed to make acceptable 
progress in understanding the potential environmental and health risks 
---------------------------------------------------------------------------
associated with the development of nanotechnology?

EHS research priority
    A continued lack of an overarching research strategy, ineffective 
research mechanisms and inadequate resources suggest that the NNI has 
not assigned a sufficiently high priority to EHS research. The NNI is 
unable to give a clear picture of the current research portfolio 
addressing nanotechnology risk, making it hard to gauge where the 
research gaps might be. An independent inventory of publicly available 
information on current research indicates that personal research 
interests, rather than overarching needs, are driving the 
portfolio.\54\ As a result, current research is predominantly focused 
on novel materials like carbon nanotubes and existing areas of 
expertise such as inhalation toxicology, while exposure routes that 
include ingestion and environmental release, and materials like 
nanoscale silver, dendrimers and smart nanoparticles are receiving less 
attention.
---------------------------------------------------------------------------
    \54\ Nanotechnology health and environmental implications. An 
inventory of current research. http://www.nanotechproject.org/18 
Accessed October 14, 2007.
---------------------------------------------------------------------------
    Overall, it is possible to find research being carried out within 
each of the twenty-five priority areas identified by NEHI. But there 
are no indications that this research is sufficiently focused, or 
extensive enough, to come close to answering critical questions.

Funding levels
    In my testimony to this committee on September 21, 2006,\55\ I made 
the case for a minimum of $50 million per year to be spent on relevant 
nanotechnology risk research. This was based on an assessment of 
critical short-term research needs, and only covered targeted research 
to address these needs.\56\ This estimate still stands. However, I must 
be clear that such an investment would need to be directed towards 
addressing a very specific suite of problems that regulators and 
industry need answers to as soon as possible--this is not envisaged as 
a general pot of money to be assigned to research that does not address 
specific and urgent nanotechnology risk goals. In other words, this is 
an investment that needs to be directed towards the right research.
---------------------------------------------------------------------------
    \55\ See supra note 16.
    \56\ See also: supra note 13.
---------------------------------------------------------------------------
    But beyond this figure, there is a need for further investment in 
exploratory research that will identify the questions we haven't 
thought of yet. It isn't possible to place a firm figure on how much 
should be spent here, but a useful rule of thumb--and one that others 
have advocated--is to ensure that at least 10 percent of the Federal 
Government's nanotechnology research and development budget is 
dedicated to strategic risk-related research. This would place the 
overall estimated EHS research budget for 2008 at $145 million--
allowing for $50 million in targeted research and $95 million dedicated 
to exploratory research. Given the nature of exploratory research, 
which requires substantial investment to make significant progress, 
this does not seem unreasonable.

What are the optimum roles for the agencies in sponsoring or conducting 
EHS research? Are responsibilities and available resources currently in 
balance?

Agency roles
    An effective nanotechnology EHS strategic research framework will 
enable and empower agencies to take a lead in addressing issues that 
fall within their competences and missions. While top-level direction 
will be essential to ensuring success, the most effective model will 
not be one of command and control, but of leadership, coordination and 
facilitation.
    An effective research framework would enable an appropriate balance 
between targeted research aimed at addressing specific questions, and 
exploratory research that helps to inform relevant questions. Targeted 
research would primarily address specific questions where answers are 
urgently needed in order to make, use and dispose of nanotechnology 
products as safely as possible. Much of this research would be funded 
by or conducted within mission-driven agencies such as the National 
Institute for Occupational Safety and Health (NIOSH) and EPA. An 
effective framework would also ensure that regulatory agencies have the 
resources to fund regulation-relevant research, or direct research that 
will inform their decision-making--including the Food and Drug 
Administration, the Consumer Product Safety Commission and the 
Occupational Safety and Health Administration.
    Research agencies such as the National Institutes of Health (NIH) 
and the National Science Foundation (NSF) would also have a critical 
role in funding targeted research, where the missions of these agencies 
coincide with research that informs specific oversight questions. For 
example, these two agencies are ideally positioned to investigate the 
underlying science of nanomaterial properties, behavior and biological 
interactions, with the aim of predicting health and environmental 
impact.
    Exploratory research within an effective strategic research 
framework would primarily be investigator-driven (within strategically 
determined bounds), and would preferentially lie within the remit of 
science-oriented agencies such as NSF and NIH. But if research funds 
are to be used effectively, it will be necessary to develop ways of 
supporting interdisciplinary research that crosses the boundary 
separating these agencies, and combines investigations of basic science 
with research into disease endpoints, with the goal of informing 
oversight decisions.
    Exploratory research should not be confined to these two agencies; 
however, there will be instances where goal-oriented but exploratory 
research will fit best within the scope of mission-driven agencies and 
will benefit from the considerable research expertise within these 
agencies. As an example, researchers in NIOSH are currently engaged in 
exploratory research that is directly relevant to identifying and 
reducing potential nanotechnology risks in the workplace.\57\
---------------------------------------------------------------------------
    \57\ See supra note 24.

Balancing responsibilities and resources
    Responsibilities and available resources are not currently in 
balance across federal agencies. Examining the $58.6 million FY 2008 
NNI budget request for nanotechnology EHS research, 49 percent is 
associated with NSF, 20 percent with NIH and the National Institute of 
Standards and Technology, 16 percent with EPA and just eight percent 
with NIOSH.\58\ These figures are not supported by clear research 
objectives, goals and plans, so it is hard to say whether the funding 
will all go to nanotechnology risk-relevant research. An assessment of 
the 2005 Federal Government's risk research portfolio could only 
identify $11 million associated with highly relevant research into the 
potential risks of engineered nanomaterials, compared to a NNI-reported 
estimate of $38.5 million--a shortfall of $27.5 million!\59\
---------------------------------------------------------------------------
    \58\ NSET (2007). The National Nanotechnology Initiative. Research 
and Development Leading to a Revolution in Technology and Industry. 
Supplement to the President's FY 2008 Budget, Subcommittee on Nanoscale 
Science, Engineering and Technology, Committee on Technology, National 
Science and Technology Council, Washington, DC.
    \59\ See supra note 13.
---------------------------------------------------------------------------
    Without clear information from the NNI on how requested funds will 
be used, it looks like that the research portfolio will be biased 
towards exploratory research, and away from targeted and oversight-
relevant research (as reflected in NSF and NIH requesting twice as much 
funding for EHS research as EPA and NIOSH combined). This imbalance 
reflects the NNI role of simply reporting individual agency funding 
plans, rather than coordinating a strategic response to research needs.
    The resulting budget figures reflect strategic thinking only 
incidentally, rather than by design--wealthy agencies invest more in a 
``hot topic'' area, while poorer agencies struggle to scrape together 
precious resources to carry out their mandated duties. The irony in 
this situation, of course, is that it is the agencies without the 
resources to do the right research that have the clearest perspective 
on what needs to be done. In the FY 2008 budget request, the NSF budget 
for nanotechnology EHS research increased by $7.8 million from FY 2006 
to $34.2 million--an increase of over one and a half times NIOSH's 
entire request for FY 2008 ($4.6 million). And this is in spite of most 
stakeholders acknowledging that addressing occupational exposure to 
engineered nanomaterials is a top priority.
    In other words, despite the need for nanotechnology risk research 
to inform oversight and regulation, the vast bulk of the requested 
funding is associated with agencies having no regulatory mission. 
Whether this is an appropriate use of funds, or merely reflects the 
spending power of the respective agencies, can only be answered by 
understanding how each agency's research will feed into an overarching 
strategic framework. But this framework does not yet exist.\60\ Until 
it does (and mechanisms are in place to implement it), the Federal 
Government is unlikely to achieve a balance between agency resources 
and responsibilities in addressing nanotechnology risks.
---------------------------------------------------------------------------
    \60\ See supra note 12.

Can the current process for developing the EHS research plan under the 
NNI be made to work, and if so, what changes are needed? If not, do you 
have recommendations for a different approach for developing and 
implementing a prioritized, appropriately funded EHS research plan with 
---------------------------------------------------------------------------
well-defined goals, agency roles and milestones?

    Earlier in this testimony, I outline what is needed in my opinion 
to realize the benefits of nanotechnology while minimizing the risks: 
acknowledging the possibility of unconventional behavior; leadership; a 
strategic plan; mechanisms to put a research strategy into practice; 
and sufficient resources to do this. But overarching these steps is the 
goal of nanotechnology risk-related research: to develop the 
information necessary to identify (or predict), assess and manage risks 
associated with nanotechnologies--in essence to use science in support 
of oversight.
    If the current process for developing the EHS research plan under 
the NNI can be made to achieve this goal--and in a timely manner--then 
we are on track to ensuring safe and sustainable nanotechnologies. But 
changes will be needed; the analysis above clearly shows that the 
current approach falls far short of the mark.
    In reality, the NNI is not an ideal organization for addressing 
nanotechnology EHS risks. It is based on ideas and concepts more 
attuned to stimulating exploratory science and developing technology 
applications than providing science in support of oversight. While the 
NNI has effectively stimulated new research initiatives across the 
Federal Government, it remains primarily a forum for sharing 
information and reporting on agency activities. Within these functions, 
the NEHI working group has provided a useful forum for agency 
representatives to coordinate activities. Yet the NNI lacks the 
structure, vision and authority to ensure strategic and coordinated 
research in the service of effective oversight.
    Nevertheless, the NNI is a useful starting point for developing a 
strategic Federal Government EHS research plan, if appropriate 
operational changes can be made. To be effective, the NNI's goals--and 
the terms under which it operates--will need to shift from a passive, 
supportive role to an active leadership role. Currently the role of the 
NEHI working group within the NNI is to:

          Provide for exchange of information among agencies 
        that support nanotechnology research and those responsible for 
        regulation and guidelines related to nanoproducts (defined as 
        engineered nanoscale materials, nanostructured materials or 
        nanotechnology-based devices, and their byproducts);

          Facilitate the identification, prioritization, and 
        implementation of research and other activities required for 
        the responsible research and development, utilization, and 
        oversight of nanotechnology, including research methods of life 
        cycle analysis; and

          Promote communication of information related to 
        research on environmental and health implications of 
        nanotechnology to other government agencies and non-government 
        parties.\61\
---------------------------------------------------------------------------
    \61\ Interagency Working Group on Nanotechnology Environmental and 
Health Implications (NEHI WG). http://www.nano.gov/html/society/
NEHI.html. Accessed October 14, 2007.

    Yet these roles do not enable the NNI to have the vision to develop 
an effective research strategy, or the authority to implement it. In my 
testimony above, I make six recommendations on what is needed to ``make 
---------------------------------------------------------------------------
nanotechnology work'':

        1.  A top-level strategic framework that identifies the goals 
        of nanotechnology risk research across the Federal Government, 
        and provides a roadmap for achieving these goals;

        2.  Mechanisms that will enable a strategic research framework 
        to be implemented;

        3.  Annual funding for nanotechnology risk-related research 
        (targeted and exploratory) that is equivalent to approximately 
        10 percent of the overall Federal Government investment in 
        nanotechnology R&D, with a minimum of $50 million per year to 
        be dedicated to targeted research;

        4.  A public-private partnership between industry and the 
        Federal Government to address specific common and critical 
        nanotechnology research needs in a timely, transparent and 
        credible manner;

        5.  An overarching communications strategy that has the 
        fourfold aims of ensuring transparency, disseminating 
        information, enabling science-based dialogue between 
        stakeholders, and supporting informed decision-making by 
        citizens, businesses, regulators, and other stakeholders; and

        6.  Leadership to ensure the successful development and 
        implementation of a government-wide strategic research 
        framework addressing nanotechnology EHS risks.

    Implementation and coordination of these recommendations will 
require new operating terms for the NNI that allow active leadership 
within the Federal Government; provide authority to develop and 
implement cross-agency strategies; bring a goal-oriented focus to 
research; and facilitate the flow of resources to where they are most 
effectively used. In making these recommendations, I am very aware that 
developing an interagency group with the authority to develop and 
implement a cross-agency strategic plan is an enormously difficult and 
contentious task. As I noted earlier, the most effective model will be 
of leadership, coordination and facilitation, and not one of command 
and control. Yet the reality is that, without active leadership from 
the top, strategic research needs will not be met, mission-driven 
agencies will not have sufficient funds to do the work that is needed, 
and the whole nanotechnology enterprise will be jeopardized.

Annex: Goals and elements of an effective EHS strategic research 
                    framework

Strategic goals
    The overarching goal for risk-based nanotechnology research can be 
succinctly expressed as developing the information necessary to 
identify (or predict), assess and manage risks associated with 
nanotechnologies. This is science in the service of safety, and not 
science for its own sake.
    There are many challenges to achieving this goal, and they 
typically fall under three broad headings:

          Providing answers to pressing questions. These are 
        questions that researchers, manufacturers and consumers are 
        asking now, and include: How can exposure to nanomaterials be 
        measured and controlled? How can I test my nanomaterial to 
        determine if it is harmful? What happens if I release my 
        nanomaterial into the environment? Am I at risk if I use 
        personal care products containing nanomaterials? How do I 
        dispose of waste nanomaterial and nanotechnology products that 
        have come to the end of their life? The answers to many of 
        these questions will require complex research, but until they 
        are answered, they present real and immediate barriers to 
        progress.

          Developing new knowledge to identify the questions 
        not currently being asked. Many aspects of nanotechnology are 
        so new that we do not yet know what are the right questions to 
        ask regarding potential risks. This knowledge will not come 
        easily from targeted research, as it is difficult to set 
        milestones on discovering the unknown. Rather, it will be 
        driven from the innovation researchers who are given the 
        freedom to explore new avenues and follow interesting leads. 
        Yet for such exploratory research to be effective in addressing 
        risks, it must be directed within an overall risk-relevant 
        framework, and mechanisms must be set in place to identify and 
        follow-up on new risk-relevant information.

          Translating research into practice: developing new 
        ways of predicting and managing risks. While the oversight of 
        nanotechnology is dogged by uncertainty, it seems relatively 
        certain that new technologies will always be one step ahead of 
        our understanding of how they might cause harm. This lag 
        between technology and regulation is clear as we look over the 
        innovations of the past one hundred years. Yet as the rate of 
        technological innovation continues to increase, it is 
        increasingly hard to justify reactive oversight that is bogged 
        down in bureaucratic inertia and is slow to take corrective 
        action. In short, emerging technologies like nanotechnology 
        challenge us to develop new, responsive and proactive 
        approaches to identifying and managing possible risks, so that 
        we might prevent a lasting legacy of harm where old approaches 
        could not keep up with new developments.

    Many of the recommended research needs made over the past few years 
by a wide range of organizations fit within these challenges, including 
those published by the NEHI group in 2006 (and the shorter list 
released in 2007). Yet the challenges themselves are not a strategy--
merely the issues that a research strategy needs to address.
    Developing an effective roadmap to addressing these challenges is 
not as simple as prioritizing the research. As I discovered while 
developing recommendations on a short-term research strategy in 2006, 
you have to work back from what you want to achieve, and map out the 
research steps needed to get there. This inevitably leads to complex 
and intertwined research threads. If this complexity is not 
acknowledged, the result is simplistic research priorities that look 
good on paper, but are ineffective at addressing specific goals.

Key elements of a strategic framework
    In developing the elements of a research strategy in the earlier 
2006 paper, and in a commentary published in the journal Nature with 
thirteen distinguished colleagues, it was clear that an effective 
research strategy addressing potential nanotechnology risks will have a 
number of key elements. These include:

          Goal-oriented research. Whether research exploring 
        new areas or research addressing a specific problem, an 
        underlying principle of an effective research strategy must be 
        science in the service of safety.

          A balance of targeted and exploratory research. An 
        effective research strategy will combine research targeted to 
        addressing specific problems, with research exploring new areas 
        of knowledge. Both are important in the long-term to address 
        practical issues and develop a sound understanding of what 
        makes a new material potentially harmful, and how to avoid that 
        harm.

          Interdisciplinary collaboration. Nanotechnology is 
        inherently interdisciplinary, and effective research addressing 
        the potential risks will be likewise. For example, early 
        toxicity studies on nanomaterials were compromised because of a 
        lack of understanding of the materials being used within the 
        toxicology community, and would have benefited from stronger 
        collaborations with materials scientists and characterization 
        experts. Yet the disciplinary barriers faced are substantial, 
        and cannot be broken down by researchers without help. 
        Illustrating the problem, some seventeen years after the first 
        toxicology studies on nanoparticles, research into nanoparticle 
        toxicity being published now is frequently hard to interpret 
        and compare with other studies, because the interdisciplinary 
        barriers in place a decade and a half ago are still reasonably 
        intact! This is just one example, but it is indicative of the 
        need for any research strategy to break these barriers down if 
        it is to be effective.

          Enabling and empowering researchers and research 
        organizations. The effectiveness of a strategic research 
        framework will only be as good as its ability to engage the 
        organizations and individuals responsible for implementing it. 
        While such a framework will of necessity be at a high level 
        and, in the case of the Federal Government, overlay all 
        departments and agencies associated with ensuring the safety of 
        emerging nanotechnologies, the expertise to make it work will 
        lie within the participating agencies, and within the broader 
        research community. Therefore, a fine balance must be struck 
        between controlling the direction of research and empowering 
        agencies and researchers to lead research efforts. This balance 
        is perhaps most important in exploratory research, where the 
        best-positioned person to see where research is leading and its 
        significance may be the principle investigator or research 
        manager. Getting the balance right between providing top-down 
        direction and enabling a degree of autonomy will be important 
        in supporting innovative research that can be incorporated into 
        a responsive strategy.

          Communication and translation. Multilateral 
        communication of research goals, activities and findings, and 
        translation of research into practical information and actions, 
        are essential to the operation and implementation of an 
        effective research strategy. These are the glue that holds an 
        otherwise well thought-through strategic plan together.

                    Biography for Andrew D. Maynard
    Dr. Andrew Maynard is the Chief Science Advisor to the Project on 
Emerging Nanotechnologies--an initiative dedicated to helping business, 
government and the public anticipate and manage possible health and 
environmental implications of nanotechnology. Dr. Maynard is considered 
one of the foremost international experts on addressing possible 
nanotechnology risks and developing safe nanotechnologies. As well as 
publishing extensively in the scientific literature, Dr. Maynard is a 
well-known international speaker on nanotechnology, and frequently 
appears in print and on radio and television.
    Dr. Maynard trained as a physicist at Birmingham University in the 
UK. After completing a Ph.D. in ultrafine aerosol analysis at the 
Cavendish Laboratory, Cambridge University (UK), he joined the Aerosols 
research group of the UK Health and Safety Executive, where he led 
research into aerosol behavior and characterization.
    In 2000, Dr. Maynard joined the National Institute for Occupational 
Safety and Health (NIOSH), part of the U.S. Centers for Disease Control 
and Prevention (CDC). Dr. Maynard was instrumental in establishing the 
NIOSH nanotechnology research initiative, which continues to lead 
efforts to identify, assess and address the potential impacts of 
nanotechnology in the workplace. Dr. Maynard also represented NIOSH on 
the Nanomaterial Science, Engineering and Technology subcommittee of 
the National Science and Technology Council (NSET), and he co-chaired 
the Nanotechnology Environmental and Health Implications (NEHI) working 
group of NSET. Both are a part of the National Nanotechnology 
Initiative (NNI), the federal research and development program 
established to coordinate the U.S. Government's annual $1 billion 
investment in nanoscale science, engineering, and technology.
    Dr. Maynard continues to work closely with many organizations and 
initiatives on the responsible and sustainable development of 
nanotechnology. He is a member of the Executive Committee of the 
International Council On Nanotechnology (ICON), he has chaired the 
International Standards Organization Working Group on size selective 
sampling in the workplace, and he has been involved in the organization 
of many international meetings on nanotechnology. Dr. Maynard has 
testified before the U.S. House Committee on Science on nanotechnology 
policy, and is a member of the President's Council of Advisors on 
Science and Technology, Nanotechnology Technical Advisory Group. Dr. 
Maynard holds an Associate Professorship at the University of 
Cincinnati, is an Honorary Senior Lecturer at the University of 
Aberdeen, UK, and has authored or co-authored over 90 scholarly 
publications.

    Chairman Baird. Thank you. We have been joined by Mr. 
Reichert. Dr. Denison?

    STATEMENT OF DR. RICHARD A. DENISON, SENIOR SCIENTIST, 
                     ENVIRONMENTAL DEFENSE

    Dr. Denison. Thank you very much for the invitation to 
present our views today.
    Environmental Defense continues to believe that 
nanotechnology promises significant health and environmental 
benefits. We also believe that a robust process to address the 
risks of this technology is absolutely essential to ensure that 
those benefits are realized. We are not alone in this view. A 
coalition of stakeholders from large and small businesses, from 
academic researchers, think tanks, consumer groups, and 
environmental NGO's have banded together over the last two 
years to consistently press for a balanced approach, publicly 
calling for much more federal money to be spent on risk 
research and for a cohesive federal strategy to be developed 
and implemented.
    Unfortunately, the Federal Government's approach under the 
NNI is well out of balance. To be fair, scientists at NNI and 
its agencies are talking and writing a great deal about the 
need to address the risks of this technology, and they in 
particular emphasize how little we know about these materials, 
how much work it will take to actually fill these gaps, and how 
important filling those gaps is to our ability to assess and to 
mitigate any potential risks.
    But there is a growing disparity between government 
scientists' words and the actions of the NNI. The problem is 
three-fold in our view. Too little is being spent on risk 
research, too little is known about what those current funds 
are being spent on, and the pace at which the Federal 
Government is moving to develop the cohesive strategy that 
everyone needs is bordering on glacial, although these days 
glaciers are moving a bit faster.
    Let me address each of these in turn. The Committee and 
previous speakers have already detailed how little of the 
federal nano R&D budget is going to risk research, on the order 
of three to four percent, and that percentage amount has 
largely unchanged over the last several years. In contrast, we 
and many others have been calling for at least 10 percent 
commitment of funds to this task, yet NNI has never publicly 
indicated its support for such an increase.
    The problem goes beyond, however, just how much is being 
spent. There is currently no good way to know how it is being 
spent, that is, what research NNI is specifically counting in 
its totals; and that is because NNI has never made public a 
listing of the projects that it is counting in its total budget 
figures. Some analyses suggest NNI may well be overcounting by 
including not only direct EHS research but also research on 
applications that it deems relevant to understanding risk. NNI 
itself has noted it has trouble drawing that line and that 
assessing relevance is a subjective exercise.
    But much of this confusion and uncertainty could be cleared 
up immediately if NNI would simply disclose what specific 
projects are being funded. All we really know is that NNI 
breaks down its numbers in terms of what agencies and 
departments get, and this shows the National Science Foundation 
whose mission is funding basic research gets the lion's share 
of the money being spent on EHS research. While there is 
certainly a role for basic research, in our view, research that 
is meant to address health and environmental issues needs to be 
primarily funded through and conducted by agencies that have 
that as their mission: EPA, NIOSH, National Institutes of 
Environmental Health Sciences, and so forth.
    As the Committee has noted, NNI has been promising to 
deliver a strategy for well over a year. It has yet to 
materialize, however, and the incremental process that NNI has 
laid out for getting there has actually led a journalist at the 
New York Times to recently quip, ``No one can accuse them of 
acting rashly.''
    Unfortunately, in Environmental Defense's view, there are 
two structural impediments that are preventing NNI from moving 
faster. First, NNI lacks the overarching budgetary and 
oversight authority that is needed to shape and direct a 
research strategy undertaken by its member agencies and 
departments. NNI functions primarily in a facilitation and 
coordination role, and it simply cannot be expected to develop 
let alone implement such a strategy.
    Second, we have become convinced that a conflict of 
interest has risen from the decision to house within NNI the 
dual, and some might say dueling, responsibilities to both 
develop and promote nanotechnology and at the same time to 
aggressively identify and mitigate its potential risks. That 
conflict in our view is both slowing down and compromising 
current efforts. It manifests itself in the budget disparity, 
in the confusion over what NNI is actually spending, and we 
think it helps to explain why things are taking so long.
    Even some individual agencies such as FDA and EPA are 
tasked with not only regulating nanotechnology but actually 
promoting it, sometimes even within the same office. All agency 
proposals pertaining to address potential risks have now to be 
vetted through a White House Nanotechnology Policy Group. These 
factors we think help to explain the disconnect between the 
words and the actions on the part of both NNI and its agencies.
    Can the NNI approach be made to work? We think two changes 
are essential. First, either a new entity needs to be created 
or an existing entity elevated significantly and given the 
responsibility and authority and the resources to develop and 
manage the implementation of an overall risk research strategy. 
This entity needs to have a core health and environmental 
mission, and Congress should request that the National 
Academies assist in developing this strategy and in overseeing 
its implementation. Second, we believe that a stronger firewall 
must be established between the parts of the Federal Government 
whose mission is to develop and advance nanotechnology and 
those parts that are charged with objectively identifying and 
mitigating its potential risks.
    To ensure that both of those goals receive comparable 
consideration, these responsibilities need to be assigned to 
different offices and staff members within those agencies.
    In sum, the risk-related activities within the National 
Nanotechnology Initiative need to be both substantially 
elevated and clearly separated from those that are dedicated to 
promoting this technology.
    Thank you very much.
    [The prepared statement of Dr. Denison follows:]
                Prepared Statement of Richard A. Denison

Introduction [1]

    Environmental Defense continues to believe that nanotechnology 
promises major health and environmental benefits. We also believe that 
implementation of a robust process to identify and address the 
potential risks of engineered nanomaterials is absolutely essential to 
ensuring that these benefits are in fact realized. A concurrent and 
balanced approach to addressing both the applications and implications 
of nanotechnology is the best hope for achieving the responsible 
introduction of this remarkable set of new technologies.
    There has been a relatively strong consensus among large and small 
industry, academic researchers, think tanks and consumer and 
environmental NGOs that this balanced approach is needed. 
Unfortunately, however, the Federal Government is pursuing an approach 
under the National Nanotechnology Initiative (NNI) that is well out of 
balance.
    To be sure, NNI and many of its member agencies are talking and 
writing a great deal about the need to address nanotechnology's risks 
as well as its benefits. One need only look at their websites and 
reports, especially those written by their scientists. But there is a 
continuing, and in some ways, growing disparity between NNI's words and 
actions.
    Over the past two years, scientists at several NNI agencies and at 
NNI itself have published documents elegantly describing how little we 
know about nanomaterials' potential hazards and exposures and how much 
work will be needed both to address these gaps and to adequately assess 
risks.[2] These documents also repeatedly draw needed attention to 
three critical facts:

        1)  Because nanomaterials have different properties than their 
        conventional counterparts, existing information on substances' 
        conventional forms is of limited use in elucidating the 
        behavior and biological activity of their nano forms.

        2)  Methods for testing nanomaterials or for measuring their 
        presence in environmental media or in organisms have largely 
        yet to be developed.

        3)  Current approaches to predicting the hazard, exposure 
        potential or fate of chemicals cannot be applied to 
        nanomaterials, because they do not account for the physical as 
        well as chemical properties that determine the latter's 
        behavior and biological activity.

    These critical gaps severely hamper our ability to apply the usual 
risk assessment and risk management procedures.
    For example, the Nanotechnology Task Force of the U.S. Food and 
Drug Administration (FDA) recently released a succinct summary of the 
state of the science of nanomaterials falling under its jurisdiction. 
Reversing its earlier position that suggested nanomaterials are really 
nothing new, FDA now acknowledges the inability to effectively predict 
nanomaterials' behavior and the need for direct testing:

         ``[A]t this scale, properties of a material relevant to the 
        safety and (as applicable) effectiveness of FDA-regulated 
        products might change repeatedly as size enters into or varies 
        within the nanoscale range. . . .Biological interactions 
        influenced by the particular chemistry and physical 
        configuration of the nanoscale material might also occur in 
        ways that are unpredictable without specific test data for the 
        material.''[3]

    Likewise, the thorough Nanotechnology White Paper published by the 
U.S. Environmental Protection Agency (EPA) notes the following:

         ``The diversity and complexity of nanomaterials makes chemical 
        identification and characterization not only more important but 
        also more difficult. A broader spectrum of properties will be 
        needed to sufficiently characterize a given nanomaterial for 
        the purposes of evaluating hazard and assessing risk. . . .The 
        limited studies conducted to date indicate that the 
        toxicological assessment of specific intentionally produced 
        nanomaterials will be difficult to extrapolate from existing 
        databases. The toxic effects of nanoscale materials have not 
        been fully characterized, but it is generally believed that 
        nanoparticles can have toxicological properties that differ 
        from their bulk material. . . .The sheer variety of 
        nanomaterials and nanoproducts adds to the difficulty of 
        developing research needs. Each stage in their life cycle, from 
        extraction to manufacturing to use and then to ultimate 
        disposal, will present separate research challenges. 
        Nanomaterials also present a particular research challenge over 
        their macro forms in that we have a very limited understanding 
        of nanoparticles' physicochemical properties.''[4]

    These reports also attach a considerable degree of urgency to the 
need to address these large and complex questions. FDA notes that ``the 
science and applications are developing at a very rapid pace,'' while 
EPA highlights ``the rapid development of nanotechnology and the 
increasing production of nanomaterials and nanoproducts,'' noting that 
hundreds of nanoproducts are already on the market and that 
``nanomaterials are already being used or tested in a wide range of 
products such as sunscreens, composites, medical and electronic 
devices, and chemical catalysts.''[5]
    Recognition of both the complexity of the task at hand and the 
urgency to get moving are widely shared beyond government. For over two 
years now, a coalition comprised of large and small companies, other 
industry groups and NGOs has publicly called for much greater attention 
to be paid to risk research, noting in particular the disparity between 
federal spending on applications versus implications research:

         ``While industry, academic, and government scientists continue 
        to vigorously explore nanotechnology's potential applications 
        in a wide variety of fields, such as groundwater cleanup and 
        cancer therapy, research on nanotechnology's potential health 
        and environmental implications has failed to keep up. Federal 
        research is essential to providing the underlying methods and 
        tools critical to developing a fundamental understanding of the 
        risk potential of nanomaterials and nanotechnologies--methods 
        and tools that all producers and users can then use to fulfill 
        their appropriate responsibility to identify potential risks of 
        their own materials and applications.''[6]

    This same coalition has also called for development of a federal 
risk research roadmap and strategy.[7]
    Unfortunately, the words in the FDA and EPA reports I referenced 
earlier have not translated into meaningful and sufficient actions by 
the Federal Government, even though they have been bolstered by the 
remarkable and unusual consensus among key stakeholders just noted. Too 
little is being spent on risk research, too little is known about what 
current funds are being spent on, and the pace at which the Federal 
Government is moving to produce a coherent risk research strategy 
borders on glacial. Let me address each of these concerns in more 
detail.

What is being spent

    NNI's 2007 budget is estimated at $1.35 billion and its 2008 budget 
request is $1.45 billion. NNI reports that the fraction of those totals 
to be spent on environmental, health and safety (EHS) research and 
development (R&D) are 3.5 percent for 2007 and 4.1 percent for 
2008[8]--a trend line that has remained nearly flat for the last 
several years in percentage terms and is only a modest increase in 
absolute dollars. In contrast, Environmental Defense has called for 
much more--at least 10 percent--of the federal nanotechnology R&D 
budget to be specifically directed, for the foreseeable future, to 
targeted EHS research (exclusive of applications research that may 
tangentially shed light on implications questions).[9] For more than 
two years, many others have joined us in making this call. In June 
2005, the CEO of DuPont and the President of Environmental Defense co-
authored an opinion editorial in the Wall Street Journal calling for an 
increase in such funding to at least 10 percent of the federal 
nanotechnology R&D budget.[10] Indeed, the coalition of industry and 
NGOs to which I just referred has also pressed Congress for a 
significant increase in federal appropriations. Yet NNI has never 
publicly called for or indicated its support for such an increase.

How current funds are being spent

    NNI's budget numbers for EHS research must be considered suspect, 
unfortunately. There is currently no way to know what research NNI is 
counting when it provides its totals, because NNI has not made public 
any listing of the projects it includes. In addition, NNI has itself 
noted that it has trouble drawing the line between direct EHS 
implications research and applications research that it maintains is 
``relevant'' to understanding implications. Last year, the Project on 
Emerging Nanotechnologies (PEN) at the Woodrow Wilson International 
Center for Scholars used NNI's 2005 budget numbers and its inventory of 
ongoing federal risk research to try to answer these questions. Of the 
roughly $40 million NNI said it was spending on ``relevant'' EHS 
research that year, PEN could identify as ``highly relevant'' only $11 
million of research and about $30 million as ``generally 
relevant.''[11] While PEN's analysis has not been updated, the lack of 
transparency on the part of NNI as to what projects it counts in 
tabulating EHS spending creates unnecessary confusion and uncertainty 
over how much is actually being spent and on what.
    To date, the only detail provided by NNI as to how this money is 
being spent is a breakdown by agency or department. From this 
breakdown, we know that the National Science Foundation (NSF), which 
funds basic research but has no public or occupational health or 
environmental mission, continues to receive the lion's share (>50 
percent) of federal risk research dollars. While there is certainly a 
role for basic research, environmental or public health research should 
be conducted primarily by, and ideally directed and overseen by, 
federal agencies that have such missions, such as EPA, the National 
Institute for Environmental Health Sciences (NIEHS), or the National 
Institute for Occupational Safety and Health (NIOSH).
    In addition, the great majority of federal risk research dollars is 
being spent on extramural research, through grants to academic and 
other institutions. Both extramural and intramural research have 
important roles to play, but to date too few funds have been devoted to 
building the needed intramural research capacity. Federal funding for 
both intramural and extramural research can and should reflect research 
priorities by more tightly focusing calls for proposals on key 
environmental and health research objectives. Increased funding for 
intramural research at federal agencies and laboratories is needed to 
conduct more applied research and to address specific priorities that 
are less likely to be efficiently addressed by academic or 
institutional research.
    Although such federal research institutions may not have the 
capacity now to fully absorb the resources needed for intramural 
research, immediate priority should be placed on building that capacity 
as rapidly as possible. This capacity-building and research agenda 
should be viewed as an investment that will facilitate the responsible 
development of emerging nanotechnologies.

Need for a comprehensive federal risk research strategy--and the means 
                    to implement it

    While NNI has been promising to deliver a risk research strategy 
that is coordinated across its agencies for well over a year, such a 
strategy has yet to materialize. Its issuance was just delayed again 
and is now projected for release in January 2008.
    Based on the process NNI has laid out for developing such a 
strategy, it still has a considerable way to go:

          Step 1--Identify EHS research needs and priorities. 
        This step took the form of a report issued in September 2006, 
        which was subjected to public comment.[12] Environmental 
        Defense's comments on this document are attached to this 
        testimony.

          Step 2--Further prioritize research needs. This step 
        came in a report issued in mid-August of this year, nearly a 
        year after the first one, and was again subjected to public 
        comment.[13] The eight-page second report was essentially a 
        boiled-down version of the first, 60-page report.

    Four more steps remain to be completed, according to NNI:

          Step 3--Evaluate in greater detail the current NNI 
        EHS research portfolio.

          Step 4--Perform a ``gap analysis'' of the NNI EHS 
        research compared to prioritized needs.

          Step 5--Coordinate and facilitate among the NNI 
        agencies' research programs to address priorities.

          Step 6--Establish a process for periodic review of 
        progress and for updating the research needs and priorities.

    It is not clear whether each of these steps is to be taken on 
sequentially, with a corresponding pause for public comment. In any 
event, as a journalist for the New York Times recently put it: ``No one 
can accuse them of acting rashly.''[14]

Key impediments to progress

    Unfortunately, in Environmental Defense's view, NNI has core 
structural impediments that prevent it from acting expeditiously to 
identify and address potential risks and from adopting a more balanced 
overall approach. The problems are two-fold. First, NNI lacks any 
overarching budgetary and oversight authority to shape and direct the 
research activities undertaken by its member agencies and departments. 
The part of NNI that is mounting current efforts in this area is the 
Nanoscale Science, Engineering and Technology Subcommittee (NSET), 
which serves primarily in a facilitation and coordination role and 
simply has not been given the necessary authority to devise and 
implement a coherent, cross-agency risk research strategy. Additional 
authority to oversee and direct federal risk-related research is 
essential to ensure two things: a) that the right questions are asked 
and answered, and b) that identified risks are comprehensively assessed 
and do not fall through the cracks between statutes, departments and 
agencies.
    Second, we have become convinced that a conflict of interest has 
arisen from the decision to house within NNI the dual functions of both 
seeking to develop and promote nanotechnology and its applications, 
while at the same time aggressively pursuing the actions needed to 
identify and mitigate any potential risks that arise from such 
applications. That conflict of interest is both slowing and 
compromising efforts by NNI and its member agencies and departments to 
effectively address nanotechnology's implications. The conflict 
manifests itself in the continuing budget disparity I have already 
discussed. It is also apparent in NNI's evident inability or 
unwillingness to clearly identify research activities devoted 
specifically to EHS concerns and sufficiently distinguish them from 
applications research that may incidentally yield data relevant to 
understanding implications. And it may help explain what's taking so 
long.
    The conflict also appears to be manifesting itself at the 
individual agency level. Some NNI agencies, including FDA and EPA, are 
themselves charged with both promoting and regulating nanotechnology 
applications, sometimes even within the same office. In addition, all 
agency proposals pertaining to addressing nanotechnology's potential 
risks must now be vetted through a White House nanotechnology policy 
group. These factors may be responsible in part for the growing 
disconnect between, on the one hand, the recognition by agencies of the 
magnitude of and urgent need to address the risk question, and on the 
other hand, the tepid response of those same agencies in terms of 
actions to be taken.
    For example, the FDA Nanotechnology Task Force's recommendations 
are vague and lack critical details on actions needed to close 
identified research and regulatory gaps. While there is a call for the 
agency to promote and participate in research, there is no mention of 
the level of resources needed, the timeframe within which this is--or 
needs--to be accomplished, or even an indication that there is any 
urgency to advance the collection of data. While the recommendations 
call on the agency to issue various forms of guidance for manufacturers 
to use on a voluntary basis, they propose that the evaluation of 
products continue on a case-by-case basis, which is essentially the 
status quo. There is no description of how the agency will or should 
address two key points: a) the greater uncertainties it has identified 
that are posed by using nanomaterials in products for which the agency 
has pre-market authority, or b) the considerable gaps in information 
for classes of products, such as cosmetics, for which the agency has no 
pre-market authority.
    Similarly, we can look at how EPA has responded to growing public 
concern over the lack of nanotechnology oversight and its own 
scientists' identification of the enormous data gaps that must be 
filled if risks are to be effectively identified and addressed. EPA has 
taken two recent steps. First, it issued a policy decision that 
considers the nano forms of existing chemicals to be no different than 
their bulk counterparts, and by so doing effectively eliminates the 
only opportunity EPA has to review or require testing of such 
nanomaterials prior to their manufacture and use.[15] Second, it issued 
a ``concept paper'' that proposes an open-ended, voluntary program to 
encourage companies to submit any information they already happen to 
possess. EPA proposes what its own advisory committee proposed nearly 
two years ago--except it has removed the strict deadlines for the 
voluntary program and the simultaneous development of mandatory 
reporting rules as a regulatory backstop, which the committee had 
included.[16]

Recommendations: Can the NNI approach be made to work?

    If NNI is to effectively address the potential risks of 
nanotechnology, two changes are essential.
    First, a new entity needs to be created, or an existing entity 
elevated, and given responsibility, ample authority and resources to do 
the following:

          Ensure the development of an overall federal research 
        strategy to identify, assess and address the potential risks of 
        nanomaterials.

          Shape and direct the overall federal risk research 
        agenda across agencies to ensure all critical needs are being 
        addressed.

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

    This entity, whether independent or housed in an existing agency, 
should have a core public health and/or environmental mission. Congress 
should also request that the National Academies' Board on Environmental 
Studies and Toxicology (BEST) take a lead role in developing the needed 
strategy, and in overseeing its implementation over a number of years. 
BEST has successfully played an analogous role in the formulation and 
execution of the U.S. Environmental Protection Agency's research 
strategy for assessing the risks of airborne particulate matter.[17]
    The second essential step is to establish a firewall between the 
parts of the Federal Government whose mission is to help develop and 
advance nanotechnology, and those parts charged with ensuring a 
thorough and objective examination of its potential risks and taking 
the steps needed to mitigate those risks. Ensuring that both goals 
receive equal consideration would require, at a minimum, that the 
responsibility to address the two distinct goals be assigned to 
different offices and senior staff members, who are given parallel and 
comparable degrees of authority, and who report directly to the highest 
levels within their individual agencies and within NNI. We believe that 
a clear division of labor and interests is critical if public 
confidence in the ability of the Federal Government to facilitate the 
responsible development of nanotechnology is to be restored.
    In sum, the activities within NNI devoted to identifying and 
mitigating the potential risks of nanotechnology need to be both 
substantially elevated in importance and clearly separated from those 
dedicated to promoting its development and application.
    Thank you for the opportunity to present our views today. 
Environmental Defense stands ready to assist the Committee as it 
considers what changes are needed in legislation to be developed to 
reauthorize NNI.

Endnotes

 1.  A biography of Dr. Denison is attached.

 2.  For example, see: U.S. Food and Drug Administration, 
Nanotechnology: A Report of the U.S. Food and Drug Administration 
Nanotechnology Task Force, July 25, 2007, at www.fda.gov/
nanotechnology/taskforce/report2007.pdf; and U.S. Environmental 
Protection Agency, Nanotechnology White Paper, February 2007, at 
www.epa.gov/osa/nanotech.htm; National Institute for Occupational 
Safety and Health, Strategic Plan for NIOSH Nanotechnology Research: 
Filling the Knowledge Gaps, at www.cdc.gov/niosh/topics/nanotech/
strat-planINTRO.html; and National Nanotechnology 
Initiative, Environmental, Health, and Safety Research Needs for 
Engineered Nanoscale Materials, September 2006, at www.nano.gov/
NNI-EHS-research-needs.pdf.

 3.  FDA, op. cit., pp. ii, 11.

 4.  EPA, op. cit., pp. 31, 70, 77.

 5.  FDA, op. cit., p. 8; EPA, op. cit., pp. 4, 13, 21.

 6.  Letter signed by 14 companies and organizations sent to Chairs and 
Ranking Members of the House and Senate Appropriations Committees, 
dated June 7, 2006, at www.environmentaldefense.org/documents/
5067-nano-appropsLetter.pdf Emphasis in original.

 7.  Letter signed by 19 companies and organizations sent to Chairs and 
Ranking Members of the House and Senate Appropriations Committees, 
dated February 22, 2007, at www.environmentaldefense.org/documents/
6015-Approps- 2007NASLetter.pdf

 8.  The National Nanotechnology Initiative: Research and Development 
Leading to a Revolution in Technology and Industry, Supplement to the 
President's FY 2008 Budget, Tables 2 (p. 7) and 6 (p. 11), at 
www.nano.gov/NNI-08Budget.pdf

 9.  Denison R.A. ``A proposal to increase federal funding of 
nanotechnology risk research to at least $100 million annually.'' 
Environmental Defense, Submitted to the National Academy of Sciences' 
Committee to Review the National Nanotechnology Initiative (April 
2005), at www.environmentaldefense.org/article.cfm?ContentID=5131

10.  See Fred Krupp and Chad Holliday, ``Let's Get Nanotech Right,'' 
Wall Street Journal, June 14, 2005, p. B2, at 
www.environmentaldefense.org/documents/
5177-OpEd-WSJ050614.pdf That same month, the 
American Chemistry Council's Panel on Nanotechnology and Environmental 
Defense issued a Joint Statement of Principles stating: ``A significant 
increase in government investment in research on the health and 
environmental implications of nanotechnology is essential.'' At 
www.environmentaldefense.org/documents/4857-ACC-
ED- nanotech.pdf And in a 2005 report on nanotechnology, 
Innovest, a leading investment research and advisory firm, said: ``We 
strongly support calls by others in the investment community for 
increased government funding of toxicology research. The NNI's lack of 
priority for this issue represents a missed opportunity to minimize 
uncertainty.'' See Innovest (2005). Nanotechnology: Non-traditional 
Methods for Valuation of Nanotechnology Producers. New York, NY. Page 
56. At www.innovestgroup.com/images/pdf/final%20nano%2010-30-06.pdf

11.  Maynard, A.D. (2006) Nanotechnology: A Research Strategy for 
Addressing Risk, pp. 3, 20, at www.nanotechproject.org/
file-download/77

12.  NNI, 2006, op. cit.

13.  National Nanotechnology Initiative, Prioritization of 
Environmental, Health and Safety Research Needs for Engineered 
Nanoscale Materials--An Interim Document for Public Comment, at 
www.nano.gov/
Prioritization-EHS-Research-Needs-
Engineered-Nanoscale-Materials.pdf

14.  Barnaby J. Feder, ``No one can accuse them of acting rashly,'' 
August 17, 2007, at bits.blogs.nytimes.com/2007/08/17/no-one-can-
accuse-them-of-acting-rashly/

15.  U.S. Environmental Protection Agency, ``TSCA Inventory Status of 
Nanoscale Substances--General Approach,'' released for public comment 
on July 11, 2007, at www.regulations.gov/fdmspublic/component/
main?main=DocumentDetail&d=EPA-HQ-OPPT-2004-0122-0057

16.  U.S. Environmental Protection Agency, ``Concept Paper for the 
Nanoscale Materials Stewardship Program under TSCA,'' released for 
public comment on July 11, 2007, at www.regulations.gov/fdmspublic/
component/main?main= DocumentDetail&d=EPA-HQ-OPPT-2004-0122-0058 The 
2005 proposal made by EPA's National Pollution Prevention & Toxics 
Advisory Committee (NPPTAC) is at www.epa.gov/oppt/npptac/pubs/
nanowgover viewdocument20051125.pdf Environmental Defense's comments on 
both of EPA's recent proposals are at www.environmentaldefense.org/
documents/7010-ED-WrittenCommentson 
EPANanoDocs09072007.pdf

17.  Board on Environmental Studies and Toxicology, Research Priorities 
for Airborne Particulate Matter: I. Immediate Priorities and a Long-
Range Research Portfolio, Committee on Research Priorities for Airborne 
Particulate Matter, National Research Council, 1998; and Research 
Priorities for Airborne Particulate Matter: IV. Continuing Research 
Progress, 2004, both at: books.nap.edu/catalog/6131.html and 
books.nap.edu/catalog/10957.html

Attachment 1

                    Biography for Richard A. Denison
    Dr. Denison is a Senior Scientist in Environmental Defense's 
Washington, DC office. With more than 20 years of experience in the 
environmental arena, he specializes in chemicals policy, hazard and 
risk assessment and management for industrial chemicals, and 
responsible development of nanotechnology.
    Dr. Denison has managed Environmental Defense's participation in 
and oversight of the U.S. High Production Volume (HPV) Chemical 
Challenge Program, initiated by Environmental Defense, the U.S. 
Environmental Protection Agency and the American Chemistry Council to 
provide basic hazard data on the 2,200 chemicals produced in the U.S. 
in the largest quantities. He also represents Environmental Defense on 
the Chemicals Committee and on the Working Party on Manufactured 
Nanomaterials of the Organization for Economic Cooperation and 
Development (OECD). Dr. Denison was recently appointed to the Science 
Advisory Panel for California's Green Chemistry Initiative. Until 
recently, he was a member of the National Pollution Prevention and 
Toxics Advisory Committee (NPPTAC), which advises EPA's toxics office. 
Dr. Denison is part of Environmental Defense's team that worked jointly 
with the DuPont Corporation to develop a framework governing 
responsible development, production, use and disposal of nanoscale 
materials.
    Dr. Denison has authored numerous papers and reports, and he is 
active in a variety of activities and forums, pertaining to chemicals 
and nanomaterial regulation and policy at the federal and State levels 
and internationally. Dr. Denison is the author of a major report, 
titled Not That Innocent, that provides a comparative assessment of 
existing and emerging industrial chemicals policies in the U.S., Canada 
and Europe.
    Dr. Denison earned a Ph.D. in Molecular Biophysics and Biochemistry 
from Yale University in 1982. He joined Environmental Defense in 1987, 
after several years as an analyst and assistant project director at the 
Office of Technology Assessment, United States Congress.

Attachment 2

                 ENVIRONMENTAL DEFENSE COMMENTS\1\ ON:
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    \1\ These comments are available online at www.nano.gov/html/
meetings/ehs/uploads/
20070131-0752-ED-comments-on
-NNI-EHS-Research-Needs-
FI NAL.doc
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    Environmental, Health, and Safety Research Needs for Engineered 
            Nanoscale Materials, released September 15, 2006

                            January 31, 2007
    Federal Register: December 8, 2006 (Volume 71, Number 236) DOC 
                            ID:FR08DE06-135

Introductory Statement

    Environmental Defense appreciates this opportunity to submit 
comments on the National Nanotechnology Initiative's document 
Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale Materials, which was released on September 15, 2006.
    Environmental Defense is a leading national environmental nonprofit 
organization representing more than 400,000 members. Since 1967, we 
have linked science, economics, law, and innovative private-sector 
partnerships to create pragmatic solutions to the most serious 
environmental problems. Among our other activities related to 
nanotechnology, we are currently working with DuPont to develop a 
comprehensive, practical and transparent approach to proactively 
evaluate and address the risks of nanomaterials across their life 
cycle.
    The National Nanotechnology Initiative's Nanoscale Science, 
Engineering, and Technology (NSET) Subcommittee of the Committee on 
Technology, National Science and Technology Council (NSTC) has 
requested comment on the research needs and prioritization criteria 
that were identified in the NSET Subcommittee document Environmental, 
Health, and Safety Research Needs for Engineered Nanoscale Materials.
    We commend the NSET Subcommittee on the preparation of this report, 
which identifies critical research and information needs for nanoscale 
materials. The Subcommittee emphasizes that these research needs were 
not presented in any priority research order, and requests feedback on 
the development of criteria for establishing priority research.
    Almost every research need identified in this report addresses a 
critical data gap. To this end we urge the U.S. Government to provide 
the necessary funds to implement an aggressive and broad research 
strategy. However, we recognize that available funds are limited and it 
is necessary to prioritize research needs.
    The NNI proposes using a ``value of information strategy'' to 
prioritize research needs. This approach is predicated on how to assign 
value to different kinds of information. The NNI document identifies 
the following factors as indicators of research value:

          The extent to which the information will reduce 
        uncertainty about benefits or risks.

          The extent to which information can be expected to 
        lead to broad knowledge about the property and behavior of 
        nanomaterials.

          The extent of expected use of the nanomaterial.

          The exposure potential for workers, consumers, or the 
        environment.

          The potential to leverage relevant existing data.

    While we agree that these are useful criteria for evaluating 
research priorities, we are concerned about applying some type of 
formal ``value of information'' methodology to the prioritization of 
nanoscale material toxicity research. At this stage, it is not possible 
to apply a typical ``value of information'' methodology to predict what 
type of research will optimally reduce uncertainty about risks or lead 
to broader knowledge and understanding of nanomaterial behavior without 
broadly speculating on potential risks and the types of information 
needed to reduce them. Value of information methodologies rely on 
quantifying the harms being reduced, which is not possible at this time 
for nanomaterial risks. Moreover, in the setting of an emerging 
technology such as nanotechnology, the economic consequences of 
obtaining or failing to obtain critical information on toxicity are in 
reality so unpredictable that formalizing the costs and benefits 
through a value of information analysis is artificial and potentially 
misleading. While some of the principles of a value of information 
approach are valid for prioritizing nanomaterials risks, we recommend 
that reference to this formal methodology be removed. In our comments 
below, we provide additional recommendations on how to proceed with 
prioritization in the face of multiple major knowledge gaps, and on the 
relative roles for industry and government research programs.
    Based on our assessment of the report Environmental Defense would 
like to provide support for the EHS research portfolio, and present 
specific comments and recommendations pertaining to the need to 
prioritize the EHS research. The summary outline of EHS research needs 
is reproduced here, with numbering and lettering added to facilitate 
direct references in the text below to the research needs identified in 
the NNI document.

1.  Instrumentation, Metrology, and Analytical Methods

        a)  Methods for detection nanomaterials in biological matrices, 
        the environment, and the workplace

        b)  Methods for standardizing particle size and size 
        distribution assessment

        c)  Methods and standardized tools for assessing shape, 
        structure, and surface area

        d)  An inventory of engineered nanomaterials and their uses

2.  Nanomaterials and Human Health

        a)  Understanding the absorption and transport of nanomaterials 
        throughout the body from different exposure routes--methods 
        development

        b)  Understanding the properties of nanomaterials that elicit a 
        biological response

        c)  Identification and development of appropriate in vitro and 
        in vivo bioassays

        d)  Methods to quantify and characterize exposure to 
        nanomaterials in biological matrices

3.  Nanomaterials and the Environment

        a)  Evaluation of testing schemes for ecological effects

        b)  Evaluation of factors affecting fate and transport

        c)  Understanding the transformation of nanomaterials under 
        different conditions

4.  Health and Environmental Surveillance

        a)  Understanding exposures in the workplace and factors that 
        affect them

        b)  Quantification of exposure from industrial, consumer, and 
        other sources

        c)  Establishment of environmental monitoring protocols

5.  Risk Management

        a)  Improve understanding of process design and engineering 
        controls

        b)  Develop ``green design'' techniques

        c)  Determine product life cycles and potential impact on EHS

        d)  Evaluate current risk communication strategies for known 
        and anticipated risks

    Below we present four overarching criteria that we believe should 
be used to prioritize the many research needs identified by NNI. These 
criteria are:

          Research that will develop the ``enabling 
        infrastructure.''

          Information that will facilitate ``look back'' 
        studies.

          Selection of materials should focus on key concerns 
        related to toxicity and biological response.

          Selection of relevant materials and methods.

Criterion 1: Research that will develop the ``enabling 
infrastructure.''

    We strongly recommend that federal funds be used first and foremost 
to acquire fundamental knowledge that is needed to develop the 
``enabling infrastructure'' for nanomaterial EHS, which is best 
addressed by the Federal Government. This ``enabling infrastructure'' 
includes developing and standardizing, for routine application, the 
methods, tools (e.g., instrumentation) and basic scientific 
understanding needed to measure and assess:

          Physical-chemical characterization of nanomaterials;

          Sampling and analysis;

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

          Biological and environmental fate and behavior;

          Acute and chronic toxicity; and

          Hazard, exposure and risk.

    Development of the enabling infrastructure will advance industry 
research in risk assessment and materials design and testing of 
specific materials and products, and will facilitate independent 
researchers in pursuit of general and applied nanoscale research.
    There are several lines of research discussed in the NNI document 
that can be included in this category. For example, we agree there is a 
critical need for the development of methods to detect, quantify and 
characterize nanomaterials in biological matrices, the environment, and 
the workplace (1a, 2d).\2\ The development of these methods will 
facilitate a cascade of additional research pertaining to fate and 
transport in humans and non-human organisms from different exposure 
routes, and fate, transport, and transformation in the environment, 
which are also of high priority, and addressed in more detail below.
---------------------------------------------------------------------------
    \2\ Numbers/letters in parentheses here and in the remainder of the 
text refer to items in the research outline provided above, to indicate 
the category and subcategory from the NNI document to which they refer.
---------------------------------------------------------------------------
    Another critical data need identified by the NNI is the development 
of methods for the standardized characterization of nanomaterials: 
particle size, size distribution, shape, structure, and surface area 
(1b, 1c). This will, in turn, advance government research on risk 
assessment, development of quantitative structure-activity 
relationships, and ultimately identification of the key properties of 
nanomaterials that elicit biological responses.
    The Federal Government also needs to plays an important role in the 
identification and development of key in vitro and in vivo bioassays 
(2c) for acute and chronic toxicity testing, and testing schemes for 
ecological effects (3a).
    A high priority should be placed on developing methods to identify 
nanomaterials that exhibit environmental persistence and/or 
bioaccumulation potential. These characteristics are critical 
indicators of concern for both environmental and human health, and 
nanomaterials exhibiting these properties require additional scrutiny. 
With such methods, research agencies could assess a broad array of 
materials and subsequently focus other lines of research on those 
materials presenting greater potential risk on the basis of their 
persistence and accumulation potential.
    Testing protocols developed by the government can then be used by 
industry to demonstrate the safety of their product or to identify 
risks requiring mitigation. They are also the key step required for the 
development of robust and health protective risk assessment and risk 
management protocols.
    The status of available assays for nanomaterials was recently 
reviewed in a workshop sponsored by Environmental Defense, the Center 
for Biological and Environmental Nanotechnology at Rice University, and 
the Woodrow Wilson Center, and attended by scientists from government, 
academia, industry, and non-profit organizations. The consensus of the 
attendees was the highest priority methods development needs include 
physical chemical characterization (structure, concentration, and 
surface properties, addressed above), and ADME/Translocation methods, 
which is equivalent to understanding the absorption and transport of 
nanomaterials throughout the body from different exposure routes (2a), 
particularly for in vivo bioassays (e.g., nanoparticles tracking, 
aggregation, transformation, solubility and stability, transmembrane 
movement, and bioaccumulation/bio persistence). The workshop 
proceedings are in preparation, and will be provided to the NNI upon 
acceptance for publication.
    Although we can and should expect industry to address product-
related research needs, the research listed above will be critical in 
generating the means by which industry can most effectively evaluate 
its own products. This is not to say that there is no role for industry 
prior to the development of the enabling infrastructure, as most 
standard apical bioassays will allow for the evaluation of potential 
toxicity, even in the absence of tissue quantification methods. For 
instance, both inhalation and instillation rodent bioassays have been 
very useful for elucidating toxicity for inhaled nanomaterials. 
Advancing research methods will require an iterative approach, 
measuring the outcome of new bioassays against standard apical 
bioassays. There is certainly the potential for government-industry and 
other stakeholder involvement in government-led initiatives in 
partnerships for methods development, and industry co-funding of such 
research should be pursued, as long as the government retains the 
ability to manage and direct it.
    Other considerations: Primary environmental or public health 
research, whether conducted intramurally or extramurally, should be 
directed and overseen by federal agencies that have an environmental or 
public health mission, such as the Environmental Protection Agency 
(EPA), the National Institute for Environmental Health Sciences 
(NIEHS), or the National Institute for Occupational Safety and Health 
(NIOSH). Currently, the National Science Foundation (NSF) funds and 
oversees more than 50 percent of the nanomaterials environmental health 
and safety research. NSF, which lacks any public health or 
environmental mission, may not be in the best position to identify and 
oversee such research.
    Both extramural and intramural research have important roles to 
play, but to date too few funds have been devoted to building the 
needed intramural research capacity. Federal funding for both 
intramural and extramural research can and should reflect research 
priorities by more tightly focusing calls for proposals on key 
environmental and health research objectives. Increased funding for 
intramural research at federal agencies and laboratories is needed to 
conduct more applied research and to address specific priorities that 
are less likely to be efficiently addressed by academic or 
institutional research.
    Although such federal research institutions may not now have the 
capacity to immediately fully absorb the resources needed for 
intramural research, immediate priority should be placed on building 
that capacity as rapidly as possible. This capacity-building and 
research agenda should be viewed as investment that will facilitate the 
responsible development of emerging nanotechnologies.

Criterion 2: Information that will facilitate ``look back'' studies.

    The prioritization of federal research should be undertaken with 
the understanding that we have critical knowledge gaps in the face of 
ongoing and growing exposures. In order to lay a foundation for 
understanding potential risks that may only manifest themselves well 
after exposures start, we need to know what types of nanomaterials are 
present in products, who is and has been employed in production, and 
who may be coming into contact with nanomaterials now. As we move 
forward in research to fill the knowledge gaps in the laboratory, the 
Federal Government should also address current and emerging exposures 
in the workplace by developing a registry of workers who have worked 
with or used nanomaterials for at least four weeks. This will not only 
aid in helping to understand ``exposures in the workplace and the 
factors that affect them'' (4a), but will also facilitate future 
epidemiologic studies of workers, a critical research need that is not 
sufficiently emphasized in the report. In addition, EPA, FDA and CPSC 
should collaborate in developing nanomaterial and nanomaterial-
containing product registries and inventories, which will also 
facilitate additional ``look back'' research to the extent it is needed 
in the future. This will help to meet the following research needs 
identified in the NNI report: an inventory of engineered nanomaterials 
and their uses (1d), and the identification and quantification of 
exposure from industrial, consumer, and other sources (4b).

Criterion 3: Selection of materials should focus on key concerns 
related to toxicity and biological response.

    Companies can and should be expected to concentrate their 
environmental health and safety research and testing programs on 
nanomaterials used in commercial applications, where they should employ 
life cycle approaches to identify all known and reasonably anticipated 
exposure scenarios. In contrast, government sponsored research should 
focus more on nanomaterials that will best elucidate general principles 
of toxicity and biological response (similar to 2b), for example, 
seeking to understand mechanisms whereby nanomaterials may readily 
translocate across biological interfaces, bioaccumulate, interact with 
cells or specific macromolecules (e.g., the stimulation of collagen 
formation in fibroblasts noted with carbon nanotubes), or generate 
reactive oxygen species. By focusing research on those nanomaterials 
that exhibit these and related characteristics of biological relevance 
and concern, federal research will advance knowledge of the features 
and characteristics most associated with biological responses, and also 
may facilitate the development of structure-activity relationships. 
Acquisition of these data not only can contribute to the construction 
of general principles regarding nanomaterials toxicity, but will also 
provide nanomaterial developers with important information that can be 
used to design ``green'' nanomaterials that do not exhibit these 
properties.
    While the costs and characteristics of some nanomaterials make the 
conduct of chronic bioassays or multi-generational testing challenging, 
in general there is likely much greater potential for nanomaterials to 
cause more subtle, chronic effects rather than acute toxicity--effects 
that may well be missed by only conducting acute testing. We therefore 
recommend that a number of nanomaterials with high potential for 
chronic exposure be tested for chronic toxicity to begin to gain 
understanding of potential long-term effects.
    The government should also pursue and fund research in a manner 
that provides not only an in-depth characterization of specific 
categories of nanomaterial, but also fully elucidates the effects of 
variations (in manufacturing processes, surface modifications, etc.) 
among materials within those categories on key biological properties. 
The NIEHS has begun this process by testing at least two variations of 
each category of nanomaterials it is studying. Only by expanding this 
approach will we begin to develop the much needed predictive capability 
to interpolate or extrapolate among structurally related materials.
    The NNI report indicates that government research efforts at the 
National Cancer Institute, National Institute for Environmental Health 
Sciences, National Institute for Occupational Safety and Health, the 
Food and Drug Administration, and the National Toxicology Program are 
focused on metal oxides (particularly TiO2 and ZnO), quantum dots, 
fullerenes, and carbon nanotubes. While it can be useful for discussion 
purposes to group nanomaterials into broad categories such as metal 
oxides, carbon-based materials, etc., the assumption that the members 
of such categories possess the same or similar biological properties is 
at this stage a hypothesis. For example production by different 
processes or surface modifications of the same basic material can 
dramatically alter the characteristics and behavior of a nanomaterial. 
Considerable empirical test data will be needed to test any ``category 
hypotheses,'' i.e., to determine the actual extent of similarity, or 
the regularity and predictability of trends, among category members, 
with respect to both hazard and exposure characteristics.

Criterion 4: Selection of relevant materials and methods.

    Research should also consider the need to test materials and 
applications that are now or are projected to be the most relevant, 
based on likelihood of release and exposure--examined on a life cycle 
basis. As noted in the report, ``. . .the exposure potential for some 
nanomaterials will be limited to nonexistent whereas exposure potential 
for other materials will exist at one or more stages of their product 
life cycle.'' Selection of the most relevant materials should be based 
on a systematic assessment of nanomaterials with known or reasonably 
anticipated human and environmental exposure potential over the life 
cycle of a broad array of materials.

Additional Comments: Need for public database for nanomaterial EHS 
data.

    The development of a publicly available database containing the 
results of environmental health and safety testing data is an urgent 
need that can be readily addressed through government funding. There is 
precedent to make this information available. One recent example of 
such a database is the EPA's High Production Volume Information System 
(HPVIS), which is providing access to hazard data on hundreds of 
chemicals. Directly relevant to nanoparticles are: 1) the NIOSH 
Nanoparticle Information Library (http://www2a.cdc.gov/niosh-nil/
index.asp), which includes physical chemical and toxicological data on 
a select number of nanomaterials, and 2) the National Cancer 
Institute's Nanotechnology Characterization Laboratory's publication of 
the results of the testing of nanomaterials, performed at the request 
of private companies (http://ncl.cancer.gov/index.asp). The reports are 
issued following a 90-day lag to allow for the management of 
confidential business information. These efforts should be consolidated 
and expanded to include the results of testing performed by industry 
laboratories to facilitate the dissemination of EHS data.

    Chairman Baird. Mr. Ziegler.

STATEMENT OF MR. PAUL D. ZIEGLER, CHAIRMAN, AMERICAN CHEMISTRY 
                  COUNCIL NANOTECHNOLOGY PANEL

    Mr. Ziegler. I am Paul Ziegler, Chairman of the American 
Chemistry Council, Nanotechnology Panel. I appreciate the 
invitation to address the House Committee on Science and 
Technology on the role of NNI in planning and implementing the 
environmental, health, and safety necessary for the responsible 
development of nanotechnology.
    ACC represents the leading companies that are engaged in 
the business of chemistry. In 2005, ACC formed the Nano Panel 
consisting of companies that manufacture, distribute, and use 
nanotechnology in business interests in products of 
nanotechnology. The panel was formed to foster the responsible 
application of nanotechnology, to coordinate nanotechnology EHS 
initiatives undertaken by member companies and other 
organizations, to facilitate the exchange of information among 
member companies and other domestic and international 
organizations on issues related to all aspects of 
nanotechnology.
    In discussing federal EHS research priorities, I first 
would like to emphasize that improved federal coordination and 
support are essential for the responsible development of 
nanotechnology and its commercial acceptance. The Federal 
Government has a unique and critically important role to play 
in coordinating and adequately funding the research on EHS 
aspects of nanotechnology. It is clear, however, from the 
August 2007 draft report of the Nanotechnology Environmental 
Health Implications Working Group, ``Prioritization of 
Environmental Health and Safety Research Needs for Engineered 
Nanoscale Materials'' that the current priority setting process 
is slow and incomplete. We applaud the part of the August 
report that focused on EHS priorities from 75 to 25. However, 
the criteria for reducing these priorities was not fully 
articulated, nor was it clear how the 25 priorities fit 
together in a cohesive strategy. Moreover, the draft report 
does not articulate the research roles of each participating 
federal agency. The panel is disappointed that there is no 
correlation of the 25 identified research areas to risk 
management or urgently needed research. We encourage NEHI to 
complete quickly the prioritization of the identified research 
areas, complete the final research strategy, and initiate the 
top priority projects. Specific projects need to be identified 
with annual funding requirements and realistic deliverables and 
timelines. The high-quality, comprehensive, and prioritized EHS 
research agenda is still missing and should: one, focus on risk 
assessments and the generation and application of information 
on the continuum of exposure, dose, and response; two, promote 
new interdisciplinary partnerships that bring visionary 
thinking to research on nanotechnology; three, support better 
understanding of the fundamental properties of nanomaterials 
that have an impact in the exposure dose response paradigm; 
four, develop processes for establishing validated standard 
measurement protocols so that individual or categories of 
materials can be studied; five, clearly delineate the 
responsibilities, programs, timelines, and anticipated results 
of funded projects for each federal agency; six, leverage 
planned and ongoing work with the Organization for Economic 
Cooperation and Development, OECD, working party on 
manufactured nanomaterials, particularly in identifying ongoing 
or planned research projects by other companies and 
interpreting the results of this research and testing of 
representative nanomaterials using standard test methods to 
assess potential health or environmental hazards.
    ACC has communicated at length with EPA, NIOSH, and other 
parties on the information that could assist by EHS research 
projects and would be useful in the near term. These issues 
include information on handling of nanomaterials in dry form 
and potential exposures; information on environmental releases 
related to production and use of nanomaterials in air, water, 
solid waste potential exposures unique to nanomaterials and 
risk management; information on the fate and transport 
mechanisms of nanomaterials in the environment; information on 
hazards of nanomaterials, basic and acute, supplemented by 
appropriate tiered decision-making structure for further 
testing; information leading to the development of workplace 
practices and guidelines; and finally, information on the 
explosion hazard potential that has been alleged with some 
nanomaterials.
    The panel also urges as an appropriate next step the 
funding of an independent review by the National Research 
Council Board of Environmental Studies and Toxicology, or BEST, 
to establish EHS research priorities for manufactured 
nanomaterials and a substantial increase in federal funding.
    On February 22, ACC along with 18 organizations requested 
that Congress appropriate $1 million for BEST to develop a 
roadmap for federal EHS projects. This would have enabled BEST 
to develop a roadmap and strategy for the Federal Government 
for EHS research needed to support safe use and development of 
nanoscale materials and technologies.
    Until appropriate measures are developed as part of the 
comprehensive research to measure the results of EHS funding, a 
specific multi-year timetable for funding is premature. The 
research strategy should be sufficiently flexible to take into 
account results from completed research, address information 
gaps that may arise and be adjusted so that projects are not 
continually funded.
    ACC and member companies of the Nanotechnology Panel 
strongly support EPA's planned Nanomaterials Stewardship 
Program. Information gained under this, along with the 
occupational exposure information gained by NIOSH, supporting 
research of other federal agencies and information from 
international bodies such as OECD will assist in prioritizing 
the EHS research projects.
    In closing, I would like to emphasize the importance of 
significant and sustained federal funding for development and 
implementing comprehensive nanotechnology research strategy. 
ACC urges the prioritization process for EHS research to be 
completed expeditiously and at best be funded and complete a 
research roadmap and strategy. While a foundation for this 
important process has been established, NNI must complete its 
task with renewed sense of urgency. The agencies need to 
identify what needs to be done, what they will do, put together 
a timeline, and do it.
    Thank you.
    [The prepared statement of Mr. Ziegler follows:]
                 Prepared Statement of Paul D. Ziegler

Introduction

    The American Chemistry Council (ACC) appreciates Chairman Gordon's 
invitation to address the House Committee on Science and Technology on 
the role of the National Nanotechnology Initiative (NNI) in planning 
and implementing the environmental, safety, and health research 
necessary for the responsible development of nanotechnology.
    ACC represents the leading companies engaged in the business of 
chemistry. ACC members apply the science of chemistry to make 
innovative products and services that make people's lives better, 
healthier and safer. ACC is committed to improved environmental, health 
and safety performance through Responsible Care, common sense advocacy 
designed to address major public policy issues, and health and 
environmental research and product testing. The business of chemistry 
is a $635 billion enterprise and a key element of the Nation's economy. 
It is one of the Nation's largest exporters, accounting for ten cents 
out of every dollar in U.S. exports. Chemistry companies are among the 
largest investors in research and development. Safety and security have 
always been primary concerns of ACC members, and they have intensified 
their efforts, working closely with government agencies to improve 
security and to defend against any threat to the Nation's critical 
infrastructure.
    In 2005, ACC formed its Nanotechnology Panel consisting of domestic 
producers that are engaged in the manufacture, distribution, and/or use 
of chemicals that have a business interest in the products of 
nanotechnology.\1\ The Panel was formed to foster the responsible 
application of nanotechnology; to coordinate nanotechnology 
environmental, health, and safety research initiatives undertaken by 
member companies and other organizations; and to facilitate the 
exchange of information among member companies and other domestic and 
international organizations on issues related to applications and 
products of nanotechnology. The Panel supports nanotechnology products 
and applications that are consistent with ACC's Responsible Care 
Program, and consistent with the Joint Statement of Principles the 
Panel and Environmental Defense issued on June 22, 2005 to help ensure 
that the commercialization of nanoscale materials proceeds in a way 
that protects workers, the public, and the environment.
---------------------------------------------------------------------------
    \1\ Panel member companies include: Air Products and Chemicals, 
Inc., Arkema Inc., Arch Chemicals, BASF Corporation, Bayer Material 
Sciences Corporation, Cytec Industries, The Dow Chemical Company, 
DuPont, Eka Chemicals, Elementis Specialties, Evonik Degussa 
Corporation, Honeywell, Oxonica, PPG Industries, Inc., Procter & 
Gamble, Rohm and Haas Company, and Sasol North America, Inc.

I.  Improved Federal Coordination and Support Are Essential for the 
---------------------------------------------------------------------------
Responsible Development of Nanotechnology and Its Commercial Acceptance

    The Federal Government has a unique and critically important role 
to play in coordinating and adequately funding research on the 
environmental, health, and safety (EHS) aspects of nanotechnology. In 
this regard, the NNI is tasked with coordinating nanotechnology 
research across dozens of federal agencies. This task necessarily 
requires a prioritized research strategy that clearly delineates the 
roles of the participating federal agencies. It is clear, however, from 
the August 2007 draft report of the Nanotechnology Environmental and 
Health Implications (NEHI) Working Group, Prioritization of 
Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale Materials, that the current priority setting process is slow 
and incomplete.
    We applaud that part of the August 2007 NEHI Working Group's draft 
report that focused the EHS research priorities from 75 to a more 
manageable 25. However, the criteria for reducing these priorities were 
not fully articulated. Nor is it clear how the 25 priorities fit 
together into a cohesive strategy. Moreover, the draft report does not 
articulate the research roles of each participating federal agency.
    The Panel is disappointed that there is no correlation of the 25 
identified research areas to risk management or ``urgently'' needed 
research. We encourage NEHI to complete quickly the prioritization of 
the identified research areas, complete the final research strategy, 
and initiate the top priority projects. Specific projects need to be 
identified with annual funding requirements and realistic deliverables. 
At the Working Group's present pace, others will be establishing a 
coherent research strategy for implementation by the various federal 
agencies without the involvement or perspective of all NEHI members.
    A high quality, comprehensive and prioritized EHS research agenda 
is still missing and should:

          Focus on risk assessments, and the generation and 
        application of information on the continuum of exposure, dose 
        and response;

          Promote new interdisciplinary partnerships that bring 
        visionary thinking to research on nanotechnology;

          Support better understanding of the fundamental 
        properties of nanomaterials that have an impact in the 
        exposure-dose-response paradigm including the key properties 
        of:

                1.  Size and size distribution;

                2.  Surface area of the primary particle;

                3.  Shape of the primary particle;

                4.  Chemical composition of the material;

                5.  Agglomeration state in the medium used to treat the 
                test system;

          Develop processes for establishing validated standard 
        measurement protocols so that individual or categories of 
        materials can be studied;

          Clearly delineate the responsibilities, programs, 
        timelines, and anticipated results of funded projects for each 
        federal agency. For example, the National Institute for 
        Standards and Technology (NIST) should take responsibility for 
        identifying what reference nanoscale materials should be 
        developed and manage their development. EPA should be 
        responsible for developing and evaluating methods to assess 
        exposure to and potential effects of exposure to nanoscale 
        materials. The Food and Drug Administration (FDA) and the 
        National Institute for Occupational Safety and Health (NIOSH) 
        should focus their research efforts on understanding the 
        absorption and transport of nanoscale materials in the human 
        body, and better utilize industry's research experience prior 
        to making final research priority recommendations. To date, 
        industry's role has been largely restricted to passive review 
        of decisions already made. Industry's considerable experience 
        could be better utilized by being actively engaged earlier in 
        the process; and

          Leverage planned and ongoing work by the Organization 
        for Economic Cooperation and Development's (OECD) Working Party 
        on Manufactured Nanomaterials, particularly in identifying on-
        going or planned research projects by other countries and 
        interpreting the results of this research, and the testing of 
        representative nanomaterials using standard test methods to 
        assess potential health or environmental hazards.

    In addition, the NNI should consider compiling a list of ongoing 
and completed EHS research or support activities already under way such 
as at the International Council on Nanotechnology (ICON). This list 
should be updated regularly and made publicly available to ensure 
important research is communicated timely and accurately. The public 
would also benefit from the NNI ensuring that databases on consumer 
products believed to contain nanomaterials are accurate.
    ACC has communicated at length with EPA, NIOSH, and other parties 
on information that could be assisted by EHS research projects and 
would be useful in the near term. These research issues include the 
following items:

          Information on the handling of nanomaterials in dry 
        forms and potential exposures to users incorporating 
        nanomaterials into product applications;

          Information on environmental releases related to the 
        production or use of nanomaterials--air, water, and solid waste 
        potential exposures unique to nanomaterials and risk management 
        methods;

          Information on the fate and transport mechanisms for 
        nanomaterials in the environment;

          Information on hazards of nanomaterials--basic and 
        acute data supplemented as appropriate by a tiered decision-
        making structure for further testing;

          Information leading to the development of workplace 
        practice guidelines; and

          Information on the explosion hazard potential that 
        has been alleged with some nanomaterials.

    Within the most recent NEHI report, ACC agrees with the 25 
identified research areas within the five research categories 
identified by the Working Group. Within Category #1, the Panel 
specifically believes that Projects 1, 2, and 5 are high priority 
research areas. The Panel notes that all the projects in Category #2 
were considered by the Working Group to be equal in priority. The Panel 
agrees with this assessment since these research areas are likely to be 
interrelated.
    The Working Group identified five priorities for Category #3--
Nanomaterials and the Environment. In its January, 2007 comments, the 
Panel noted the importance of research on environmental transport and 
fate of nanomaterials. The Panel recommends that Projects 4 and 5 
dealing with transport and fate receive the highest priority. Category 
#4 covers health and environmental exposure assessment and includes 
research projects currently underway. The Panel encourages the Working 
Group to consider the pilot studies underway by NIOSH that are designed 
to characterize worker exposure and better understand workplace 
processes and factors that determine occupational exposure to 
nanomaterials. Risk management methods are addressed in Category #5, 
and the Panel notes that the Working Group established priorities for 
each of the five identified areas. The Panel believes that all five 
areas are important research priorities, but notes that accurately 
communicating information on the hazards from and potential exposure to 
nanomaterials should remain a top priority.

II.  The Panel Urges as an Appropriate Next Step the Funding of An 
Independent Review By the National Research Council Board of 
Environmental Studies and Toxicology (BEST) to Establish EHS Research 
Priorities For Manufactured Nanomaterials and a Substantial Increase in 
Federal Funding of EHS Programs For Manufactured Nanomaterials

    The Panel believes that the National Academy of Sciences' Board of 
Environmental Studies and Toxicology (BEST) has an important role to 
play in completing the ``next steps'' articulated in the NEHI Working 
Group's report. On February 22, 2007, ACC, along with 18 organizations 
requested that Congress appropriate $1 million for BEST to develop a 
roadmap for federal EHS research projects and set priorities suitable 
for federal funding (letter appended to this statement). This funding 
would enable BEST to develop a roadmap and strategy for the Federal 
Government for environmental, health, and safety research needed to 
help support the safe development and use of nanoscale materials and 
nanotechnologies.
    At current funding levels, only a small percentage of the NNI funds 
have been directed to environmental, health, and safety research. 
Moreover, the federal budget at other agencies with a significant 
interest in nanotechnology, such as EPA and NIOSH, is inadequate in 
light of the enormity of the task at hand. The Panel believes that a 
more appropriate balance is needed between the funding of potential 
health effects studies and environmental studies. In general, the Panel 
believes that approximately 5-10 percent of the overall NNI budget 
should be focused on EHS research projects on an annual basis. This 
range is consistent with the range of funding private industry devotes 
to research and development. Additionally, more funds should be 
directed to environmental exposure research.
    Until appropriate metrics are developed (as part of a comprehensive 
research strategy) to measure the results of the EHS research funding, 
a specific multi-year timetable for funding is premature. The research 
strategy should be sufficiently flexible to take into account results 
from completed research, address information gaps that may arise, and 
be adjusted so that projects are not continually funded.

III.  Identifying and Minimizing Potential Health and Environmental 
Risks Is Consistent With the Responsible Development of Nanotechnology

    ACC's Nanotechnology Panel member companies are committed to 
support and actively promote the safe manufacture and use of the 
products of nanotechnology, consistent with the ACC's Responsible Care 
program--a set of ethical principles and management systems, now 
nearing its 20th year, designed to improve continuously its member 
companies' safety, health and environmental performance. This long-
established program helps guide the Panel members' approach to the 
development of nanotechnology, just as it does for more conventional 
and better understood industrial chemicals and processes.
    ACC and the member companies of its Nanotechnology Panel strongly 
support EPA's planned Nanomaterials Stewardship Program (NMSP). 
Information gained under the NMSP, along with occupational exposure 
information gained by NIOSH, supporting research of other federal 
agencies, and information from international bodies such as OECD, will 
assist in prioritizing EHS research projects for the foreseeable 
future.

IV.  Conclusion

    In closing, ACC would like to emphasize the importance of 
significant and sustained federal support for developing and 
implementing a comprehensive nanotechnology research strategy, 
particularly in areas of worker safety, human health, and the 
environment. Federal Government support for a comprehensive EHS 
research agenda is essential to the sustained and responsible 
development of nanotechnology.
    ACC urges that the prioritization process for EHS research be 
completed expeditiously and that BEST be funded to complete a research 
roadmap and strategy.
    While the foundation for this important process has been 
established, NNI must complete its task with a renewed sense of 
urgency.

                     Biography for Paul D. Ziegler

Education

1984--Program for Executives, Carnegie Mellon University

1976--Master of Science in Hygiene, University of Pittsburgh, Graduate 
        School of Public Health

1973--Master of Public Health in Environmental Health, University of 
        Pittsburgh, Graduate School of Public Health

1968--Bachelor of Science in Pre-Med (Biology/Chemistry), Lincoln 
        Memorial University, Harrogate, Tennessee

Professional Experience

April 1, 2007-Present

    Retired/Consultant

October 2003-April 1, 2007 (Retired this date)

    Global Director Product Compliance Assurance, PPG Industries, Inc. 
Report to Global Director EHS, serving all PPG SBU's. Globally this 
position is responsible for reviewing and assessing product/process 
related risk, of PPG's products and businesses at an SBU and Corporate 
level. This includes but is not limited to three major components: 1) 
Risk Assessment of PPG products and SBU processes & systems; 2) 
Technical management of any product compliance issues, discrete 
enforcements events and product-related litigation in conjunction with 
the Law Department and outside counsel; 3) Horizon or long-term 
assessments relating to globally emerging product regulations and 
liability trends. Work closely with all appropriate functions and SBU's 
and keep the appropriate levels of management informed.

October 1999-October 2003

    Global Director Product Stewardship, PPG Industries, Inc. Report to 
Corporate Vice President EHS, serving 16 SBU's on a global basis. 
Responsibilities include development and implementation of policies/
programs to ensure products can be developed, produced, distributed, 
used and disposed of in a safe and environmentally sound manner and 
advise customers on their safe use and handling. EHS concerns will be 
integrated into all aspects of our businesses.
    As part of the Corporate EHS Leadership Team, have duty to drive 
the EHS Process and Management System into the SBU's and manufacturing 
facilities, integrating it into each Strategic Business Unit providing 
technical assistance/guidance to the SBU, as they develop/tailor their 
requirements to meet the EHS management needs of the SBU and facilities 
worldwide.
    Supervise a group of 32 associates, focusing on HazCom, Regulatory 
Compliance, Hazardous Materials Transportation, Toxicology, EHS IT, and 
share supervision of European Group. Also responsible for Global 
Emergency Response. As part of our Regulatory focus, we must deal with 
FDA/USDA/NSF/FIFRA issues, providing assistance to SBU's, utilizing 
outside counsel/technical consultants as appropriate, develop GMP/GLP 
documents and participate in various inspections.
    Member of a number of standing committees--EHS Leadership; 
Management Development/Talent Review; Salary Review; Quality Council; 
European EHS Council; Acquisition/Divestiture Committee; Customs/NAFTA 
Steering Committee.

April 1987-October 1999

    Director, Environmental Health Sciences for C&R Group, PPG 
Industries, Inc. Report to Director, C&R Manufacturing. 
Responsibilities involve the development and implementation of policies 
to protect and promote the health and safety of all individuals who 
might be affected by the processes, products and/or use of PPG 
products. Assure Group compliance with laws, rules, regulations and 
Company Policy/procedures for environmental, health and safety issues. 
This includes responsibility for personnel, products, testing, 
environmental concerns, and facility assets. This also involves Group, 
Corporate and regulatory liaisons for worldwide operations. Administer 
a comprehensive program covering all product safety, health, 
toxicology, environmental and safety issues. Act as a focal point for 
conveying information and coordinating health, safety/product safety, 
toxicology and medical activities for the C&R Group.
    This position is responsible for all of the activities and 
responsibilities affecting the health of individuals and must be aware 
of safety and environmental issues, both inside and outside the 
Company. This covers all activities, processes and products of the C&R 
Group, including U.S., Canadian and international operations. 
Internationally, the incumbent is responsible for development and 
control of the product safety, industrial hygiene and medical 
activities of affiliates companies.
    Supervised a group of 47 associates in EHS and a European Group of 
12 associates.

July 1986-March 1987

    Manager, Product Safety, Staff Group, Mobay Corporation (Plastics 
and Rubber, Coatings Rhein-Chemie, Fibers). Reported to the Director, 
Corporate Industrial Hygiene and Regulatory Compliance and had 
responsibility for administering a comprehensive program in the areas 
of health, environmental, product safety, regulatory and emergency 
response; coordinator for the Mobay Emergency Response Team.

1984-June 1986

    Manager, Occupational and Environmental Health and Safety, Group 
Level, Mobay Corporation (Plastics/Coatings/Organic and Rubber 
Chemical/Corporate Business Development/Deerfield Urethane, Inc./Rhein-
Chemie/Newark Compounding Facility/Wolff Walsrode). Reported to the 
Executive Vice President and had the responsibility for administering a 
comprehensive program in the areas of health, environmental, product 
safety and emergency response for those products handled by the 
operating units; coordinator for the Mobay Emergency Response Team.

1976-1984

    Manager for the Plastics and Coatings Division of Mobay Chemical 
Corporation. Responsible for administering a comprehensive program 
covering all product safety and health considerations from research 
through actual marketing of the product as necessary to meet the 
requirements of the law and the Corporate guidelines for product 
safety; coordinator for the Mobay Emergency Response Team.

1974-1975

    Product Manager/Noise Pollution Specialist with USC Incorporated, 
an environmental/engineering consulting firm in Pittsburgh, 
Pennsylvania.

1973-1974

    Environmental Protection Specialist with the Department of 
Environmental Resources for the State of Pennsylvania in Pittsburgh, 
Pennsylvania.

Organizations/Societies

American Industrial Hygiene Association (AIHA), National and Local

Society of Chemical Hazard Communication (SCHC)

National Paint and Coatings Association (NPCA)

American Chemistry Council (ACC)

                               Discussion

    Chairman Baird. Thank you, Mr. Zeigler, and again, thanks 
to all of our witnesses. Outstanding information and very 
enlightening perspectives.
    It is a very difficult task here because, you know, on the 
one hand both Dr. Ehlers and I and several other members of the 
panel are trained as scientists and you can't ask someone to 
prove the negative. It can't be done. But neither is one 
justified therefore in assuming the negative, and so the task 
before us is how can we try to predict and anticipate what 
might happen, while at the same time not hamstringing some 
potentially very, very valuable areas of research. And that is 
a difficult and tall order. It however is one that probably has 
been neglected many times in technologies in the past as Dr. 
Ehlers mentioned with certain pesticide applications. But very 
often in the history of humankind we have come up with 
innovations that we thought to be marvelous and they have had 
adverse consequences, and only down the road do we recognize 
those.
    So I commend all of you for what is actually fairly rare 
and extremely difficult matter, which is to try to anticipate 
something that we don't know yet what it will be. So the 
questions that we will ask are not in any way meant to be 
accusatory or condemning. I know the difficulty and the 
challenge. But one of the obvious questions would be, so here 
is this important report, prioritizing the needs, and it is now 
somewhat overdue to say the least. What have the hang-ups been 
and when might we expect it. Dr. Teague?
    Dr. Teague. I guess I would like to bring up or re-
emphasize a couple of things that I said in my opening comments 
that are written in the written testimony. The first one is I 
think that there is a sort of a general impression that the 
U.S. and the Federal Government is behind what we should be 
doing relative to the EHS research. I think it should be really 
emphasized that if you look at what the Federal Government has 
done over the timeframe that we have been looking at 
nanotechnology, that the U.S. has, as I indicated, far and away 
invested more money in EHS research than any country in the 
world. We have, if you look at the publication of research in 
the United States that is funded mainly through the NNI, we 
publish far more papers in EHS research than any other country 
in the world. We put in place----
    Chairman Baird. I am going to interrupt you because I have 
somewhat limited time and you pointed all this out in your 
testimony, and it is valuable. But what I am hearing from other 
folks and the question actually was what is the delay in the 
report, and what I am hearing from other folks is one, yes, 
there has been a lot of research conducted but it is not clear 
exactly what that research is. A second issue is it is not 
clear how that was prioritized, and those are both valid 
questions. My belief is that the purpose of the report is to 
help at least answer the second of those questions, in other 
words, how it is prioritized. And to say we spent a lot of 
money on research but it is not known exactly what the research 
is and it is not known how that was prioritized begs the 
question of when will this report be due and why has it been 
delayed, notwithstanding the various other things you have 
addressed.
    Dr. Teague. Okay. I will go directly to your question. This 
report has been in the process of developing. We have gone 
through the steps that I indicated. Even since the last 
hearing, we convened one public hearing based upon the 
September report to get public feedback on that. We have 
instituted and worked with OMB to get a data call to get a full 
look at the government portfolio in EHS-related research. We 
have those results. We are now analyzing those results, and we 
are comparing those against the priorities that are laid out in 
the August document in which we had to prioritize needs.
    So we are working toward that. You say why is it taking so 
long? There are 20 agencies, 20 organizations involved in this, 
and even more particular, experts, program managers, decision-
makers on funding, every aspect that is involved in trying to 
build consensus on how we move forward. I hope you agree that 
when you have that many groups involved in it, that it can take 
time; but we think that the time is well-spent. If we were to, 
if anyone were to come forward with a plan which did not have 
and was not developed on the basis of consensus of the experts 
within the agencies, with our international collaborators--we 
are working very intensively with the International 
Standardization Organization, we are working intensively with 
OECD, we are working with ICON, we are working with those 
collaborators as input into our decision-making process.
    We expect to have this report out later this year or early 
next year, but I assure you that going through this very 
deliberative process is essential. It obtains buy-in by the 
agencies. They are the ones who will be doing and making 
decisions on the funding. Our hope is that this document which 
we come forward with will be based upon a consensus input from 
the agencies, will have buy-in by the agencies. We want to work 
with them and not do anything to them, and to get their full 
buy-in you need to have much exchange, and dialogue. And the 
analysis of the data call that we got from OMB has been gone 
over and is being gone over in great detail. It has been combed 
and recombed to ensure that we answer some of the criticisms 
that I heard at the table today to make sure that when we do 
publish the list of projects, and we will do so, after it has 
been vetted with the agencies and after we try to address any 
confidentiality issues that might be involved in revealing 
projects and associated researchers.
    So we think the process is working. We have a huge amount 
of buy-in and coordination among the agencies, and as I said, 
we share this. We want to do it right. We want to do it right 
the first time, and this aim to do well-based, well-thought-out 
science that has good buy-in for the agencies we think is 
absolutely essential to move forward.
    Chairman Baird. I appreciate the clarifications. It is 
certainly understandable 20 agencies is perhaps the reason for 
the glacial pace. It is the equivalent to the mass of a small 
glacier, and I can only imagine how difficult. I think there is 
merit to that. However, I will in the later round of 
questioning--I will yield to Dr. Ehlers in a second; but I 
think there is also legitimacy in exploring some of the 
suggestions about in the future whether some alternative 
executive structure is needed, or agency. I am not advocating 
it, I just want to explore that question with the various 
panels.
    But for now I will recognize Dr. Ehlers for five minutes.
    Mr. Ehlers. Thank you, Mr. Chairman. And I would point out 
that Congress was always referred to as moving at a glacial 
pace, but I think we are really outstripping work that has been 
done on nanotechnology safety. So that is kind of comforting to 
us. We at least are moving faster than some.
    Dr. Kvamme, I really appreciate your being here and your 
testimony and also your work on PCAST. You have done a good job 
there. You mentioned that funding increases for EHS, 
environment, health, and safety, are appropriate, but to quote 
you, you note it is also crucial to note that EHS research also 
depends on advances in non-EHS areas, and you gave as examples 
instrumentation development and basic research on 
nanomaterials. I really appreciate that because all the 
nanotechnology hearings we have been going through, it seems to 
me everyone is so intrigued with the future of nanotechnology 
and they are doing the developmental research; and I am just 
not convinced we are doing the basic research that is necessary 
to achieve what we really need to know and to proceed on EHS 
research. So I just wondered how do you think these advances 
could be integrated into a strategic plan, and I will be asking 
Dr. Colvin a similar question in a few minutes. You can start 
thinking about that.
    Mr. Kvamme. Sure. I think the most important thing to 
realize is that the interrelationship that I referred to in my 
testimony. Let us just take the case of bio-nano. You are 
trying to do a good health thing, and so obviously you don't 
want to hurt the patient while you are trying to deliver the 
therapy. So the inter-relationships of the actual application 
and the health and safety aspects are like this, they are tied 
right together. And that of course takes other things. It takes 
instrumentation, it takes the capability of monitoring the 
things. Dr. Colvin mentioned this whole aspect of 
predictability. I mean, that is exactly what we are looking for 
from, for example, the human genome project. Predictability. 
That will take time, but it will also take a lot of 
instrumentation, a lot of things of that nature. But using just 
that example, and that example applies to numerous other areas 
other than bio-nano, you have to be knowing what you are trying 
to do as well as its relative safety, and in that case, the 
health of the individual is tied into the whole thing.
    Mr. Ehlers. Well, I appreciate that insight. One of the 
most fascinating articles I have ever read by Gerald Holton of 
Harvard who traced the development of high-temperature 
conductivity, and it just astounded me reading that, that all 
of the ancillary things you think that have no relationships 
whatsoever, which turned out to play a crucial role in the 
development; and I think that is the situation here, too.
    Dr. Colvin, you commented that you thought the U.S. 
Government could fix the problem of measuring risk of 
nanotechnology quickly and for a relatively low cost. I 
appreciate your optimism. Optimism is what makes the world go 
'round, what made this nation great. I have also noted it is 
entirely appropriate for you to be optimistic because generally 
the more youthful people are more optimistic. And so that is a 
good spirit to have, but I would like for you to try to be more 
specific. How can we do that? I mean, how much is your 
optimism----
    Dr. Colvin. Well, you took my date, so let me clarify it. I 
think that certainly I don't think that you can solve all of 
the problems. That particular comment, I regret to inform you, 
actually concerned what I consider to be the most immediate 
needs for the investments that this government is making in 
nano-EHS, and that is to make sure that all of the 
investigators funded in these programs from whatever agency 
agree on the basic terminology, the basic methods, and the 
basic way that we approach doing our science. Right now there 
is enormous conflict, different labs don't get the same data 
with apparently the same materials; and that sort of disharmony 
is really creating a technical literature which is not 
conclusive, which is typical for young science. But when that 
science impacts decisions, that is a problem.
    So unfortunately what I was saying is that to fix that 
problem, to get the research community to harmonize and really 
come to a rapid agreement on how they are going to do this 
research--just the tools--I think can be done fairly quickly 
and doesn't involve the kinds of longer-term research 
strategies that would be necessary. I think that the academic 
research community and the government research community needs 
to have, you know, the ability to create standards like the 
Miami standards used in approaching ray analysis for the 
minimal information needed to interpret quantitative biological 
data. There is a model for us to use. And that kind of process 
took under two years, was a lot of workshops, the use of the 
latest in electronic web communication to help create a kind of 
a rules to live by if you are publishing papers in the area. 
And that kind of investment, in that case, it was made by the 
NIH in their human genome work, really transformed and 
accelerated how quickly people could extract information from 
that research.
    Right now I can't go to an agency and get that, even 
little, tiny amounts of money to hold a workshop so we can all 
get together and hash out, you know, what is the best way to 
measure toxicity for this material. And so that is the need 
that I see is so critical, easy to fix, but if we just sort of 
let it go and hope it will all work out, it will just take a 
lot longer. So I think that is a critical research need, and in 
our international workshops, every researcher was just begging 
their governments to set, you know, little, small amounts of 
money to help them communicate with each other outside the peer 
review channels which is what is happening now. And that is 
really the piece I talked about. And I am optimistic that we 
could do it, yes.
    Mr. Ehlers. Well, as John Gardner observed years ago, you 
have to be optimistic because if you aren't, you will never 
solve the problem.
    Dr. Colvin. That is right.
    Mr. Ehlers. Thank you very much.
    Chairman Baird. Ms. Hooley, the gentlelady from Oregon and 
the author of the Nanotechnology in the Schools Act. I am 
sorry, Mr. McNerney is ahead of Ms. Hooley. My apologies. Dr. 
McNerney from California.
    Mr. McNerney. Thank you. You teased my good colleagues, Ms. 
Hooley here, but I will accept that anyway.
    Dr. Colvin, I spent a lot of my career in the modeling 
field, and I was intrigued by your comment about developing--
what did you call it--a predictive simulation tool or tools. 
Where are we in that effort? Just elaborate on that a little if 
you would.
    Dr. Colvin. It is a very exciting concept. So I think that, 
you know, maybe 20 years ago the field of biology really 
remained descriptive in nature; and what we have seen in the 
last decade, even the last five years, is a revolution. You 
know, predicting biology is not like predicting the weather 
anymore. We have ways of measuring the responses of organisms 
that are extremely sensitive. We have amazing computational 
tools that are now able to integrate data taken from many 
experiments, and there is some very exciting developments in 
how you might integrate that data into graphical interfaces. So 
you might have a virtual fish or virtual ecosystem that you 
could actually put an imaginary nanoparticle into and predict a 
response. That is not the stuff of science fiction. That is the 
stuff that our Federal Government is currently funding in other 
areas, including nanotech.
    So I want to see those kinds of capabilities that I think 
American science leads in drawn into this problem. So I think 
that some of the tools that are out there right now that 
weren't there are actually some of the tools of 
bioinformatics--the data mining technologies we have to go into 
vast amounts of literature and extract correlations and trends, 
some of the tools that are happening in predicting complex 
systems which are coming from areas as diverse as control 
theory and moving in developmental biology. These are really 
the cutting-edge areas of science in this country, and they are 
perfectly suited to addressing these problems. And I think that 
agencies like the National Science Foundation and others 
realize that enormous capability. I don't think it is a one-
year program, but I think that you can begin to build these 
simulations, begin to have theoreticians as diverse as, you 
know, folks who work at the quantum mechanical level talking to 
people who might think on the micron level, all the way up to 
an ecosystem biologist who thinks about the kilometer world. 
And you can make those nanometer-kilometer transitions happen. 
And I think that that is actually one of the more exciting 
areas.
    In our ICON workshops, we held out that vision as something 
to organize our theoreticians, our computational biologists, 
our toxicologists around it; and I think everybody got really 
enthusiastic and was able to also translate that enthusiasm 
into a very structured approach to that. So I think that in my 
own personal opinion, that is a very exciting area, and it is 
one that we could actually do that; and nanoparticles and 
nanotechnology are just a really good sort of first problem for 
that confluence of informatics biology and materials to come 
together.
    Mr. McNerney. So as far as today is concerned, there is not 
much resources available for that sort of process?
    Dr. Colvin. No, unfortunately it is a go-to-the-Moon kind 
of project, so it is not something I can sort of throw one 
grant in and do. It takes me working with very good modelers. A 
lot of good--I mean, it takes a village. So this is why I 
suggested it in my written testimony as one example--there are 
many others--of a great long-term thing that this government 
could actually make happen; but to do so will take a planning 
process that I am really hoping that they will be able to 
achieve. But I absolutely think it is doable and it is 
something that many of us in the field are trying to work 
towards in our own ways. But I think the Federal Government and 
governments world wide could do a lot to really think through 
how could we achieve that.
    Mr. McNerney. All right. Thank you. That sounds very 
exciting. I would like to see us follow up with that a little 
bit.
    Dr. Denison, you mentioned the problem of insufficient 
oversight on the money that is being spent on EHS and also the 
need for single leadership position. Do you think that is 
achieved through legislation or through administrative means 
going back to the Administration?
    Dr. Denison. It is a very good question. I think the NNI, 
the National Coordinating Office, and the NEHI itself have 
struggled with this issue and have in essence had to go through 
a process that was hard to direct from the top, if you will, 
because of the nature and the way in which that committee is 
structured and the overarching facilitation role that it is 
intended to play.
    That was part of the original concept of what NNCO was 
supposed to be, a coordinating office. So I am not very hopeful 
that that kind of more directed and top-down approach that I 
think most people think we need, can be accomplished without 
some new authority, and that that authority probably does need 
to come through a legislative means. So there may be some ways, 
and I would be certainly happy to consider other ways of doing 
it, but I think it is certainly something that in the 
reauthorization process that you are starting should be given 
serious attention.
    Mr. McNerney. Thank you.
    Chairman Baird. The Committee has been joined by Dr. 
Gingrey and also Dr. Lipinski. Next, Dr. Bartlett.
    Mr. Bartlett. Thank you very much. Nanotechnology is a 
relatively new technology, and most I think of our citizens 
have little understanding of what it is. They kind of know what 
the risks are to using explosives. When you use plastics they 
can smother you or mechanical things can cut you or poke you or 
compress you. Drugs and chemicals can affect your skin----
    Chairman Baird. Is this a Halloween speech, Dr. Bartlett?
    Mr. Bartlett. Your brain, your kidney, and so forth. 
Radiation, I think they have a general understanding that these 
little particles go whizzing through your body and disrupt the 
machinery of the cells, so they can cause many and varied 
disruptions of the body's physiology and chemistry. What is 
there about nanotechnology that is unique? Are there things 
about nanotechnology that are different than the various 
categories of risk that I went through that we require new 
research protocols? I think the average citizen has little 
appreciation of the risks that nanotechnology could bring in 
addition to those that I have mentioned above for all of these 
other risks. Anybody?
    Dr. Maynard. If I could take a stab at answering that. I 
think it is a very good question because of course we have got 
to establish whether there really is anything different and 
unique about nanotechnology before we begin to say we need to 
do lots of research into the potential risks. I think the 
easiest way of demonstrating that is to take an everyday 
object. Forget about a nanotechnology for the moment, but take 
something like this glass. Pretend that it was made out of 
glass rather than plastic, and if I asked you, well, what harm 
could you do with that? You would say, well, obviously you can 
hit somebody with it, you can throw it, you can smash it. If 
you have got a sharp edge, you can cut somebody with it. All of 
those risks are associated with the physical nature of it as 
well as the chemistry. We all understand that. The physical 
form of something is really important.
    When we get down to the nanoscale, that holds true exactly 
the same it does for something like this. The only difference 
is we cannot see the nanoscale materials, so we tend to forget 
the physical form is important, and we think we can tell 
everything about it just looking at the chemistry. Of course, 
if I told you you could tell everything about the risk of a 
glass just by looking at what it is made of, which is glass, 
you would say, that is ridiculous. I would also say it is 
ridiculous to say you can understand everything about risk of a 
nanomaterial just by looking at the chemicals it is made up of. 
That is the challenge we face, understanding that added 
dimension of the physical form of the materials; and we know 
from research that has already gone on that physical form that 
is important in determining how they harm either the 
environment or people.
    Mr. Bartlett. Yes, sir?
    Dr. Denison. May I make----
    Mr. Bartlett. Floyd, you were going to----
    Dr. Denison. Let me just add one point to that. I think 
Andrew is right about the physical as well as chemical makeup 
being essential. Part of the problem with these materials is 
that they tend to behave in ways that are different from 
ordinary chemicals that we are used to dealing with because of 
their physical form. So for example, particles in this nano-
range can get into places that materials that are either 
smaller or larger can't necessarily get to. These materials are 
also being designed to be highly persistent, very non-able to 
be broken down. If those materials, as we know from other 
experience, get into the environment or get into people, that 
persistence can become a problem.
    So there are certain characteristics that are being 
designed into these materials for functional reasons, 
performance reasons that have a flipside. Now, we cannot over-
generalize and we cannot leap to the conclusion that all of 
these materials are necessarily problematic. I personally think 
certain applications of certain materials, a fairly narrow set, 
are likely to be culprits, but we can't yet identify which ones 
are going to be those problems because we don't yet know enough 
about how to correlate these properties with their biological 
activity.
    Mr. Kvamme. I think the important thing to realize here is 
that this has been true for every new technology. I had the 
pleasure of being at the birth of the semiconductor industry in 
1959, '60, '61, in that time. We worked with chemicals that 
were also used in San Quentin to put people to death as 
diffusants. You had to be very, very careful from a risk point 
of view. Yes, they were chemicals, yes, they were larger than 
what we're talking about now. But take the biofuel that I 
referred to before. The small molecule that goes through the 
blood-brain barrier, those have been, you know, researched and 
they are very, very difficult to figure out. We were involved 
in a company studying the Alzheimer's issues of what was going 
on in that particular barrier. So yes, there is differences, 
but a lot of the significant ways of looking at the problem 
aren't really a whole lot different in my view. However, I 
would say it is important to have this integration that I 
talked about before of application and safety risk. If you tear 
those apart and you create a silo for EHS only and it is not 
informed by the application, I will disagree with some of my 
fellow panelists here, I think you are making a huge mistake. 
You are going against the multi-disciplinary thing that we have 
learned in our universities is so valuable, having a cross-link 
of capabilities. You have to understand both to get the right 
answers in my view, and that is why I speak so strongly to the 
point of integration and the way the program is now and not 
setting up some czar for EHS. I don't think that will be an 
informed approach.
    Chairman Baird. The gentleman's time has actually expired, 
but I am going to extend it a little bit because I think it is 
an outstanding line of questions. So if there are others? Dr. 
Teague, please.
    Dr. Teague. Yes. I guess you were speaking of 
nanotechnology and within the NNI we have discussed at length 
the question of what is nanotechnology, and I would say the 
general definition that we have adopted involves the ability to 
work and control matter at the nanoscale. And it is that 
ability to control matter at the nanoscale which we say is 
approximately one to 100 nanometers which is very, very small. 
I typically say, for me to get an understanding that a sheet of 
paper is 100,000 nanometers thick; that helps me get a feel for 
how tiny the nanometer is. And I think going to Mr. Kvamme's 
point about the need for integration; and the point was made 
that at this nanoscale, there is a possibility that matter at 
this scale can penetrate cell walls and things of that nature. 
It is so important to understand that that has the potential to 
be a hazard to cells and to the body, but it also offers an 
opportunity to deliver therapies. So it is hard to say, is the 
ability of a nanoscaled material to penetrate cell walls and to 
go inside cells, is that good or bad? It could be good if you 
are trying to get therapy into a particular location in the 
body. If it happens to be that it poses a hazard, then we hope, 
and I think by this integration again, both trying to seek 
application as well as to understand their risk, if you 
integrate those, then you can use the control of matter at the 
nanoscale. If it is a hazard, we hopefully can control it and 
we can make it more benign with that high degree of control 
that we have at the nanoscale that is being offered by 
nanotechnology.
    Mr. Bartlett. Mr. Chairman, it might be worth just a moment 
for the layman who is reading this to note what the blood-brain 
barrier is. If you are trying to get a chemical, a drug, to the 
brain, it does not get there anywhere near as easily as it gets 
to other parts of the body. So when you are treating an 
infection there, an antibiotic which will treat it effectively 
in other parts of the body just doesn't get through this 
mysterious blood-brain barrier. I haven't been involved in this 
technology for a number of years now. Do we know what it is 
now?
    Chairman Baird. Mr. Bartlett, I am going to--we are well 
over time for you and I want to make sure we get the other 
witnesses. I think the analogy we would all understand is 
blood-brain barrier is similar to the difficulty getting 
information from witnesses into the brains of the Members of 
the Committee. Very comparable process.
    Ms. Hooley, the author of Nanotechnology in the Schools 
Act.
    Ms. Hooley. I want to thank all of our witnesses today. I 
think nanotechnology holds so much promise, and there is so 
much we still don't know about it.
    If we think five years ahead, what would be the various 
options, if we were determined through implication studies, 
that there were unintended consequences to nanotechnology? Any 
one of you want to answer? Go ahead.
    Dr. Denison. I think we need to always keep in mind the 
range and types of applications of these materials that we are 
addressing. And there is no question that some applications are 
going to be relatively easy to contain or control. They pose 
very little risk of exposure because of the nature of the 
application. Material that is imbedded in a permanent way 
inside of a matrix is going to be much less of a problem than 
something that you put into a cosmetic that you apply to your 
skin.
    So I think one of the things we need to be prepared to do 
is to recognize that there may be types of applications for 
certain materials that we simply don't know enough about to 
advance significantly. And the concern I have is that we are 
not applying the brakes in certain places. We already have 
nanomaterials of a variety of types in cosmetics, in dispersive 
applications that are going to introduce these materials in a 
fairly uncontrolled way and exposing the people and the 
environment.
    So I think what we need to do is go cautiously in those 
types of applications, and we have every reason to expect they 
are going to be dispersive or directly expose people until we 
know more about these materials and their properties and 
whether they in fact pose risks. That is the major piece of 
advice I would offer.
    Ms. Hooley. Anyone else want to tackle that?
    Mr. Ziegler. Yes. I certainly agree with what Dr. Denison 
just said. You really need to understand along the life cycle 
of any chemical where are the potential exposures, and some of 
the basic stuff that certainly that I look for at the grass 
roots, being a practicing industrial hygienist, is what is the 
exposure in production. If I am dealing with a powder, it can 
be pretty high. The risk is significant. The potential hazard 
is great, but if I can get that into a matrices, into a resin, 
or into a solution, that hazard and risk is still there but it 
goes way down. And I think that is something that really helps 
us understand how we need to control this or approach it. It is 
quite common with any chemical that we develop that we have to 
understand what the exposure is going to be along the 
manufacture, incorporation into products, and then at the end-
use level. That certainly is one of the gaps that I think 
exists that we don't have a good way to get an exposure. 
Fortunately, most of the manufacturing is closed-system; and we 
try to get it into some matrices before it is just put into the 
environment so the next level of use has a lot more control of 
the exposure.
    Ms. Hooley. Cadmium is currently used in a lot of new 
nanotechnology applications, but it is a heavy metal, similar 
toxicity problems as mercury or lead. In light of the recent 
concerns about lead in consumer products, what is to prevent 
these nanotechnology applications that use cadmium from being 
the next type of consumer product that cause safety concerns?
    Dr. Teague. Let me take a shot at that.
    Ms. Hooley. All right.
    Dr. Teague. I am aware that cadmium is used in some of the 
quantum dot products, cadmium selenide and some of the other 
ones because of its fluorescent properties. I am not too much 
aware of it being used in other products. In general, the view 
that we have is that the current regulatory system that is in 
place from EPA, from FDA, from CPSC, from OSHA are such that 
they are appropriate for handling any of these new materials. 
They have each taken special attention to any of the new 
nanomaterials. Each one of the agencies that I have mentioned 
have formed task forces within their agencies to pay special 
attention to nanomaterials and to consider how their regulatory 
authorities would apply to such materials. The other aspect of 
this issue is that it is the responsibility of the 
manufacturers to ensure that any materials, any products which 
come on the market, are safe. The regulatory agencies are there 
to make sure that that is true, but it is the manufacturers' 
responsibility to ensure that products, materials, devices are 
safe when they come to the marketplace, and we feel confident, 
I feel confident, that that is the case with respect to 
nanomaterials.
    So in the case of cadmium, that particular one, and I think 
those are being sold in relatively small quantities, mostly for 
experimental applications, at this particular point. Some of it 
is being used as a means of quick diagnosis because they have 
the nice fluorescence, better than natural fluorescent 
materials.
    Ms. Hooley. Anyone else? Dr. Denison.
    Dr. Denison. Yes, I think you raise an important point that 
I think highlights the importance of designing the materials 
from the start to avoid potential problems downstream. Using 
materials that we know to be highly toxic like cadmium in 
applications where we either don't know or we can expect some 
release to happen is not a good principle to start with. So 
there is quite a bit of talk about green nanotechnology----
    Ms. Hooley. Right.
    Dr. Denison.--which one element of that is designing out 
the potential toxicity or later risk of these materials from 
the beginning. While I think Clayton is right that the current 
uses of these are relatively limited, quantum dots including 
cadmium-based quantum dots are being looked at for a lot of 
other applications and may be much higher in volume and so 
forth. And the problem with our current regulatory structure is 
that for many of the application areas for nanomaterials they 
do not provide a sufficient look at those materials before they 
hit the market. They either don't meet the thresholds of 
tonnages of materials that trigger an assessment or they go in 
applications that are regulated by agencies that only have 
post-market authorities, to look at a problem only after it has 
arisen, like the Consumer Product Safety Commission, like the 
FDA with cosmetics.
    So for those uses in particular, we need to be very careful 
about using materials that we have any reason to expect are 
inherently toxic.
    Chairman Baird. May I comment? We are expecting votes at 
11:30, and in order to make sure that all Members of the 
Committee have the chance to ask questions, I am going to 
shorten this.
    Ms. Hooley. I just want to--five seconds. I would hope that 
we do everything we can. Nanotechnology has such great 
importance I think to our future, and I would hope that we 
would do everything we can as we see materials being used that 
are toxic materials, that we figure out a way to get rid of 
them before we even start.
    Chairman Baird. The gentleman from Georgia, Dr. Gingrey.
    Mr. Gingrey. Mr. Chairman, I thank you. You are on such a 
Halloween roll today, I probably ought to yield my time to you, 
but I do have one question I want to ask and one statement I 
would like to make, too. We have passed through this committee 
and thanks to the Chairman and my colleagues on both sides of 
the aisle, passed green chemistry legislation. We passed it in 
the last Congress as well, and hopefully we will get our 
buddies in the other body to help us get that through; and here 
Dr. Denison just mentioned green nanotechnology. It is amazing, 
but we need to do on the growth scale, if you will, we need to 
move forward with that.
    I am going to ask my question to Dr. Maynard, but hopefully 
there will be enough time some of the others can weigh in as 
well. Dr. Maynard, you described the Federal Government's 
leadership role in nanotechnology EHS research, I think you 
said, as slow, badly conceptualized, poorly directed, 
uncoordinated, and underfunded.
    Dr. Maynard. Did I really say that?
    Mr. Gingrey. Why don't you tell us what you really think? 
My question is how would you make NEHI more effective? If you 
could address that for us I would appreciate it.
    Dr. Maynard. Well, first of all, let me acknowledge that 
though I agree with that statement, people in the Federal 
Government, Clayton Teague and others, have actually been 
working very hard to try to make this work, and I applaud their 
efforts. But as I said in my testimony, trying hard is not good 
enough.
    If you look at NEHI at the moment, it is hamstrung in a 
number of ways. It is hamstrung because people just do not have 
the time to do the work that needs to be done. Everybody is 
very, very thinly stretched in that committee. They need the 
time to do the right work. It is also hamstrung because they 
have little or no authority. They can coordinate activities but 
they really can't get what needs to be done to ensure things 
like this are safe, rather than just talking about what needs 
to be done. They are hamstrung because they don't have a clear 
perspective of what the goals are they are trying to achieve.
    And getting back to a point Floyd made earlier about 
collaboration between different areas to ensure nanotechnology 
succeeds. I applaud that. That is essential that we get the 
people developing nanotech applications and working with the 
people understanding risks. But if you are going to develop 
these things safely, you have got to address specific risk-
based questions. You have got to understand what those 
questions are and what you have got to do to address them, and 
what we have at the moment is we have an applications-driven 
attitude where the people setting the questions really don't 
understand how risk science works; and to solve that, you have 
got to have somebody in leadership that understands the risk-
based issues, the oversight issues, and the regulatory issues. 
If you don't have that, I cannot see progress being made.
    Dr. Teague. May I respond to that as well?
    Mr. Gingrey. Please.
    Dr. Teague. I would say that in general among the NEHI 
Working Group, by and large no one believes that a nano-EHS 
czar is a good idea. In fact, they think it is a bad idea. And 
the reason that I think everyone feels so strongly that it is a 
bad idea is that no one agency, I don't think even any 
centralized organization, would even come close to having the 
breadth and the depth of the expertise represented both in the 
applications research as well as in the toxicology and other 
fields needed as is present in all of the NNI agencies. The 20 
agencies I referred to by and large are not just the research 
agencies, they are all the regulatory agencies as well. And one 
of the reasons that some of those things come to play as much 
as they do is that one needs to do a lot of careful planning 
and analysis to do good research. A lot of the research that 
was done early on was certainly not coordinated from the 
Federal Government. I think that is why some of it did produce 
some very premature results and a lot of wrong conclusions were 
drawn from it. By the careful planning and by tapping into the 
depth of experts within the Federal Government and our 
collaboration with others outside, I think that we have by far 
the best approach to trying to carry out appropriate research 
in a careful, deliberately planned way. If one doesn't do that, 
the result is typically bad research and research that leads to 
premature and often poor results, poor understanding, and 
leading to, I think, a lot of misleading conclusions that have 
already been drawn because the research was not planned, not 
well-conducted.
    Mr. Gingrey. Mr. Chairman, if the other witness can respond 
very briefly. I know we are running out of time.
    Mr. Kvamme. I would just make the point that I think the 
real struggle here is do you do this top-down or bottom-up? The 
way we looked at it from a PCAST point of view is there is a 
lot of stuff bottoms-up that is happening, and I think it is 
very, very good stuff. I invite you to go onto Dr. Colvin's 
website. A lot of good stuff is coming up, and we are learning 
a lot. And I would only say that is the way the semiconductor 
industry got started, and we have been pretty successful at it. 
That is the way the Internet industry came in, that is the way 
the micro-computer came on. I think if you top-down this too 
much at this early stage, you are making a mistake.
    Chairman Baird. I thank the gentleman, and Dr. Gingery is 
being modest when he referred to this committee passed the 
green chemistry bill. It was his bill.
    Mr. Honda has been a leader and well at the forefront of 
the nanotech issue, introduced House Res. 3235 I believe it 
was, and Mr. Honda, thanks for joining the Committee and 
welcome.
    Mr. Honda. Thank you, Mr. Chairman, and I thank you for 
inviting me. Just very quickly, I appreciate this kind of 
conversation because that bill does address some of the issues 
that our blue-ribbon task force that we formed in Silicon 
Valley and some of the questions and directions are being 
addressed in some of your conversations; and permeating through 
a lot of the recommendations was the issue of ethics, and I 
think that that is something that as a schoolteacher I would be 
always looking for. But I am assuming that that is part of your 
value system anyway.
    A couple of quick questions, and if the bell rings, then I 
will ask if you could respond in writing; but you were talking 
about modeling and terminology on modeling, and I guess the 
question I have is that when we get to a certain scale in the 
nanoparticle activities, the chemistry and the physics all 
change. In the modeling area, how do you become predictive in 
an area that is not known and unpredictable? And I guess my 
second question would be nanoparticles have always existed. It 
is nothing new. As a science teacher, I always wondered, then 
how did we handle nanoparticles up to now naturally? What are 
the differences between a natural-occurring and manipulated 
nanoparticles versus man or human manipulated particles? Those 
are the two kinds of questions that have been plaguing me.
    Dr. Colvin. Let me quickly do this so I can give my other 
panelists a chance to speak. So the predictive models are 
possible. We actually are pretty good at predicting, for 
example, the changing colors of quantum dots from fundamental 
principles of quantum mechanics. So we actually know that part. 
How we are going to do it I think in the EHS arenas--you know, 
I live in Houston, Texas, and when the hurricanes head to us, 
there are all these predictive models. But they don't say one 
track; they give us a direction with a range. So I think a lot 
of the predictive modeling that is developed is actually 
statistical. It is not saying exactly what is going to happen. 
It is saying likely to happen and with what confidence. So that 
would be one comment on predictive modeling.
    Mr. Honda. Almost like human variabilities?
    Dr. Colvin. Right, and that is a very important point 
because I think humans tend to want certainty, and there will 
be ranges. And as we get better, we will narrow up those models 
and make them more precise; but that is how we will start.
    The second part on the natural nanoparticles, that is a 
fascinating question. They are out there. It doesn't mean that 
all nanoparticles will be safe. There are plenty of natural 
things that are not safe, but it does mean that biological 
organisms probably have developed ways of processing them. And 
in fact, there is already clear evidence that a lot of in vivo 
animal studies of nanoparticle interaction shows that our 
immune system is quite capable of addressing particular 
oxidative stress that is introduced by particles that you don't 
see in organisms that are single cellular, for example. So that 
is a really important point, and I would just say there is a 
lot we need to do to bring that out.
    Dr. Teague. I guess one thing that is very important about 
your question, and I think sometimes it is a misconception, and 
that misconception is that sometimes at the nanoscale some of 
our science is new. As Dr. Colvin just indicated, quantum 
mechanics doesn't change at this scale. We have the basic 
fundamental science to undergird what we are doing, and with 
the new computational power, new particular algorithms that are 
being developed, we can actually compute from what scientists 
call an ab inito calculation, just direct quantum mechanics, 
and can predict many other properties up to reasonable sized 
nanostructures. We run out of steam at about 10,000-100,000 
atoms--but at this size we can predict the properties quite 
well. I would also, going back to something you mentioned 
earlier, point out that predictive toxicology is something that 
the NNI has focused on some and very happy to hear the subject 
of modeling brought up in this discussion. We have worked with 
Vicki on some of this. But there is a center that is driving 
some of this in EPA at the Research Triangle Institute. There 
is a center for predictive toxicology that is focusing on 
modeling toxicology--now they are turning their attention 
toward the predictive toxicology of nanomaterials. And I would 
just endorse what she said about your second question.
    Dr. Maynard. Can I just very briefly address that second 
question? You are exactly right. As you are sitting there, you 
are breathing in at least 10 billion nanoparticles per minute, 
and you look reasonably healthy. We have all to deal with 
these. There are two but's here. The first but is we know 
historically people breathe in nanoparticles; some people die. 
They are not safe. The second thing is, we have evolved to deal 
with certain types of nanoparticles. If you introduce a brand-
new type of nanoparticle to people, we cannot predict that it 
will be as safe as the ones we are breathing all the time.
    Chairman Baird. Dr. Denison, one final comment?
    Dr. Denison. Yes, very quickly. I would just want to 
amplify that one of the reasons that the risk part of 
nanotechnology started getting attention is precisely because 
we know that small particles in that range that are 
incidentally produced, primarily through combustion, diesel 
exhaust particles, and the like, do in fact have major health 
problems. They cause health concerns in people that are exposed 
to them. So that is part of the motivation for recognizing that 
there is a potential here for engineered materials to have 
similar risks.
    Mr. Honda. Thank you. Mr. Chairman, thank you in the name 
of Robin Williams, nano-nano.
    Chairman Baird. Dr. Lipinski and we have about 10 minutes 
left, five minutes and we will have to wrap it up. Dr. 
Lipinski.
    Mr. Lipinski. Well, I will probably make this less than 
five minutes, although I just ran out. I had a resolution in 
the Transportation Committee, and by the time I had got there 
it had already passed. That teaches me that maybe you are 
better off not being there.
    If I could only find my questions here. First thing, I 
would like to thank the Chairman for holding this hearing, and 
I want to emphasize Chairman Baird is the only one that I allow 
to call me doctor. But as a former chemical engineer, 
especially as someone who is very interested in helping to make 
this a more green world, it is good to see this article here in 
Business Week about saving energy by fighting friction, about 
use of nanotechnology to make anything that has a fluid flow 
more efficient through nanotechnology. I think it is very 
important that especially since we hear about all these issues 
right now with the safety of consumer products, especially for 
children's toys, but other things that are not really getting 
the attention that they deserve. I believe when they are going 
out to the public, I think it is very important that as 
nanotechnology really more and more--there are nanotech 
products out there, and as the world moves more toward using 
more nanotech in our products, I think it is very important 
that we look at these issues. I thank the Chairman for holding 
this hearing.
    One thing I wanted to ask, are we right now looking at 
comparatively the new nanotech products? Are we comparing those 
to products that may already be out there that they are 
replacing because some of the products that they may be 
replacing already have, you know, concerns, safety problems 
with them. Is that really going on? Is that type of comparison 
going on or is it just a comparison to an ideal of something 
that we have no problems with it? Because I hate to say that 
but there is a trade-off there. Dr. Maynard.
    Dr. Maynard. Many of the first generation of products that 
are appearing are really just extensions of existing products. 
So nanotechnology is what I refer to as nowhich technology. You 
take something which you have already got and you make it 
better using nanotechnology. And so if you look at Consumer 
Products, that is where most people are going to come face to 
face with nanotechnology. But of course as you look to the 
future, there are going to be brand-new nanotechnology 
solutions to challenges, and that I think is where you are 
going to see brand-new technologies develop.
    So there is a little bit of mix of both. But certainly as 
far as the everyday person in the street goes, the things that 
we keep coming into contact with now and over the next few 
years are just going to be extensions of conventional 
technologies and material.
    Mr. Ziegler. I would like to make a comment here to your 
question. I think in some cases the answer is a resounding yes. 
The work that is going on with nanotechnology today is 
replacing something that is a problem. For instance, chrome-6, 
chrome-3, the chromates. For corrosion resistance, I do know 
there is work going on. It is not going on at a rapid pace, but 
it is going on and there are going to be some trials and then 
there has got to be a lot of testing and probably three or four 
years on certain pieces of equipment so that we know that it 
will perform; but it is based on nano. It is a much safer 
product than having the chromates in the workplace or in 
landfills or in the air. So I think it is not just an extension 
of products in every case that we are accustomed to today.
    Dr. Teague. I would like to add very much the same comment. 
I think that quite soon nanotechnology-based products will be 
replacing some that are on the market. I think one of the ones 
that is probably most imminent, and I am not sure if we are 
talking five or 10 years, but in that neighborhood, one could 
very well see nanotechnology-based light bulbs; which again are 
using the quantum dots that we talked about earlier as 
fluorescent agents. Using the nanotechnology-based light bulbs, 
one is talking about increasing efficiency by 50 percent above 
what the fluorescent lights are so that you could have a huge 
impact not only in terms of energy efficiency, it also turns 
out if you look at it very carefully; you compare the metals 
and the elements that are being used in the nanotechnology 
based light bulbs which have been demonstrated in the 
laboratory already and in some of them in early products; you 
reduce even the mercury which is present in fluorescent light 
bubs. So if you look at it in terms of the balance between 
products and what impact they might have in terms of long life 
cycle analysis, the nanotechnology-based products are typically 
more efficient and have a lot less of the toxic elements in 
their actual manufacture and in their use.
    Mr. Lipinski. Thank you. Thank you, Dr. Chairman.
    Chairman Baird. Very interesting and appropriate line of 
questioning to finish with, an exciting enterprise but also one 
that we want to make sure we do right; and I thank all the 
panelists for their efforts. We have about five minutes for my 
colleagues on the panel here to make the vote, so with this we 
are going to adjourn the hearing but I wanted to express my 
deep appreciation for all the Members who offered their 
outstanding testimony today; and we will look forward to the 
report when it comes out and to further progress in this 
important field.
    Thank you, and with that the hearing stands adjourned.
    [Whereupon, at 11:40 a.m., the Subcommittee was adjourned.]
                               Appendix:

                              ----------                              


                   Answers to Post-Hearing Questions




                   Answers to Post-Hearing Questions
Responses by E. Clayton Teague, Director, National Nanotechnology 
        Coordination Office (NNCO)

Questions submitted by Chairman Brian Baird

Q1.  Is the environmental, health and safety research (EHS) funded and 
planned for funding under the National Nanotechnology Initiative 
coordinated with related research being carried out abroad? Are there 
formal mechanisms available to help coordinate EHS research 
internationally? How does the funding under the NNI in this area 
compare to foreign research support levels?

A1. The EHS research funded and planned for funding under the NNI is 
coordinated with related research being carried out abroad through 
three formal mechanisms: first, participation and leadership on the 
Organization for Economic Cooperation and Development (OECD) Working 
Party on Manufactured Nanomaterials (WPMN) and OECD's Working Party on 
Nanotechnology; second, participation and leadership on the 
International Organization for Standardization (ISO) Technical 
Committee on Nanotechnologies (TC229) Working Group on Environmental 
and Health Aspects of Nanotechnologies; and third, close coordination 
between solicitations for EHS research by U.S. research agencies and 
their equivalents of the European Union. Additional information 
follows.

          The Unites States currently chairs the OECD WPMN. The 
        working party has a number of projects focused on EHS research 
        including the gathering, sharing, and prioritization of 
        information on research and research needs among member 
        countries and regions participating in the working party. Other 
        projects include cooperation on voluntary schemes and 
        regulatory programs, co-operation on risk assessment, and 
        information sharing regarding national strategies and policies 
        for managing EHS research regarding nanomaterials. One project 
        has recently selected a set of representative nanomaterials for 
        extensive testing, while another is evaluating the 
        applicability of existing international testing protocols to 
        nanomaterials.

          The ISO TC229 has participation by 27 member nations 
        and offers excellent means for communication among member 
        nations about EHS research through the introduction, selection, 
        and formulation of new work items. New work items leading to 
        international documentary standards for the TC and its Working 
        Group are based on results of research and needs for 
        standardization as the research results are moved from the 
        laboratory into commercial products.

          At the agency level, the current U.S. solicitation 
        supporting investigations of fate, transport, transformation, 
        and exposure of engineered nanomaterials (jointly funded by 
        EPA, NSF, and DOE) is closely coordinated with a parallel 
        solicitation by the European Community. In addition, at the 
        country-to-country level, U.S. agencies are seeking appropriate 
        partners for nano-EHS research under bilateral science and 
        technology agreements.

    Even with some reasonably focused efforts to obtain information 
about the funding levels for EHS research for nanomaterials by other 
countries, we have only limited anecdotal information. The information 
we have suggests that the U.S. funding for this research is, by amount 
and by percentage of national funding for nanotechnology R&D, 
significantly larger than any other country. Most other countries and 
regions have only begun funding of EHS research on nanomaterials in the 
last year or so, whereas the U.S. began funding of this research at the 
NNI's inception in 2001 and since then has been increasing the level of 
funding at a high rate.

Q2.  Dr. Maynard has suggested a mechanism for the government to 
partner with industry to fund EHS research that would support the needs 
of government in formulating a regulatory framework for nanomaterials 
and the needs of industry on how to develop nanotechnology safely. The 
idea is to use the Health Effects Institute model, which studies the 
health effects of air pollution. Do you believe this would be a good 
model for developing a government/industry research partnership for EHS 
research related to nanotechnology?

A2. Government/industry partnerships are already a valuable part of 
ensuring the vigor and quality of programs to address nanotechnology 
EHS research needs. There are several avenues for supporting such 
partnerships, for example, the NIH/NCI Nanotechnology Characterization 
Laboratory and Cooperative R&D Agreements between individual companies 
and federal agencies. Further, NIH, working with several other 
agencies, is exploring how the Foundation for the National Institutes 
of Health might be used to support such research with funding being 
jointly provided by the Federal Government and by industry. Thus, as 
the NNI moves forward in exploring collaborative work with industry, 
the Health Effects Institute (HEI) model might offer some additional 
insights for developing a government/industry research partnership for 
EHS research related to nanotechnology.
    In assessing the appropriateness of the HEI model for supporting 
EHS nanotechnology research there are several major differences between 
the avenues being explored by federal agencies for nanotechnology EHS 
research and that of the HEI model that need to considered. First, 
research funded through the HEI is for materials which are not 
proprietary while at this early stage in nanotechnology's development 
engineered nanomaterials typically are proprietary. Second, while the 
HEI model is based on joint efforts between one agency and one 
industrial sector (EPA--primarily, with some special projects involving 
one to two other agencies, and the worldwide motor vehicle industry), 
nanotechnology EHS research engages a large number of agencies (over 
20) and multiple industry sectors. Third, the HEI model examines health 
effects associated predominantly with air pollution originating from 
mobile sources and therefore only examines one route of exposure, that 
of inhalation. Fourth, challenges associated with nanotechnology EHS 
research arise from a number of factors such as the diversity of 
classes and types of engineered nanomaterials and their applications in 
many areas, e.g., biomedical, consumer products, food, energy, and 
environmental sectors. Further, the number of application areas is 
continuing to grow at a rapid pace. Therefore, it is not clear that the 
HEI model offers advantages over the avenues already being pursued 
individually and jointly by the agencies under the NNI.
    The NNI operating through the NSET Subcommittee, the NEHI Working 
Group, the NNCO, the NNI member agencies, and their formalized 
interactions with industrial liaison groups for various industrial 
sectors provides a broad-based model for planning and conducting 
nanotechnology EHS research in collaboration with industry. This model 
enables the required multidisciplinary approach and provides a means by 
which the research can be guided by the missions and responsibilities 
of federal agencies. Further, this model provides a mechanism to 
integrate and leverage the expertise that exists across the Federal 
Government and the broad cross section of research efforts underway in 
government, academia, and industry. Finally, the model provides federal 
programs with information that not only meets their needs in a timely 
and cost-effective manner but also addresses private sector needs/
guidance on nanotechnology EHS from a wide range of industries. For 
example, the NNI document released in September of 2006, 
``Environmental, Health, and Safety Research Needs for Engineered 
Nanoscale Materials'' and the more recently released draft EHS research 
priorities document were both based in part on substantial input from 
two of the industrial liaison groups that the NNI has been working 
with, representing the chemical and electronics/semiconductor 
industries, respectively. These two groups collaborated in formulating 
a list of recommended EHS research priorities, in close coordination 
with the NNI agencies.

Q3.  Mr. Ziegler and Dr. Denison recommended that the National Academy 
of Sciences be tasked to take a lead role in developing the EHS 
research strategy and assessing its implementation over time. What is 
your view of this recommendation?

A3. The need for a nanotechnology EHS research strategy was recognized 
by the NNI agencies and a completed EHS research strategy document is 
imminent. Therefore, tasking the National Academy of Sciences to 
develop such a strategy at this time would be duplicative. Assessing 
the research strategy and the effectiveness of its implementation over 
time is an appropriate role for the National Academy of Sciences. The 
NSET Subcommittee already has contracted with the NAS to evaluate the 
NNI's EHS research strategy that will be published in the next couple 
of months. In general such targeted external review by the NAS can be 
considerably more helpful to the NNI agencies than a broad assessment 
that attempts to address many diverse aspects. The NNAP provides broad 
oversight; the NAS can be most helpful by offering more narrowly 
focused reviews.
    The NSET members believe that employing agency expertise in 
assessing both regulatory and scientific needs for nanotechnology EHS 
research has resulted in a rigorous research strategy and has 
appropriately integrated agency expertise and responsibilities into the 
strategy.

Q4.  One of the key aspects of carrying out EHS research is to have 
agreed terminology and standards for characterization of nanomaterials;

Q4a.  Is this getting sufficient attention under the NNI? What is the 
role of NIST in this area?

A4a. Under the NNI, development of an appropriate terminology (and 
nomenclature) is receiving a high level of attention. Many of the NNI 
member agencies are participating in the ISO Technical Committee on 
Nanotechnologies (ISO TC229) Working Group on Terminology and 
Nomenclature, and the Director of the NNCO is Chair of the ANSI 
Technical Advisory Group (TAG) to ISO TC229. NIST, several branches of 
DOD, DOE, EPA, NIOSH, NASA, and the National Cancer Institute are 
active members of the ANSI TAG. Some NNI agencies are also engaged in 
standards development efforts by ASTM, IEEE, and SEMI. All these 
standards development organizations and ISO TC229 are also very active 
in developing documentary standards for the measurement and 
characterization of nanomaterials and for many aspects of the exposure 
and potential hazards of nanomaterials.
    With respect to physical reference standards, NIST is in the 
process of producing ``standards'' relevant to nanotechnology EHS. 
These include:

          RM 8011-8013 gold nanoparticles in three mean 
        particle sizes 10 nm, 30 nm, and 60 nm

          RM 8281 single wall carbon nanotubes with long and 
        short lengths in solution

    In addition NIST is currently working with NIOSH, NIEHS, and the 
NTP on the development of other standards for nanotechnology EHS needs. 
NIST hosted an NNI Workshop on Standards for EHS Research Needs for 
Engineered Nanoscale Materials on September 12-13, 2007. The purpose of 
the workshop was to develop guidance on what physical and documentary 
standards are required to enable sound risk assessment and risk 
management of engineered nanomaterials. In the longer-term, the 
workshop will facilitate the development of standards needed for 
understanding and managing occupational exposure to engineered 
nanomaterials; nanomaterial fate and transport in the environment; and 
nanomaterial potential impacts on human health and the environment.

Q4b.  Is there a role for NNI to provide direct assistance to 
nanotechnology companies, particularly small companies, to help them 
characterize new nanomaterials, which will thereby assist the companies 
in assessing the potential environmental and health risks of the new 
materials?

A4b. In general, the Federal Government does not assist companies in 
characterizing new chemical substances, whether or not they are 
nanoscale materials. Nevertheless, there are definitely roles for the 
NNI to provide direct assistance to small and large nanotechnology 
companies to assist them in assessing potential EHS risks of new 
nanoscale materials. Some examples already underway follow.
    The Nanotechnology Characterization Laboratory jointly supported by 
NCI, FDA, and NIST offers services to characterize new nanomaterials 
and is also developing and publishing recommended protocols for 
assessing the potential health risks of new nanomaterials.
    The NNI-established user facilities offer small and large 
businesses access to state-of-the-art instrumentation and facilities 
that can be used for characterizing new nanomaterials and studying 
their interactions with biosystems. (A list of these user facilities is 
provided in the NNI Supplement to the President's 2008 Budget.)
    NIOSH offers ``Programs for Nanotechnology in the Workplace'' to 
provide companies with guidance for implementation of engineering 
controls, use of personal protective equipment, and management 
practices for working with nanomaterials. NIOSH also conducts Health 
Hazard Evaluations to find out whether there are health hazards to 
employees caused by exposures or conditions in the workplace, including 
concerns related to nanotechnology. Finally, NIOSH has an 
interdisciplinary field team of researchers that partners with 
employers and others in conducting field studies to observe and assess 
occupational health and safety practices in facilities where 
nanotechnology processes and applications are used.
    FDA, EPA and CPSC have all announced that they will work with 
businesses to guide them regarding their use of specific nanomaterials 
in products.

Questions submitted by Representative Vernon J. Ehlers

Q1.  Please tell us more about how the agencies are working together on 
nanotechnology in general and specific to EHS issues, especially in 
areas where there may be some overlap. How are you making sure that 
efforts are not being duplicated?

A1. In general the NNI member agencies work together to coordinate both 
their intramural and extramural funding for nanotechnology R&D. 
Numerous interagency activities are detailed in the 2004 NNI Strategic 
Plan and in the annual NNI Supplements to the President's Budgets. To 
support the advancement of this broad and complex field, the NNI 
creates a framework for a comprehensive nanotechnology R&D program by 
establishing shared goals, priorities, and strategies for agencies to 
leverage their expertise and resources. Duplicative work is less likely 
at the outset of any program, but with time and growth of R&D efforts 
attention needs to be paid, both within and across agencies to ensure 
duplication is avoided. However, differences in agency missions 
decrease the likelihood that identical research will be funded by more 
than one agency.
    This NNI framework is implemented for nanotechnology EHS research 
primarily through the NEHI Working Group. This working group provides a 
forum for the sharing and reviewing project-specific information for 
coordination. Such communication and collaboration among agencies also 
minimizes the potential for undesirable duplication. Joint 
solicitations typically involving two to five agencies are specifically 
designed to avoid duplication of efforts among the participating 
agencies.
    Three statements from the NNI member agencies illustrate the 
effectiveness of this approach for nanotechnology EHS research. Others 
for more general nanotechnology research are provided in the Appendix 
to my written testimony.
    From the EPA: The U.S. EPA's, Office of Research and Development 
(ORD) and the National Toxicology Program, as well as the National 
Institute for Occupational Health and Safety, have initiated 
collaborative interactions in their intramural (in-house) and 
extramural nanomaterials health effect research efforts. These 
interactions have their origins in the development of the NNI, NSET, 
``Environmental, Health, Safety Research Needs for Engineered Nanoscale 
Materials'' document. These interactions have been further enhanced 
through invitations by EPA's ORD to the National Toxicology Program and 
the NIOSH nanomaterials health effects lead scientists to visit ORD's 
National Health and Environmental Effects Laboratory to present their 
research activities and to identify areas where common interests and 
complementation could be pursued with minimal duplication of efforts. 
These activities have led to the following collaborative interactions 
with ORD's intramural nanomaterials health effects research:

          NIOSH scientists are collaborating with ORD's 
        intramural investigators to apply unique cell biology 
        technology and gene expression profiling at EPA to compare the 
        molecular pathology of granulomas induced by asbestos fibers or 
        carbon nanotubes to identify common or different mechanisms of 
        injury.

          EPA, NIOSH, and NIEHS have collaborated in generating 
        and funding extramural grants addressing nanomaterials health 
        effects research needs. The results of these activities are 
        communicated amongst the participating federal agencies in 
        their annual grantees meeting.

          A final example of EPA's work with the National 
        Toxicology Program is provided in the response to Question 1 
        from Congressman Lipinski.

    From the USDA Forest Service: For the USDA Forest Service, which 
has no in-house expertise in nanotechnology EHS but is charged with 
advancing new uses for forest-derived nanomaterials and incorporating 
nanomaterials developed in other industry sectors into forest products, 
the NNI is providing: 1) extremely valuable advice and counsel on the 
priority issues for EHS; 2) information and coordination on how 
nanomaterials must be categorized and characterized with respect to EHS 
risks; 3) leadership with engaging public groups and entities on EHS 
issues and concerns; and 4) contact points in other agencies who have 
capabilities in EHS who can help identify risks with respect to forest-
derived nanomaterials.
    From NIST: Through the efforts of the NEHI Working Group and the 
NNCO like the September 2006 ``Environmental, Health, and Safety 
Research Needs for Engineered Nanoscale Materials'' document and the 
NNI/NIST Workshop mentioned above, as well as others organized by the 
various agencies, the agencies interact at multiple levels, which 
minimizes overlap and at the same time allows for considerable exchange 
and communication between agencies. While there is no one way to 
develop a research strategy, we believe that the one developed by the 
NNI is the best one for the agencies because--if for no other reason--
the agencies participated in its development and have a commitment to 
it. Call it buy-in or ownership, if you will, but it's essential to 
creating a research agenda that the agencies themselves will support 
and thus fund.

Q2.  On the issue of stovepiping EHS research versus integrating it 
into all research, do all current NNI grants currently include an EHS 
component? If not, should they? Why or why not?

A2. For clarification, the only ``NNI grants'' are through the NNI 
member agencies. Agency missions drive the way in which EHS research 
may or may not be incorporated into grants for nanomaterial and 
nanotechnology research and whether EHS research is an implicit or 
explicit component. Of the NNI's 25 participating federal agencies, 13 
fund safety-related research and/or have regulatory authority to guide 
safe use of nanomaterials.
    In some cases, the model better suited to the science is having 
scientists with the experience, facilities, and understanding conduct 
EHS research, rather than adding an EHS component to all research. But 
when the research effort brings interdisciplinary efforts together, EHS 
is clearly a part. One model is NIH grants for medical applications and 
pharmacological research in which EHS is not a separately funded 
component, but by necessity is an integral part of the research. A 
different model is DOD sensor work, in which EHS is a component, but 
the grant does not directly fund EHS research. For their parts, DOE and 
NSF do include an EHS requirement in their grants.
    Stepping back a moment, it is important to keep in mind that the 
state of scientific understanding of how engineered nanoscale materials 
of various compositions interact with biological systems is incomplete. 
So government-funded basic and applied research toward understanding 
the EHS impacts of nanomaterials broadly falls into three areas: not 
only (1) research to develop instrumentation and methods for measuring, 
characterizing, and testing nanomaterials and for monitoring exposure 
and (2) research contributing to safety assessments of nanomaterials 
and nanomaterial-based products, but also (3) research to expand 
knowledge and further the understanding of how nanomaterials behave.
    The very breadth and multidisciplinary nature of nanotechnology and 
the collaborative focus of the Nanotechnology Environmental and Health 
Implications (NEHI) working group expands the capabilities of agency 
missions.
    Although not all grants by NNI member agencies include EHS 
components, certainly for some types of research, biomedical 
applications research in particular, the government is actively 
encouraging researchers to address safety and effectiveness issues as 
early as possible in the innovation cycle. Many NIH-funded research 
projects include safety testing as a part of routine procedures as the 
research progresses. As another example, one of the objectives of FDA's 
Critical Path Initiative is to encourage researchers to incorporate 
into their research, at the earliest possible stages, procedures that 
will help them later in the process of satisfying FDA requirements for 
demonstrating safety and effectiveness of the final products that might 
eventually emerge as a result of that research.

Questions submitted by Representative Daniel Lipinski

Q1.  Much of the EHS research to date has focused on exotic materials 
with unrealistic exposure-scenarios. While that is useful in 
establishing information on an upper bound of the hazard, the context 
is rarely communicated and it creates fear. What is critical is that we 
make sure nano-enabled products are as safe or safer than what we use 
today.

     As I understand it, the hazard of a nanomaterial often depends 
upon much more than the size and type of material, but also surface 
properties, purity, etc. that relate to how it is made. How is the 
toxicology work underway controlling for this? Are researchers using 
standardized, well characterized materials? If not, how can we make use 
of the research findings?

A1. Much of the EHS research to date has been focused on several of the 
engineered nanoscale materials being produced in the largest 
quantities, e.g., TiO2, and single- and multiple-walled carbon 
nanotubes. The current stage for producing many engineered nanoscale 
materials is such that the chemical composition and physical 
characteristics of manufactured nanomaterials can vary substantially 
between batches and vendors. Because of this variability and general 
poor characterization of materials used, research findings from much 
early toxicology research on engineered nanomaterials are difficult to 
interpret. Many studies are having to be repeated with better-
characterized materials in order to establish a better understanding of 
the correlation of a particular biological response to a specific 
engineered nanoscale material. Recognizing the importance of the need 
for well characterized materials for the conduct of toxicology studies, 
the NNI agencies are funding and conducting research to develop a suite 
of reference materials and improved instrumentation to analyze and 
characterize nanomaterials, both as raw materials and as materials in 
biological systems. A suite of reference nanomaterials--stable 
materials for which the chemical and physical properties are rigorously 
characterized to verify the composition or properties of their 
products--are being developed to overcome these problems. Within 
workshops and standards committee considerations NNI agencies are 
participating in expert discussions on what might comprise a minimum 
set of measurements that would enable consistency among materials used 
and reported on by researchers and accepted means to specify 
nanomaterials for efficient commerce.
    Due to the numerous types of reference materials needed for 
different groups or classes of nanomaterials, a coordinated, 
interagency research effort is required to support the significant and 
necessary level of R&D. Pure samples are needed and instruments with 
the ability to determine the elemental composition, accurate 
dimensions, location, and chemical state of all atoms in nanomaterials 
must be developed. The critical and relevant physical parameters (size, 
shape, composition) must be identified. Reliable methods for 
distributing these standards also must be established. While NIST will 
have a major role in developing and validating instrumentation and 
methods, multiple NNI agencies will need to be involved. NASA and DOD 
will play a key role in identifying materials and processes likely to 
be used in the composites industry. Contributions from agencies such as 
the EPA and NIOSH will be essential to describing the use of these 
materials in environmental and workplace monitoring settings. The 
expertise of the NIH and FDA will be critical for identifying the 
relevant parameters to be characterized for health and safety research.
    The National Toxicology Program (NTP) has provided and shared with 
EPA's intramural health and ecological effects investigators well 
characterized engineered/manufactured nanomaterials of common interest 
to both EPA and NTP in order to examine cellular models of toxicity to 
complement NTP's animal toxicology studies in an effort to: 1) identify 
alternative test methods and approaches to assess/predict the toxicity 
of nanomaterials; 2) develop an enhanced health effects database that 
could be integrated and used for health risk assessment of 
nanomaterials; and 3) assist or guide subsequent sub-chronic and/or 
chronic animal toxicity studies of engineered/manufactured 
nanomaterials of interest for both agencies/programs. This format using 
and sharing well characterized identical nanomaterials of common 
interest will be pursued in future NTP and EPA nanomaterials 
toxicological studies.

Q2.  It seems that most of the early uses of nanotechnology and 
nanomaterials are for existing products and processes, many of which 
are far from ideal from a health and environmental safety perspective. 
What is being done to systematically compare the risks and benefits of 
the nanoscale alternative against the conventional approach in use 
today so that we accelerate the substitution of nanomaterials where 
they are superior (e.g., when replacing a known toxin)?

A2. The ``green'' potential of nanotechnology--the capacity to reduce 
pollution through the redesign of industrial processes and the 
replacement of toxic solvents, poisonous metals, and corrosive 
chemicals with less hazardous nanomaterials--is widely acknowledged to 
be great. NNI agencies funding research in green chemistry include the 
National Science Foundation, the Department of Energy, and the 
Environmental Protection Agency. EPA's recent Pollution Prevention 
through Nanotechnology Conference (held September 25-26, 2007) brought 
together representatives from industry, academia, non-governmental 
organizations, and government to discuss current practices and 
potential research in three major areas where nanotechnology can 
contribute to pollution prevention:

        a.  Products: Less toxic, less polluting, and wear-resistant.

        b.  Processes: More efficient and waste-reducing.

        c.  Energy and Resource Efficiency: Processes and products that 
        use less energy and fewer raw materials because of greater 
        efficiency.

    Inputs from this workshop will provide guidance for both intramural 
and extramural funding of nanotechnology research by EPA.

Q3.  The discussion around nanomaterials tends to focus on 
``engineered'' nanomaterials which are roughly defined as those that 
are purposefully created. However, the volume of naturally occurring 
and ultrafine particles produced by combustion, as well as those used 
as fillers in rubber tires or plastics is many orders of magnitude 
greater than the newly engineered nanomaterials. What are we doing to 
ensure that we leverage the body of EHS knowledge on these particles? 
Are we missing the forest from the trees by emphasizing only 
``engineered nanomaterials''? What efforts are there to assess the 
comparative hazard posed by engineered nanomaterials against incidental 
or naturally occurring nanomaterials?

A3. Existing knowledge about EHS implications of ultrafine particles is 
being leveraged to address potential EHS concerns regarding 
nanomaterials, both naturally occurring and engineered nanoparticles. 
NIOSH and DOE, for example, have drawn upon existing knowledge bases to 
provide guidance about workforce safety and engineered nanomaterials. 
Other agencies are focusing on understanding the behaviors of 
nanomaterials, incidental and engineered, in biological systems and the 
environment. Many of the analytical methods being used for 
characterization of engineered nanomaterials are ones that have been 
developed and applied to ultrafine particles. Examples include electron 
microscopy, dynamic light scattering, gas absorption measurements of 
surface area, etc. Limited research has been conducted to date that 
explores the comparison of effects of incidental or natural nanoscale 
particles with those of engineered nanomaterials.
    The EPA Nanotechnology White Paper, Feb. 2007, recognized the 
paucity of data for engineered nanomaterials health effects relative to 
the amount of data available for ultrafine particles from emission 
sources. The White Paper also recognized the need to query existing 
ultrafine particle toxicity databases in order to determine the extent 
to which they could provide insight into the engineered nanomaterials 
hazard identification, mechanism(s) of injury, and mode(s) of action 
relative to ultrafine particles present in ambient air. These 
comparisons are critical to determining whether there are potentially 
unique health effects, and to understanding mechanisms of injury, 
related to the novel physicochemical properties of engineered 
nanomaterials. EPA's Office of Research and Development (ORD) 
intramural engineered nanomaterials health effects research, supported 
through its Nanotechnology Initiative, has started toxicology studies 
comparing the pulmonary and cardiovascular toxicity, hazard 
identification, and mechanism of injury of specific combustion 
particles and engineered nanomaterials. Proposals to continue the 
comparative toxicological assessment of environmental ultrafine 
particles and engineered nanomaterials are being considered by ORD for 
continued research support within its developing multi-year plans.
    In terms of missing the forest from the trees by emphasizing only 
``engineered nanomaterials,'' research funded under the NNI has focused 
primarily on engineered nanomaterials, their properties, and their 
interactions with biosystems. However, if one takes a perspective in 
terms of the quantity of the two types of materials to which the 
general population is exposed or the quantity introduced into the 
environment, engineered nanomaterials are a small part of the forest. 
(The quantity of ultrafine particles to which the general population is 
and has been exposed is much greater than that for engineered 
nanomaterials.)
    Much understanding of the implications of ultrafine particles 
interactions with biosystems also may be gained from studies using 
engineered nanomaterials since they are typically far more uniform 
than, for example, PM combustion byproducts in their physical and 
chemical properties, e.g., size distribution, chemical composition, 
atomic and molecular structure, than are those of ultrafine particles. 
These more uniform properties and the degree of control of matter at 
the nanoscale offered by nanotechnology are enabling major advances in 
our understanding of the interactions of all nanomaterials with 
biosystems.
    Some specific examples follow of research being conducted and 
information being provided about working with engineered nanomaterials, 
built on the knowledge of working with ultrafine particles.

          EPA's Particulate Matter research program is the lead 
        federal program examining health and environmental effects 
        associated with exposure to airborne particulate pollution in 
        order to support the National Ambient Air Quality Standard for 
        Particulate Matter. A critical research goal within EPA's 
        Particulate Matter research program is linking particulate 
        health effects from ultrafine particles generated from the 
        combustion of fossil fuels. EPA's Particulate Matter research 
        will provide potentially important information regarding the 
        dosimetry/translocation, hazard identification, and health 
        effects of inadvertently produced ultrafine particles.

          NIOSH's experience in researching and defining 
        characteristics, properties, and effect of ultrafine particles 
        such as welding fumes and diesel particulates provide a strong 
        foundation for its current nanotechnology research activities. 
        Existing studies on human or animal exposure to ultrafine and 
        other respirable particles provide a basis for generating 
        hypotheses about the possible adverse health effects from 
        exposures to similar materials on a nanoscale. The studies of 
        ultrafine particles may provide useful data to generate 
        hypotheses for further testing. The studies in cell cultures 
        provide information about the cytotoxic properties of 
        nanomaterials that can guide further research and toxicity 
        testing in whole organisms.

          Based on leveraged research and the limited amount of 
        information about the potential risks from handling 
        nanomaterials in workplaces and laboratories, NIOSH has issued 
        its ``Guidance for Handling Nanomaterials and Precautionary 
        Measures for Employees and Workers Handling Engineered 
        Nanomaterials'' document, which is in wide circulation and has 
        been proposed for adoption by ISO TC-229.

          Current NIOSH research includes a five-year multi-
        disciplinary study into the toxicity and health risks 
        associated with occupational nanoparticle exposure. Another 
        study examines ultrafine particle intervention studies in 
        automotive plants.

          Within DOE, preliminary research suggests that some 
        controls used in conventional laboratory settings will work 
        effectively as guidance for handling engineered nanoparticles 
        and nanostructured porous materials. Based on the available 
        science, DOE has issued an ``Approach to Nanomaterial 
        Environmental Safety & Health'' document, which compiles 
        recommended practices for laboratory staff and information 
        about the safety and health effects related to nanomaterials, 
        particle measurement, and control effectiveness.

          Several of the leading researchers in the toxicology 
        of ultrafine particles have received major grants to do 
        nanotechnology-related toxicology research. These grants were 
        awarded by a variety of agencies, including DOD, NSF and EPA to 
        support research directed explicitly towards the understanding 
        of EHS aspects of engineered nanomaterials/nanoparticles.

          Nanotechnology--specific EHS work has been done in 
        the EPA health laboratory in rats and various in vitro systems, 
        including human cells, and in mice. This research has in one 
        way or another been predicated on work with basic comparisons 
        of engineered versus other ultrafine particles.

Q4.  To what extent is the toxicity research relevant to ``real world'' 
situations? To what extent are federally funded efforts using the 
routes of exposure or formulations that emulate the nanomaterials being 
used in available products?

A4. NNI member agencies are funding toxicity research they consider 
highly relevant to ``real world'' situations. For example, research is 
being funded to understand better the potential for exposure to 
engineered materials during manufacturing processes and during use of 
products containing engineered nanomaterials. Research is also underway 
aimed at improving our understanding of what happens to engineered 
nanomaterials as they may be introduced into the environment throughout 
the full life cycle of the materials and products containing these 
materials. Potential hazards of these materials are the other half of 
the potential risks posed by these materials. Research on potential 
hazards due to the introduction of these materials into biosystems--
from the cellular level to the full system level--is also underway.
    As the National Academies concluded in their 2006 assessment, it is 
not possible to draw general conclusions on engineered nanomaterials 
since not all nanomaterials are alike. There is still science to be 
done in this area. Research results already indicate that certain 
nanomaterials are safe as used in products today, while other 
nanomaterials cannot be safely used in living systems in unmodified 
form. While there are research questions still to answer, the prospects 
for the safe use of many, if not most, nanomaterials are great.
    We know that some early research on potential toxicity of 
nanomaterials, including some with highly publicized results showing 
potential negative health effects, did not reflect ``real world 
situations'' with likely exposure dosages, pathways, or even pure 
samples of the materials in question. In fact, it has been shown that 
initial toxicity observed for carbon nanotubes in one study was due to 
metal contaminants in the tested samples (Ni, FE, Co)--materials used 
as a catalyst during the production process. In another study the mice 
being tested suffocated from the ``instillation'' (injection into the 
throat or lungs) of a large quantity of carbon nanotubes--not from 
material-specific toxic effects.
    Appropriate prioritization of the Federal Government's research on 
potential toxicity of nanomaterials is underway through the interagency 
process I described in my testimony, which does factor in the need to 
conduct such research in a way that is relevant to real-world 
conditions and to focus first on the most likely exposure routes.

Q5.  The NNI Authorization Act requires that a strategic plan for 
program activities be prepared and updated at three-year intervals. The 
next update is due in December 2007. Will the updated plan be released 
on time?

A5. Yes. Work to update the NNI Strategic Plan has been underway since 
early 2007 and delivery of the updated Strategic Plan to Congress as 
called for in the NNI Authorization Act is expected to be on or before 
December 30, 2007.
                   Answers to Post-Hearing Questions
Responses by E. Floyd Kvamme, Co-Chair, President's Council of Advisors 
        on Science and Technology

Questions submitted by Chairman Brian Baird

Q1.  Progress in understanding the risks of nanotechnology will require 
balance among fundamental research and research that is more directed 
and product specific. NSF funds basic environmental, health and safety 
(EHS) research, and at present, its research portfolio comprises 50 
percent of the total federal effort in EHS research. Has PCAST reviewed 
the funding balance among agencies contributing to EHS research and 
does PCAST believe the current funding allocation represents the 
correct balance?

A1. PCAST's review of the NNI is ongoing, and as part of that process I 
met recently with NIST, FDA, NIOSH, EPA and NSF agency representatives 
personally to get an updated understanding of the overall approach and 
infrastructure for nanotechnology EHS research. The current 
nanotechnology EHS funding allocation among federal agencies does 
appear to be effectively coordinated via the NNI and naturally balanced 
in a manner consistent with individual agency's mission, expertise, and 
capacity. Through the NNI, the agencies have undertaken a number of 
joint solicitations and other jointly funded activities relevant to 
nanotechnology EHS research. The increases in basic and applied EHS 
research appear to be matched to the increase in capacity for high 
quality research. If there is one area that should receive greater 
funding, it is the area of metrology and standards. This area is the 
focus of NIST, which plans to direct a portion of its increased funding 
under the American Competitiveness Initiative toward nanotechnology 
EHS-related research (if the FY 2008 appropriation bill for NIST is 
passed).

Q2.  PCAST was given the responsibility to serve as the statutorily 
created advisory committee for the National Nanotechnology Initiative. 
The statute requires the advisory committee to assess all aspects of 
the management, coordination, implementation, and content of the NNI 
and to report on its findings every two years to the President and 
Congress. The last report was released in May of 2005. What is the 
status of the next report, which is due this year, and when will it be 
made available?

A2. The PCAST anticipates reviewing the findings and recommendations 
from its review at its meeting on January 8, 2008. We have 
intentionally delayed this report somewhat to allow the council to 
include a review of the updated NNI strategic plan, which is to be 
completed by the end of the year. In my testimony presenting our first 
review of the NNI, I recommended that PCAST's reviews of the NNI be 
changed to once every three years, consistent with the period for 
updating the strategic plan and for the triennial reviews by the 
National Research Council, both of which are to be assessed in the NNAP 
review. It was my understanding at that time that the members viewed 
this quite favorably and we have, therefore, worked to this timeframe. 
In your reauthorization of the NNI, we would suggest that this formal 
change in the legislation be made.

Q3.  Is PCAST satisfied that the NNI is adequately coordinating EHS 
research with related foreign research efforts?

A3. As called for in our last report, the NNI is taking a leadership 
role in coordinating EHS activities internationally, particularly 
within the Organization for Economic Cooperation and Development (OECD) 
and the International Standardization Organization (ISO). The OECD 
Working Party on Manufactured Nanomaterials, which is chaired by Jim 
Willis of the EPA, is the body that is leading efforts to share EHS 
information and coordinate the collaborative development of information 
that is needed by governments and industries worldwide. Also, Clayton 
Teague chairs the U.S. ANSI-accredited Technical Advisory Group and 
heads the U.S. delegation to the ISO technical committee on 
nanotechnologies, which is working to develop standards for 
instrumentation, reference materials, test methods, and EHS practices. 
ISO standards often are adopted widely and PCAST endorses the NNI's 
continued participation and leadership in these activities. As a result 
of this international work, PCAST is very pleased with the increase in 
international coordination that has occurred since our first report.

Q4.  Dr. Maynard has suggested a mechanism for government to partner 
with industry to fund EHS research that would support the needs of 
government in formulating a regulatory framework for nanomaterials and 
the needs of industry on how to develop nanotechnology safely. The idea 
is to use the Health Effects Institute model, which studies the health 
effects of air pollution. Do you believe this would be a good model for 
developing a government/industry research partnership for EHS research 
related to nanotechnology?

A4. As a general model for government-industry partnership, the Health 
Effects Institute is centered primarily on one area (air pollution) and 
essentially one industry (automakers). This model does not translate 
easily to the much broader area covered by nanomaterials and the 
diversity of nanomaterial-related EHS risks and benefits, which cannot 
be confined to one industry. Moreover, unlike in the case of the HEI, 
the information of interest and use to industry would likely be 
considered proprietary. Furthermore, it is not clear who would shoulder 
the burden and what incentives may be applied. Nonetheless, PCAST is 
pleased that the NNI has been reaching out to the private sector 
through consultative advisory boards and has reached agreement with the 
semiconductor, chemicals, and forest products industries. These 
agreements focus on strengthening government-industry interactions with 
respect to nanotechnology development, including the need to understand 
potential EHS risks. It is very possible that in our upcoming report, 
we will call for extending this type agreement to additional industry 
groups.

Q5.  Mr. Ziegler and Dr. Denison have recommended that the National 
Academy of Sciences be tasked to take a lead role in developing the EHS 
research strategy and assessing its implementation over time. What is 
your view of this recommendation?

A5. As mentioned above, the NAS is already responsible for assessing 
the NNI as a whole on a triennial basis. The PCAST welcomes this review 
and is taking NAS recommendations from its first report into 
consideration in completing its current updated review of the program. 
According to the NNI agencies, an interagency-developed plan for EHS 
nanotechnology research is near completion. Therefore, it seems 
duplicative to ask the NAS to begin work on such a plan. Rather, it 
would be helpful if the Academy were asked to assess the NNI plan and 
provide expert review and feedback to ensure it is complete and 
scientifically sound. PCAST intends to review the NNI EHS research 
strategy when it becomes available. Subsequent review by the NAS of the 
strategy would be welcomed.

Q6.  One of the key aspects of carrying out EHS research is to have 
agreed terminology and standards for characterization of nanomaterials.

Q6a.  Is this getting sufficient attention under the NNI? What is the 
role of NIST in this area?

Q6b.  Is there a role for NNI to provide direct assistance to 
nanotechnology companies, particularly small companies, to help them 
characterize new nanomaterials, which will thereby assist the companies 
in assessing the potential environmental and health risks of the new 
materials?

A6a,b. Establishing standards (in terms of materials, methods, minimum 
data sets for characterization, etc.) is the right area to focus 
attention. NIST is expanding its nanotechnology efforts here (again 
largely under the increased funding provided for by the ACI) and is 
expanding collaborations with other agencies (e.g., NCI, NCL) and 
industry in the process. All the agency representatives I have met have 
pointed to the central role of NIST in characterization and standard 
setting for nanotechnology. NIST recently hosted a workshop focused on 
nanomaterials EHS. Such work will facilitate responsible nanotechnology 
development across the board, including in industry and small 
companies, and represents some of the best assistance the NNI can 
provide to ``raise all boats.'' PCAST may suggest broader roles for the 
NNI in future reports in this all important area of standard setting 
and characterization for each of the many potential suppliers of 
nanotechnology based products.

Questions submitted by Representative Vernon J. Ehlers

Q1.  On the issue of stovepiping EHS research versus integrating it 
into all research, do all current NNI grants currently include and EHS 
component? If not, should they? Why or why not?

A1. Many current NNI grants have components relevant to nanotechnology 
EHS, as appropriate or related to the specific research aims. It is 
essential that these efforts are not separated from applications 
research or institute them artificially, which risks waste and 
redundancy in research funding. On the other hand, it would not be 
prudent to require that every research grant or project include an EHS 
component. Some researchers do not have the capacity to do such work. 
Rather, all researchers should have the ability to access and share EHS 
information with the nanotechnology research community broadly. As 
PCAST completes its next review, we will, undoubtedly discuss this 
important area of balance between applications and EHS research and the 
interplay between them.

Questions submitted by Representative Daniel Lipinski

Q1.  Much of the EHS research to date has focused on exotic materials 
with unrealistic exposure scenarios. While that is useful in 
establishing information on an ``upper bound'' of the hazard, the 
context is rarely communicated and it creates fear. What is critical is 
that we make sure nano-enabled products are as safe or safer than what 
we use today.

     As I understand it, the hazard of a nanomaterial often depends 
upon much more than the size and type of material, but also surface 
properties, purity, etc. that relate to how it is made. How is the 
toxicology work underway controlling for this? Are researchers using 
standardized, well characterized materials? If not, how can we make use 
of the research findings?

A1. Although some early studies were done using nanomaterials that were 
poorly characterized, researchers are increasingly aware of what 
constitutes well-characterized samples. Scientists are in the process 
of identifying the relevant parameters to include to sufficiently 
characterize a specific nanomaterial, including size, aspect ratio, 
surface chemistry, and charge, for example. However, nanomaterials are 
extremely diverse and controlling parameters will vary for different 
materials. This highlights again the importance of NIST in establishing 
standard reference materials, methodologies, and tools to help guide 
the research and development community as it continues to build a 
knowledge base that will inform future research. As I will comment on 
below in response to Ranking Member Hall's question, each generation of 
tests will improve our knowledge of what input parameters are critical 
to understanding outcomes of tests.

Q2.  It seems that most of the early uses of nanotechnology and 
nanomaterials are for existing products and processes, many of which 
are far from ideal from a health and environmental safety perspective. 
What is being done to systematically compare the risks and benefits of 
the nanoscale alternative against the conventional approach in use 
today so that we accelerate the substitution of nanomaterials where 
they are superior (e.g., when replacing a known toxin)?

A2. Risk vs. benefit comparisons occur on an application-specific basis 
(e.g., sunscreens, nanocrystalline formulations of approved drugs). To 
my knowledge, this process doesn't differ from the normal process of 
evaluating new and improved approaches for any application, whether 
they are nano-enabled or not.

Q3.  The discussion around nanomaterials tends to focus on 
``engineered'' nanomaterials which are roughly defined as those that 
are purposefully created. However, the volume of naturally occurring 
and ultra-fine particles produced by combustion, as well as those used 
as fillers in rubber tires or plastics is many orders of magnitude 
greater than the newly engineered nanomaterials. What are we doing to 
ensure that we leverage the body of EHS knowledge on these particles? 
Are we missing the forest from the trees by emphasizing only 
``engineered nanomaterials''? What efforts are there to assess the 
comparative hazard posed by engineered nanomaterials against incidental 
or naturally occurring nanomaterials?

A3. The NNI agencies are indeed leveraging experience and knowledge of 
the EHS implications from studies of naturally occurring and ultra-fine 
particles. This is a prime example why a separate entity to oversee the 
entire federal nanotechnology EHS research effort is not advisable, as 
it would create a new ``stovepipe'' and inevitably limit input from the 
expertise resident in the agencies. Furthermore, a number of structures 
already exist and are working along this line. For example, EPA has 
extensive experience dealing with particulate matter in its Office of 
Air and Radiation.

Q4.  To what extent is the toxicity research relevant to ``real world'' 
situations? To what extent are federally funded efforts using the 
routes of exposure or formulations that emulate the nanomaterials being 
used in available products?

A4. The relevance of a given work in toxicity research to the real-
world varies by study and the investigators' specific aims, and again, 
as mentioned earlier, current research is helping to inform future 
research. The National Toxicology Program, which incorporates expertise 
from NIEHS, EPA, and FDA, is leading the way in systematically 
evaluating a number of classes of nanomaterials in commercially 
available products, including carbon nanotubes, gold- and silver-based 
particles and metal oxides.

Questions submitted by Representative Ralph M. Hall

Q1.  With your semiconductor industry background, you have great 
experience in bringing new technologies to market. How is 
nanotechnology different from other technologies? How did you deal with 
new technology uncertainty when the semiconductor industry was in its 
infancy?

A1. Each new technology seems to bring its own set of challenges but, 
generally speaking, they are similar in that there are unknowns that 
must be understood and which do not tend to be discovered in an ordered 
fashion. Specifically, when looking at the early days of the 
semiconductor business, we were blessed in that the earliest text on 
the mechanisms at work in a semiconductor (Electrons and holes in 
semiconductors, with applications to transistor electronics by Dr. 
William Shockley--circa 1948) was a very accurate description of 
semiconductor phenomena. But knowing which processes would be most 
effective and manufacturable took a couple of decades. In the early 
days, we worked in germanium, silicon, gallium arsenide, as well as 
other materials. Germanium was most common in that it was easiest to 
work with. Silicon posed many problems in that its surface 
characteristics were difficult to understand. Years of experiments, of 
course, paid off in the eventual understanding of the many nuances of 
the material. One of the most important lessons learned was that with 
each succeeding series of experiments, one needed to do more 
characterization of the input materials to assure the accuracy of the 
output. Without fail, when early experiments were completed, a desire 
to have made additional measurements before the experiment started was 
present. But progress was made as each generation of data gathering 
used knowledge earned from the previous work. Today, in nanotechnology, 
a similar process is taking place. Some are critical of early 
experiments were of limited value because certain parameters were not 
specified or input materials were poorly characterized. But, if that 
early work informs the next set of experiments, progress is made and 
knowledge of what parameters and characterizations are needed in future 
work is established. The other essential is to share results. Published 
papers, conferences and other mechanisms were used in the early 
semiconductor days. The International Solid State Circuits Conference 
held each year in Philadelphia was a major meeting point. This is 
partly why I feel that measuring the number of publications and 
conferences is an important part of measuring progress at this early 
stage in nanotechnology development.
                   Answers to Post-Hearing Questions
Submitted to Vicki L. Colvin, Professor of Chemistry and Chemical 
        Engineering; Executive Director, International Council on 
        Nanotechnology; Director, Center for Biological and 
        Environmental Nanotechnology, Rice University

    These questions were submitted to the witness, but were not 
responded to by the time of publication.

Questions submitted by Chairman Brian Baird

Q1.  Dr. Maynard has suggested a mechanism for government to partner 
with industry to fund environmental, health and safety (EHS) research 
that would support the needs of government in formulating a regulatory 
framework for nanomaterials and the needs of industry on how to develop 
nanotechnology safely. The idea is to use the Health Effects Institute 
model, which studies the health effects of air pollution. Do you 
believe this would be a good model for developing a government/industry 
research partnership for EHS research related to nanotechnology?

Q2.  Is there a satisfactory level of international collaboration and 
coordination of EHS research? What is the role here of non-governmental 
organizations, such as the International Council on Nanotechnology?

Q3.  The President's Council of Advisors on Science and Technology 
(PCAST) was assigned by the President to serve as the statutorily 
created outside advisory committee for the National Nanotechnology 
Initiative. How useful is PCAST as a means for private sector 
organizations to provide input to the planning and prioritization 
process for EHS research under the NNI? Are there other mechanisms 
available for stakeholders to have a voice in this process?

Q4.  Mr. Ziegler and Dr. Denison have recommended that the National 
Academy of Sciences be tasked to take a lead role in developing the EHS 
research strategy and assessing its implementation over time. What is 
your view of this recommendation?

Q5.  One of the key aspects of carrying out EHS research is to have 
agreed terminology and standards for characterization of nanomaterials.

        a.  Is this getting sufficient attention under the NNI? What is 
        the role of NIST in this area, and do you have recommendations 
        for how progress in these standards setting activities can be 
        accelerated?

        b.  Is there a role for NNI to provide direct assistance to 
        nanotechnology companies, particularly small companies, to help 
        them characterize new nanomaterials, which will thereby assist 
        the companies in assessing the potential environmental and 
        health risks of the new materials?

Questions submitted by Representative Vernon J. Ehlers

Q1.  With regard to the tools that you say are needed ``to correlate 
the functional properties of nanomaterials,'' can you speak to where we 
are on our research to develop these tools?

Q2.  On the issue of stovepiping EHS research versus integrating it 
into all research, do all current NNI grants currently include and EHS 
component? If not, should they? Why or why not?

Questions submitted by Representative Daniel Lipinski

Q1.  Much of the EHS research to date has focused on exotic materials 
with unrealistic exposure scenarios. While that is useful in 
establishing information on an ``upper bound'' of the hazard, the 
context is rarely communicated and it creates fear. What is critical is 
that we make sure nano enabled products are as safe or safer than what 
we use today.

     As I understand it, the hazard of a nanomaterial often depends 
upon much more than the size and type of material, but also surface 
properties, purity, etc. that relate to how it is made. How is the 
toxicology work underway controlling for this? Are researchers using 
standardized, well characterized materials? If not, how can we make use 
of the research findings?

Q2.  It seems that most of the early uses of nanotechnology and 
nanomaterials are for existing products and processes, many of which 
are far from ideal from a health and environmental safety perspective. 
What is being done to systematically compare the risks and benefits of 
the nanoscale alternative against the conventional approach in use 
today so that we accelerate the substitution of nanomaterials where 
they are superior (e.g., when replacing a known toxin)?

Q3.  The discussion around nanomaterials tends to focus on 
``engineered'' nanomaterials which are roughly defined as those that 
are purposefully created. However, the volume of naturally occurring 
and ultrafine particles produced by combustion, as well as those used 
as fillers in rubber tires or plastics is many orders of magnitude 
greater than the newly engineered nanomaterials. What are we doing to 
ensure that we leverage the body of EHS knowledge on these particles? 
Are we missing the forest from the trees by emphasizing only 
``engineered nanomaterials''? What efforts are there to assess the 
comparative hazard posed by engineered nanomaterials against incidental 
or naturally occurring nanomaterials?

Q4.  To what extent is the toxicity research relevant to ``real world'' 
situations? To what extent are federally funded efforts using the 
routes of exposure or formulations that emulate the nanomaterials being 
used in available products?

Questions submitted by Representative Ralph M. Hall

Q1.  Please share your thoughts on the idea of establishing a separate 
program office to oversee EHS research. Why is such an office needed 
for nanomaterials versus other materials? What authorities would such 
an office need to have? What are the possible pitfalls of such an 
approach? How would you prevent the perception of adding another level 
of federal bureaucracy to the mix? As an alternative to creating a new 
office, how can we improve the mechanisms we currently have in place to 
achieve the same goals?
                   Answers to Post-Hearing Questions
Responses by Andrew D. Maynard, Chief Science Advisor, Project on 
        Emerging Nanotechnologies, Woodrow Wilson International Center 
        for Scholars, Washington, D.C.

Questions submitted by Chairman Brian Baird

Q1.  Mr. Ziegler and Dr. Denison have recommended that the National 
Academy of Sciences be tasked to take a lead role in developing the 
environmental, health and safety (EHS) research strategy and assessing 
its implementation over time. What is your view of this recommendation?

A1. Two years ago, I would have strongly recommended such an action, as 
long as it included a strong work plan that enabled the development of 
a robust multi-stakeholder strategy, with a planned series of reviews 
and revisions. However, the U.S. Government has run out of time to 
develop such strategies, and needs to start taking action on doing the 
relevant risk research as soon as possible.
    A number of reports and reviews over the past few years have 
identified the short-term research needed to support safe 
nanotechnology 
development.\1\,\2\,\3\,\4\,
\5\,\6\ With hundreds of commercial and consumer products 
making nanotechnology claims currently on the market and nanomaterials 
easily available for online purchasing (as I exhibited during my 
testimony), there is little excuse for not taking action on these 
research needs and questions now.
---------------------------------------------------------------------------
    \1\ RS/RAE (2004). Nanoscience and nanotechnologies: Opportunities 
and uncertainties, The Royal Society and The Royal Academy of 
Engineering, London, UK, 113 pp.
    \2\ Denison, R.A. (2005). ``A proposal to increase federal funding 
of nanotechnology risk research to at least $100 million annually,'' 
Environmental Defense, Washington, DC.
    \3\ NIOSH (2005). Strategic plan for NIOSH Nanotechnology Research, 
National Institute for Occupational Health and Safety. Draft.
    \4\ Maynard, A.D. (2006). Nanotechnology: A research strategy for 
addressing risk, Project on Emerging Nanotechnologies, Woodrow Wilson 
International Center for Scholars, Washington, DC.
    \5\ NSET (2006). Environmental, health and safety research needs 
for engineered nanoscale materials. Subcommittee on Nanoscale Science, 
Engineering and Technology, Committee on Technology, National Science 
and Technology Council, Washington, DC.
    \6\ EPA (2007). U.S. Environmental Protection Agency Nanotechnology 
White Paper, Environmental Protection Agency, Washington, DC. EPA 100/
B-07/001. February.
---------------------------------------------------------------------------
    However, looking to the future, there is a need for a long-term 
plan of action. I would therefore recommend that the government put in 
place a strategy for dealing with short-term issues as soon as 
possible, and that the National Academy of Sciences (NAS), or a similar 
independent body, take a lead role in developing, reviewing and 
revising a longer-term research strategy. To be effective, this would 
require publication of a strategic plan within 12 months, followed by 
periodic reviews over the subsequent five years.
    Commitment to a robust review/revision process is essential in 
order to respond adequately to the evolving development path of 
nanotechnologies, especially as new information on nanomaterial health 
and safety becomes available. In addition, any strategic plan must be 
accompanied by the will, mechanisms and resources to enact it.
    Thus, my recommendation is for parallel tracks of government taking 
action on a short-term strategy now, with NAS or a similar organization 
taking the lead on longer-term planning, implementation and review of 
an EHS research strategy. Both tracks should have multi-stakeholder 
involvement, and should facilitate international coordination of 
research strategies and actions.

Q2.  You suggested in your testimony the need for an individual to be 
designated to take a leadership role for EHS research under the NNI. 
Could you elaborate on the characteristics and functions of this 
leadership role and suggest how to implement the proposal?

A2. First, let me stress that any effective approach to addressing 
nanotechnology EHS issues must involve multiple agencies and must 
engage key decision-makers in the respective agencies.
    However, effective leadership is imperative for this approach to 
succeed. A highly capable person with the time, responsibility, 
authority and desire to work with agencies across the Federal 
Government should fill this leadership role, so as to develop and enact 
workable solutions to the EHS nanotechnology challenges. This person 
would need a clear understanding of the issues involved in developing a 
cross-agency EHS research program, as well as the respect of 
researchers and decision-makers within the agencies.
    As I envision this much-needed oversight position, the individual 
in this leadership role would have the assigned authority to engage and 
collaborate with agencies at the levels where decisions are made and to 
bring people to the table to find mutual solutions to hard problems. 
Such problems may entail identifying ways to share resources across 
agencies, to coordinate and integrate research activities, to work in a 
collaborative manner to address broad challenges, and to break down 
institutional barriers.
    To create this proposed leadership role, it is my personal and 
professional opinion that Congress could include a provision in the 
Twenty First Century Nanotechnology Research and Development Act 
reauthorization that either establishes this authority, or requires the 
National Nanotechnology Initiative (NNI) to establish this authority. I 
recommend that Congress provide sufficient funding for this position on 
an annual basis.

Q3.  The President's Council of Advisors on Science and Technology 
(PCAST) was assigned by the President to serve as the statutorily 
created outside advisory committee for the National Nanotechnology 
Initiative. How useful is PCAST as a means for private sector 
organizations to provide input to the planning and prioritization 
process for EHS research under the NNI? Are there other mechanisms 
available for stakeholders to have a voice in this process?

A3. PCAST draws on input from a wide range of people, through the 
Nanotechnology Technical Advisory Group (NTAG)--on which I serve. 
However, NTAG and the process of engagement and input are not 
transparent.
    While the NTAG provides input to the review of the NNI, it is not a 
mechanism that is well-suited for transparent and multi-stakeholder 
input to the process of planning and prioritizing EHS research. 
Alternative mechanisms currently do not exist to achieve this, beyond 
the occasional public meetings and consultations held by NSET. These 
public meetings and consultations are not strategically effective in 
engaging stakeholders.
    A robust review and assessment process--whether undertaken by the 
NAS or another organization--would lead to a significant increase in 
stakeholder input. But this process is too slow and cumbersome to guide 
strategic research and policy decisions on a regular basis. In my 
testimony, I propose establishing a federal advisory committee that 
would allow transparent input from and review of an evolving research 
strategy by industry, academia, non-government organizations and other 
stakeholders.

Q4.  One of the key aspects of carrying out EHS research is to have 
agreed terminology and standards for characterizing nanomaterials.

          Is this getting sufficient attention under the NNI? 
        What is the role of NIST in this area?

          Is there a role for NNI to provide direct assistance 
        to nanotechnology companies, particularly small companies, to 
        help them characterize new nanomaterials, which will thereby 
        assist the companies in assessing the potential environmental 
        and health risks of new materials?

A4. Terminology and characterization standards are essential for 
effective EHS research. But there are dangers in standards work 
unnecessarily delaying EHS research. In the first instance, it is 
incorrect to assume that no research can proceed until global standards 
are in place--research is about exploring the unknown and will 
frequently set the agenda for standards development, rather than being 
subject to it. Secondly, there is a danger in assuming that standards 
developed to support the commercial development and use of 
nanotechnologies are also suitable for governing EHS research. But 
there is not a one-size-fits-all solution here.
    In the short-term, good research practices are needed to ensure new 
data can be interpreted effectively.
    In the long-term, researchers need as much help as they can get in 
understanding the characteristics of nanomaterials, in a way that will 
allow for the cross-comparison and most effective use of studies.
    NIST is the lead U.S. agency in developing characterization methods 
and has a critical role in leading in and facilitating the development 
of applicable standards. The NNI has supported NIST's role, but further 
support is needed. In addition, other agencies with EHS expertise need 
to be empowered to participate in the standards process, with staff 
time and resources made available to do the job effectively.
    A central nanomaterials characterization facility focused on EHS 
characterization would strongly support small companies. For such a 
facility to be effective it must:

        1.  be developed within an overarching strategy for EHS 
        research;

        2.  complement other approaches to materials characterization, 
        and provides a service to developers/companies lacking the 
        resources to do the necessary work; and

        3.  focus specifically on EHS-relevant characterization 
        methodologies.

Questions submitted by Representative Vernon J. Ehlers

Q1.  To date, there is no evidence of any harm from a product which 
uses nanotechnology. Are you worried about nanotechnology in products? 
Are we doing a good job of prioritizing our research efforts between 
final products and other byproducts of nanoproduction?

A1. The short answer to this question is: yes. I am worried about the 
widespread and uncontrolled use of engineered nanomaterials in 
products, and I do not believe we are doing a good job prioritizing 
research to understand the risks of either these materials, or their 
byproducts.
    We have a great opportunity here to learn from past mistakes; to 
avoid significant harm and halt the development of a legacy of adverse 
health and environmental impacts that emerge only years or decades 
after consumers (including children) have been using products and 
exposed to unknown risks. The reality is that new engineered 
nanomaterials are entering the market now, with little understanding of 
how they will impact on health and the environment. We are aware of 
over 570 manufacturer-identified nanotechnology consumer products,\7\ 
and these represent just the tip of the engineered nanomaterial 
iceberg. If we are to understand how to use these materials safely and 
wisely, we need action now.
---------------------------------------------------------------------------
    \7\ Maynard, A.D. and E. Michelson. (2007). A Nanotechnology 
Consumer Products Inventory.'' Project on Emerging Nanotechnologies, 
Woodrow Wilson International Center for Scholars, Washington, DC. 
Available at: http://nanotechproject.org/consumer (accessed November 
14, 2007).
---------------------------------------------------------------------------
    The current research portfolio is not prioritized to address and 
manage the impact of these materials--or their byproducts. As I noted 
in my testimony, carbon nanotubes are being sold and used now, with the 
assumption that they are as safe as graphite. But the toxicity data--
while inconclusive--suggests the material could be much more harmful. 
This is just one example. In the meantime, other materials, including 
titanium dioxide, nano silver and other nanomaterials, are being used 
with increasing frequency. We are doing a poor job of responding to the 
fact that they may present a different risk to what conventional 
thinking would tell us. Not all of these materials will be harmful. But 
without good information, is this a risk we are willing to take?
    In addressing potential risks, a life cycle approach is needed--as 
I and a number of colleagues have highlighted in the journal Nature.\8\ 
This means looking at the byproducts of production and use as well 
(whether they are nano or not), and the end-of-life impacts. Such an 
approach is fundamental to a strategic research program, and yet it is 
not in evidence.
---------------------------------------------------------------------------
    \8\ Maynard, A.D., R.J. Aitken, et al. (2006). ``Safe handling of 
nanotechnology.'' Nature 444(16):267-269.

Q2.  On the issue of stovepiping EHS research versus integrating it 
into all research, do all current NNI grants currently include an EHS 
---------------------------------------------------------------------------
component? If not, should they? Why or why not?

A2. Not all federally funded nanotechnology research includes an EHS 
component, although an increasing number of large programs do. Yet I 
believe the keys here are collaboration and partnership across 
programs, not necessarily integration of EHS research into all aspects 
of research. Understanding the potential impacts of engineered 
nanomaterials is complex, and progress will only be made through 
interdisciplinary collaboration that includes the developers of 
materials, as well as those equipped to address potential harm.
    Attempts to integrate EHS research into applications-focused 
projects can lead to divisive battles for resources between 
applications and implications research. This could lead to 
inexperienced researchers doing EHS research in a way that does not 
progress the state of knowledge. It also runs the danger of addressing 
very specific EHS challenges, while leaving other equally important 
challenges untouched. Of the majority of instances that I am aware, 
integrated research programs have a primary focus on developing 
applications, with risk-based research forming a relatively small 
component of the research portfolio. This does have the disadvantage of 
marginalizing risk research--implying that it is not as important or as 
worthy as the applications research. Yet if we want the highest quality 
of research into understanding potential adverse impacts, it must be 
given the same respect as any other scientific endeavor.
    On the other hand, well-executed integrated programs can and do 
encourage close collaboration and partnerships between researchers 
developing applications and understanding risks. We are seeing this in 
some of the National Science Foundation-funded nanotechnology research 
centers. The Niche Manufacturing Flagship in Australia is also 
following this model,\9\ where applications and implications 
researchers are working toward a common goal of developing safe and 
successful applications.
---------------------------------------------------------------------------
    \9\ Niche Manufacturing Flagship. Available at: http://
www.csiro.au/org/NicheManufacturingFlagshipOverview.html (accessed 
October 19, 2007).
---------------------------------------------------------------------------
    The bottom line is that an integrated approach can work well, but 
is not always the best way to address every important EHS issue. 
Rather, mechanisms and funding are needed that enable strong 
partnerships and collaborations between applications and implications 
researchers, either within or outside research programs.

Questions submitted by Representative Daniel Lipinski

Q1.  Much of the EHS research to date has focused on exotic materials 
with unrealistic exposure scenarios. While that is useful in 
establishing information on an ``upper bound'' of the hazard, the 
context is rarely communicated and it creates fear. What is critical is 
that we make sure nano-enabled products are as safe or safer than what 
we use today.

     As I understand it, the hazard of a nanomaterial often depends 
upon much more than the size and type of material, but also surface 
properties, purity, etc., that relate to how it is made. How is the 
toxicology work underway controlling for this? Are researchers using 
standardized, well characterized materials? If not, how can we make use 
of the research findings?

A1. The attributes underlying nanomaterial hazard are complex, and we 
are just beginning to learn what is important. As others and I have 
noted in previous publications, we need to explore somewhat artificial 
(i.e., not necessarily commercially relevant) nanomaterials, to 
understand what attributes are important and why. But we also need more 
targeted research that addresses materials that are in or will enter 
commercial production. Both approaches are complementary.
    I do not believe that EHS research that explores how well-defined 
(but not necessarily commercially relevant) nanomaterials behave 
necessarily creates fear, any more than basic research into how the 
world works creates false hope. However, it is possible that people 
sometimes miscommunicate or misunderstand such research. In this case, 
rather than limiting important research from fear of how people will 
react to the findings, there needs to be greater education and 
engagement on nanotechnology between policy-makers, industry and the 
public, to enable informed decision-making. This is a recommendation I 
make in my written testimony.
    Regarding the challenges of characterizing materials used in 
investigations, it is essential that researchers adequately describe 
the materials and study protocols they use, if studies are to be 
interpreted and compared effectively. This is not an easy task: 
researchers are having to learn new techniques and protocols, and we 
are not yet sure how we should be characterizing nanomaterials in 
toxicity or exposure studies. A number of groups are currently working 
on this, including the International Council On Nanotechnology (ICON) 
and the American Chemistry Council nanotechnology panel. But it is 
researchers in academia and industry, who are frustrated by the lack of 
guidance and progress from the Federal Government on nanomaterial 
characterization approaches, who are driving current efforts.

Q2.  It seems that most of the early uses of nanotechnology and 
nanomaterials are for existing products and processes, many of which 
are far from ideal from a health and environmental safety perspective. 
What is being done to systematically compare the risks and benefits of 
the nanoscale alternative against the conventional approach in use 
today so that we accelerate the substitution of nanomaterials where 
they are superior (e.g., when replacing a known toxin)?

A2. There is some work underway to compare the risks and benefits of 
nanoscale alternatives against conventional materials; however, a clear 
systematic approach has not yet been established. Many manufacturers of 
new commercial nanoproducts make claims about the benefits of their 
products as compared to conventional products; however, it is unclear 
the extent to which they are systematically evaluating the risks of the 
nanomaterials or nanoproducts they create or use to comparable products 
made with larger-scale materials. Yet, in recent years, conferences, 
papers, and researchers have encouraged the incorporation of life cycle 
assessment (LCA) or life cycle thinking into nanomaterial and product 
design and development to create products that are safer and greener 
during production, use and at end-of-life.
    Green nanotechnology approaches encourage the replacement of 
existing products with new nanoproducts that are more environmentally 
friendly throughout their life cycles, among other risk mitigation 
goals. Ultimately, green nano may help accelerate the substitution of 
nanomaterials where they are superior as well as safe.
    A number of scientists are engaging in this area as described in 
the Project on Emerging Nanotechnologies' Green Nanotechnology 
report.\10\ These scientists are applying the lessons from green 
chemistry and green engineering to nanotechnology in their laboratories 
and incorporating life cycle thinking into the design and production of 
new nanomaterials and products. These chemists and engineers seek to 
design processes that are as clean and efficient as possible, use both 
benign and less toxic material inputs, and prevent waste.
---------------------------------------------------------------------------
    \10\ Schmidt, K. (2007). ``Green nanotechnology: It's easier than 
you think.'' PEN 08. Washington, DC, Woodrow Wilson International 
Center for Scholars, Project on Emerging Nanotechnologies. Available 
at: http://www.nanotechproject.org/file-download/187 
(accessed November 15, 2007).
---------------------------------------------------------------------------
    Efforts to develop systematic approaches to evaluating the risks 
and benefits of nanomaterials include (a) a recent study by researchers 
at the Oregon Nanoscience and Microtechnologies Institute applying the 
principles of green chemistry to nanoscience,\11\ and (b) a 
nanotechnology life cycle assessment workshop of international experts 
convened in October 2006 by the European Commission's Nano & Converging 
Science and Technologies Unit, EPA's Office of Research & Development, 
and the Project on Emerging Nanotechnologies. This collaboration 
resulted in a joint report on nanotechnology and life cycle 
assessment.\12\ This report provides recommendations for moving forward 
with assessing the life cycle impacts of nanotechnologies without near-
perfect data. EPA is actively studying the positive environmental uses 
of nanotechnology, as compared to existing technologies and materials. 
The agency's National Center for Environmental Research is funding 
grants for research in green nanotechnology.
---------------------------------------------------------------------------
    \11\ Dahl, J.A., B.L.S. Maddux, and J.E. Hutchison. 2007. ``Toward 
Greener Nanosynthesis.'' Chem. Rev. 107(6):2228-2269.
    \12\ PEN and EC. (2007). ``Nanotechnology and Life Cycle 
Assessment: A Systems Approach to Nanotechnology and the Environment. 
Synthesis of results obtained at a workshop in Washington, DC, October 
2-3, 2006.'' Project on Emerging Nanotechnologies, Woodrow Wilson 
International Center for Scholars, and European Commission. Available 
at: http://www.nanotechproject.org/fileG5-download/168 (accessed 
November 15, 2007).
---------------------------------------------------------------------------
    As laudable as these initiatives are, they will be ineffective if 
not pursued within the context of a strategic plan. Nanotechnology 
cannot be seen in isolation, and the potential impacts of developing 
and using specific nanotechnology solutions need to be balanced against 
the risks of not pursuing these technologies. Yet this does not give 
carte blanche to implementing nanotechnology solutions that look good, 
but have not been fully evaluated. The prudent approach is to develop 
these technologies with as clear an understanding of the science-based 
pros and cons as possible. This will only happen within the context of 
a top-down research strategy.

Q3.  The discussion around nanomaterials tends to focus on 
``engineered'' nanomaterials which are roughly defined as those that 
are purposely created. However, the volume of naturally occurring and 
ultra-fine particles produced by combustion, as well as those used as 
fillers in rubber tires or plastics is many orders of magnitude greater 
than the newly engineered nanomaterials. What are we doing to ensure 
that we leverage the body of EHS knowledge on these particles? Are we 
missing the forest from the trees by emphasizing only ``engineered 
nanomaterials''? What efforts are there to assess the comparative 
hazard posed by engineered nanomaterials against incidental or 
naturally occurring nanomaterials?

A3. In addressing the potential impact of engineered nanomaterials, 
there is much we can learn from the impacts of incidental nanomaterials 
on human health and the environment. But nanotechnology also provides 
the tools to create new nanoscale materials to which our bodies have 
not been exposed before, and have not necessarily evolved to deal with. 
While it is often useful to discuss incidental and engineered 
nanomaterials as separate issues, a strong research strategy should 
integrate knowledge on both areas.
    EHS research is conducted to protect people and the environment, 
irrespective of the type of harmful agent. Thus, having a strategic 
research plan that enables a free flow of information from where it 
resides to where it is needed--regardless of how the technologies or 
the materials are classified--is essential. In developing the Project 
on Emerging Nanotechnologies' publicly accessible EHS research 
database,\13\ we recognized the importance of having access to 
information on all types of nanomaterials. For this reason, we include 
and categorize research addressing both incidental and naturally 
occurring nanomaterials.
---------------------------------------------------------------------------
    \13\ PEN (2007). Nanotechnology Environmental and Health 
Implications Inventory of Current Research. Project on Emerging 
Nanotechnologies, Woodrow Wilson International Center for Scholars, 
Washington, DC. Available at: http://nanotechproject.org/18 (accessed 
November 14, 2007)
---------------------------------------------------------------------------
    But the bottom line is that engineered nanomaterials present unique 
potential threats to our health and the environment; while we can and 
must learn from associated research areas, we need a strategy that 
clearly articulates the nanotechnology-specific questions that need 
answering, and how they are to be answered.

Q4.  To what extent is the toxicity research relevant to ``real world'' 
situations? To what extent are federally funded efforts using the 
routes of exposure or formulation that emulate the nanomaterials being 
used in available products?

A4. Strategic research is needed both on fundamental mechanisms of 
action of nanomaterials in humans and the environment--which will help 
predict the behavior of new nanomaterials and develop new understanding 
of what makes them harmful--and on specific nanomaterials in commerce. 
But without a clear strategy, there will be no coordination of these 
complementary approaches, and no hope of making systematic progress. 
This is the situation we find ourselves in now.
    In my analysis of the research portfolio last year, it was clear 
that a bottom-up approach to EHS research (i.e., one where the 
researchers dictate the agenda) has led to a preponderance of 
scientifically interesting studies of questionable relevance, and major 
gaps in the research portfolio for addressing commercially relevant 
materials and significant routes of exposure. For instance, much 
research has focused on carbon nanotubes and inhalation exposure. Yet 
relatively little research is being carried out on prevalent, although 
perhaps less scientifically stimulating, materials like silver 
nanoparticles, and other exposure routes such as ingestion.
    The only way of redressing the balance is to complement bottom-up 
driven research with a top-down strategy, that enables goal-oriented 
targeted and exploratory research with the aim of providing relevant 
answers that industry and regulators can use.

Q5.  You and Dr. Denison call for ten percent or more of the Federal 
Government's nanotechnology research and development budget be 
dedicated to goal-oriented EHS research. As pointed out by Dr. 
Denison's testimony, only 4.1 percent of NNI's 2008 budget is to be 
spent on EHS R&D. Would you please elaborate on this and explain how 
you came up with this 10 percent figure? Would the other panelists 
please comment on this recommendation?

A5. As I argue in my testimony, research funding must be tied to a 
research strategy, which will allow for a systematic allocation of 
funds and the review of progress towards clear goals. Targeted research 
goals arise from specific questions that need to be answered if we are 
to develop safe ways of using the current generation of engineered 
nanomaterials. In my July 2006 analysis,\14\ I evaluated how much it 
would cost to address the most pressing questions and attained an 
estimate of $50 million per year. In addition to this targeted 
research, exploratory research (including basic research) is needed to 
develop the knowledge needed to ask and address longer-term questions. 
This research should still be goal-oriented, but its exploratory nature 
precludes attaching definite dollar figures to the cost of generating 
new knowledge. As an example, the goal of developing methods to predict 
the toxicity of new engineered nanomaterials requires the generation of 
new knowledge through exploratory research, but it is impossible to 
tell how much this research will cost to yield results. Yet a line must 
be drawn somewhere on how much funding will be allocated to such 
research.
---------------------------------------------------------------------------
    \14\ Maynard, A.D. (2006). Nanotechnology: A research strategy for 
addressing risk, Project on Emerging Nanotechnologies, Woodrow Wilson 
International Center for Scholars, Washington, DC.
---------------------------------------------------------------------------
    The figure of 10 percent of the NNI budget for both targeted and 
exploratory EHS research will enable valuable research to proceed 
without unduly biasing the funding portfolio towards risk-based 
research. With less than 10 percent, exploratory research becomes 
starved and thus prevents the generation of new knowledge essential to 
tackling future problems. With more than 10 percent, it becomes hard to 
justify EHS research funding to managing possible (and even 
speculative) risks arising from associated nanotechnology research.
    Assigning 10 percent of the nanotechnology R&D budget to risk 
research also makes a number of very clear statements: risk research 
and risk researchers have a credible and a critical role to play; the 
Federal Government is dedicated to supporting the commercial 
development of nanotechnology with the knowledge necessary to use it 
safely; and the Federal Government are committed to a transparent and 
accountable plan for ensuring the safe development of nanotechnology.

Questions submitted by Representative Ralph M. Hall

Q1.  Please share your thoughts on the idea of establishing a separate 
program office to oversee EHS research. Why is such an office needed 
for nanomaterials versus other materials? What authorities would such 
an office need to have? What are the possible pitfalls of such an 
approach? How would you prevent the perception of adding another level 
of federal bureaucracy to the mix? As an alternative to creating a new 
office, how can we improve the mechanisms we currently have in place to 
achieve the same goals?

A1. I have not suggested that a separate program office is needed to 
oversee EHS research, but rather that leadership is needed (together 
with a strategic plan, and the resources and means to implement it) to 
ensure that the right research is done to underpin the development of 
safe nanotechnologies--and to support the U.S. Government's significant 
investment in nanotechnology research and development.
    The current approach to ensuring the right research is done is 
clearly not working. I demonstrated this in my testimony with the 
example of carbon nanotubes--a material that anyone can purchase online 
and use. The questions we need to answer in order to use this material 
safely are not rocket science: Does exposure occur in the workplace? 
How can we measure it? How toxic is the material? Does it behave like 
asbestos? How much will be released into the environment? And so on. 
Yet current research plans do not seem geared to addressing pressing 
questions like these in a timely manner. The question is, therefore, 
what does it take to fix the system?
    In my written testimony, I make several recommendations on actions 
that are needed if we are to provide industry, regulators and the 
public with the answers they need to develop and use the products of 
nanotechnology safely. From these recommendations, it is very clear 
that leadership with authority is needed to enable research, oversight 
and regulatory agencies to work within their respective authorities 
toward the common goal of ensuring the safety of emerging 
nanotechnologies. It is also clear that EHS research needs a champion--
a person who understands its relevance and value; a person who can 
counter misconceptions that risk research is somehow a poor cousin of 
basic and applications-focused research; and a person who understands 
how risk research works.
    Such leadership could reside within the current NNI structure. But 
to be effective, this appointed person would need to be given authority 
to engage agencies at the highest level in order to lead a coordinated 
and strategic response to the challenges raised by emerging 
nanotechnologies. This champion would also need the authority to 
channel strategic research to addressing regulatory oversight issues.
                   Answers to Post-Hearing Questions
Responses by Richard A. Denison[1], Senior Scientist, Environmental 
        Defense

Introduction

    Before addressing Subcommittee Members' specific questions, 
Environmental Defense wishes first to elaborate on the recommendations 
we offered in our testimony on changes needed for the NNI to 
effectively identify and address the potential risks of nanoscale 
materials, as our recommendations bear directly on many of these 
questions. We also wish to address what we believe to be serious 
mischaracterizations of our positions provided by two other witnesses 
at the hearing. Finally, we describe a federal precedent and potential 
model for restructuring the NNI. This model directly addresses our and 
others' mounting concern that nanotechnology's potential risks are not 
being sufficiently addressed because the same entity has been charged 
with both promoting and providing oversight of this technology. The 
restructuring we suggest would help to ensure that nanotechnology's 
risk implications get the attention they need, even as federal 
investment in nanotechnology development proceeds.
    Our two main recommendations are as follows: First, we recommend 
creating a new entity, or elevating an existing entity, with the 
responsibility to develop and oversee a federal research strategy to 
identify, assess, and address the potential risks of nanomaterials. 
This entity should be provided with ample budgetary and independent 
management authority and sufficient resources, and should have a core 
public health and/or environmental mission. Second, we recommend 
establishing a clearer and stronger separation in decision-making and 
management between the parts of the Federal Government whose mission is 
to help develop and advance nanotechnology, and those parts charged 
with ensuring a thorough and objective examination of its potential 
risks and taking steps needed to mitigate those risks.
    Hearing witnesses Dr. Clayton Teague and Mr. Floyd Kvamme 
inaccurately depicted Environmental Defense's recommendations in their 
prepared statements and in response to Subcommittee Members' questions. 
They repeatedly and incorrectly stated or implied that we and other 
witnesses critical of their efforts (a) are calling for appointment of 
an EHS research ``czar'' and (b) intend for EHS research to be 
conducted in isolation (in a ``silo''), wholly removed from research on 
nanotechnology applications. Neither is the case.
    Environmental Defense is indeed very concerned about the NNI's 
continuing lack of sufficient direction, leadership, and authority to 
develop and implement an effective and coherent risk research strategy 
across the Federal Government. This lack of focus is not the result of 
happenstance, in our view, but rather it is embedded in the origins and 
management structure of the NNI itself.
    With apologies for the ``alphabet soup,'' note that the National 
Nanotechnology Coordination Office (NNCO, headed by Dr. Teague) is 
managed under the Nanoscale Science Engineering and Technology (NSET) 
Subcommittee of the Committee on Technology (CoT), which is part of the 
National Science and Technology Council (NSTC). The NSTC is advised by 
the President's Council of Advisors on Science and Technology (PCAST, 
co-chaired by Mr. Kvamme). PCAST has been designated as the National 
Nanotechnology Advisory Panel (NNAP), which is charged with reviewing 
the federal nanotechnology research and development program.
    The core mission of all of these entities is the advancement of 
technology in the U.S. The NNCO staff, the NSET and CoT chairs, and the 
PCAST/NNAP membership are populated almost entirely with 
technologists--individuals trained in materials sciences or with 
technology development expertise and experience.[2] From a historical 
perspective, this makeup is not surprising, as the NNI was created with 
the primary aim of advancing nanotechnology. (Of the eleven areas of 
activity delineated for the national nanotechnology program called for 
under the 21st Century Nanotechnology Research and Development Act of 
2003, only a small part of one of them addresses health or 
environmental implications; the other ten focus on advancing 
nanotechnology applications.[3])
    Although the staffing and membership composition described above is 
quite appropriate for the NNI's work to develop and promote 
nanotechnology applications, it is entirely inappropriate when it comes 
to addressing nanotechnology's implications--it potential risks. 
Scientists trained and experienced in understanding health or 
environmental risks, rather than technologists, need to direct and 
implement the NNI's efforts to identify and address nanomaterial 
hazards and exposure potential. Delivering the right expertise is 
crucial, as is providing some distance from, and an effective 
counterbalance to, the inevitable boosterism of technologists charged 
with a promotional role.
    The effect of the current imbalance is evident in the hearing 
statements of technologists Mr. Kvamme and Dr. Teague, defending the 
NNI's risk-related efforts. Even as they professed that the NNI is 
serious about addressing nanotechnology's potential risks, both 
witnesses claimed or implied that concerns about nanotechnology's risks 
are overblown. In his written statement, Mr. Kvamme stated the 
following:

         ``Already, research is shedding light on some of the questions 
        being asked. Specifically, a study at Purdue on the 
        environmental impact of manufactured nanoparticles on ordinary 
        soil showed no negative effects; Georgia Tech scientists are 
        doing similar work. Researchers at Dayton University are 
        working on the health and safety aspects of the use of 
        nanodiamonds as drug delivery vehicles with encouraging 
        results. University of Oregon chemists are looking at the use 
        of nanomaterials to clean up toxic groundwater contaminants 
        that have until now been difficult to remove. In vivo tests at 
        Rice University have found no immediate adverse health effects 
        from carbon nanotubes injected directly into the bloodstream 
        and that the liver seems to collect these materials effectively 
        for excretion.'' (emphases added)[4]

    This ``summary'' of the available risk research on nanomaterials is 
highly selective and biased, as it over-generalizes findings and 
highlights only ``exonerative'' results while ignoring many other 
studies that indicate potential concerns. It is also entirely at odds 
with the far more balanced rendition of the facts provided by NNI 
Agency health and environmental scientists.[5]
    Dr. Teague, in response to a Subcommittee Member's question, stated 
the following:

         ``A lot of the research that was done early on, even though it 
        was certainly not coordinated and from the Federal Government, 
        and I think that is why some of it did produce some very 
        premature results and a lot of wrong conclusions were drawn 
        from it. By the careful planning and by tapping into the depth 
        of experts within the Federal Government, and our collaboration 
        with others outside, I think that we have, by far, the best 
        approach to trying to carry out appropriate research in a 
        careful, deliberately planned way. If one doesn't do that, the 
        result is typically bad research and research that leads to 
        premature and often poor results, poor understanding and 
        leading to, I think, a lot of misleading conclusions that have 
        already been drawn there often, because the result was not 
        planned, not well-conducted.''[6]

    While we certainly have no quarrel with the need for more and 
better coordinated research, Dr. Teague's implication that only ``bad'' 
research has indicated the potential for risks again reflects a very 
biased view of the available literature. It also is not indicative of 
what any good health or environmental scientist in the field would 
state to be the case.
    Indeed, a review just published in Nanotoxicology found that the 
``vast majority'' of nearly 430 journal papers reporting on toxicity 
testing of various nanoparticles identified adverse effects in 
laboratory animals or cell lines.[7]
    What concerns Environmental Defense most about these statements, 
however, is that senior NNI and PCAST members seem to believe it is 
their role to downplay evidence that suggests that engineered 
nanomaterials may pose risks to health or the environment.
    The mechanism the NNI is using to address nanotechnology's 
potential risks is the Interagency Working Group on Nanotechnology 
Environmental and Health Implications (NEHI). NEHI's stated mission is 
to:

          provide for exchange of information among agencies 
        that support nanotechnology research and those responsible for 
        regulation and guidelines related to nanoproducts (defined as 
        engineered nanoscale materials, nanostructured materials or 
        nanotechnology-based devices, and their byproducts);

          facilitate the identification, prioritization, and 
        implementation of research and other activities required for 
        the responsible research and development, utilization, and 
        oversight of nanotechnology, including research methods of life 
        cycle analysis; and

          promote communication of information related to 
        research on environmental and health implications of 
        nanotechnology to other Government agencies and non-Government 
        parties.[8]

    Environmental Defense agrees with the importance and necessity of 
such ``bottom-up'' functions of interagency information exchange, 
facilitation, and communication, but we believe they are not enough to 
produce and effectively implement a risk research strategy. We think 
the record speaks for itself: a string of unmet promises to deliver the 
strategy, and near-universal disappointment in the scope and quality of 
the interim documents delivered to date by NEHI.[9]
    We support retaining and continuing to use the ``bottom-up'' 
approach to gain input from the full range of agencies and individuals 
with expertise in relevant fields. This approach needs to be 
supplemented, however, with a ``top-down'' capacity, designating a 
smaller group of senior health and environmental scientists with the 
authority to direct and oversee both the EHS research budgets and 
associated activities within and across NNI agencies. These scientists 
should be drawn from NNI agencies with missions to protect human health 
and/or the environment and related research capabilities. Whether 
situated within the current NNI structure or outside of it, this 
executive body needs to have decision-making authority that is 
independent of those parts of NNI charged with advancing nanotechnology 
development. (Our written testimony elaborates further on why this 
separation of roles is needed.)
    With regard to the claim of other witnesses that Environmental 
Defense favors somehow isolating implications research from 
applications research, we absolutely do not. We fully recognize both 
the need for and the benefits of ``cross-fertilization,'' as well as 
the importance of simultaneously pursuing and sharing the results, from 
different lines of research. It would clearly be counterproductive to 
obstruct such opportunities for synergism or to impede the free flow of 
research ideas and results. Our point instead is that addressing risk 
implications requires conducting research that is both intended and 
directly targeted to answer specific risk-relevant questions. Such 
research should also be undertaken and directed by--and judgments as to 
its adequacy, quality and interpretation made by--scientists trained in 
the health or environmental sciences who work at agencies charged with 
the pursuit of health or environmental missions. It is equally 
important that the specifics of the projects and amount of funding 
spent on such research be transparently and clearly identified and 
accounted for separate from applications research, some of which may 
well yield findings relevant to understanding risk.

A federal precedent--and potential model--for our recommended approach

    Our nation has faced similar situations in the past, when mounting 
concern that a technology's potential risks received insufficient 
attention because the same entity had been charged with both promoting 
and providing oversight of that technology. The Atomic Energy 
Commission (AEC), for example, first established by the Atomic Energy 
Act of 1946, was explicitly assigned the functions of both encouraging 
the use of nuclear power and regulating its safety. Concerns about this 
dual charge grew among both proponents and critics of nuclear power, 
coming to a head in the mid-1970s, when Congress abolished the AEC. 
Congress then assigned the oversight functions of the AEC to a new 
entity, the Nuclear Regulatory Commission (NRC), and shifted federal 
nuclear energy research and development to the U.S. Department of 
Energy (DOE).[10]
    The NRC's mission and work specifically includes risk research: 
``As part of its regulatory program, the NRC conducts an extensive 
research program to provide independent information and expertise to 
support its safety decision-making.''[11] This research is conducted 
through the NRC's Office of Regulatory Research, which ``[p]rovides 
leadership and plans, recommends, manages and implements programs of 
nuclear regulatory research.'' The Office also engages in considerable 
cooperative research with ``DOE and other federal agencies, the nuclear 
power industry, U.S. universities, and international partners.''[12] 
However, it operates and is managed independently, and the NRC has in 
place extensive guidelines and procedures intended to assure it avoids 
conflicts of interest (COI) that could arise from its use of DOE 
laboratories for technical assistance and research,[13] or from its 
hiring contractors who have also worked on or are competing for DOE 
contracts.[14]
    Hence--far from operating in a ``silo'' and being unable to take 
advantage of the ``cross-fertilization'' arising from research 
conducted on applications--the NRC has established an approach intended 
to allow for safety research to be conducted in a manner that 
transparently manages COI, while also maintaining its independent 
decision-making. While we make no representation as to the NRC's 
performance, we believe the Committee should seriously examine the NRC 
example as a precedent and potential model for the kinds of changes 
that may be needed to reform the NNI. Such reform would, in our view, 
help to ensure that nanotechnology's risk implications get the 
attention they need, even as federal investment in nanotechnology 
development proceeds.
    Our specific responses to Questions for the Record follow.

Questions submitted by Chairman Brian Baird

Q1.  Dr. Maynard has suggested a mechanism for government to partner 
with industry to fund environmental, health and safety (EHS) research 
that would support the needs of government in formulating a regulatory 
framework for nanomaterials and the needs of industry on how to develop 
nanotechnology safely. The idea is to use the Health Effects Institute 
model, which studies the health effects of air pollution. Do you 
believe this would be a good model for developing a government/industry 
research partnership for EHS research related to nanotechnology?

A1. We agree that the Health Effects Institute (HEI) provides a good 
model for governing public-private research partnerships, for several 
reasons. First, because the research findings have implications for 
needed regulatory controls that may be controversial, it would be 
beneficial to have an objective, scientifically excellent third party, 
which neither makes nor is a stakeholder in policy-making (i.e., is 
outside of government and the regulated industry), conduct such 
research. Second, given the considerable technical demands of the 
research, the HEI model--which employs the finest academic scientists 
as research planners, performers and peer reviewers--will help assure 
high-quality and credible research results. Third, situating this 
research in a high-quality independent institution will help foster the 
development of a focused and consistent research strategy in a way that 
may be more difficult to achieve with multiple competing government 
agencies. Finally, HEI employs a number of governance and operational 
procedures to help ensure transparency, credibility and integrity in 
its research; these include a commitment to release all research 
results (positive or negative), reliance on governance and advice by 
independent expert committees, and insulation of the review and release 
process from sponsor influence.

Q2.  The President's Council of Advisors on Science and Technology 
(PCAST) was assigned by the President to serve as the statutorily 
created outside advisory committee for the National Nanotechnology 
Initiative. How useful is PCAST as a means for private sector 
organizations to provide input to the planning and prioritization 
process for EHS research under the NNI? Are there other mechanisms 
available for stakeholders to have a voice in this process?

A2. As noted in our Introduction, PCAST, like the NNI itself, has as 
its core mission the advancement of technology in the U.S. Not 
surprisingly, PCAST's membership is therefore made up almost entirely 
of technologists--individuals trained in materials sciences or with 
expertise and experience in the area of technology development.[15] 
Only three of the 36 PCAST members have health science or environmental 
science expertise, and none has a risk science background. This mission 
and composition, while appropriate for overseeing NNI's primary goals 
related to developing and promoting nanotechnology applications, are in 
appropriate when it comes to overseeing or judging how well the NNI is 
addressing nanotechnology's implications--its potential risks. 
Scientists trained and with extensive experience in understanding 
health or environmental risks--not technologists--need to oversee and 
advise NNI's efforts to identify and address nanomaterial hazards and 
exposure potential. In our view, PCAST's ability to effectively execute 
its assigned advisory tasks is impeded by the same problem we have 
identified within the NNI itself: insufficient separation between the 
promotional and oversight roles it is being expected to play.
    In addition to this structural or compositional constraint, the 
only mechanism PCAST seems to have developed for gaining outside 
input--its Nanotechnology Technical Advisory Group (NTAG)--operates 
virtually entirely out of sight. No description of the NTAG--its 
members, its mission or charge, its operating guidelines, whether or 
when it meets--is available on the PCAST website.[16] (In the interest 
of full disclosure, Environmental Defense was extended but declined an 
invitation to join the NTAG primarily because we were concerned that it 
appears to operate largely out of public view.) This approach is in 
marked contrast to the manner in which federal advisory committees are 
structured and operate, pursuant to the Federal Advisory Committee Act 
(FACA).

Q3.  Dr. Maynard suggested the need for an individual to be designated 
to take a leadership role for EHS research under the NNI. Do you agree 
with this recommendation, and if so, how would you define the 
characteristics and functions of this leadership role and how could the 
proposal be implemented?

A3. We agree with the need for more centralized and independent 
leadership and increased decision-making authority sufficient to direct 
and oversee federal nanotechnology risk research, although we think 
that designation of a small group of experienced individuals with a 
somewhat diverse set of backgrounds and expertise in health and 
environmental fields, rather than a single individual, may be 
preferable. In our Introduction, we have described in some detail the 
characteristics, functions and authorities such an entity would need to 
effectively direct a federal risk research program. We have also 
suggested that the Nuclear Regulatory Commission and its Office of 
Nuclear Regulatory Research provide both a precedent and potential 
model. Most important, such an executive body needs to have decision-
making authority that is independent of those parts of NNI charged with 
advancing nanotechnology development.

Q4.  One of the key aspects of carrying out EHS research is to have 
agreed terminology and standards for characterization of nanomaterials.

        a.  Is this getting sufficient attention under the NNI? What is 
        the role of NIST in this area?

        b.  Is there a role for NNI to provide direct assistance to 
        nanotechnology companies, particularly small companies, to help 
        them characterize new nanomaterials, which will thereby assist 
        the companies in assessing the potential environmental and 
        health risks of the new materials?

A4a,b. While deciding on terminology and standards for characterization 
has proven challenging both domestically and internationally, we 
believe the NNI is devoting sufficient attention to these important 
matters. Because terminology and standards for characterization must be 
agreed upon by a variety of industry sectors, academic researchers, and 
government bodies in different countries, there is only so much the NNI 
can do to help the parties come to agreement. The National Institute of 
Standards and Technology (NIST) has an important role to play in both 
helping to set the standards and then developing and making available 
reference materials for those standards. To our knowledge, NIST is 
adequately engaged in these processes.
    The Federal Government, through entities such as NIST and the 
Nanomaterial Characterization Laboratory of the National Cancer 
Institute, has been assisting both private sector and academic groups 
with nanomaterials characterization. This is indeed an important and 
useful role for the government to play, and the NNI should encourage 
its member agencies to assist with characterization. The NNI itself 
does not have the facilities to carry this out.

Questions submitted by Representative Vernon J. Ehlers

Q1.  On the issue of stovepiping EHS research versus integrating it 
into all research, do all current NNI grants currently include and EHS 
component? If not, should they? Why or why not?

A1. The choice need not be between either incorporating an EHS 
component into every research grant or stovepiping risk research into a 
completely separate program. Environmental Defense does not believe it 
makes sense to compel all researchers to add EHS research questions 
into their projects, as--many of them may lack the relevant EHS 
expertise. Rather, there ought to be a mechanism to ensure that 
federally funded investigators pursuing basic or applications-oriented 
research projects, which may provide insight into EHS questions (e.g., 
how nanomaterials interact with biologic systems), at least share their 
findings with EHS researchers. They should also coordinate their 
studies wherever possible (e.g., by conducting testing on the same 
materials, utilizing the same reference materials or methods for 
nanomaterial characterization).
    As described in our Introduction, maximizing research coordination 
and sharing of results among investigators conducting applications and 
EHS implications research is highly beneficial and should be 
encouraged. However, in addressing EHS implications, it is essential to 
conduct research that is both intended and targeted to answer specific 
risk-relevant questions. Scientists trained in the health or 
environmental sciences who work at agencies charged with the pursuit of 
health or environmental missions should undertake and direct this 
research, and they should be the judges of its adequacy, quality and 
interpretation. It is equally important that the specifics of the 
projects and amounts spent on such EHS-targeted research be 
transparently and clearly identified and accounted for separate from 
applications research, even while fully acknowledging that some 
applications research will yield findings relevant to understanding 
risk.

Questions submitted by Representative Daniel Lipinski

Q1.  Much of the EHS research to date has focused on exotic materials 
with unrealistic exposure scenarios. While that is useful in 
establishing information on an ``upper bound'' of the hazard, the 
context is rarely communicated and it creates fear. What is critical is 
that we make sure nano-enabled products are as safe or safer than what 
we use today.

A1. We will address the question of ``upper bound hazard'' and 
``unrealistic exposure scenarios'' under the related Question 4 below.
    We do not agree that current EHS research on nanomaterials is 
focusing on exotic materials. Most studies to date have focused on a 
range of engineered nanomaterials that are either already in commerce 
in significant amounts (e.g., titanium dioxide) or are now subject to 
considerable research interest and poised to enter commerce in the near 
future (e.g., carbon nanotubes). Some less common engineered 
nanomaterials (e.g., quantum dots) are confined mostly to biomedical 
research applications, but they are also being examined for use in a 
broader range of applications (e.g., photovoltaic cells, LED 
displays).[17]

Q1a.  As I understand it, the hazard of a nanomaterial often depends 
upon much more than the size and type of material, but also surface 
properties, purity, etc. that relate to how it is made. How is the 
toxicology work underway controlling for this? Are researchers using 
standardized, well characterized materials? If not, how can we make use 
of the research findings?

A1a. There is currently substantial variation in the degree and quality 
of physico-chemical characterization performed on nanomaterials used in 
toxicology studies.[18] The questioner is correct in suggesting that 
the results of studies with poor characterization are of limited use. 
Efforts to develop a scientific consensus are underway both 
domestically and internationally, and the government laboratories are 
setting a high standard for physicochemical characterization in their 
own work. The development of international voluntary standards and 
characterization requirements for publication in scientific journals 
are both underway. Lastly, NIST and its international counterparts are 
developing and promoting the use of standardized reference 
nanomaterials. All of these efforts will improve the credibility and 
usefulness of research results.
    One obstacle to sharing characterization data is the fact that 
manufacturers frequently consider such information to be Confidential 
Business Information (CBI), which greatly impedes the ability of the 
government, nanomaterial users, third-party researchers, and the public 
to independently conduct adequate toxicity testing or interpret the 
results. Ultimately, fully addressing the characterization issue will 
require both an understanding of the types of information that are most 
important for nanomaterials, as well as an agreement on what 
information needs to be released to strike the right balance between 
the need to sufficiently inform and to protect legitimate CBI.

Q2.  It seems that most of the early uses of nanotechnology and 
nanomaterials are for existing products and processes, many of which 
are far from ideal from a health and environmental safety perspective. 
What is being done to systematically compare the risks and benefits of 
the nanoscale alternative against the conventional approach in use 
today so that we accelerate the substitution of nanomaterials where 
they are superior (e.g., when replacing a known toxin)?

A2. We agree that most current nanomaterial applications represent 
incremental modifications of existing products and processes. We are 
not aware of evidence or analysis, however, indicating that such 
modifications have typically yielded any significant health or 
environmental benefits over the processes and products they are 
intended to replace. Indeed, most of the nanomaterialcontaining 
products introduced onto the market to date have been intended to 
provide other consumer benefits (e.g., stain resistance, scratch 
resistance, strength enhancement, etc.), not to provide direct health 
or environmental benefits or replace of a specific toxic chemical. 
(Some producers may argue that the slew of recently introduced 
nanosilver-containing products claiming antimicrobial activity provide 
health benefits, but that assertion is far from established, in our 
view, and could easily be offset by the harm they could cause to 
beneficial microbes.) Nonetheless, there is no question that 
considerable nanotechnology research and development is underway that 
is intended to deliver products and processes that offer health or 
environmental benefits. Nanotechnology holds significant promise in 
this regard.
    Determining whether and to what extent risks are reduced and 
environmental or health benefits are realized is complex. Virtually all 
experts agree that a systematic comparison will require considering the 
full life cycles of the materials being compared, and that much of the 
information needed to perform such comparisons may be unavailable or 
difficult to compile. In many cases there may also be tradeoffs: 
reduced energy consumption of a nano-enabled product during use might 
be offset by increased production energy, for example.
    Proponents of Green Chemistry are already mounting efforts to 
ensure that its principles[19] are fully understood and applied by 
developers of nanomaterials.[20] While it cannot be assumed that nano-
enabled products and processes will be inherently safer or yield health 
or environmental benefits, the potential for these outcomes exists and 
will be more likely to be realized through conscious design decisions.

Q3.  The discussion around nanomaterials tends to focus on 
``engineered'' nanomaterials which are roughly defined as those that 
are purposefully created. However, the volume of naturally occurring 
and ultrafine particles produced by combustion, as well as those used 
as fillers in rubber tires or plastics is many orders of magnitude 
greater than the newly engineered nanomaterials. What are we doing to 
ensure that we leverage the body of EHS knowledge on these particles? 
Are we missing the forest from the trees by emphasizing only 
``engineered nanomaterials''? What efforts are there to assess the 
comparative hazard posed by engineered nanomaterials against incidental 
or naturally occurring nanomaterials?

A3. Newly engineered nanomaterials have both similarities and major 
differences with natural or incidental combustion particles and 
industrial ultrafine particles that have been around for decades or 
longer. Several points need to be made. First, there should be no 
assumption that non-engineered nanoparticles to which we are exposed, 
or even engineered nanoparticles that have been in use for some time, 
are ``safe.'' It is precisely our recognition that inhaled ultra-fine 
combustion particles can traverse the lungs and cause damage not only 
to the lungs but also elsewhere in the body (including to the 
cardiovascular system) that prompted much of the initial concern about 
engineered nanomaterials. The considerable literature and methods 
available on ultrafine combustion particles are indeed being used 
extensively to inform our efforts to understand the potential risks of 
engineered nanomaterials.
    Second, in many cases, little or no testing of even large-volume 
``existing'' engineered nanomaterials has been required as a condition 
to remain on the market, and for some of these so-called ``legacy'' 
nanomaterials, very few studies have been conducted. We would welcome 
greater scrutiny of such materials, as well as newer engineered 
nanomaterials, as well as comparisons among them.
    Third, while it may be viewed as inequitable to hold newly 
engineered nanomaterials to a higher threshold of safety than older 
engineered nanomaterials, it would be an even more serious mistake to 
fail to ascertain the potential toxicity of newly engineered 
nanomaterials out of a belief that exposures will never be significant 
compared to more familiar materials. Some nanomaterials are being 
considered for use or already used in applications that will widely 
disperse them in the environment. For example, EPA's Office of Air and 
Radiation is evaluating an application for use of nano cerium oxide as 
a fuel additive. This application is eerily reminiscent of our 
experience with leaded gasoline, where initial assumptions that the 
lead would never be released from motor vehicle tailpipes in sufficient 
quantities to cause meaningful exposure or harm turned out disastrously 
wrong. We should not repeat this mistake with insufficiently tested 
nanoparticle fuel additives.
    Samsung's washing machines, which claim to infuse nanosilver 
particles into the washwater[21] (which then go down the drain), raised 
objections from operators of municipal wastewater treatment facilities, 
who were concerned about potential environmental effects of the 
resulting wastewater treatment plant influents and effluents, given 
that silver exhibits significant ecotoxicity.[22] Other nanomaterial 
applications already on the market entail direct human exposure, most 
notably sunscreens and cosmetics; the latter are not subject to any 
pre-market review despite the certainty of human exposure.[23]
    Fourth, the precise and highly homogeneous composition of most 
engineered nanomaterials, and their intended use in specific 
applications, could well lead to exposures of a wholly different nature 
and magnitude than those associated with natural or incidental 
nanomaterials.

Q4.  To what extent is the toxicity research relevant to ``real world'' 
situations? To what extent are federally funded efforts using the 
routes of exposure or formulations that emulate the nanomaterials being 
used in available products?

A4. This question, like the preface to Mr. Lipinski's questions, is 
essentially asking whether the laboratory conditions used in toxicity 
testing realistically simulate conditions under which actual exposures 
occur.
    There are important scientific and policy justifications for the 
approaches used to characterize the potential hazards of a substance, 
independent of how or in what form someone might be exposed to it. 
First, hazard characterization is intentionally conducted independent 
of exposure characterization (which are typically then combined to 
characterize risk); the former is used to identify the inherent hazards 
of a material, while the latter step is when factors affecting the 
nature and extent of exposure--e.g., form of the material, likely dose, 
etc.--are taken into account.
    Second, the goal of hazard identification is to characterize the 
full extent of potential adverse affects that could be associated with 
exposure to a substance across an entire population. The exposed 
population will exhibit a range of responses even to the same exposure. 
In order to ensure that the most susceptible or vulnerable members of 
society are protected, hazard identification must be able to identify 
upper bound effects.
    Third, toxicologists' obvious need to rely on animal rather than 
human studies requires, for sound scientific reasons, that they employ 
what the lay person may think are ``unrealistic'' exposure scenarios. 
Consider the very high doses typically used in animal studies. Certain 
adverse health effects, such as malignant tumors, are typically 
relatively infrequent events. Under ``realistic'' exposures, an effect 
seen in a human population at a frequency, say, of one in ten thousand 
to one in a million, would nevertheless be considered to occur at a 
high incidence.
    Given that it is unrealistic and unethical to use ten thousand or a 
million laboratory animals in a study, we must rely on high-dose 
exposures to increase the chances that we will observe these rare 
events, should they be associated with the chemical being tested, in a 
much smaller number of laboratory animals, within a reasonable time 
span. We can then extrapolate the observed effects to predict what 
would occur in humans at much lower doses or over longer periods of 
time.
    This is the risk-based approach to public health protection that 
has evolved over the last 60 years. Laboratory techniques have been 
developed to provide useful information for predicting toxicity in the 
``real world.'' While the resulting information is not perfect, and 
examples of inaccuracies are available, overall the information 
generated using validated, standardized laboratory tests allows 
scientists and policymakers to make informed decisions about the 
relative safety of different materials. All of these challenges 
inherent in developing a basis for predicting the effects of real world 
exposures apply equally to nanomaterials. They are among the reasons we 
are calling for more federal investment in, and a more strategic 
approach to, nanomaterial risk research.
    With regard to our ability to know or predict what real world 
exposures will be, it is important to first recognize the complexity in 
defining what constitutes the ``real world'' for a class of materials 
like nanomaterials, the fate and behavior of which are presently poorly 
understood. Many nanomaterials are likely to take multiple forms when 
one considers the full value chain or life cycle, from production 
through end use and disposal or post-use management. At each stage, the 
potential for releases into the environment or exposures to workers, 
consumers or the public are possible. Clearly, there is no single 
``real world'' situation.
    Seeking to limit testing at this early stage to only certain routes 
of exposure or certain formulations rests on the questionable 
assumption that we know exactly how these materials are produced, used 
and disposed of, now and for the foreseeable future. Most of this 
information is not available, and is almost certain to change. Before 
C60 fullerenes (``buckyballs'') started showing up in skin creams 
offered for sale, few would have ever predicted such a use or the 
associated routes of exposure. Under our current regulatory system, 
except in limited circumstances, even new nanomaterials can be produced 
and used in any number of ways without the producer or user having to 
inform the government or gain its approval. There is essentially no 
tracking of the production and use of nanomaterials. This is another 
reason why it is so important to gain an understanding of the inherent 
hazard of a material, which is relevant no matter how it may be used or 
encounter people or the environment.
    It is also premature to assume we know or can predict how 
nanomaterials behave in the body or the environment. As just one 
example, consider the conventional wisdom has been that, once released 
to the environment, nanomaterials would always aggregate and lose their 
``nano-ness.'' This assumption is already proving to be wrong. Because 
aggregation reduces or interferes with functionality and performance, 
developers of these materials are finding ways to modify or treat 
nanomaterials to better maintain them in a dispersed state. And recent 
studies of carbon nanotubes have revealed that mixing them with natural 
river water actually leads to a stable suspension of individual CNTs, 
due to their interaction with humic acids present in the water.[24]

Q5.  You and Dr. Maynard call for ten percent or more of the Federal 
Government's nanotechnology research and development budget be 
dedicated to goal-oriented EHS research. As pointed out in Dr. 
Denison's testimony, only 4.1 percent of NNI's 2008 budget is to be 
spent on EHS R&D. Would you please elaborate on this and explain how 
you came up with this 10 percent figure? Would the other panelists 
please comment on this recommendation?

A5. Our call to devote at least 10 percent of the Federal R&D 
nanotechnology budget to direct EHS research for the foreseeable future 
is based on an assessment of the scope, magnitude and complexity of the 
needed research.[25] It is also informed by reference to a number of 
analogous or related cost benchmarks, which are briefly noted below. 
Our full analysis and associated documentation is included here as 
Attachment 1; we prepared this analysis at the request of the National 
Academies' Committee to Review the National Nanotechnology Initiative.
    Benchmarks we used to derive the minimum 10 percent figure include 
the following:

          Government and non-government experts' assessments of 
        the costs of conducting the needed research--including basic 
        material characterization, development of the needed 
        infrastructure (e.g., methods, tools, instrumentation), and 
        assessment of risks in specific exposure settings (e.g., 
        workplaces). Each of these tasks by itself is estimated to 
        require at least a major fraction of the 10 percent EHS 
        investment we call for.

          Actual testing costs for identifying the hazard 
        potential of conventional chemicals, which indicate the 
        potential for testing costs per substance to extend into the 
        millions of dollars.

          The budget--averaging $60 million annually--for a 
        roughly analogous research program to characterize the risks of 
        airborne particulate matter (PM), which EPA undertook based on 
        a strategy developed and overseen by the National Academies' 
        Board on Environmental Studies and Toxicology (BEST) between 
        1998 and 2004. As noted by BEST, this budget covered only a 
        portion of EPA's and the Nation's research needs to understand 
        the risks of airborne PM. This task, while complex, is 
        considerably more restricted in scope than what is expected to 
        be needed to assess potential risks of nanomaterials.

Q6.  You mentioned in your testimony that over the past two years 
scientists at several NNI agencies and at NNI itself have published 
documents describing how little we know about nanomaterials' potential 
hazards and exposures and how much work will be needed both to address 
these gaps and to adequately assess risks. Yet everyday new 
nanotechnologies are entering the marketplace. Would you like to 
comment further on this finding? Would the other panelists care to 
address this issue?

A6. My written statement addresses this issue in considerable detail, 
and provides examples of the agencies' recognition of the magnitude of 
the research and regulatory task at hand, contrasted with the rather 
tepid actions being taken by those same agencies. These responses 
illustrate the growing disconnect between what most stakeholders--
industry included--believe government should be doing in the face of 
nanotechnology's rapid commercialization, and what it is actually 
doing. This situation is at or near the point putting at risk the 
public's confidence in both government and industry's ability or 
willingness to responsibly address the development of this technology. 
That, in turn, puts public acceptance--and the success--of 
nanotechnology itself at risk.

Questions submitted by Representative Ralph M. Hall

Q1.  Please share your thoughts on the idea of establishing a separate 
program office to oversee EHS research. Why is such an office needed 
for nanomaterials versus other materials? What authorities would such 
an office need to have? What are the possible pitfalls of such an 
approach? How would you prevent the perception of adding another level 
of federal bureaucracy to the mix? As an alternative to creating a new 
office, how can we improve the mechanisms we currently have in place to 
achieve the same goals?

A1. The Introduction to this document addresses these questions in 
detail.

Endnotes

 1.  My colleagues Drs. John Balbus and Caroline Baier-Anderson 
assisted in preparing our answers to these questions for the record.

 2.  See www.nano.gov/html/about/nnco.html (NNCO); www.nano.gov/html/
about/nsetmembers.html (NSET); www.ostp.gov/nstc/html/
G5-committees.html#cot (CoT); and www.ostp.gov/PCAST/membership2.html 
(PCAST). Only three of the 36 members of PCAST have a health science or 
environmental science expertise, and none has a risk science 
background.

 3.  See Section 2(b) of the Act, available at 
frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=108G5-congG5-publicG5-laws&docid=f:publ153.108

 4.  Statement of Mr. Floyd Kvamme, Co-Chair of the President's Council 
of Advisors on Science and Technology, House Science Committee hearing 
held on 10/31/07, page 2, available at democrats.science.house.gov/
Media/File/Commdocs/hearings/2007/research/31oct/Kvamme--testimony.pdf

 5.  For example, see: U.S. Food and Drug Administration, 
Nanotechnology: A Report of the U.S. Food and Drug Administration 
Nanotechnology Task Force, July 25, 2007, at www.fda.gov/
nanotechnology/taskforce/report2007.pdf; and U.S. Environmental 
Protection Agency, Nanotechnology White Paper, February 2007, at 
www.epa.gov/osa/nanotech.htm; National Institute for Occupational 
Safety and Health, Strategic Plan for NIOSH Nanotechnology Research: 
Filling the Knowledge Gaps, at www.cdc.gov/niosh/topics/nanotech/
stratG5-planINTRO.html

 6.  Transcribed from the webcast of the hearing, starting at 
approximately one hour 29 minutes, available at science.edgeboss.net/
real/science/scitech07/103107.smi.

 7.  See Hansen, Steffen Foss, Larsen, Britt H., Olsen, Stig I. and 
Baun, Anders, ``Categorization framework to aid hazard identification 
of nanomaterials,'' Nanotoxicology, published online November 13, 2007.

 8.  See www.nano.gov/html/society/NEHI.htm

 9.  See testimony of non-government witnesses at the Committee's 
hearings held on November 17, 2005 (science.house.gov/publications/
hearingsG5-markupsG5-details.aspx?NewsID=979); September 21, 2006 
(science.house.gov/publications/
hearingsG5-markupsG5-details.aspx?NewsID=1186); and October 31, 2007 
(science.house.gov/publications/
hearingsG5-markupsG5-details.aspx?NewsID=2021).

10.  See ``NRC--Regulator of Nuclear Safety'' (www.nrc.gov/reading-rm/
doc-collections/nuregs/brochures/br0164/r4/) and ``Our History'' 
(www.nrc.gov/about-nrc/history.html) on the NRC's website.

11.  See ``Regulatory Research'' (www.nrc.gov/about-nrc/history.html) 
on the NRC's website.

12.  See webpage for the Office at www.nrc.gov/about-nrc/organization/
resfuncdesc.html

13.  See NRC memoranda titled ``Organizational Conflict of Interest 
Regarding Department of Energy Laboratories'' dated January 6, 1998 
(www.nrc.gov/reading-rm/doc-collections/commission/secys/1998/secy1998-
003/1998-003scy.html) and February 5, 1999 (www.nrc.gov/reading-rm/doc-
collections/commission/secys/1999/secy1999-043/1999-043scy.html).

14.  See NRC memorandum titled ``Memorandum Report: Audit of NRC 
Oversight of Its Federally Funded Research and Development Center,'' 
May 28, 2002 (www.nrc.gov/reading-rm/doc-collections/insp-gen/2002/02a-
011.pdf).

15.  See www.ostp.gov/PCAST/membership2.html

16.  This situation with the NTAG is in partial contrast to PCAST 
itself, whose members and meeting agendas are posted at ostp.gov/pcast/
pcast.html

17.  See, for example, Evident Technologies, the self-described 
``leader in quantum dot product development'' (www.evidenttech.com/
applications.html).

18.  One review just published in Nanotoxicology of nearly 430 
nanoparticle toxicology papers found that, while the vast majority 
showed evidence of adverse effects, there was also a serious lack of 
characterization of the tested materials. See Hansen et al., 2007, op. 
cit.

19.  See ``12 Principles of Green Chemistry,'' www.epa.gov/
greenchemistry/pubs/principles.html, originally developed by Paul 
Anastas and John Warner, Green Chemistry: Theory and Practice (Oxford 
University Press: New York, 1998).

20.  See, e.g., Paul Anastas and Julie Zimmerman (2007). ``Green 
Nanotechnology: Why We Need a Green Nano Award & How to Make it 
Happen.'' Washington, DC: Project on Emerging Nanotechnologies, Woodrow 
Wilson International Center for Scholars, at www.nanotechproject.org/
fileG5-download/206; and other information at www.nanotechproject.org/
tags?tag=green

21.  See ww2.samsung.co.za/silvernano/silvernano/washingmachine.html

22.  See letter dated January 26, 2006 to Jim Jones, Director, EPA 
Office of Pesticide Programs, from Chuck Weir, Chair, Tri-TAC (a 
technical advisory group for Publicly Owned Treatment Works (POTWs) 
jointly sponsored by the California Association of Sanitation Agencies, 
the California Water Environment Association, and the League of 
California Cities), at www.tritac.org/documents/letters/
2006G5-01G5-27G5-EPAG5-SamsungG5-SilverG5-Wash.pdf

23.  Sunscreens qualify as over-the-counter (OTC) drugs, and as such 
are required by FDA to meet more extensive requirements than are 
cosmetics, though considerably fewer than for prescription drugs. With 
respect to pre-market approval, if a new active ingredient is used in a 
sunscreen, some testing is required for both efficacy and dermal 
effects before such a product can be marketed. Use of an already 
reviewed active ingredient does not require such approval. One point of 
remaining ambiguity, however, is the extent to which FDA will consider 
nano versions of active ingredients they have already reviewed in their 
larger forms to be new active ingredients. See U.S. Food and Drug 
Administration, 2007, op. cit.

24.  Hyung H, Fortner J.D., Hughes J.B., Kim J. 2007. Natural organic 
matter stabilizes carbon nanotubes in the aqueous phase. Environ. Sci. 
Technol. 41(1):179-184.

25.  In addition to the information and sources provided in Attachment 
1, more recent reports by federal agencies have elaborated further on 
the broad scope of research needed. See reference in Endnote 5.

Attachment 1

A proposal to increase federal funding of nanotechnology risk research 
                   to at least $100 million annually

             Richard A. Denison, Ph.D., Senior Scientist[1]
                         Environmental Defense
                               April 2005
    Environmental Defense has called for the Federal Government to 
dedicate at least $100 million annually, sustained for a period of at 
least several years, to research directly related to elucidating the 
health and environmental risks of nanotechnology.[2] This document 
summarizes our reasoning and support for calling for such an outlay.
    There is, of course, no single ``magic number'' nor a precise means 
to determine the right dollar figure, given the wide-ranging set of 
research issues needing to be addressed and the significant associated 
uncertainty as to the anticipated results. Nevertheless, we believe 
that the amount we propose represents a reasonable, lower-bound 
estimate of what is needed.
    Below we first provide some context appropriate to consider in 
assessing both the need for and costs of risk-related research on 
nanomaterials. We then describe the major complexities involved in 
assessing these risks and the broad scope of research needed to address 
them. Finally, we provide a number of benchmarks that we believe 
strongly support our proposal for spending at least $100 million 
annually nanotechnology risk research. These benchmarks include: 
experts' assessments of the expected research costs; hazard testing 
costs for conventional chemicals; and EPA budgets for airborne 
particulate matter risk research.

Context for judging risk research spending

    In our view, both the public and private sectors' best interests 
are served by an investment to identify and manage potential 
nanotechnology risks now, rather than to pay later to remediate 
resulting harms. History demonstrates that embracing a technology 
without a careful assessment and control of its risks can be extremely 
costly from both human and financial perspectives. The failure to 
sufficiently consider the adverse effects of using lead in paint, 
plumbing, and gasoline has resulted in widespread health problems that 
continue to this day, not to mention extremely high remediation costs. 
Asbestos is another example where enormous sums of money were spent by 
private companies for remediation, litigation, and compensation, even 
beyond that spent by the public sector to alleviate harm to human 
health and the environment. Standard & Poor's has estimated that the 
total cost of liability for asbestos-related losses could reach $200 
billion.[3]
    Initial research raises serious concerns that nanomaterials have 
the potential to pose significant health and environmental risks. The 
limited data now available demonstrate the potential for some 
nanomaterials to be both persistent and mobile in the environment and 
in living organisms; to cross the blood-brain barrier; and to be 
capable of damaging brain, lung and skin tissue.[4]
    These initial studies only highlight how little is known about the 
health and environmental effects of engineered nanomaterials. Despite 
the uncertainty, the rapid development of nanomaterial applications is 
outpacing efforts to understand their implications--let alone ensure 
their safety. Thousands of tons of nanomaterials are already being 
produced each year,[5] and hundreds of products incorporating 
nanomaterials are already on the market.[6] The global market for 
nanotechnology products is expected to reach at least $1 trillion over 
the next decade.[7] Given the length of time it will take to develop an 
adequate understanding of the potential risks posed by a wide variety 
of nanomaterials, and to apply this knowledge to inform appropriate 
regulation, it is imperative that we dedicate substantial funding for 
comprehensive risk research programs now.
    The National Nanotechnology Coordination Office (NNCO) estimates 
that fiscal year 2004 spending for environmental and health 
implications research stood at only $8.5 million, less than one percent 
of the total NNI budget.[8] Since then, such spending appears to be 
rising somewhat: Requested funding for FY 2006 from federal agencies 
under the NNI for health and environmental research totals $38.5 
million, just under four percent of the total FY 2006 nanotechnology 
development budget for these agencies of $1.05 billion.[9] While an 
annual expenditure of $100 million represents an additional significant 
increase over the current level, it is still a small fraction of the 
more than $1 billion now being directed annually towards nanotechnology 
development through the National Nanotechnology Initiative (NNI). 
Moreover, it is a modest investment compared to the potential benefits 
of risk avoidance and to the $1 trillion or more that nanotechnology is 
projected to provide to the world economy by 2015.[10]

Complexity of defining nanomaterial risks

    There is broad agreement among stakeholders that addressing the 
potential risks of nanotechnology will be an unusually complex task. 
Despite its name, nanotechnology is anything but singular; it is a 
potentially limitless collection of technologies and associated 
materials. The sheer diversity of potential materials and 
applications--which is a source of nanotechnology's enormous promise--
also poses major challenges with respect to characterizing potential 
risks. Nanotechnology entails:

          many fundamentally different types of materials 
        (e.g., metal oxides, quantum dots, carbon nanotubes), and 
        hundreds or thousands of potential variants of each;

          many novel properties potentially relevant to risk 
        (e.g., size, structure, reactivity, surface chemistry, 
        electrical and magnetic properties)

          many potential types of applications (e.g., fixed in 
        a matrix vs. freely available, captive vs. dispersive use);

          many categories and types of uses (e.g., medical 
        devices, pharmaceuticals, environmental remediation, and 
        consumer products ranging from cosmetics to electronics);

          multiple points of potential release and exposure 
        over the full life cycle of a given material/application (e.g., 
        during production, use, disposal);

          multiple potential means of release (e.g., in 
        emissions, in wastes, from products);

          multiple potential routes of exposure (e.g., 
        inhalation, dermal, oral);

          multiple potentially exposed populations (e.g., 
        workers, consumers as well as public); and

          potential to cause environmental as well as human 
        health-related impacts.

Scope of needed research

    Even before the research that will allow hazards and exposures to 
be quantified, a number of more fundamental needs must be addressed. We 
currently lack a good understanding of which specific properties will 
determine or are otherwise relevant to nanomaterials' risk potential. 
Many of the methods, protocols and tools needed to characterize 
nanomaterials, or to detect and measure their presence in a variety of 
settings (e.g., workplace environment, human body, environmental media) 
are still in a very early stage of development.
    Nor is it clear the extent to which we can rely on our existing 
knowledge about conventional chemicals to predict risks of 
nanomaterials. The defining character of nanotechnology--the emergence 
of wholly novel properties when materials are reduced to or assembled 
at the nanoscale--carries with it the potential for novel risks and 
even novel mechanisms of toxicity that cannot be predicted from the 
properties and behavior of their bulk counterparts. By their very 
nature many nanomaterials are more reactive per unit mass than their 
conventional counterparts. For example, aluminum in the form used in 
many applications, such as the ubiquitous soda can, is prized because 
of its lack of reactivity, but it becomes highly explosive in nano-
form--hence its potential use as a rocket fuel catalyst.
    Moreover, we already know that even extremely subtle manipulations 
of a nanomaterial can dramatically alter its properties and behavior: 
Tiny differences in the diameters of otherwise identical quantum dots 
can alter the wavelength of the light they fluoresce; slight changes in 
the degree of twist in a carbon nanotube can affect its electrical 
transmission properties. We have yet to develop the means to 
sufficiently characterize or systematically describe such subtle 
structural changes--a clear prerequisite to being able to consistently 
and rigorously apply and interpret the results of toxicological 
testing. And only then can we begin to assess the extent to which such 
subtle structural changes may affect the toxicity of a material--or the 
extent to which such a property is stable or may be transformed in the 
environment or the human body.
    Until these threshold questions about nanomaterials' potential 
risks are answered, it is unclear whether or to what extent we will be 
able to rely on methods widely used to reduce the amount of traditional 
toxicological testing needed to characterize conventional chemicals: 
the ability to identify ``model'' materials, which upon 
characterization could serve as a basis for extrapolation to ``like'' 
materials.
    Among the types of risk research needed are the following:

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

          Biological fate (extent and rate of absorption, 
        distribution, metabolism, elimination)

          Environmental fate and transport (persistence, 
        distribution among media, transformation)

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

    For each of these areas, existing testing and assessment methods 
and protocols need to be re-examined to determine the extent to which 
they can be modified to account for nanomaterials' novel 
characteristics or need to be supplemented with new methods. Similar 
challenges will arise with respect to methods and technologies for 
sampling, analysis and monitoring, all of which will be needed to 
detect nanomaterials and their transformation products in living 
systems and in various environmental media.

Benchmarks for risk research spending

    Our view that significantly more needs to be spent on 
nanotechnology risk research is informed and supported by: a) other 
experts' assessments, b) our knowledge of testing costs associated with 
hazard characterization programs for conventional chemicals, and c) the 
research budgets recommended for and expended on a roughly analogous 
risk characterization effort, namely EPA's research on risks of 
airborne particulate matter. A summary of these various information 
sources is provided below.
Experts' assessments:

          Experts from a variety of fields have declared that 
        NNI's current funding for nanotechnology risk research needs to 
        be significantly increased. Invited experts to a workshop 
        sponsored by the Nanoscale Science Engineering, Science and 
        Technology Subcommittee (NSET) of the NNI, held in September 
        2004, called for at least a 10-fold increase in federal 
        spending on nanotechnology risk-related research, relative to 
        the approximately $10 million spent in FY 2004.[11]

          At that same workshop, a representative of the 
        Nanotechnology Initiative at the National Institute for 
        Occupational Safety and Health (NIOSH) provided an estimate of 
        the investment needed just to begin to address workplace safety 
        issues--which accounts for only one of the numerous settings 
        where release and exposure to nanomaterials may occur. That 
        estimate, which is based on an internal analysis conducted by 
        NIOSH researchers, is that an investment of $10-20 million per 
        year for at least 10 years will be needed--assuming the funds 
        are able to be directed at targeted research to address 
        specific predetermined issues. The representative further 
        indicated that the investment necessary to identify the issues 
        to target and to more broadly address nanotechnology 
        implications in the workplace as the technology matures will be 
        significantly larger.[12] (NIOSH's current funding level for 
        this research is considerably lower, $2-3 million per year. In 
        2004, NIOSH initiated a five-year program to assess the 
        toxicity of ultrafine and nanoparticles, funded at about $1.7 
        million in FY 2004 and about $2.3 million in FY 2005.[13] 
        According to NNI, NIOSH has requested $3.1 million for FY 2006 
        for this type of work.[14])

          At a briefing held on March 22, 2005, to preview the 
        findings of an upcoming report by the President's Council of 
        Advisors on Science and Technology (PCAST) that has been 
        charged with reviewing the NNI, John H. Marburger III, Science 
        Adviser to the President and chief of the White House Office of 
        Science and Technology Policy, noted that the toxicity studies 
        now underway are ``a drop in the bucket compared to what needs 
        to be done.''[15]

          The chemical industry has also concluded that 
        nanotechnology risk research should be highly prioritized and 
        highly funded relative to other activities by the NNI. In a 
        nanotechnology development roadmap requested by the NNI, the 
        industry identifies an essential need to increase our 
        ``understanding of the fundamental scientific principles 
        operating at the nanoscale, including interdependent structure-
        property relationships.'' The roadmap highlights as critical 
        research needs the following:

                  development of characterization tools, 
                including real-time characterization methods and tools 
                and the associated infrastructure for their development 
                and use; and

                  environment, health and safety, including 
                assessment of human health and environmental impact 
                hazards, determination of exposure potentials for 
                nanosized materials, and handling guidelines for 
                operations involving nanomaterials.

           The report calls for sustained research in these areas over 
        twenty years, and assigns its top or high priority ranking to 
        each of the subtopics under these key elements. While actual 
        dollar figures are not provided, the report indicates that two 
        of these subtopics--development of real-time characterization 
        methods and tools, and assessment of human health and 
        environmental impact hazards--will require a level of 
        cumulative R&D investment that is the highest of any assigned 
        to the priority research requirements.

          Finally, other expert comments on nanotechnology risk 
        research needs and costs indicate that even setting up the 
        initial infrastructure for adequate risk research will involve 
        significant resources. The United Kingdom's Royal Society and 
        Royal Academy of Engineering, in its seminal July 2004 report, 
        Nanoscience and nanotechnologies: Opportunities and 
        uncertainties, calls for the UK government to devote 
        5-6 million ($9.5-11.3 million) per annum for 10 
        years just to do its part to develop the methodologies and 
        instrumentation needed to set the stage for actual testing of 
        nanomaterials.[16]

Hazard endpoint testing costs:
    There are several estimates available from chemical hazard 
assessment programs that can be used as context for providing at least 
a lower bound on the costs of testing a nanomaterial for hazardous 
properties. These costs are for the testing of a conventional chemical 
for an assortment of hazard (toxicity plus environmental fate) 
endpoints of concern; notably, they do not include costs associated 
with assessing exposure, which is also needed to assess risk.
    It must be noted that these estimates provide only a very rough 
means of extrapolating to the anticipated costs of hazard testing for a 
given nanomaterial. A definition of what constitutes the needed set of 
such endpoints sufficient to characterize hazard has yet to be defined. 
Moreover, the number of different nanomaterials requiring testing is 
another major unknown, but could be very large.
    Below we discuss several available hazard testing cost estimates.

          At one end of the spectrum is the so-called Screening 
        Information Data Set (SIDS), developed by the Chemicals Program 
        of the Organization for Economic Cooperation and Development 
        (OECD), which consists of about 20 data elements and--as its 
        name indicates--represents the minimum hazard information 
        considered necessary to screen chemicals in order to set 
        priorities for further scrutiny. SIDS focuses primarily on 
        short-term toxicity to mammals (as models for human toxicity) 
        and aquatic species (as a subset of indicators of potential 
        ecological toxicity). The U.S. Environmental Protection Agency, 
        which employs the SIDS in its High Production Volume (HPV) 
        Challenge,[17] estimates the cost of producing a full set of 
        SIDS data at $250,000 per chemical,[18] which is generally 
        consistent with an industry estimate of up to $275,000 per 
        chemical.[19] While SIDS is useful in setting priorities for 
        further action among conventional chemicals, the information it 
        provides is too limited to be sufficient to characterize the 
        risks posed by nanomaterials.

          Testing cost estimates have been prepared in a 
        Business Impact Assessment document prepared for the European 
        Commission's Enterprise Directorate in support of the European 
        Union's chemical policy proposal called REACH (for 
        Registration, Evaluation and Authorization of Chemicals). REACH 
        proposes different levels of testing that depend primarily on 
        the production tonnage of a chemical. At the lowest production 
        volumes, a base set of test data--roughly equivalent to the 
        SIDS discussed above--would be required, the generation of 
        which is estimated to cost -151,700 (about $198,000). The most 
        extensive test battery applicable to the highest-volume 
        substances--and considered generally sufficient to inform a 
        full risk assessment--is estimated to cost -1,664,260 (about 
        $2,170,000).[20]

          An even more extensive test battery (and perhaps a 
        more appropriate one for characterization of many 
        nanomaterials, at least initially) is that required of 
        pesticides under the Federal Insecticide, Fungicide and 
        Rodenticide Act (FIFRA). This hazard-only test battery consists 
        of up to 100 individual data elements,[21] with the actual 
        requirements varying by factors such as use and volume of use. 
        When supplemented with detailed exposure information, EPA 
        generally considers this dataset sufficient to conduct a risk 
        assessment for a pesticide. An upper estimate of $10 million 
        per chemical for testing costs has been indicated by the 
        Agricultural Research Service for a pesticide proposed for 
        major food crop use, with costs for most pesticides being 
        ``significantly less.''[22]

Recommended and actual EPA research budgets for risks of airborne 
        particulate matter:
    As an additional benchmark for judging the appropriate level of 
federal expenditure for nanomaterial risk research, we considered the 
recommended and actual budgets for EPA research conducted over the past 
several years on risks posed by airborne particulate matter (PM). In 
1998, at the request of EPA, a committee of the Board on Environmental 
Studies and Toxicology (BEST) of the National Research Council assessed 
the state of research in this arena and additional needs, setting out a 
13-year research agenda and associated recommended budget.[23] In 2004, 
in the fourth report in its series, the committee looked back over the 
research actually conducted and the associated budget expended by EPA 
in the six years since its first report.[24]
    We recognize, of course, the substantial differences between the 
nature of, state of knowledge concerning, and risk-related research 
needs for, airborne particulate matter (PM) and nanomaterials. Even in 
1998, it was already clear that airborne PM exacts an enormous toll in 
terms of human morbidity and mortality--clearly not the case with 
nanomaterials, although we believe there is an opportunity through 
proactive research and action to identify and avoid such risks. Our aim 
here is not at all to claim any direct analogy between the two classes 
of materials or the magnitude of their risks, but rather to utilize the 
careful assessment done of the scope of research needed to assess risk.
    If anything, the scope of needed research on nanomaterials is 
considerably broader--and hence likely to cost more--than is the case 
for airborne PM. Our reasoning is as follows. Airborne PM is a complex 
mixture of relatively well-characterized chemicals produced by a 
discrete (though highly diffuse) set of sources, to which exposure 
occurs through a single route, inhalation. In contrast, nanomaterials:

          are comprised of many entirely novel classes of 
        materials;

          will be applied and used in ways that will create the 
        potential for release and exposure through many more pathways 
        (e.g., oral, dermal; via drinking water);

          in addition to being present in air emissions, may be 
        present in wastes, water discharges and a wide array of 
        products;

          through incorporation into products, may result in 
        exposure of consumers, as well as the general public and 
        workers; and

          pose potential environmental as well as human health 
        risks that need to be considered.

    Hence--independent of the ultimate magnitude of risk identified--
the assessment of that risk is likely to be considerably more involved 
and costly for nanomaterials than for airborne PM.
    The research agenda and budget for airborne PM recommended by NRC 
in 1998 called for EPA to spend $40-60 million annually for the first 
six years, and declining amounts thereafter, from $31 million in year 
seven to 15 million in year 13. The NRC noted explicitly that its 
recommended budgets should not be interpreted as sufficient to 
encompass all of the airborne PM risk research needed to be conducted 
by EPA or the Nation as a whole.[25]
    Actual EPA expenditures during the first six years of the research 
program (FY 1998-2003) were relatively similar to the recommended 
amounts, as reported by NRC in its 2004 report:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    The NRC's 2004 report, which represents a ``mid-course'' review of 
EPA's airborne PM research, found that the allocated money had been 
well spent, noting rapid progress in some areas, slower in others, and 
with much work remaining to be done.
    Given that addressing the potential risks of nanomaterials will 
very likely entail considerably greater complexity than is the case for 
airborne PM, we believe the NRC's assessment of research needs and 
associated budget needs for airborne PM risk-related research strongly 
supports our call for the Federal Government to be devoting at least 
$100 million annually over a number of years to address the major 
unknowns and uncertainties associated with the burgeoning field of 
nanotechnology.

Conclusion

    The rapid commercialization of nanotechnology, coupled with the 
clear risk potential of at least certain nanomaterials demonstrated in 
initial studies, lends urgency to the need for the Federal Government 
to direct more of its major investment in nanotechnology development 
toward research aimed at identifying the potential risks and the means 
to address them. There is a remarkable degree of agreement among 
experts and stakeholders from a range of perspectives on both the need 
and the urgency. There is also considerable agreement that assessing 
these risks will be a complex task, given the range of materials and 
potential applications involved and the current lack of knowledge and 
experience with such materials. A broad scope of research will be 
needed, first to identify the key characteristics of nanomaterials 
relating to hazard and exposure; second, to adapt existing or develop 
new testing methods; and third, to actually assess the magnitude of 
hazard and exposure potential of specific nanomaterials.
    We have also provided a number of benchmarks, which taken together 
strongly support our call for the Federal Government to spend at least 
$100 million annually on a sustained basis to fund research directly 
related to understanding the potential health and environmental risks 
of nanotechnology:

          Experts' assessments of the costs of conducting the 
        needed research--including basic material characterization, 
        development of the needed infrastructure (e.g., methods, tools, 
        instrumentation) and assessment of risks in specific exposure 
        settings (e.g., workplaces). Each of these tasks by itself is 
        estimated to require at least a major fraction of the $100 
        million investment we call for.

          Actual testing costs for identifying hazard potential 
        for conventional chemicals, which indicate the potential for 
        testing costs per substance to extend into the millions of 
        dollars.

          The recommended and actual EPA research budgets for 
        characterizing the risks of airborne particulate matter, which 
        have totaled at least half of the amount we have proposed be 
        devoted to risk research on nanomaterials. As made clear by the 
        National Research Council in recommending these amounts, they 
        cover only a portion of EPA's and the Nation's needs for 
        research to understand the risks of airborne PM. While this 
        task is complex, it is considerably more restricted in scope 
        than what is expected to be needed to assess potential risks of 
        nanomaterials.

    Federal initiatives on nanotechnology to date have done a great job 
in accentuating and accelerating the enormous potential benefits of 
nanomaterials. To date, however, federal agencies have yet to come to 
terms with their equally critical role in identifying, managing and 
ideally avoiding the potential downsides. A far better balance between 
these two roles must be struck if nanotechnology is to deliver on its 
promise without delivering unintended and unforeseen adverse 
consequences.

Endnotes

 1.  Environmental Defense staff members Dr. John Balbus, Scott Walsh 
and Karen Florini reviewed and provided substantial input into this 
paper.

 2.  See Environmental Defense's written statement submitted to the 
National Academies' Committee to Review the National Nanotechnology 
Initiative at its March 24-25, 2005 Workshop on Standards for 
Responsible Development of Nanotechnology, Washington DC; and letter 
dated November 15, 2004 from Environmental Defense to Dr. Mihail Roco, 
Chair, NSTC Subcommittee on Nanoscale Science, Engineering and 
Technology (also attached to our written statement).

 3.  Standard & Poor's, Insurance: Property-Casualty Industry Survey, 
July 15, 2004.

 4.  To assist the Committee, we attached a bibliography of references 
and associated abstracts of risk-related research studies on 
nanomaterials to our written statement provided to the Committee's at 
its March 24-25, 2005 workshop reviewing the National Nanotechnology 
Initiative.

 5.  See The Royal Society and the Royal Academy of Engineering, 
Nanoscience and nanotechnologies: Opportunities and uncertainties, 
London, July 2004, pp. 26-7, available online at www.nanotec.org.uk/
finalReport.htm. This estimate is provided for the 2003-2004 timeframe, 
with rapidly escalating quantities projected thereafter.

 6.  See, for example, an unofficial list of nanomaterial-containing 
products compiled by EPA as of July 2004, posted by the ETC Group 
online at www.etcgroup.org/documents/nanoproductsG5-EPA.pdf; and a 
description of current nanotechnology applications at www.nanotech-
now.com/current-uses.htm

 7.  See, for example, Lux Research, Sizing Nanotechnology's Value 
Chain, October 2004, summary available online at 
www.luxresearchinc.com/press/RELEASEG5-SizingReport.pdf ``Sales of 
products incorporating emerging nanotechnology will rise from less than 
0.1 percent of global manufacturing output today to 15 percent in 2014, 
totaling $2.6 trillion.'' Also see National Science Foundation, 
Societal Implications of Nanoscience and Nanotechnology, March 2001, p. 
3, available online at www.wtec.org/loyola/nano/
NSET.Societal.Implications/nanosi.pdf ``. . .projected total worldwide 
market size of over $1 trillion annually in 10 to 15 years. . .''

 8.  E. Clayton Teague, Responsible Development of Nanotechnology, 
National Nanotechnology Coordination Office, April 2, 2004, available 
online at www.technology.gov/OTPolicy/Nano/04/0402G5-Teague-
Infocast.pdf

 9.  National Science and Technology Council, Nanoscale Science, 
Engineering and Technology Subcommittee of the Committee on Technology, 
The National Nanotechnology Initiative: Research and Development 
Leading to a Revolution in Technology and Industry: Supplement to the 
President's FY 2006 Budget, March 2005, p. 38.

10.  See endnote 7.

11.  Phibbs, P., Daily Environment Report, 9/13/04, p. A-3, ``Federal 
Government Urged to Boost Spending on Managing Risks Posed by 
Nanotechnology,'' quoting experts invited to NSET's Research Directions 
II workshop held in Washington, DC on 9/8-9/04.

12.  Phibbs, P., ibid., quoting NIOSH scientist Andrew Maynard's 
statement at NSET's Research Directions II workshop held in Washington, 
DC on 9/8-9/04; and A. Maynard, personal communication, 4-20-05.

13.  See National Nanotechnology Initiative, ``NNI Environment and 
Health Safety Research,'' available online at www.nano.gov/html/facts/
EHS.htm

14.  National Science and Technology Council, op. cit.

15.  R. Weiss, ``Nanotech Is Booming Biggest in U.S., Report Says,'' 
Washington Post, March 28, 2005, p. A6, available online at 
www.washingtonpost.com/wp-dyn/articles/A5221-2005Mar27.html

16.  The Royal Society and the Royal Academy of Engineering, op. cit., 
p. 48.

17.  See EPA's website for the U.S. HPV Challenge, www.epa.gov/chemrtk/
volchall.htm

18.  See www.epa.gov/chemrtk/hpvq&a.pdf

19.  See the American Chemistry Council's summary of the U.S. HPV 
Challenge, online at memberexchange.americanchemistry.com/randt.nsf/
unid/nnar-4dfn3h

20.  Risk & Policy Analysts Ltd, Revised Business Impact Assessment for 
the Consultation Document, Working Paper 4, prepared for the European 
Commission Enterprise Directorate-General, October 2003, Annex 1, 
available online at www.rpaltd.co.uk/tools/downloads/reports/
reachrevisedbia.pdf Figures cited here assume that all listed tests are 
required to be conducted, that none of the tests have previously been 
conducted, and that no estimation techniques are allowed as a 
substitute for testing.

21.  Requirements are summarized at www.epa.gov/pesticides/regulating/
data.htm. Regulations specifying testing requirements are at 40 CFR 
Part 158.

22.  See ``EPA and Pesticide Registration Issues,'' USDA Agricultural 
Research Service, available online at www.ars.usda.gov/is/np/mba/jan97/
epa.htm

23.  Board on Environmental Studies and Toxicology, Research Priorities 
for Airborne Particulate Matter: I. Immediate Priorities and a Long-
Range Research Portfolio, Committee on Research Priorities for Airborne 
Particulate Matter, National Research Council, 1998, available online 
at books.nap.edu/catalog/6131.html

24.  Board on Environmental Studies and Toxicology, Research Priorities 
for Airborne Particulate Matter: IV. Continuing Research Progress, 
Committee on Research Priorities for Airborne Particulate Matter, 
National Research Council, 2004, available online at books.nap.edu/
catalog/10957.html

25.  Board on Environmental Studies and Toxicology, 1998, op. cit., 
Table 5.1, page 101. Amounts include research management, including 
research planning, budgeting, oversight, review, and dissemination, 
cumulatively estimated by the committee at 10 percent of project costs.

26.  Board on Environmental Studies and Toxicology, 2004, op. cit., 
Table S-1, page 6.
                   Answers to Post-Hearing Questions
Responses by Paul D. Ziegler, Chairman, American Chemistry Council 
        Nanotechnology Panel

Questions submitted by Chairman Brian Baird

Q1.  What do you see as the relative roles of the government and 
industry related to research on environmental, health and safety (EHS) 
aspects of nanotechnology?

A1. The Panel believes that the Federal Government and industry each 
have distinct but interrelated roles in EHS research pertinent to 
nanotechnology. The government has the primary role of identifying and 
conducting basic EHS research. The Federal Government is plainly in the 
best position to identify and coordinate government-funded research and 
the multi-disciplinary expertise of the many participating agencies 
engaged in the EHS aspects of nanotechnology. Federal research is 
essential to providing the underlying methods and tools critical to 
developing a fundamental understanding of nanoscale materials and 
nanotechnologies. These methods and tools can be used by all 
nanotechnology producers and users to fulfill their role in the 
responsible development of nanotechnology. Industry also has several 
critically important roles. First, industry should assist with and 
comment upon the government's identification of research priorities as 
industry is well-positioned to help inform the government's 
understanding of which nanotechnology product platforms are nearing 
commercialization or are commercially important. Together, the 
government, industry, and other stakeholders can identify research 
priorities that will best correlate with real world realities and 
challenges. Second, once equipped with the tools and methods critical 
to developing an understanding of nanomaterials, industry is best able 
to discharge its responsibility of assuming the primary role of 
characterizing the EHS implications of specific types of nanoscale 
materials or technologies that enable specific types of manufactured 
products.

Q2.  You note in your testimony that industry's role in developing 
research priorities to date has been ``largely restricted to passive 
review of decisions already made.'' Do you have recommendations on how 
to address this? Does industry have a voice through the outside 
advisory process for the NNI that is currently handled by the 
President's Council of Advisors on Science and Technology (PCAST)?

A2. The Panel believes that industry's role in the identification and 
communication of research priorities could be given better expression 
if industry were engaged earlier in the process. While PCAST provides 
some limited opportunity for the expression of stakeholder views in 
this area, it is not clear how industry's participation in PCAST (and 
comment upon various National Nanotechnology Coordination Office (NNCO) 
Nanotechnology Environmental Health Implications (NEHI) research 
prioritization initiatives) actually translate into the identification 
of research priorities. Industry's role traditionally has been one of 
passive comment on the product of a deliberative process in which it is 
not engaged. The Panel believes that the product of this process would 
be substantively enhanced and more reflective of industry's significant 
expertise in this area if industry were more substantively engaged in 
the deliberative process itself, as opposed merely to commenting upon 
the result of that process.

Q3.  Through what mechanisms could government and industry work more 
collaboratively to address risk-research needs for nanotechnology? How 
does the American Chemistry Council's Nanotechnology Panel coordinate 
with federal activities?

A3. There are multiple mechanisms that facilitate collaboration between 
the government and industry to address effectively risk-research needs 
pertinent to nanotechnology. First, and as noted above, the Panel 
believes it could add significant value if it were more substantively 
engaged earlier in the deliberative process in identifying research 
priorities. Second, the Panel is supportive of public-private 
partnerships that enable both the government and industry 
collaboratively to fund strategically important research in targeted 
EHS areas. Third, the Panel has been very active in supporting the 
concept of and helping to build the foundational elements of the U.S. 
Environmental Protection Agency's (EPA) voluntary Nanoscale Materials 
Stewardship Program (NMSP). The Panel participated in the National 
Pollution Prevention Toxics Advisory Committee (NPPTAC) as a member of 
the Ad Hoc Work Group on Nanoscale Materials, and has consistently 
supported EPA's efforts to design and implement a voluntary program 
designed to collect and generate information and data on nanoscale 
materials. The Panel is also engaging in extensive outreach to other 
stakeholders to help ensure the NMSP, once commenced, is successful and 
attracts robust participation. The Panel also has signed-on to multiple 
letters to Congress expressing the views of diverse stakeholders 
including industry, researchers, and non-government organizations, 
urging greater funding for EHS nanotechnology research and the funding 
of a National Academies' Board of Environmental Studies and Toxicology 
(BEST) initiative to develop and monitor implementation of a 
comprehensive, prioritized EHS nanotechnology research roadmap for all 
federal agencies. These letters are attached for your information and 
review.

Q4.  Dr. Maynard has suggested a mechanism for government to partner 
with industry to fund EHS research that would support the needs of 
government in formulating a regulatory framework for nanomaterials and 
the needs of industry on how to develop nanotechnology safely. The idea 
is to use the Health Effects Institute model, which studies the health 
effects of air pollution. Do you believe this would be a good model for 
developing a government/industry research partnership for EHS research 
related to nanotechnology?

A4. The Panel believes that the Health Effects Institute (HEI) model is 
one of several models that may potentially serve as a suitable model 
for structuring government/industry research partnerships. The Panel is 
engaged with other stakeholders in identifying suitable models based on 
existing public-private partnership models. The Panel believes, however 
that the process of identifying a suitable model is an iterative one. 
More discussion is needed to identify the unique aspects of EHS 
nanotechnology research needs before the elements of existing models, 
including the HEI model, the Foundation for the National Institutes of 
Health model, and other relevant models, can be assessed to ensure the 
appropriate elements of a construct suitable to nanotechnology EHS 
research are identified. Once this foundational work is completed, 
stakeholders will be better able to build a model appropriate for EHS 
nanotechnology public-private partnerships. The Panel is open to 
considering all appropriate models, but believes that it is premature 
now to conclude that any one existing model, including the HEI model, 
is appropriate for EHS nanotechnology research purposes.

Q5.  The President's Council of Advisors on Science and Technology 
(PCAST) was assigned by the President to serve as the statutorily 
created outside advisory committee for the National Nanotechnology 
Initiative. How useful is PCAST as a means for private sector 
organizations to provide input to the planning and prioritization 
process for EHS research under the NNI? Are there other mechanisms 
available for stakeholders to have a voice in this process?

A5. PCAST is, of necessity, very high-level. As such, it cannot be 
expected to deal explicitly with research needs at a useful level of 
detail. PCAST has sought external advice from stakeholders on several 
occasions. The pathway to more industry involvement may be elsewhere, 
as discussed in the response to Question 1. If desired, PCAST could be 
augmented with industry representatives with nanotechnology expertise.

Q6.  One of the key aspects of carrying out EHS research is to have 
agreed terminology and standards for characterization of nanomaterials.

Q6a.  Is this getting sufficient attention under the NNI? What is the 
role of NIST in this area?

A6a. As best as the Panel can discern, NNI's role in terminology and 
standards development has been expressed principally, if not 
exclusively, in participating in the ANSI TAG and ISO 229 standards 
development process. The Panel welcomes NNI's participation, and 
believes that it is a critical partner in these important standards 
setting initiatives. The Panel urges NIST and other agencies, as 
appropriate, to become more engaged in initiatives intended to 
prioritize, discuss, and help define and resolve morphology issues.

Q6b.  Is there a role for NNI to provide direct assistance to 
nanotechnology companies, particularly small companies, to help them 
characterize new nanomaterials, which will thereby assist the companies 
in assessing the potential environmental and health risks of the new 
materials?

A6b. The Panel believes there is considerable merit in the suggestion 
that NNI has a role in providing nanotechnology companies assistance in 
characterizing nanomaterials with a view toward better identifying, 
characterizing, and mitigating potential environmental and health risks 
posed by nanoscale materials. The Panel would be interested in working 
with NNI and other interested stakeholders in exploring how best NNI 
could provide such assistance.

Questions submitted by Representative Vernon J. Ehlers

Q1.  How does the chemical industry deal with new technology 
uncertainty in the development of new products?

A1. The chemical industry has a well documented and distinguished 
history of addressing proactively and thoroughly the implications of 
new technology. All Panel member companies support and promote the safe 
use and manufacture of products and applications of nanotechnology, as 
well as any new technology, consistent with the Responsible Care 
Program. Responsible Care is a global initiative of the international 
chemical industry that is practiced currently in 52 countries, and has 
been for over two decades. Participating entities share a common 
commitment to advancing the safe and secure management of chemical 
products and processes. Specific Responsible Care practices may vary 
from country to country as they are determined by each country's laws 
and national industry association. Participating in Responsible Care 
is mandatory for ACC member companies, all of which have made CEO-level 
commitments to uphold these program elements: measuring and publicly 
reporting performance; implementing the Responsible Care Security Code; 
applying the modern Responsible Care management system to achieve and 
verify results, and obtaining independent certification that a 
management system is in place and functions according to professional 
standards.
    Since 1988, ACC members have significantly improved their 
environmental, health, safety, and security performance through the 
Responsible Care Program. This commitment requires a third-party 
certified management system that incorporates the following product 
stewardship elements: ensure that health, safety, security, and 
environment and resource conservation are considered for all new and 
existing products and processes; provide information on health, safety, 
security, and environmental risks and pursue protective measures for 
employees, the public, and other key stakeholders; and support 
education and research on the potential health, safety, environmental 
effects of its products and processes. More information on the 
Responsible Care Program is available at http://
www.responsiblecare.com.
    The Panel has also prepared and conducted a survey on practices 
followed by Panel member companies who participated in the survey. In 
addition to workplace practices, the Panel survey collected information 
on potential exposures (which were found to be exceedingly trivial), 
confirmed the existence and implementation of exposure control programs 
for nanomaterials handling, and related information pertinent to 
nanomaterials use and risk mitigation measures used in the workplace. 
The summary of this survey is available at http://
www.americanchemistry.com/nanotechnology.

Q2.  On the issue of stovepiping EHS research versus integrating it 
into all research, do all current NNI grants currently include an EHS 
component? If not, should they? Why or why not?

A2. To the best of the Panel's information and belief, not all NNI 
grants include an EHS component. The Panel believes that while not all 
NNI grants may be explicitly relevant to EHS issues, all NNI grants 
should include a component that explicitly seeks consideration of the 
EHS implications of the actions contemplated under the grant.

Questions submitted by Representative Daniel Lipinski

Q1.  Much of the EHS research to date has focused on exotic materials 
with unrealistic exposure scenarios. While that is useful in 
establishing information on an ``upper bound'' of the hazard, the 
context is rarely communicated and it creates fear. What is critical is 
that we make sure nano-enabled products are as a safe or safer than 
what we use today.

     As I understand it, the hazard of a nanomaterial often depends 
upon much more than the size and type of material, but also surface 
properties, purity, etc. that relate to how it is made. How is the 
toxicology work underway controlling for this? Are researchers using 
standardized, well characterized materials? If not, how can we make use 
of the research findings?

A1. The Panel strongly advocates that all physical/chemical 
considerations be included in toxicology studies. As you may know, 
several prominent national and international symposia and workgroups 
convened over the past several years have strongly suggested that 
certain physical characteristics of study substances must be determined 
and reported by investigators conducting toxicological studies on 
nanomaterials. One set of recommendations published by Oberdoerster et 
al., 2005 in Particle and Fibre Toxicology,\1\ strongly suggests 
specific physical properties of nanomaterials, including median size, 
size distribution, zeta potential, surface chemistry, surface 
topography, shape, etc., be characterized in conjunction with any 
investigation of their potential hazards. The Panel strongly suspects 
that research findings presented on nanomaterials that are not well 
characterized along the lines noted above may well distort the hazard 
potential of nanomaterials to the point of invalidating the findings. 
Research findings can be utilized to the maximum by ensuring that the 
subject materials are well characterized along the lines outlined 
above.
---------------------------------------------------------------------------
    \1\ Oberdorster G., Maynard A., Donaldson K., Castranova V., 
Fitzpatrick J., Ausman K., Carter J., Karn B., Kreyling W., Lai D., 
Olin S., Monteiro-Riviere N., Warheit D., Yang H., Principles for 
characterizing the potential human health effects from exposure to 
nanomaterials: elements of a screening strategy, Part Fibre Toxicol 
Oct. 6;2:8.

Q2.  It seems that most of the early uses of nanotechnology and 
nanomaterials are for existing products and processes, many of which 
are far from ideal from a health and environmental safety perspective. 
What is being done to systematically compare the risks and benefits of 
the nanoscale alternative against the conventional approach in use 
today so that we accelerate the substitution of nanomaterials where 
---------------------------------------------------------------------------
they are superior (e.g., when replacing a known toxin)?

A2. The Panel does not necessarily agree with your statement that 
``many'' early uses of nanotechnology are ``far from ideal from a 
health and environmental safety perspective.'' That said, you raise a 
good point about the need to develop strong risk/benefit principles and 
practices to help ensure that the substitution of macro-scale materials 
with nanoscale materials reaps EHS benefits. The Panel is a supporter 
of lifecycle analyses (LCA) approaches, and believes that the 
application of well defined LCA tools and programs will assist 
innovators and others in assessing the comparative benefits of 
nanoscale materials over their macroscale counterparts. LCA for 
nanomaterials includes the assessment of potential risk throughout the 
product's life cycle or planned life cycle. LCA considerations include 
considerations from material sourcing, through production and use, to 
end-of-life disposal or recycling. LCA considerations should also 
include how the material's properties, hazards, and exposures may 
change during the material's life cycle (for example, because of 
physical interactions during manufacturing or use, or from chemical 
changes that may occur as it breaks down after disposal).
    EPA's Design for the Environment (DfE) has been a leader in 
identifying the pollution prevention opportunities offered by 
nanotechnology. EPA recently convened a symposium, Pollution Prevention 
Through Nanotechnology, http://www.epa.gov/oppt/nano/nanopconfinfo.htm, 
in which many applications of nanoscale materials and structures were 
identified as having compelling pollution prevention benefits. The 
Panel supports continued research in LCA and related areas.

Q3.  The discussion around nanomaterials tends to focus on 
``engineered'' nanomaterials which are roughly defined as those that 
are purposefully created. However, the volume of naturally occurring 
and ultrafine particles produced by combustion, as well as those used 
as fillers in rubber tires or plastics is many orders of magnitude 
greater than the newly engineered nanomaterials. What are we doing to 
ensure that we leverage the body of EHS knowledge on these particles? 
Are we missing the forest from the trees by emphasizing only 
``engineered nanomaterials''? What efforts are there to assess the 
comparative hazard posed by engineered nanomaterials against incidental 
or naturally occurring nanomaterials?

A3. We concur that the volume of naturally occurring nanoscale 
materials and those produced through combustion products dwarf the 
volume of engineered nanomaterials. A key difference between engineered 
and non-engineered materials is that non-engineered materials may be 
poorly defined in a variety of ways including size and purity. Any EHS 
impacts are difficult to attribute to a particular property. Many 
engineered nanomaterials can be well defined using available tools 
making it easier to correlate potential EHS impacts to specific 
properties. Using existing LCA information from naturally occurring 
nanomaterials or nanomaterials that are produced incidentally is 
accomplished through ``bridging.''

Q4.  To what extent is the toxicity research relevant to ``real world'' 
situations? To what extent are federally funded efforts using the 
routes of exposure or formulations that emulate the nanomaterials being 
used in available products?

A4. The Panel agrees with the implicit concern in this question, that 
being there may be a disconnect between ongoing federal research and 
near-term research needs relevant ``to `real world' situations,'' or at 
the least concerned that we lack a high degree of confidence that there 
is a correlation between ongoing research and research results that 
serve real world situations. It is because of this concern the Panel 
has urged Congress, as set forth in the attached letters, to consider 
funding the NAS/BEST to prepare and implement a comprehensive federal 
EHS nanotechnology research roadmap.

Questions submitted by Representative Ralph M. Hall

Q1.  It is our understanding that responsible manufacturers and users 
of nanomaterials, including presumably some of your members, are 
generating information about their properties that could be relevant to 
understanding their biological and environmental behavior. How can that 
information be shared so that risk assessment and risk management in 
general can be improved and so that developers can design more benign 
materials and avoid pitfalls?

A1. The Panel intends to share information through its participation in 
the EPA NMSP. An noted above, the Panel has been a strong and 
consistent supporter of the NMSP, and believes that Panel members and 
many other stakeholders will participate in this important voluntary 
program. Additionally, industry is encouraging all OECD participating 
countries to help develop an EHS research database as part of the 
ongoing efforts of the OECD's Working Party on Nanomaterials Steering 
Group (SG) 1 project. The objective of SG 1 is to develop a global 
resource that identifies research projects that address environmental, 
human health, and safety issues associated with manufactured 
nanomaterials. The database will include projects that are planned, 
underway, or completed, and build upon the database of the Woodrow 
Wilson International Center for Scholars: Nanotechnology Health and 
Environmental Implications: An Inventory of Current Research.
    Industry is required to inform users of the hazards of any product, 
whether or not they are nanoscale materials, on Material Safety Data 
Sheets and labels as required by OSHA's Hazard Communication Standard. 
We are also required to inform EPA of any previously unknown 
Unreasonable Risks under the requirements of TSCA Section 8(e) for 
industrial chemicals and under FIFRA Section 6(a)(2) for pesticides.

Q2.  Are companies holding back on the development of nanotechnology 
products because of a lack of regulations? Do you feel that actual 
nanotechnology products are being mislabeled in order to stem public 
concern?

A2. The Panel is unaware of any of its members ``holding back'' on 
nanotechnology innovation due to the perceived ``lack of regulations.'' 
Panel members companies and many other business stakeholders are well 
aware of the panoply of federal and State regulations that apply to the 
manufacture of products, including the products of nanotechnology. The 
Panel thus believes that the perception that there is a ``lack of 
regulations'' is a misperception. The Panel is unaware of any specific 
products that are being ``mislabeled'' to stem public concern.

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