Oversight of Next Generation Nano

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					    Project on Emerging

Oversight of Next geNerAtiON

                          J. Clarence Davies

                                               Pen 18
                                               April 2009
CPSC – Consumer Product Safety Commission

eC – European Commission

ePA – Environmental Protection Agency

eU – European Union

FDA – Food and Drug Administration

FTe – full-time equivalent (personnel)

IBM – International Business Machines Company

IPPC – Integrated Pollution Prevention and
Control (an EU directive)

MIT – Massachusetts Institute of Technology

nIOSH – National Institute of Occupational
Safety and Health (U.S. Department of Health
and Human Services)

nnI – National Nanotechnology Initiative

nOAA – National Oceanic and Atmospheric
Administration (U.S. Department of Commerce)

OeCD – Organization for Economic Coop-
eration and Development

OSHA – Occupational Safety and Health
Administration (U.S. Department of Labor)

Pen – Project on Emerging Nanotechnolo-
gies, Woodrow Wilson International Center
for Scholars

ReACH – Registration, Evaluation, Autho-
rization and Restriction of Chemicals (an EU

SP – sustainability plan

TSCA – Toxic Substances Control Act

Un – United Nations

USGS – U.S. Geological Survey (Department
of the Interior)
Oversight of Next geNerAtiON

                   J. Clarence Davies

                    Pen 18 April 2009
C On Te nT S
               1    Preface

               2    about the author

               3    executive Summary

               5    acknowledgmentS

               7    introduction

               9    i. the future of nanotechnology
               9          nanotechnology research and development
               12         applications of current research
               15         characteristics of next-generation nano

               20   ii. exiSting overSight and next-generation nanotechnology
               20         requirements for an adequate oversight System
               21         existing oversight applied to next-generation nano

               24   iii. the future of overSight
               24          institutional framework
               27          Product regulation
               29          integrated Pollution control
               30          technology oversight and assessment
               32          monitoring
               32          risk assessment
               34          enforcement
               34          international cooperation
               35          Public involvement
               36          the Path ahead

               37   aPPendix: aPProximate dollarS and PerSonnel in ProPoSed
                    dePartment of environmental and conSumer Protection

               38   bibliograPhy

J. Clarence “Terry” Davies and I first became acquainted when I was appointed the first
Administrator of the Environmental Protection Agency and he had just finished working on
the plan that created the new agency. In the almost 40 years since then, the world has learned
much about environmental problems and how to deal with them, and by many measures the
environment is cleaner than it was in 1970. But, as described in Terry’s report, the challenges
of the 21st century are daunting and require new approaches to oversight. We need a more
effective and efficient oversight system, one that can deal with nanotechnology and other
scientific advances as well as the multitude of existing problems.
    In this report, Terry provides some broad and innovative suggestions about what such
an oversight system might look like. He describes a new Department of Environmental and
Consumer Protection that would be more of a science agency than the current regulatory
ones and that would incorporate more integrated approaches to oversight and monitoring. He
suggests for discussion a new law that would focus on product regulation and new tools that
could be used to deal with future health and environmental problems.
    These suggestions are an important contribution to the dialogue that is needed to formulate
a better oversight system. As Terry says, his proposals are intended to be the beginning of a
discussion, not its conclusion.
    Over 20 years ago at a national conference on risk assessment, I said that I do not believe
technology necessarily is going to master us. We are smart enough to take advantage of the
fruits of technological advances and to minimize or eliminate risks to people and the envi-
ronment. But we need to learn from past mistakes and be able to anticipate future challenges.
Terry’s report uses the experience of the past to suggest the policy directions of the future.
I share his hope that the report will spur the thinking and dialogue needed to deal with the
problems that lie ahead.

                                                        — William D. Ruckelshaus


    J. Clarence “Terry” Davies, a senior advisor to the Project on Emerging Nanotechnologies and
    a senior fellow at Resources for the Future, is one of the foremost authorities on environmental
    research and policy. He helped pioneer the related fields of risk assessment, risk management,
    and risk communication, and his work has advanced our understanding of cross-media pol-
    lution—the tendency of pollutants to move across boundaries, from air to water to land, re-
    vealing shortcomings in the legal and regulatory framework. He has authored three previous
    reports on nanotechnology for the Project on Emerging Nanotechnologies.
        Davies served during the first Bush administration as Assistant Administrator for Policy,
    Planning and Evaluation at the U.S. Environmental Protection Agency (EPA). Earlier, he was
    the first examiner for environmental programs at the Bureau of the Budget (now the Office
    of Management and Budget). In 1970, as a consultant to the President’s Advisory Council on
    Executive Organization, he co-authored the plan that created EPA. Dr. Davies also was Execu-
    tive Vice President of the Conservation Foundation, a non-profit think tank on environmental
    policy; Executive Director of the National Commission on the Environment; and a senior staff
    member at the Council on Environmental Quality, where among other activities, he wrote the
    original version of what became the Toxic Substances Control Act. He has served on a number
    of committees of the National Research Council, chaired the council’s Committee on Deci-
    sion Making for Regulating Chemicals in the Environment, chaired the EPA Administrator’s
    Advisory Committee on Toxic Substances and served on EPA’s Science Advisory Board. In
    2000, he was elected a Fellow of the American Association for the Advancement of Science
    for his contributions to the use of science and analysis in environmental policy.
        Davies is the author of The Politics of Pollution, Neighborhood Groups and Urban Renewal, Pol-
    lution Control in the United States and several other books and monographs addressing environ-
    mental policy issues. A political scientist by training, Davies received his B.A. in American
    government from Dartmouth College and his Ph.D. in American government from Columbia
    University. He taught at Princeton University and Bowdoin College, and has helped mentor
    a generation of environmental policy researchers.


Since 1980, the capability of the federal agencies responsible for environmental health and
safety has steadily eroded. The agencies cannot perform their basic functions now, and they
are completely unable to cope with the new challenges they face in the 21st century. This
paper describes some of these challenges, focusing on next-generation nanotechnologies, and
suggests changes that could revitalize the health and safety agencies.
    Oversight of new technologies in this century will occur in a context characterized by
rapid scientific advancement, accelerated application of science and frequent product changes.
The products will be technically complex, pose potential health and environmental problems
and have an impact on many sectors of society simultaneously. They may also raise challenges
to moral and ethical beliefs. Nanotechnology embodies all of these characteristics as well as
particular ones that challenge conventional methods of risk assessment, standard setting and
oversight implementation.
    The federal regulatory agencies already suffer from under-funding and bureaucratic os-
sification, but they will require more than just increased funding and minor rule changes to
deal adequately with the potential adverse effects of the new technologies. New thinking, new
laws and new organizational forms are necessary. Many of these changes will take a decade or
more to accomplish, but there is an urgent need to start thinking about them now.
    To stimulate discussion, this paper outlines a new federal Department of Environmental and
Consumer Protection. The new agency, which would be composed largely of existing agen-
cies, would have three main components: oversight, research and assessment and monitoring.
It would be a scientific agency with a strong oversight component, in contrast to the current
regulatory agencies, which are primarily oversight bodies.
    The proposed agency would foster more integrated approaches, and this would require
new legislation. A unified approach to product regulation is necessary to deal with current
programs like monitoring and newer challenges like nanotechnology. A more integrated ap-
proach to pollution control was necessary even before the Environmental Protection Agency
(EPA) was created in 1970, and since that time, the need has only increased. Integrated facility
permitting, such as exists in the European Union (EU), is one avenue to pursue. Economics-
based approaches, such as cap-and-trade, would also help streamline pollution control. The
essential functions of monitoring the environment and analyzing the results are widely scat-
tered throughout the government and need to be brought together. The design of the proposed
new agency incorporates the proposals for an Earth Systems Science Agency and a Bureau of
Environmental Statistics. The new agency would need to be able to do technology assessment,
forecasting, and health and safety monitoring.
    The organizational, legislative and other changes described in the paper are intended to
be a starting point for discussion, not a set of fixed conclusions. Also, they are not intended to
supersede or take away from the need for immediate reform, for example, for modernization
of the Toxic Substances Control Act (TSCA). However, the dialogue about new approaches

    needs to start now. The proposals contained in the report should help frame the discussion
    and give it focus.
        The paper describes some of the developments that will determine the future of technology
    and some changes that would equip the federal government to deal with the new 21st-century
    science and technology. The oversight system is broken now. Revolutionary technologies like
    nanotechnology and synthetic biology are being commercialized now. The proposed over-
    sight system is just a starting point for thinking about change, but change is urgently needed.


I am grateful to the Project on Emerging Nanotechnologies for its support and encouragement
and also to Resources for the Future for its continuing support. This paper could not have
been produced without the help of people other than the author. Dave Rejeski allowed me to
cover areas that were well beyond the scope of the original assignment, and he provided many
useful comments and suggestions. Julia Moore’s unstinting support and encouragement have
made working at the Wilson Center a pleasure, and she has provided both intellectual and
psychological assistance in getting this paper written. Andrew Maynard put in so much time
and effort that more than once I offered him co-authorship of the report. That he declined
shows how wise he is. I am very grateful to him for undertaking to make it appear as if I knew
more than I really know about the science of nano. Todd Kuiken served ably as researcher, and
Colin Finan helped in various ways. Three outside reviewers—Michael Rodemeyer, Mun-
roe Newman and Mark Greenwood—provided many useful comments. As usual, my wife,
Barbara, put in many hours of work on the paper. Like Andrew Maynard, she is entitled to
co-authorship but was wise enough to decline. Having failed to get any co-authors, I accept
all responsibility for the contents of the report.

                                                        — J. Clarence Davies

                               Oversight of next-Generation nanotechnology                               7


For the first time in human history, we are            Nanoscale materials often behave differ-
close to being able to manipulate the basic        ently than materials with a larger structure
forms of all things, living and inanimate, take    do, even when the basic material (e.g., silver
them apart and put them together in almost         or carbon) is the same. Nanomaterials can
any way the mind can imagine. The sophis-          have different chemical, physical, electrical
tication with which scientists are learning to     and biological characteristics. For example, an
engineer matter at the nanometer scale is giv-     aluminum can is perfectly safe, but nano-sized
ing us unprecedented mastery of a large part       aluminum is highly explosive and can be used
of our environment. The world of the future        to make bombs.
will be defined by how we use this mastery.            The novel characteristics of nanomaterials
    In contrast to the sweeping and dramatic       mean that risk assessments developed for ordi-
possibilities of new technologies, the govern-     nary materials may be of limited use in deter-
ment agencies responsible for protecting the       mining the health and environmental risks of
public from the adverse effects of these tech-     the products of nanotechnology. While there
nologies seem worn and tattered. After almost      are no documented cases of harm attributable
30 years of systematic neglect, the capability     specifically to a nanomaterial, a growing body
of federal health and safety regulatory agencies   of evidence points to the potential for unusual
ranges from very weak to useless. The focus        health and environmental risks (Oberdorster
of regulatory reform in this period has mostly     2007; Maynard 2006). This is not surprising.
been on how to get around the existing regula-     Nanometer-scale particles can get to places in
tory structure rather than on how to improve       the environment and the human body that are
it. The regulatory system was designed to deal     inaccessible to larger particles, and as a conse-
with the technologies of the industrial age.       quence, unusual and unexpected exposures can
A large gap exists between the capabilities of     occur. Nanomaterials have a much larger ratio
the regulatory system and the characteristics      of surface area to mass than ordinary materials
of what some are calling the next industrial       do. It is at the surface of materials that biologi-
revolution, and that gap is likely to widen as     cal and chemical reactions take place, and so
the new technologies advance.                      we would expect nanomaterials to be more
    Nanotechnology involves working at the         reactive than bulk materials. Novel exposure
scale of single atoms and molecules. The U.S.      routes and greater reactivity can be useful at-
government defines nanotechnology as “the          tributes, but they also mean greater potential
way discoveries made at the nanoscale are put to   for health and environmental risk.
work” (; accessed 9/19/08). The            Oversight consists of obtaining risk in-
nanoscale is roughly 1–100 nanometers. For         formation and acting on it to prevent health
comparison, the paper on which this is printed     and environmental damage. An underlying
is more than 100,000 nanometers thick. There       premise of this paper is that adequate over-
are 25.4 million nanometers in an inch and 10      sight of nanotechnology is necessary not only
million nanometers in a centimeter.                to prevent damage but also to promote the
development of the technology. The United           present even greater oversight challenges than
States and Europe have learned that oversight       the current technology. And nothing less than
and regulation are necessary for the proper         a completely new system will suffice to deal
functioning of markets and for public accep-        with the next generations of nanotechnology.
tance of new technologies.                             The paper begins with an examination of
   The application of current oversight systems     the future of nanotechnology. It then analyzes
to current forms of nanotechnology has been         the capacity of current oversight policies and
analyzed for both the United States and Europe      authorities to deal with the anticipated tech-
(see, for example, Davies 2006; Davies 2007;        nological developments. Concluding that the
Royal Society and Royal Academy of Engi-            existing systems are inadequate, the major
neering 2004). The existing oversight systems       part of the paper is devoted to thinking about
in the United States have been found to be          a more adequate oversight system for new
largely inadequate to deal with current nano-       technologies in general and for nanotechnol-
technology (Davies 2006, 2007, 2008; Taylor         ogy in particular. Failure to think about new
2006, 2008; Felcher 2008; Breggin and Pend-         forms of oversight perpetuates the status quo
ergrass 2007; Schultz and Barclay 2009). This       and, in the long run, invites negative effects
paper looks at future generations of nanotech-      that could undermine the promise of the new
nology. Not surprisingly, it finds that they will   century’s technologies.
                                Oversight of next-Generation nanotechnology                             9


Predicting the future of any major technol-          types of applications of the technology. The
ogy is difficult. On the one hand, there of-         most straightforward categorization is that used
ten is a tendency to underestimate the impact        by James Tour (2007) based on work in his
of a technology and the pace of its develop-         Rice University laboratory. He categorizes
ment. Nanotechnology development already             nanotechnologies as passive, active or hybrid
is outpacing the predictions made when the           (i.e., technologies that are intermediate be-
NNI (National Nanotechnology Initiative)             tween active and passive). Tour estimates the
was created in 2000. At that time, the focus         time it will take to commercialize each of these
was on the impact nano might have in 20–30           types as 0–5 years for passive nanotechnolo-
years (Roco 2007). Now, the analysis firm Lux        gies, 15–50 years or more for active nanotech-
Research predicts that by 2015 nano will be          nologies and 7–12 years for hybrids.
incorporated in $3.1 trillion of manufactured            According to Tour, almost all the current
goods worldwide (Lux Research 2008) and              applications of nano are passive, and most in-
will account for 11 percent of manufacturing         volve adding a nanomaterial to an ordinary
jobs globally (Lux Research 2006).                   material as a way of improving performance.
    Alternatively, the promise of a technology       For example, he notes that adding carbon
and the pace of its development may be exag-         nanotubes to rubber can greatly increase the
gerated. There are many examples of techno-          toughness of the rubber without reducing its
logical advances that were predicted to be im-       flexibility. Passive nanotechnology applications
minent but that had not materialized decades,        include using materials like carbon nanotubes,
or even centuries, later. A further complication     silver nanoparticles and porous nanomateri-
is that a technology can develop in completely       als—materials containing holes that are nano-
unanticipated directions and be applied in ways      meters in diameter. These applications use
that no one envisaged.                               nanomaterials to add functionality to prod-
    This section begins by reviewing several         ucts by nature of their physical and chemical
analyses of nanotechnology’s future and of cur-      form, rather than by how they respond to their
rent nanotechnology research. It then reviews        environment.
applications of the research that are likely to          Tour defines an active nanotechnology as one
occur in the next 10–20 years. It concludes by       where “the nano entity does something elabo-
distilling the attributes that are likely to char-   rate.” He gives the example of a “nanocar,” a
acterize future technologies in general and the      unique nano-engineered molecule that can be
next generation of nanotechnology specifically.      used to physically move atoms from one place to
                                                     another (see illustration on “Beyond Synthetic
  nAnOTeCHnOLOGY ReSeARCH AnD                        Chemistry)”. One goal of next-generation nan-
                DeVeLOPMenT                          otechnology is to imitate nature by designing
The major attempts to analyze the future of          systems and devices that construct things from
nanotechnology have tried to categorize the          the bottom up, (i.e., that make things atom by
types of research being conducted and/or the         atom and molecule by molecule). This means

     BeYOnD SYnTHeTIC CHeMISTRY: An example of next Generation nanotechnology

     *Computer generated image of molecular “nanocars”.

     Most scientists agree that we have only scratched the surface of the full range of
     molecules that could be made, if only we had better tools and a more complete
     understanding of how things work at the nanoscale. Building on advances in
     science and engineering, next generation nanotechnologies will enable the
     design and construction of increasingly complex molecules that rival those             **Scanning Tunneling Microscope image of “nanocar”
     found in biology in terms of their sophistication. For example, Dr. James Tour           molecules. The four carbon-60 molecules making
                                                                                              up the wheels of each “nanocar” are easily visible.
     and his research group at Rice University are engineering an innovative new
     class of molecules dubbed “nanocars,” that can move across a surface, and
     potentially ferry materials from one point to another at a nanometer scale.1,2 Scientists are discovering that many
     biological processes depend on billions of molecules carrying out physical tasks, including ferrying materials
     around to construct, repair and fuel living cells. Mimicking these processes using artificial molecules—like the
     “nanocars”—may open the door to constructing sophisticated new materials and products as diverse as medi-
     cines, electronic devices and building materials.

     1. Sasaki, T., Osgood, A.J., Alemany, L.B., Kelly, K.F., and Tour, J.M. 2008. Synthesis of a Nanocar with an Angled Chassis. Toward Circling
     Movement. Organic Letters. 10(2), 229-232.

     2. Vives, G. and J. M. Tour (2009). “Synthesis of Single-Molecule Nanocars.” Acc. Chem. Res. 42(3): 473-487.

     *Image courtesy of the American Chemical Society

     **Image courtesy of the James M. Tour Group.
                                 Oversight of next-Generation nanotechnology                             11

that starting only with individual molecules one      to Roco (2007, p. 28), the third generation
could make computer chips, super-strong materi-       encompasses “systems of nanosystems with
als, biological tissue or almost anything else. The   three-dimensional nanosystems using various
basic methods by which this could be done are         syntheses and assembling techniques such as
self-assembly, molecular construction or a com-       bioassembling; robotics with emerging be-
bination of the two. Novel nanodevices such as        havior, and evolving approaches.” It includes
the nanocar could be used as a basis for molecular    “directed multiscale self assembling … artifi-
construction. Practical applications of bottom-up     cial tissues … and processing of information
construction are open to anyone’s imagination,        using photons.” The fourth generation “will
but could include repair of human tissue or the       bring heterogeneous molecular nanosystems
generation of energy using photosynthesis.            where each molecule in the nanosystem has
    M. C. Roco, one of the driving forces be-         a specific structure and plays a different role”
hind the NNI, has developed a more detailed           (Ibid., p. 29). It will include macromolecules
typology of nanotechnologies (Roco 2004,              “by design,” nanoscale machines and interface
Roco 2007). He identifies four generations            between humans and machines at the tissue
of nanotechnologies: passive nanostructures,          and nervous system levels.
active nanostructures, systems of nanosystems             Even knowledgeable experts have expressed
and molecular nanosystems.                            difficulty distinguishing among Roco’s last
    Almost all the current applications and uses      three generations and understanding some of
of nanotechnology belong to Roco’s first gen-         the applications that he describes. However, at
eration, a category that is basically the same as     a minimum, they point to future developments
Tour’s passive category. Uses in this category        and uses of nanotechnology that are increas-
most frequently entail combining a nanomate-          ingly sophisticated, and that lead to materials
rial with some other material to add function-        and products that behave in different (even
ality or value, and the behavior of the nanoma-       unanticipated) ways according to how they
terial does not change appreciably over time.         are used. These materials and products will be
    Roco’s second generation, active nanostruc-       very different from those of the present and
tures, typically involves nanometer-scale struc-      will have an impact on a broad spectrum of
tures that change their behavior in response to       sectors and users.
changes in their environment. These changes               A third typology was developed by Vrishali
might come about as a result of a mechanical          Subramanian, who conducted a comprehen-
force, a magnetic field, exposure to light, the       sive bibliographic search of research on ac-
presence of certain biological molecules or a         tive nanostructures for the Woodrow Wilson
host of other factors. Roco envisages active          International Center for Scholars’ Project on
nanostructures as being integrated into much          Emerging Nanotechnologies (PEN) (unpub-
larger devices or systems, to make them usable        lished research paper). Her analysis suggests
in practice. Examples include new transistors         that the following categories of active nano-
and other electronic components, targeted             structures emerge from the research litera-
drugs and chemicals designed for particular           ture: (1) remote actuated—a nanotechnology
functions—along the lines of Tour’s nanocars.         whose active principle is remotely activated;
    The third- and fourth-generation nano-            (2) environmentally responsive—a nano-
technologies are more abstract. According             technology that is sensitive to stimuli such as

     pH, temperature, light or certain chemicals;         nanotechnology marks a tipping point from
     (3) miniaturized—a nanotechnology that is            simple, chemistry-based products to sophisti-
     a conceptual scaling down of larger devices          cated products that incorporate complex and
     and technologies; (4) hybrid—nanotechnology          adaptive structures at the nanoscale.
     involving uncommon combinations (biotic-
     abiotic, organic-inorganic) of materials; and (5)     APPLICATIOnS OF CURRenT ReSeARCH
     transforming—nanotechnology that changes             Almost every area of human activity will be
     irreversibly during some stage of its use or life.   affected by future nanotechnologies. Medi-
     She notes that active nanostructure prototypes       cine, food, clothing, defense, national security,
     do not necessarily fall into only one of these       environmental clean-up, energy generation,
     categories and that in fact if an innovation falls   electronics, computing and construction are
     into more than one category it is likely to be       among the leading sectors that will be changed
     more complex and dynamic.                            by nanotechnology innovations. Here is a small
         Almost all observers predict that an im-         sampling of research likely to result in practical
     portant aspect of future nanotechnology will         applications within the next 15 years:
     be its merging with other technologies and
     the subsequent emergence of complex and in-              Smart drugs—cancer treatments. A
     novative hybrid technologies. Biology-based          good deal of research, involving a variety of
     technologies are intertwined with nanotech-          different nanotechnologies, is being devoted to
     nology—nanotechnology is already used to             cancer detection and cure (Zhang 2007). One
     manipulate genetic material, and nanomate-           of the main goals of using nanotechnology for
     rials are already being built using biological       medical purposes is to create devices that can
     components. The ability inherent in nano-            function inside the body and serve as drug de-
     technology to engineer matter at the smallest        livery systems with specific targets (Pathak and
     scale is opening unexpected doors in areas like      Katiyar 2007). Current treatments for cancer
     biotechnology, information technology and            using radiation and chemotherapy are invasive
     cognitive science, and is leading to new and         and produce debilitating side effects. These
     transformative connections between these and         treatments kill both cancerous and healthy
     other fields. Some experts, such as Mike Roco        cells. Nanotechnology has the potential to treat
     and Bill Bainbridge (2003), predict that the         various forms of cancer by targeting only the
     convergence of nanotechnology, biotechnol-           cancer cells. Researchers at Rice University
     ogy and information and cognitive sciences           have developed a technique utilizing heat and
     will be the defining characteristic of the 21st      nanoparticles to kill cancer cells. Gold-coated
     century. Others have gone much further, sug-         nanoparticles designed to accumulate around
     gesting that nanotechnology is one of a suite        cancer cells are injected into the body. Sources
     of technologies that will precipitate a period       of radiation, similar to radio waves, are then
     of unprecedented life-transforming techno-           used to transmit a narrow range of electromag-
     logical advances this century—the so-called          netic frequencies that are tuned to interact with
     technological singularity popularized by Ray         the gold nanoparticles. The particles are heated
     Kurzweil (2006). Although these ideas may            by the radiation and can kill the cancer cell
     seem closer to the realm of science fiction than     without heating the surrounding non-cancerous
     science fact, it is hard to avoid the sense that     cells (O’Neal et al. 2004).
                                Oversight of next-Generation nanotechnology                              13

    Mauro Ferrari and his research team at          is occupied by the materials that actually store
the University of Texas have been focusing          the electricity. In order to increase the “energy
on early detection of cancer using lab-on-a-        density” of a battery the amount of inactive ma-
chip technology with particles that can sort        terials needs to be reduced. Angela Belcher and
out and concentrate proteins of interest from       her associates at MIT have engineered a virus
blood samples. The same team is using inject-       for use as a “programmable molecular building
able nanomaterials to act as carriers for drugs     block to template inorganic materials growth
that are able to avoid biological barriers and      and achieve self-assembly.” These engineered
target specific parts of the body (University of    viruses were used to grow nanowires of cobalt
Texas 2006).                                        oxide, which act as the anode of a battery; cobalt
    Military applications. The U.S. Army            oxide could significantly increase the storage
and the Massachusetts Institute of Technology       capacity of lithium ion batteries and also be used
(MIT) are cooperating on a large-scale pro-         to construct micro-batteries (Nam et al. 2008).
gram to use nanotechnology to design a new          Building upon this, Belcher’s group genetically
battle suit for soldiers. The goal is to create a   engineered viruses that first coat themselves
“bullet-resistant jumpsuit, no thicker than or-     with iron phosphate which can then grab hold
dinary spandex, that monitors health, eases in-     of carbon nanotubes (acting as the cathode) cre-
juries, communicates automatically and reacts       ating a network of highly conductive material
instantly to chemical and biological agents”        (Lee et al., 2009). By combining the two com-
( /; accessed 11/7/08).       ponents (anode and cathode) the research team
    Next-generation computer process-               has developed a prototype battery about the size
ing. Many researchers are exploring the use of      of a coin that has the same energy capacity of
nanomaterials and nanotechnology techniques         a battery that may be used in a hybrid vehicle
to vastly improve computers. In 2007, Inter-        (Trafton, 2009). Using the ability of the virus
national Business Machines Company (IBM)            to self-assemble, Belcher’s group hopes to create
researchers used self-assembling nanotechnol-       a fully self-assembled high performance battery
ogy to improve current flow in chips by 35          that could be placed on fibers, circuits or other
percent. This new approach, called air-gap          materials (Nam et al. 2008).
technology, is expected to quadruple the num-           Complex materials—a super-adhesive.
ber of transistors that can be put on a chip. The   Scientists and engineers often look to nature
natural process that forms seashells, snowflakes    to solve complex problems or to develop tech-
and enamel on teeth is used to form trillions       nologies that have the capability of mimicking
of holes to create insulating vacuums around        nature. For example, the gecko’s ability to stick
miles of nano-scale wires packed next to each       to surfaces and walk up walls with ease has led
other inside each computer chip.                    researchers to design materials that can mimic
    Programmed biology—the smallest                 the microscopic elastic hairs that line this ani-
batteries. Battery technology is a major stum-      mal’s feet (see illustration on Complex Materi-
bling block for a variety of applications, rang-    als). Using carbon nanotubes, Liangti Qu and
ing from electric automobiles to miniaturized       colleagues at the University of Dayton (Ohio)
implantable medical devices. One of the major       have created a material that has an adhesive
limitations of current battery technology is that   force about 10 times stronger than that of a
less than half of the space/weight of a battery     gecko’s foot. These carbon nanotube materials

     COMPLeX MATeRIALS: An example of next Generation nanotechnology

     Advanced nanotechnology is enabling scientists to develop sophisticated new materials that can be used in
     novel ways. For instance, researchers have created a gecko-inspired adhesive with ten times the stickiness of a
     gecko’s foot, by combining vertically aligned nanotubes with curly spaghetti-like nanotubes.

     Credit: Zina Deretsky, National Science Foundation after Liangti Qu et al., Science 10/10/2008

     have a much stronger adhesion force parallel to                       “applications that had been previously con-
     the surface they are on than that perpendicular                       sidered impossible” (Shalaev 2008). These ap-
     to the surface. The result is a material that can                     plications include an “electromagnetic cloak”
     be used to attach a heavy weight to a verti-                          that bends light around itself, thereby making
     cal surface, and yet be peeled off with ease.                         invisible both the cloak and an object hidden
     And just as a gecko is able to walk up vertical                       inside; and a “hyperlens” that could be added to
     surfaces with ease, the material opens up the                         conventional microscopes allowing them to be
     possibility of creating clothing that will enable                     used to see down to the nanoscale and thus to
     humans to achieve the same feat.                                      see viruses and possibly DNA molecules (Ibid.)
         Metamaterials - controlling the flow                                  Energy generation and use. New gen-
     of light. A whole new field of scientific re-                         erations of nano-based sensors, catalysts and
     search, called transformation optics, has been                        materials have already resulted in major re-
     made possible by the ability of nanotechnol-                          ductions in energy use, and further progress is
     ogy to create new materials that bend light                           certain. The ConocoPhillips oil company re-
     “in an almost arbitrary way,” making possible                         cently awarded a three-year, $1.2 million grant
                                Oversight of next-Generation nanotechnology                            15

to the University of Kansas to research the use     and the current global recession will probably
of nanotechnology to enhance oil recovery           delay the commercialization of new discover-
(ConocoPhillips press release, 12/2/08). Na-        ies because companies and investors have less
noscale catalysts and nanoporous membranes          money and are more risk averse. However,
are, under some circumstances, being used to        accelerating paces of scientific discovery, as
facilitate production of biomass fuel. Energy       well as of commercial adoption, have been
transmission could potentially be made much         characteristic of nanotechnology development.
more efficient by using engineered nanomate-
rials. Throughout the renewable-energy sector,             CHARACTeRISTICS OF neXT-
nanotechnology has the potential to increase                   GeneRATIOn nAnO
process efficiencies and process yields, decrease   By extrapolating from the development of
costs and enable energy processes that would        nanotechnology and drawing upon experience
not be attainable any other way. Nanotechnol-       with other new technologies, one can identify
ogy is transforming photovoltaic cells through      a number of characteristics of next-generation
the development of new and less expensive           nano. They divide into characteristics that are
manufacturing techniques and new methods            generic to most new technologies and char-
of generating high-surface-area structures, op-     acteristics that are unique or particularly ap-
timizing sensitivity and increasing the spectral    plicable to nano.
absorbency of the cells (Saunders et al. 2007).        The generic characteristics include:
Other applications in the renewable-energy             Rapid scientific advancement. It often
sector include using nanoscale surface proper-      has been noted that most of the scientists who
ties and novel nanofabrication techniques to        have ever lived are alive today. The people,
increase production of electricity in hydrogen      tools, resources and institutions that currently
fuel cells. Most renewable-energy technologies      exist to further scientific knowledge dwarf
can be made more efficient using various forms      those of any previous period in human history
of nanotechnology, at least at the laboratory       (see Bowler and Morus 2005). The result is
scale. Whether these efficiencies translate into    that more scientific knowledge is developed,
economic efficiencies will depend on fabrica-       and is being developed more rapidly, than at
tion and other costs (Saunders et al. 2007).        any other time in history. Because many of the
    The timeframes within which these inno-         tools and concepts have broad application, the
vations will be commercialized will be dif-         pace of development is continually accelerat-
ferent for different innovations and will vary      ing. This is illustrated by the dramatic rise in
depending on who is doing the estimating.           nanotechnology patents (see Fig. 1).
For example, Tour (2007, p. 361) estimates the         Rapid utilization of science. New sci-
commercialization horizon for active nano-          ence is put to practical application more rap-
technologies as 15–50 years, noting that “the       idly today than at any time in the past. The
truly exciting developments in nanotechnol-         line between science and technology has been
ogy … are often 30–50 years away, or even 100       completely blurred. Telecommunications, es-
years out.” Roco (2007, p. 28), in contrast, pre-   pecially the computer and the Internet, allow
dicts that even the most advanced of his gen-       new technologies to be rapidly disseminated
erations will begin to be commercialized by         throughout the world. The breakdown of
2015 or 2020. Roco may be overly optimistic,        traditional cultures has removed many of the

     FIGURe 1. nanotechnology-based patents*
                                                 United States
                         1200                    European Group






                                                                                                                                     Y E AR

     *Adapted from Chen and Roco, 2009.

     intellectual and cultural barriers to adopting                                                                                  few anchors in everyday experience. These
     new technologies.                                                                                                               characteristics make it difficult for even knowl-
         Frequent product changes. A corollary                                                                                       edgeable lay people to understand what the
     of the rapid pace of scientific and technologi-                                                                                 new technology can do. The complexity not
     cal development is that the characteristics of                                                                                  only creates an impediment to communicat-
     products change frequently (see Fine 2000;                                                                                      ing with the public but also places demands
     Mazurek 1999). The frequency with which                                                                                         on oversight agencies to acquire new types of
     both products and manufacturing processes                                                                                       experts—experts who may be few in number
     change is a challenge for any oversight system                                                                                  and expensive to hire.
     because the pace of bureaucratic and regula-                                                                                       Potential health and environmental
     tory procedures has not noticeably increased:                                                                                   problems. New technologies often have un-
     indeed, it may well have slowed under the ac-                                                                                   anticipated or unwanted consequences. As
     cumulated weight of procedural requirements.                                                                                    our knowledge of both human and ecosystem
         Technical complexity. Nanotechnol-                                                                                          functioning has increased, we have learned
     ogy, like most new technologies, is complex.                                                                                    more about the ways in which technology can
     It draws on several disciplines, including phys-                                                                                have an impact on health and the environment.
     ics, chemistry and biology, and on numer-                                                                                       The realization that most new technologies
     ous sub-specialties within those disciplines.                                                                                   have the potential for such impacts is the major
     It uses highly technical vocabulary, sophis-                                                                                    reason for applying oversight. For example, in
     ticated mathematics and concepts that have                                                                                      the 1960s and 1970s it was recognized that the
                                 Oversight of next-Generation nanotechnology                                17

potential for adverse effects from chemicals was      this, but only rarely is there a considered debate
not limited to isolated and occasional aberra-        about the consequences of a new technology
tions but was something that had to be consid-        or about priorities among technologies. The
ered for all new chemicals. The realization led       technology of public-participation mechanisms
to passage of the Toxic Substances Control Act        lags behind the science-based technologies of
(TSCA) in the United States and to analogous          the 21st century.
legislation in Europe.                                    The characteristics of nanotechnology—
    Broad social impact. The most important           especially next-generation nanotechnology—
of the new technologies, such as nanotechnol-         that make it particularly challenging include:
ogy and genetic engineering, transcend the                Changes in the materials. A number of
categories that are usually applied to technolo-      nanomaterials in the advanced research stage
gies. We traditionally talk about medical or          are designed to change their characteristics
transportation or energy technologies, but            under specified circumstances. Materials may
nano, for example, will have major impacts            change in response to an external stimulus,
on all these sectors and many others as well. It      electromagnetic radiation, temperature or
is no exaggeration to say that nanotechnology         changes in pH. The change may be irreversible
will change the way we live.                          or temporary. Any changes in a nanomaterial
    Potential challenges to moral and ethi-           over time and under different circumstances
cal beliefs. A consequence of the broad im-           complicate oversight because the risk may
pact of the new technologies is that they may         change as the material changes.
have applications or implications that raise basic        Lack of risk assessment methods. Even
moral questions. If nanotechnology can be used        first-generation nanotechnologies challenge
to improve the functioning of the human brain,        traditional risk assessment methods. Multiple
should it be used that way? And if so, for whose      characteristics contribute to the toxicity of
brains? If nanoscale materials are incorporated       many nanomaterials; they include not just
in foods to improve nutrition, shelf life or taste,   mass or number of particles but also the shape
should the food have to be labeled to show that       of the particles, the electrical charge at the par-
nano has been used? If synthetic biology, us-         ticle surface, the coating of the particle with
ing nanotechniques, can create new life forms,        another material and numerous other charac-
should it be allowed to do so? When technolo-         teristics. Science has yet to determine which of
gies raise these kinds of questions, the general      these characteristics are most important under
public should be an important player in the           what circumstances, and determining this will
development and application of the technology.        not be easy. There are thousands of potential
The public will play a role as consumer when          variants of single-walled carbon nanotubes
the technology is marketed, but society has not       (Schmidt 2007, p. 18), and single-walled
yet developed institutions or mechanisms that         carbon nanotubes are only one of hundreds
enable the public to express its voice and be         of types of nanomaterials. Next-generation
heard when the technology is still being devel-       nanomaterials will pose even greater prob-
oped. The public in its role as taxpayer should,      lems, depending on the materials, functions,
at a minimum, have a voice in which tech-             and types of applications.
nologies the government funds and supports.               Self-assembly. A number of next-gen-
Congress obviously exercises some control over        eration nanotechnologies entail designing

     materials that arrange themselves into com-         harmful. While at present it is by no means
     plex and useful nanoscale structures with little    certain that these are valid concerns, they need
     or no additional manipulation. Engineered           careful consideration as increasingly sophisti-
     molecules and nanoparticles, when mixed             cated self-assembling nanomaterials and de-
     together, naturally form into increasingly          vices are conceived and explored.
     complex structures that may result in more              Self-replication. Self-replication can be
     energy-efficient manufacturing and the pos-         seen as an extension of self-assembly. Self-as-
     sibility of designing nanomaterials that can        sembly that leads to the growth of a nanomateri-
     assemble in normally inaccessible places—such       al with a repeating structure is the simplest form
     as within the body. Crystals are a very simple      of self-replication. More complex systems are
     form of self-assembly: under the right condi-       being studied, including nanoscale systems that
     tions, atoms naturally assemble together into       utilize DNA or other “blueprints” to multiply
     regular structures—often with valuable prop-        and grow in a different pattern. These systems
     erties. Most biological systems rely on self-       can be designed to construct duplicates of them-
     assembly at the nanoscale—where, under the          selves or to construct other systems. These and
     right conditions, molecules assemble to form        other approaches overlap and can be combined.
     proteins with specific shapes and chemistries,      Rodemeyer (2009) notes that “scientists at Ari-
     which in turn combine to form increasingly          zona State University have recently reported be-
     complex systems and, eventually living organ-       ing able to use a cell’s DNA replication process
     isms. Nanotechnology researchers are working        to produce copies of a designed DNA nano-
     on engineering advanced nanomaterials that          structure, illustrating the overlapping paths of
     self-assemble into useful structures in a variety   synthetic biology and nanotechnology. Indeed
     of environments. Potential applications range       … the distinction between the two disciplines
     from self-assembling templates for nanoscale        is likely to disappear.” Some researchers hope
     integrated circuits to self-assembling biologi-     to break from biology completely and to create
     cal structures that can aid nerve regeneration.     artificial (non-biological) nanoscale devices that
         Simple self-assembly—such as crystal for-       are able to produce copies of themselves in much
     mation—does not raise specific new challeng-        the same way that cells do. However, there is
     es. However, three aspects of self-assembly and     considerable skepticism over the likelihood of
     its use in next-generation nanotechnologies         complex non-biological self-replicating systems
     potentially raise new challenges in under-          becoming a reality in the foreseeable future.
     standing and addressing risks: (1) the in-situ          Society has had some experience over-
     transformation of materials from one form to        seeing self-replicating systems in the form of
     another, with the resulting substance having        genetically modified plants and organisms.
     a very different risk profile than that of the      But that experience probably does not provide
     precursor materials; (2) the unanticipated and      a good model for regulating nanotechnolo-
     uncontrolled self-assembly of nanomaterials in      gy-based advances that combine elements of
     places where they could cause harm—such as          biological and non-biological systems. Fears
     within the body or the environment; and (3)         expressed over self-replication nanotechnolo-
     the possibility that under some circumstances       gies, such as the “grey goo” scenario, are al-
     self-assembly could set off a chain reaction        most definitely unfounded. Self-replicating
     of nanomaterial formation that could prove          systems need the right environment and the
                              Oversight of next-Generation nanotechnology                             19

right “food” to survive, and even if scientists   be ended” (Vinge 1993). This paper is neither
were able to create artificial self-replicating   predicting the end of the human era nor pro-
nanodevices, it is highly unlikely that they      posing an oversight system for self-willed ro-
could survive outside the laboratory. Nev-        bots, but it is important to be aware that some
ertheless, the challenges of developing and       future technologies will pose challenges unlike
using more realistic self-replicating systems     any we have dealt with in the past.
safely need to be thought through, if potential      Next-generation nanotechnologies will strad-
untoward consequences are to be avoided           dle areas of expertise and application in complex
    Within this century, the combination of       ways, and they will respond and adapt to the
nanotechnology, artificial intelligence, com-     environment in which they are used. There is
puter science and perhaps synthetic biology       a danger that because of their invisibility, they
may produce a machine that is many times          will be treated like simple atoms and molecules
more intelligent than humans. Vernor Vinge,       from an oversight perspective. This would be as
a professor of mathematical sciences, predicted   inappropriate as regulating human-scale products
in 1993 that “within thirty years, we will have   by the atoms and molecules of which they are
the technological means to create superhuman      made. Instead, new thinking is needed on how to
intelligence. Shortly after, the human era will   ensure the safe use of nanoscale products.

     2. eXISTInG OVeRSIGHT AnD neXT-
        GeneRATIOn nAnOTeCHnOLOGY
     A series of papers by this author and others           the magnitude of such risks. Such an assess-
     have examined the applicability of U.S. over-          ment requires both general scientific knowl-
     sight mechanisms to first-generation nano-             edge and data about each specific technology
     technologies (see cites above). All these authors      and product.
     have found serious gaps and inadequacies with               The relationship between science and data
     current oversight. If there are serious problems       is complex. Without an adequate scientific
     with oversight of current technology, it should        framework there is no way to know what data
     not be surprising that the problems of oversee-        to collect. For example, which aspects of a
     ing future technological developments will be          nanomaterial are most relevant in determining
     even greater. New oversight mechanisms are             its toxicity? As noted above, more than a dozen
     needed.                                                characteristics have been suggested even for
         This section describes the problems that           relatively simple nanomaterials. What will be
     may arise when the current system is applied to        needed in addition with more complex active
     next-generation nanotechnologies. Although             nanotechnologies? Without better scientific
     it focuses on U.S. oversight, some references          knowledge we do not know what data to col-
     will also be made to European institutions and         lect and examine. On the other hand, progress
     policies. The section begins with a description        in developing the necessary scientific knowl-
     of the requirements for an adequate oversight          edge often depends on having a lot of data on
     system so that the reader has a basis for evaluat-     specific materials. Only by having such data
     ing the current system. It then analyzes how           can we develop and test the needed scientific
     existing oversight programs would apply to             hypotheses.
     new technologies.                                           Oversight cannot directly improve scien-
                                                            tific knowledge. It can, however, make clear
        ReqUIReMenTS FOR An ADeqUATe                        the need for such knowledge, frame the ques-
                  OVeRSIGHT SYSTeM                          tions that need to be answered and, through
     An adequate oversight system must, at a mini-          requirements imposed on manufacturers,
     mum, be able to assess potential risks from a          generate the data needed by scientists. How
     technology, minimize the chances that the risk         to apply adequate oversight when the state of
     will occur and maintain surveillance to iden-          scientific knowledge is not adequate is one of
     tify risks that do occur. It should perform these      the basic dilemmas in developing and applying
     functions while minimizing adverse impacts             21st-century oversight mechanisms. In most
     on technological innovation or market func-            cases, the science related to risk will be primi-
     tions and while giving the public confidence           tive and uncertain, but the potential risks will
     that the system is effective and that it allows        be serious enough so that lack of oversight will
     public opinion to be heard.                            not be an acceptable option.
         The starting point for any oversight system             Once information about the potential risks
     is the ability to identify the risks that a technol-   of a new material or product has been obtained,
     ogy may pose and to assess the likelihood and          an adequate oversight system must be able to
                                Oversight of next-Generation nanotechnology                                21

impose requirements that prevent adverse ef-         assure that manufacturers know what informa-
fects from occurring or at least minimize the        tion is needed, collect the information in a reli-
risks from the new product. This can be done         able way and do not abuse their responsibility.
in a variety of ways. Restrictions may be put            Most existing oversight systems fall far short
on the product as a condition for allowing it        of the criteria outlined above. An examination
to be marketed. Standards may be established         of how specific current oversight authorities
to prevent worker or environmental expo-             would apply to new nanotechnologies reveals
sure while the product is being manufactured,        many problems.
transported, stored, used or disposed of. Re-
strictions or requirements may be imposed on             eXISTInG OVeRSIGHT APPLIeD TO
the product after it has been marketed, or the       neXT-GeneRATIOn nAnOTeCHnOLOGY
manufacturer may be required to withdraw the         Existing oversight of nanotechnology applies
product from the market altogether. Additional       to three categories: substances, products and
steps can be taken to encourage green design         wastes. Each category poses particular kinds
and pollution prevention.                            of problems.
    Because of the complexity of new technolo-           Nanomaterials or substances are regulated
gies and the rapid pace of invention and adop-       in the United States by TSCA and in Europe
tion, the science will probably be inadequate        by the regulation on Registration, Evaluation,
to fully identify all the risks a new material or    Authorization and Restriction of Chemicals
product will pose. For this reason, even more        (REACH). The term substances is used in U.S.
than in the past, it will be necessary to estab-     law; chemicals is used in EU law and materials is
lish requirements and systems for identifying        used in scientific and common parlance. This
adverse effects of a product after it is in com-     report uses the three terms interchangeably.
mercial use. A high degree of international              TSCA’s weaknesses have been documented
cooperation will be necessary for such systems       elsewhere (see Davies 2006, 2007; Schierow
to work effectively.                                 2007). The act is unable to regulate existing
    These oversight requirements should be ap-       substances at all. EPA has explicitly declined to
plied with a constant awareness of the need to       consider nanomaterials as new substances un-
encourage technological innovation and eco-          less they have a novel molecular structure, and
nomic growth. The “cowboy ideology” that             therefore most nanomaterials are not regulated.
views regulation as antithetical to free markets     Even manufacturers of the 30-or-so nanoma-
has proven to be false in sector after sector.       terials whose structures have been considered
Productive markets require effective regulation.     novel have not, with one exception, been re-
However, there is an undeniable tension be-          quired to submit safety data. EPA must show
tween the two. It is unlikely that government        that the substance poses an “unreasonable risk”
agencies will improve their efficiency, speed        before it can require the data to determine
and expertise sufficiently to keep pace with         whether the substance poses a risk.
technological innovation. To avoid setting up            TSCA was enacted in 1976 and has not been
large obstacles to that innovation, oversight        significantly changed since that time. REACH,
mechanisms will have to rely more on manu-           by contrast, is a relatively new regulation; it was
facturers to assess and control risks. At the same   enacted by the European Union (EU) in 2007.
time, oversight will have to be structured to        It erases the distinction between new and old

     substances, and it puts the burden of proof on     and a residual category of consumer products
     the manufacturer to show that a substance is       for which the Consumer Product Safety Com-
     safe. However, many of the REACH require-          mission (CPSC) is, in theory, responsible. The
     ments are triggered by volume of production,       structure in the EU is similar in the sense that
     generally an inappropriate metric to apply to      multiple product categories are regulated by a
     nanomaterials. Since REACH’s enactment             variety of agencies at both the national and EC
     there have been ongoing discussions in the Eu-     levels. The U.S. product-focused systems vary
     ropean Commission (EC) about how nanoma-           in stringency. Most are on the more stringent
     terials should be treated under the regulation.    end of the spectrum, placing the burden of
     (For the current status of these discussions see   proof on the manufacturer and requiring ex-
     European Commission 2008.)                         tensive safety testing. However, as an example
         As will be discussed in the next section of    at the other end of the spectrum, the CPSC
     this paper, oversight of future nanotechnolo-      is so lacking in legal authority and financial
     gies will probably have to focus on products       resources that most consumer products in the
     rather than on substances because the same         United States are, for all practical purposes,
     substance will have widely different impacts       unregulated (see Felcher 2008). Although
     depending on the products in which it is used.     more than half the nanoproducts in the PEN
     Beyond that, the new technologies will pose        inventory are under CPSC’s jurisdiction, the
     major problems for both TSCA and REACH.            commission to date has spent only $20,000 on
     Will a nanostructure composed of a few mol-        nanotechnology (for a literature search) (Ibid.).
     ecules be considered a chemical? If the nano-          Because the specific characteristics of specific
     material or structure changes form when            products are likely to determine the adverse
     exposed to particular stimuli, which form is       effects that might occur, future oversight will
     subject to regulation? If nanoscale substances     need to focus primarily on products. The basic
     self-assemble to create new substances, how        difficulty, from the oversight perspective, is the
     will that be regulated? These are just some of     overwhelming number of products that exist
     the reasons that a focus on products is likely     and the large number of new ones that come
     to be necessary. Although REACH is far su-         on the market daily. Furthermore, most prod-
     perior to TSCA in its ability to protect the       ucts do not pose serious risks to health or the
     public, neither regulatory scheme is likely to     environment, so trying to regulate all of them,
     be effective in providing oversight for new        even if possible, would be a significant waste of
     nanotechnologies.                                  resources. It is neither possible nor desirable that
         Some regulatory programs in the United         the government regulate all products, and it will
     States and Europe focus on specific products.      be even less possible in the future as the number
     In the United States, these products include       and variety of products increase.
     drugs, medical devices and food additives              The third type of regulatory program fo-
     regulated by the Food and Drug Administra-         cuses on pollution and wastes or, in the case
     tion (FDA); pesticides and fuel additives that     of occupational safety and health, on places.
     are registered by EPA; beef, poultry and some      In the United States, examples are the pro-
     other farm products regulated by the Depart-       grams under the Clean Air and Clean Water
     ment of Agriculture; vaccines regulated by the     Acts, the laws dealing with disposal of hazard-
     Centers for Disease Control and Prevention;        ous substances and the Occupational Safety
                                 Oversight of next-Generation nanotechnology                               23

and Health Act. In the EU, pollution is dealt             The inadequacy of the current system to
with primarily through the Integrated Pollu-          deal with new technologies is obvious. Espe-
tion Prevention and Control (IPPC) direc-             cially in the United States, regulatory oversight
tive. Workplaces are regulated primarily by the       has always been somewhat deficient, and over
governments of the member nations.                    the past 30 years it has been allowed to dete-
    For nanotechnology, and probably for other        riorate to the point where only major changes
future technologies as well, both monitoring          can rescue it. On both sides of the Atlantic, ex-
and control methods are problematic. In the           treme free market ideologies have contributed
absence of adequate pollution monitoring and/         to the erosion of oversight. Furthermore, there
or control methods, prevention has to be the          has been a failure to anticipate and analyze the
primary method of protecting humans and the           new technologies that are being created and
environment. In the United States, and per-           commercialized at an ever-increasing rate.
haps in Europe, waste laws focus on pollution             Gaps in the oversight system are signifi-
after it is created. They are not very effective      cant. In the United States, cosmetics and di-
in preventing pollution. The usefulness of pol-       etary supplements, both product types that
lution control laws is thus likely to be limited,     use nanotechnology and involve high human
and greater reliance will have to be placed on        exposure, are subject to laws that prohibit effec-
product control laws.                                 tive oversight.
    Moreover, pollution control laws are like-            Two of the most important oversight prob-
ly to become less important because greener           lems are large and encompassing but are fre-
manufacturing methods will result in reduced          quently overlooked. One problem is that no
pollution from manufacturing plants. This is          country has a comprehensive and coordinated
not to say that pollution problems will disap-        oversight system. Both the United States and
pear. In fact, a number of studies have shown         the EU have individual programs that deal
that current methods of producing nanomateri-         with particular aspects of nanotechnology, but
als are often energy intensive and use a variety      these programs are fragmented and uncoordi-
of toxic materials (Sengul et al. 2008; Kushnir       nated. In the United States there is no effort to
and Sanden 2008; Healy et al. 2008; Eckelman          develop an overall system for nano oversight,
et al. 2008; Singh et al. 2008). It is difficult to   much less for dealing with other new technolo-
evaluate the results of these studies, at least for   gies that will shape the 21st century (see, for
nanomaterials, because they do not take into          example, Rodemeyer 2009).
account either the smaller mass of nanomateri-            The second problem is the absence of in-
als produced or the environmental efficiencies        stitutions and mechanisms for dealing with
that result from nano applications. For example,      the social impacts of new technologies. We do
one study (Kushnir and Sanden 2008) empha-            not have good ways of examining the impacts
sizes that production of carbon nanoparticles is      of technologies or getting public input on the
“2 to 100 times more energy-intensive” than           impacts, and we often lack good tools for en-
production of aluminum, but the study mea-            couraging positive social impacts or discourag-
sures energy intensity per weight of production       ing negative ones.
without mentioning that, by weight, aluminum              The next section describes a new approach
production is five orders of magnitude greater        designed to address the problems of technol-
than carbon nanoparticles production.                 ogy oversight.

     This section explores what a more adequate           of these would be a basic function of the new
     oversight system might look like. The ap-            agency. Finally, the section analyzes several
     proach proposed is largely non-incremental           additional important areas that require new
     because, in the author’s view, the existing sys-     approaches—risk assessment, enforcement,
     tem is so deficient and the new challenges are       international cooperation and public involve-
     so different from those of the past that it would    ment. Each of these functions cuts across the
     be a mistake to try to deal with them by tin-        basic organizational building blocks described
     kering with the existing system. The political       earlier in the section.
     system operates incrementally except when
     faced with a crisis, and it is to be fervently             InSTITUTIOnAL FRAMeWORK
     hoped that no crisis arises with respect to nano     A new oversight system is urgently needed
     or any other technology. However, over the           both because of the pitiful state of the current
     long run, the political system also responds to      system and because of the nature of the new
     models of what could or should exist. Goals          challenges presented by technological change.
     and ideals, even if a sharp departure from the           The characteristics of the new technol-
     status quo, can influence the thinking of policy     ogy have been described above. The current
     makers and the public. Many of the changes           oversight system was designed to deal with the
     described below will take a decade or more to        problems of steam engine technology in the
     accomplish, but there is an urgent need to start     context of a pre-computer economy. It was
     thinking about them now.                             based on assumptions that most problems are
         The proposals set forth in this report are       local, that programs can be segmented and iso-
     intended to be the start of a dialogue, not its      lated from each other, that technology changes
     conclusion. The purpose is to draw attention         slowly and that all the important problems have
     to the need for basic reform and to frame the        been identified. All of these concepts are no
     magnitude and direction of the needed chang-         longer valid, if they ever were.
     es. If the proposals catalyze a serious discussion       The antiquated conceptual basis of the sys-
     of oversight policies to deal with the problems      tem has been made more evident by the mas-
     of the coming decades, then this report will         sive erosion of money and manpower from a
     have achieved its purpose.                           system that always suffered from inadequate
         A new system requires a new organization,        resources. However, resources alone are not
     new legal authorities and new oversight tools.       what is needed. New concepts, new types of
     This section begins with a description of a new      organizations and new tools are necessary to
     hypothetical organization, the Department            provide the knowledge and flexibility for ef-
     of Environmental and Consumer Protection.            fective oversight.
     Then, to describe the new authorities and tools          A new structure for 21st-century oversight
     that would be required and to flesh out the          requires more integrated approaches at every
     nature of the new organization, the paper dis-       level. The current fragmented system was tol-
     cusses product regulation, pollution control,        erable as long as the problems were limited in
     monitoring and technology assessment. Each           scope and localized in scale. This is no longer
                                 Oversight of next-Generation nanotechnology                                25

the case. The problems of the 21st century have       agency with an oversight component. Both
a potentially broad impact that is not limited to     the research and assessment component and
any single geographic area. They do not and           the monitoring component of the new agen-
will not fit into the compartments delineated         cy would focus on science, and each of these
by current legislation.                               components probably would be larger than the
    At the level of individual programs, frag-        oversight component. The scientific complex-
mentation hinders effectiveness now. There are        ity of 21st-century problems requires oversight
almost more pollution control programs than           agencies that have strong scientific compe-
anyone can count, and pollution control and           tence.
prevention are handicapped because current                An additional need is for laws and organi-
government regulations focus narrowly on air          zations that are flexible enough to respond to
pollution, water pollution or various forms of        the characteristics of technology described in
disposal. In another area, environmental moni-        the first part of this paper. The existing U.S.
toring is inefficient and unsatisfactory because      federal oversight agencies have generally been
of the multiple agencies trying to monitor in-        too small to have much flexibility. All their
terconnected parts of the environment, each           resources are devoted to survival and to the
agency doing it in its own way.                       performance of the minimal required func-
    At a broader level, regulation of different       tions; they have limited ability to anticipate
kinds of products can benefit from draw-              and respond to new problems or to consider
ing on the same risk research or the same             new ways of doing things.
systems for monitoring adverse effects. Dif-              Meeting these needs would require both
ferent types of research can benefit from a           new laws and a new organization. This short
single source of monitoring data. There are           paper does not cover new laws in any detail,
many such synergisms.                                 although some suggestions are included in the
    Another pressing need is for scientific sup-      discussion below. A new organization that
port that is based on high-quality research and       would provide more integration, better science
that is relevant to the needs of oversight. In        and more flexibility is outlined in Figure 2.
the United States, both EPA and FDA have                  The organization depicted in Figure 2
had the advantage of in-house scientific sup-         could provide a more adequate basis for over-
port, but the amount of support is inadequate.        sight than the current system does. It would
A recent report by a subcommittee of the              focus oversight on products, pollution and
FDA Science Board stated, “The FDA can-               the workplace, and do so in a more integrated
not fulfill its mission because its scientific base   way. In addition to an oversight function, the
has eroded and its scientific organizational          organization would have major components
structure is weak” (U.S. FDA 2007, p. 3).             devoted to monitoring and research. The re-
FDA and EPA have had problems attracting              search function would also deal with technol-
and retaining good scientists because most            ogy assessment and forecasting.
scientists would prefer to work for a science             A new agency would make many syner-
agency than for an oversight agency.                  gisms possible among the different functions
    Unlike the current EPA and FDA, which             and programs shown in Figure 2 and would
are oversight agencies with a scientific com-         facilitate integration of closely related programs.
ponent, the new agency would be a scientific          Although this paper focuses on nanotechnology,

     FIGURe 2. Hypothetical Department of environmental and Consumer Protection

                                                          Dept. of Envt’l & Consumer

                                                                 Research &
                             Oversight                                                                   Monitoring

                                                                Research Labs
                             Integrated                        Risk Assessment          Earth Systems   Health Effects   Bureau of Envt’l
     Product Regulation                       Workplace
                          Pollution Control                   Tech. Assessment         Science Agency   Surveillance        Statistics

     the reorganization would improve the govern-                        and personnel based on estimated need. The
     ment’s ability to handle almost all major envi-                     proposed agency would be among the smaller
     ronmental and consumer programs. For ex-                            federal cabinet departments but not the smallest.
     ample, it would allow climate change research                       In terms of full-time equivalent (FTE) personnel,
     and modeling to be brought together under                           for example, it would be ten times larger than the
     one agency (under the research and monitoring                       Department of Education and four times larger
     functions). The same agency would be respon-                        than the Department of Housing and Urban De-
     sible for controlling greenhouse gases (under the                   velopment. However, it would be half the size of
     oversight function), and the head of the agency                     the Treasury Department and a quarter the size
     could formulate overall climate policy with the                     of the Department of Homeland Security.
     benefit of advice from both the scientific and                          The new agency would be significantly
     regulatory components of the agency.                                larger than the current EPA or any of the other
         The new agency would incorporate six                            federal oversight agencies. The oversight func-
     existing agencies: EPA, the U.S. Geological                         tions should be housed in a larger organization
     Survey (USGS), the National Oceanic and                             not only because of the relationship between
     Atmospheric Administration (NOAA), the                              size and flexibility noted above but also be-
     Occupational Safety and Health Administra-                          cause the current small size of the regulatory
     tion (OSHA), the National Institute of Oc-                          agencies makes them vulnerable to becoming
     cupational Safety and Health (NIOSH) and                            even smaller. The “large getting larger” seems
     CPSC. New units would have to be established                        to be the organizational analogue of the rich
     for risk assessment, forecasting, technology as-                    getting richer. Smaller agencies have less influ-
     sessment, health monitoring and the Bureau of                       ence and are less able to influence policy than
     Environmental Statistics.                                           larger agencies are. Aside from this political
         The appendix provides some dollar and per-                      point, the small size of the oversight agencies
     sonnel estimates for the hypothetical agency.                       prevents them from being able to devote re-
     The estimates are based on the current size of the                  sources to new problems, and in the 21st cen-
     component agencies plus some additional dollars                     tury new problems will arise frequently.
                                 Oversight of next-Generation nanotechnology                             27

    Large size can have the disadvantage of           go through multiple stages, each stage being a
encouraging slow and rigid decision-making            separate product. For example, carbon nano-
and discouraging innovation and creativity. To        tubes (one product) can be combined with plas-
reduce these disadvantages, many of the com-          tic in a compound used for car bodies (a second
ponents of the new agency would be allowed            product), and that compound is incorporated in
to operate with a good deal of independence.          a finished automobile (a third product). A mate-
The success of the new organization would             rial is usually a product, and the same material
depend greatly on the degree to which it could        can be incorporated in many products.
strike a good balance between integration and              An oversight system based only on products
independence of the components.                       would be better than the current mixed system.
    Other functions could be added to the new         The way in which the material is used, the way
agency. For example, food-safety programs,            it is combined with other materials, and other
currently scattered among four federal agen-          factors are critical for determining whether
cies, could be consolidated in the proposed           adverse effects will occur (Royal Commission
department. However, this function and other          on Environmental Pollution 2008). There-
functions are not included here because they          fore, materials by themselves do not provide
are subject to other legislative proposals or         a good basis for evaluating risk. If some types
other considerations beyond the scope of this         of carbon nanotubes can cause asbestos-type
paper. Consideration should be given to cre-          problems, for example, these problems can
ating a commission to consider the composi-           be avoided by combining the nanotubes with
tion of the new agency as well as possible new        other materials, by using them only in closed
oversight laws and tools.                             systems or by making minor changes in the
                                                      form of the nanotubes. Regulation of products
          PRODUCT ReGULATIOn                          will capture these differences—regulation of
A central question for oversight is whether it        the material will not. Whether it is possible to
should focus on materials or products. The            establish an oversight system based on products
answer will determine many of the most im-            rather than materials will depend on what the
portant parameters of the oversight system.           system looks like.
The current oversight systems focus on both                At least two principles should underlie
materials and products. Materials are regu-           oversight of products. First, oversight should
lated by TSCA and REACH; various kinds of             encompass the life cycle of the product—man-
products, (e.g., drugs, pesticides and beef ), are    ufacture, use and disposal. Transportation is
regulated under a variety of other laws.              also part of the life cycle, but it can be regu-
    Materials are substances with particular char-    lated separately by the Department of Trans-
acteristics. TSCA defines them as substances          portation. Second, the degree of oversight,
with a particular molecular composition, al-          i.e., the stringency of regulatory requirements,
though size or form should be added as a relevant     should be related to the anticipated harm the
defining characteristic to deal with nanotechnol-     product will cause. This is a function of the
ogy. Other characteristics of a material, such as     severity of anticipated harm and the likelihood
radioactivity, may also be relevant for oversight.    that it will occur.
    Products are items that are sold to public con-        The government is not likely to have
sumers, manufacturers or others. A product may        detailed and current information about the

     composition of a product, its intended use or        efficiency, restricted substances and recycling.
     its anticipated effects. Only the manufacturer       DuPont, in cooperation with Environmental
     will be able to know or obtain this informa-         Defense, developed a framework for analyzing
     tion on a timely basis. Thus, the government         the risks of nanomaterials (www.nanorisk-
     inevitably must depend on the manufacturer  The framework is applied
     to reliably test the product and to accurately       to all new DuPont nanoproducts. For many
     report relevant information to the government.       chemicals, the SP would resemble the chemical
     The penalties for distorting, concealing or fail-    safety assessments required under REACH.
     ing to obtain required data must be sufficiently          Because every product (except those ex-
     great to deter such behavior.                        empted) would have to have an SP, manufac-
         A previous report (Davies 2006, p. 19) sug-      turers would be able to know the potential
     gested that the information required of the          risks of components they use by requiring their
     manufacturer be incorporated in a sustain-           suppliers to provide them with the SPs for the
     ability plan (SP) that the manufacturer would        components. This would be a major benefit
     compile. A plan would be required for each           to manufacturers of complex products like
     product. The plan would contain a summary            automobiles. At present, auto manufacturers
     of known information about the components            may be legally liable for problems caused by
     of the product, the adverse effects of the prod-     components they use, but they may have no
     uct, a life-cycle analysis of the product describ-   practical way to find out what the risks of the
     ing its use and manner of disposal and an ex-        components are. REACH (Article 34) requires
     planation of why the product would not cause         risk information to be passed on from any ac-
     any undue risk. The government would define          tor in the supply chain to the next actor or
     as precisely as possible what data are required      distributor up the supply chain.
     and what constitutes undue risk. Risk would               Special efforts will be needed to inform
     include mechanical risks (e.g., from chainsaws       small businesses about the requirements and
     or collapsing baby cribs) as well as chemical        to provide these businesses with technical as-
     and biological risks. It seems reasonable to re-     sistance to help them meet the requirements.
     quire every manufacturer of a product to know        A variety of programs can be used to do this.
     this information before selling the product.         Small businesses should not be exempted from
     The government could require additional in-          oversight because some of the most dangerous
     formation for particular categories of products.     products are made by small manufacturers, and
     The SP would have to be updated if the manu-         it is not unreasonable to expect them to assess
     facturer became aware of new information that        whatever dangers their products might pose.
     affected the product’s risk.                              What would be done with the sustainability
         A number of firms have voluntarily pro-          plan and what additional information, if any,
     duced statements similar to a sustainability         it would have to contain, would depend on
     plan. For example, Apple issued an environ-          the harm the product might cause. A possible
     mental report on its MacBook Air laptop              typology is as follows:
     computer (                   Category 1: This category would be for
     resources/pdf/MacBook-Air-Environmental-             products that have a very low probability of
     Report.pdf ). The report includes sections on        having adverse effects. There would be no
     climate change, energy efficiency, material          oversight; the SP would simply be retained by
                                Oversight of next-Generation nanotechnology                           29

the manufacturer, or, if there were clearly no      government to designate which category the
significant risks, the product manufacturers        product belonged in.
might be exempted from the SP requirement              For categories 3 and 4, the burden of proof
altogether. Examples of category 1 products are     would be on the manufacturer to demonstrate
books, furniture and some industrial tools—         that the data in the SP were valid and adequate
probably 70–90 percent of all products in com-      and that they supported the conclusion that the
merce. There is always the possibility that new     product would not or did not pose undue risk.
evidence will move a category 1 product to a        The government might have to show some
different category.                                 cause for categorizing a product as category 3.
    Category 2: This category would be for             As noted above, the major challenge in
products for which risk-communication mea-          regulating products is the enormous number
sures should be sufficient to avoid adverse ef-     of products on the market at any given time.
fects. The manufacturer would be required to        For example, CPSC oversees 15,000 types of
use the SP as the basis for a product safety data   products, and each type contains numerous
sheet to be given to users and/or for labeling      individual products. Inevitably, the number
for consumers. Examples of products in this         of products placed in each category would, to
category would include some household clean-        some extent, be determined by the resources
ing products and industrial catalysts that are      available to the government oversight agency.
consumed in the manufacturing process.              The first two categories would require only
    Category 3: Post-market review of the           spot checking by government, and category
SP by government. This category would con-          3 probably would apply to only a relatively
sist of category 1 or 2 products suspected of       small number of products. Category 4 would
causing adverse effects after having been sold.     require intensive use of government resources.
The government would be empowered to halt           Consideration should be given to paying for
manufacture and/or distribution of the product      product approval through fees, as is now done
pending a review of its safety.                     for drug registration by FDA, although steps
    Category 4: This category would be for          would need to be taken to avoid some of the
products that have some probability of causing      problems with the FDA system. Consideration
adverse health or environmental effects. There      should also be given to making public on a reg-
would be pre-market review of the product.          ular and timely basis whatever gap may exist
Products in category 4 would include pesti-         between resources and oversight requirements.
cides, fuel additives and products containing       This could be done by requiring the agency to
designated types of materials (e.g., persistent     regularly publish the number of products that
organic pollutants).                                should be reviewed but for which resources
    The government would define the cat-            were not available to do the review.
egories and decide which products belong
in which categories. To the extent possible,           InTeGRATeD POLLUTIOn COnTROL
the government would assign broad classes of        Pollution control is control or prevention of
products to particular categories. If a manu-       harmful wastes. Pollutants are unwanted by-
facturer wanted to produce a product that was       products of manufacture or use. Unlike ma-
not included in one of the previously assigned      terials or products, they have no value and the
classes, it would have to submit a request to the   oversight goal can be to reduce pollutants to

     the smallest amount possible. This goal is not       (air pollution control, etc.) requires several
     applicable to materials or products because,         different types of permits, and in addition to
     since they have value, the benefits of the prod-     the federal permits there are state and local
     uct to society must be weighed against the cost      permits. A large facility will require several
     of its adverse effects. Even with respect to toxic   filing cabinets (or many megabytes of com-
     materials it is necessary to consider the benefits   puter space) for the contents of the different
     they provide. Pollutants that can be recycled        permits it holds. The system not only results
     become, strictly speaking, products because          in bureaucratic duplication and confusion but
     someone will pay for them and therefore they         also makes permitting opaque to the public.
     have a value.                                        Moreover, because of the fragmentation, it
         The dividing lines into which pollution          fails to control a significant portion of a facil-
     control has been segmented are a significant         ity’s environmental impact (Ibid.). Although
     handicap in dealing with present and future          the EU’s IPPC system operates in a political
     problems. For example, control of nanopar-           and cultural context different from that of the
     ticles released during manufacture must be           United States, the United States would benefit
     based on preventing the releases from occur-         from adopting an approach more like the EU’s.
     ring. Trying to deal with the problem by sepa-           The linkage between oversight of prod-
     rately regulating releases to the air or the water   ucts and control of pollution (wastes) has not
     or land, as current law does, will not work.         been adequately explored on either side of the
         In Europe, integrated pollution control is       Atlantic. Regulation of materials and prod-
     a reality (U.S. EPA 2008). In 1996, the EU           ucts may, in some cases, be the most effective
     approved the IPPC directive. The directive           and efficient way of preventing or reducing
     mandated that each EU member nation es-              wastes. In the United States, the linkage is rec-
     tablish a system based on an integrated pollu-       ognized—TSCA authorizes the EPA Admin-
     tion permit for each facility. The EU set up a       istrator to, among other things, regulate the
     mechanism to assist the countries with such a        manufacture, use and disposal of a substance
     system, in particular by defining sector-spe-        that presents or will present an unreasonable
     cific Best Available Technology, the standard        risk (TSCA sec. 6(a)). However, these authori-
     to be incorporated in each permit. The IPPC          ties have rarely been used. In the 30-year his-
     permits cover not only disposal to air, water        tory of TSCA, EPA has used these authorities
     and land, but also such matters as energy and        to regulate a total of six existing chemicals
     water use, noise and odors, accidents and facil-     (Schierow 2007, p. 17). It is likely that to deal
     ity decommissioning.                                 with future problems, the product control laws
         As stated in a comprehensive U.S. govern-        will need to become a more significant part of
     ment report on IPPC permits in the United            environmental protection.
     Kingdom, “the U.S. does not have a corre-
     sponding, all-inclusive environmental statute             TeCHnOLOGY OVeRSIGHT AnD
     to address emerging challenges on a compre-                           ASSeSSMenT
     hensive, ongoing, and straightforward ba-            A technology can be defined either as a body of
     sis.” (U.S. EPA 2008, p. xi). A U.S. facility        scientific knowledge and its application or as
     typically must have dozens of environmental          the practical application of a particular body
     permits (Davies 2001). Each federal program          of scientific knowledge. To the extent that
                                Oversight of next-Generation nanotechnology                               31

the definition includes scientific knowledge,        change and estimating future sales of comput-
it probably would be impossible to regulate          ers are all elements of technology assessment.
this kind of knowledge and, even if it were          However, what is needed is a capability to con-
possible, it would be counterproductive. Over-       sider the overall impacts of major new tech-
sight focuses on the applications of a technol-      nologies and to do so while there is still time to
ogy. However, the line between the science           deal with the impacts. This requires a forecast-
and its applications may be difficult to draw,       ing capability as well as an assessment capabil-
especially when dealing with the social impli-       ity. The techniques for doing forecasting and
cations of technology. Would a new material          assessment have not received the attention they
that enabled the human brain to grow addi-           need. Not coincidentally, the institutions for
tional neurons be considered science or the          making forecasts and conducting assessments
application of science? Focusing on particular       are weak or non-existent (see Davies 2008,
applications may miss the overall impacts of a       pp. 23-24).
technology, and by the time the implications             Involving the public in the evaluation of
of the applications become clear it may be too       new technologies poses many difficulties. It
late to effectively influence the direction the      should be understood that the public will be-
technology takes. With only a few exceptions         come involved, politically and economically, as
(e.g., nuclear power) technology as such is not      protestors or boosters or customers. However,
and should not be regulated in the same sense        the involvement is mostly after the technol-
that products and wastes should be regulated.        ogy has become established. The future of the
However, oversight can take forms other than         world’s people will be shaped by new technol-
regulation.                                          ogies, but there is usually no opportunity for
    The impacts of new technologies on so-           people to consider which technologies should
ciety in the 21st century will be huge. We           be promoted, which should be discouraged
can deal with these impacts to some extent           and how to deal with the consequences and
by regulating products, materials and wastes.        impacts of any particular technology before
But many of the most important impacts will          the impacts occur.
not be captured within these categories. When            How the government should influence the
one thinks of the impacts of the automobile          direction of new technology is also a knot-
on society, air pollution does not seem to be        ty question. The government exerts a major
among the biggest, important as it is. Three         influence now through financial support for
things are needed for oversight of technology:       private research and development, appropria-
(1) an assessment of the technology’s impacts,       tions for defense and other science-intensive
especially unintended impacts; (2) ways for          government programs and regulations (or the
the public to understand the technology’s im-        absence of regulations) on various activities.
pacts and register its views; and (3) ways for the   All these actions usually are taken piecemeal,
government to translate the public’s views into      without any coherent strategy for the overall
actions. None of these requirements is being         technological future of the world or even for
satisfactorily met.                                  the future of any particular technology.
    In one sense, technology assessment is done          Consideration should be given to using
all the time. Measuring pollution from vari-         “social impact statements” analogous to the
ous sources, modeling the impact of climate          environmental impact statements required of

     government projects. The statements would          $1 billion budget and 8,500 employees (Ibid.).
     provide a vehicle for the public to learn about    The structure in Figure 2 would adopt the
     new technologies and for both the public and       experts’ proposal but would make the Earth
     the government to consider what steps, if any,     Systems Science Agency a semi-independent
     should be taken to maximize the beneficial         part of the proposed Department of Envi-
     impact of the technology and to minimize its       ronmental and Consumer Protection. The
     adverse effects. Who would prepare the state-      monitoring part of the department also would
     ments, when would they be prepared, what           include the EPA monitoring functions and a
     would be their scope and level of detail and       Bureau of Environmental Statistics, analogous
     how they would be disseminated are all ques-       to the Bureau of Labor Statistics. The bureau
     tions that would need to be answered.              proposal has been around for 20 years and has
         Individual government agencies need to         several times come close to becoming law,
     become more aware of their impact on techno-       but has never quite made it usually because
     logical development and of the impact of tech-     of extraneous factors.
     nologies on society. The foremost example is           In addition to the Earth Systems Science
     the military, which has given us a large number    Agency, there should be a human-health
     of significant technologies ranging from DDT       monitoring component. Given the uncertain-
     to the Internet. The Department of Defense         ties of risk assessment for new technologies,
     should establish a Defense Technology Review       some adverse consequences of new products
     Board to weigh the civilian as well as the mili-   will probably be missed when the product is
     tary consequences of new military technology.      first commercialized. These consequences will
     Board members would have to be privy to all        not be identified unless there is an extensive
     aspects of defense research and development.       surveillance system that spots abnormal health
     The board would provide advice both to the         phenomena such as an excess number of cases
     military departments and to the President’s        of a given disease or a spike in emergency room
     Science Advisor.                                   admissions. It is beyond the scope of this paper
                                                        to provide details about such a system, but it
                    MOnITORInG                          should be coordinated with other domestic and
     Monitoring is an essential part of oversight. It   international health reporting systems and it
     provides the link between government actions       should be as unobtrusive as possible.
     and the real world. The institution outlined
     in Figure 2 would do two types of monitor-                      RISK ASSeSSMenT
     ing—environmental and human.                       The above discussion provides some detail
         Environmental monitoring in the United         about the major components shown in Figure
     States includes a broad set of functions con-      2. Four functions cut across most of the com-
     ducted by a number of agencies. Recently, a        ponents: risk assessment, enforcement, inter-
     distinguished group of science policy experts      national cooperation and public involvement.
     proposed combining the two largest agencies,       Each of these will be discussed in the context
     NOAA and USGS, into a single, independent          of 21st-century technologies.
     Earth Systems Science Agency (Schaefer et             Adequate oversight of new technologies
     al. 2008). NOAA has a budget of nearly $4          will depend on our ability to forecast the risks
     billion and 12,000 employees. USGS has a           the technologies pose. Forecasting the risk
                                Oversight of next-Generation nanotechnology                                 33

involves basic scientific information about the      cheaper than current tests that rely on labora-
technology, test data on specific products and       tory animals (Service 2008).
risk assessment. Each of these components has            The type of risk assessment usually done
a different source and different characteristics.    by the government has evolved into a highly
    Basic scientific information comes pri-          sophisticated set of procedures. Risk assessment
marily from university and government                must be used if government decision makers
laboratories. The motives for developing the         are to make rational decisions.
information include scientific curiosity, the            Risk assessment was developed to meet the
possibility of obtaining grants and contracts        needs of decision makers. It did not grow out
and the possibility of making money through          of any scientific questions, and assessments typi-
patents and/or start-up companies. Meeting           cally are not scientific products; they are a way
societal needs, such as identifying the risks of     of organizing and analyzing data about a par-
new technologies, is often not a major con-          ticular substance or product. They are not sci-
sideration in setting the basic science agenda.      entific because only in unusual cases can they be
This is one reason why it is important for gov-      empirically verified. The typical risk assessment
ernment oversight agencies to have their own         may result in a finding that substance X will
scientific resources.                                produce Y number of additional cancer cases per
    Testing of specific products is done primar-     million people exposed. However, whether Y
ily by their manufacturers, either in-house or       is zero or 1,000 in reality will never be known
through contract laboratories. It is beyond the      and typically is unknowable because there are
resources of government agencies to test the         too many other causes of cancer. Regulatory
multitude of products and, in any case, the          decisions almost always must be taken based on
manufacturer will be most knowledgeable              the weight of the available evidence. Conclusive
about the products it is making.                     scientific proof is usually not to be had, although
    Testing for new kinds of products can            the better the available science the easier it is to
be problematic. For example, it is often not         do a risk assessment and the more accurate the
known what end points (e.g., cancer, asthma,         assessment is likely to be.
fish mortality) to look for when testing nano-           Because decisions typically must be based
materials nor is it understood which character-      on balancing the available evidence, the de-
istics of the material are associated with adverse   fault assumption about who has the burden
effects. In the absence of testing, conclusions      of proof is critically important. Rodemeyer
about the safety of a product or material are        (2009) has observed that “in many cases in-
often based on analogous materials that have         formation about risks of a new technology is
been tested. However, by definition, new             simply unavailable or uncertain. In such cases,
types of materials and products do not have          the regulatory decision depends upon the de-
exact analogues that have been tested. When          fault policy assumptions about the inherent
technologies are evolutionary, as many nano-         safety of the technology. In turn, the default
technologies are, analogues may help predict         policy assumption is shaped by the framing
behavior, but they are still generally not an al-    of the new technology in relation to existing
ternative to testing. The technology of testing      technologies.” (Also see Jasanoff 2005.)
is itself changing, and there has been progress          REACH primarily puts the burden on the
in developing tests that are much faster and         manufacturer to prove safety, whereas TSCA

     puts it on the government to prove risk. This             pollution control structure (see http://www1.
     makes REACH a more effective oversight law.     ; ac-
     Industry occasionally argues that the burden              cessed 11/11/08). Eff luent fees and charges
     should be on the government because it is not             have also been used in a few situations and have
     possible to prove safety, but this is a fallacious        been suggested as an approach that could be
     argument. It is not possible to conclusively prove        used more widely. It is not clear whether these
     the safety of a product just as it is usually im-         kinds of approaches could be used for oversight
     possible to conclusively prove the risk. Risk and         of useful products (as contrasted with wastes)
     safety are both operationally defined by required         and, at the least, caution must be exercised
     tests, and it is equally difficult to prove either one.   when proposing that incentives developed for
                                                               curbing wastes be applied to useful products.
                      enFORCeMenT                                  Insurance is another incentive that can be
     Enforcement has two related dimensions—in-                important. It can be used either negatively or
     centives and compliance. The stronger the in-             positively. Negatively, one insurance company
     centives the better the compliance, but the two           has already refused to insure for any damage
     dimensions involve different considerations.              connected with nanotechnology (Rizzuto
         The increasingly rapid pace of technologi-            2008), citing the lack of adequate risk infor-
     cal innovation and the diversity of the inno-             mation. If other companies follow suit, this
     vations have made it difficult to apply many              could be a major incentive for more research
     of the older enforcement approaches. Newer                and more testing of products by private firms.
     approaches have emphasized economic incen-                Insurers could deny insurance to manufactur-
     tives and flexibility. Liability has been used            ers that did not have a sustainability plan. On
     as the major incentive in one U.S. waste law              the positive side, insurance could be given to
     (the Comprehensive Environmental Response,                manufacturers against tort suits if the manu-
     Compensation, and Liability Act of 1980),                 facturer had an adequate sustainability plan and
     and it might be possible, for example, to make            had implemented that plan, and the tort suit
     manufacturers legally liable for failure to de-           covered a subject that was included in the plan.
     velop a sustainability plan or for any adverse                With respect to compliance, the key question
     consequences that could reasonably have been              probably is the extent to which voluntary com-
     foreseen but that were not included in the plan.          pliance can be relied upon. The answer depends
     A downside to using liability and litigation in           on the cultural context and may differ between
     implementing regulatory oversight is that gov-            Europe and the United States. At least for the
     ernment employees might have to spend large               United States, oversight in many contexts has
     amounts of time giving testimony in court,                shown voluntary compliance to be undepend-
     making depositions and participating in litiga-           able. Legally enforceable requirements, vigor-
     tion in other ways. This might seriously affect           ously implemented, are necessary to deal with
     their ability to perform their primary duties             the usually small, but important, percentage of
     (Mark Greenwood, personal communication).                 firms that are not good corporate citizens.
         Cap-and-trade programs, such as the one
     used in the U.S. regulation of sulfur dioxide                  InTeRnATIOnAL COOPeRATIOn
     emissions from power plants, have been pro-               The combination of a worldwide economy and
     posed as a substitute for much of the existing            near-instantaneous communication among
                                Oversight of next-Generation nanotechnology                              35

all nations has made technology oversight an        environmental effects that occur and that could
international issue. Every oversight function,      be attributed to a product. The OECD has
from research to enforcement, now has impor-        made a start on the first two. The third is an
tant international dimensions. The challenge is     important function that needs to be supported,
how to embody the international dimensions          perhaps by a joint effort of the World Health
in effective institutions.                          Organization and the UN Environment Pro-
    A web of international organizations exists.    gram. An international system for reporting
The EU is itself an international organiza-         adverse effects would have to draw heavily on
tion. The Organization for Economic Co-             existing surveillance systems.
operation and Development (OECD), which                  As this is written, the worldwide economic
includes most of the industrialized nations,        crisis and the collapse of the Doha round of in-
has taken a variety of initiatives related to new   ternational trade talks have made the future of
technology. It has agreed to test 14 generic        all international efforts uncertain. One outcome
nanomaterials for health and environmen-            of the current crisis could be a stronger set of
tal effects, and has established a database for     international institutions, even perhaps includ-
sharing research information on potential ad-       ing the basis for an internationalized system for
verse effects of manufactured nanomaterials         dealing with new technologies and products.
,en_2649_37015404_42464730_1_1_1_1,00.                         PUBLIC InVOLVeMenT
html). The United Nations has several com-          Transparency should be the hallmark of over-
ponents relevant to oversight including the         sight activities. Without it, the public interest
World Health Organization, the UN Envi-             tends to get submerged beneath the interests
ronment Program, and the International La-          of bureaucrats, politicians and special interests.
bor Organization. Many non-governmental             Transparency becomes even more important
international organizations, including inter-       in the context of new technologies because if
national trade associations and mixed public-       the public senses that secrets are being kept
private organizations such as the International     and motives are being hidden it may reject a
Organization for Standardization, play a part       new technology regardless of its benefits. As
in oversight efforts.                               the International Risk Governance Coun-
    In the long run, an international regime for    cil (2007, p. 8) has noted, the new technolo-
product oversight may develop to match the          gies will require more public involvement
international trade in products. At the least,      because their “social, economic and political
the U.S. and European regulatory approaches         consequences are expected to be more trans-
should be made consistent (see Breggin and          formative.” The challenge, as expressed by
Falkner 2009). In the interim, the emphasis         the Royal Commission on Environmental
should be on information sharing.                   Pollution (2008, p. 72), “is to find the means
    At least three types of information should      through which civil society can engage with
be made available internationally: (1) research     the social, political and ethical dimensions
results on adverse effects of a technology; (2)     of science-based technologies, and democra-
standards, regulations and other oversight poli-    tize their ‘license to operate’… a challenge of
cies and decisions applied to a product or tech-    moving beyond the governance of risk to the
nology; and (3) reports of any adverse health or    governance of innovation.”

         The 21st Century Nanotechnology Re-             oversight through their role as consumers, and
     search and Development Act, the law govern-         the products they buy may be influenced by
     ing nano research in the United States, requires    the opinions of the insiders.
     the National Nanotechnology Coordina-                   A goal of public policy has been to move
     tion Office to provide “for public input and        people from the bystander category to the
     outreach to be integrated into the [National        informed category. This is consistent with a
     Nanotechnology] Program by the conven-              Jeffersonian view of democracy and is an im-
     ing of regular and ongoing public discussions,      portant way of reducing the chances that the
     through mechanisms such as citizens’ panels,        public will react against a technology based on
     consensus conferences, and educational events,      propaganda or misinformation. How success-
     as appropriate” (PL 108-153, sec. 2(b)(10)(D)).     ful efforts to inform the public can be, what
     The National Science Foundation has experi-         methods can be used and how to draw the line
     mented with some of these techniques, but           between information efforts and propaganda
     overall, little effort has gone into implementing   are important subjects that are beyond the
     this part of the law. Other countries have also     scope of this paper.
     experimented with new public participation
     mechanisms to deal with technology (see, for                     THe PATH AHeAD
     example, Jones 2008).                               This is a short paper that covers a broad range
         In the context of new technology over-          of topics. A previous report (Davies 2008) laid
     sight, the public can be thought of as three        out the steps that can be taken in the short run
     groups: (1) the insiders—industry representa-       to improve nanotechnology oversight. This
     tives, non-governmental organizations, aca-         paper broadens the coverage in that the sugges-
     demic experts, labor union representatives;         tions for new oversight mechanisms cover all
     (2) the somewhat informed general public;           technologies, not just nanotechnology. It also
     and (3) the bystanders. The majority of the         stretches the timeframe—the focus is technolo-
     population falls in the category of bystand-        gies and policies over the next several decades.
     ers. They do not know about or understand           The paper is an exercise in both technology
     the new technologies and they do not follow         forecasting and policy envisioning. If the fore-
     what the government does or says about them.        casts are even roughly accurate, then thinking
     However, even the bystanders may influence          about new policies is urgently needed.
                                       Oversight of next-Generation nanotechnology                                             37


   Agency              Oversight                  Research                  Monitoring                      Total
                      $s          FTes           $s          FTes           $s          FTes           $s           FTes
   ePA              6,600        14,800         600          1,900         300           600         7,500       17,300
   CPSC               65          400                                                                  65           400
   OSHA              500         2,000                                                                500         2,000
   nOAA                                        1,750        5,500         1,500        6,800         3,250       12,300
   USGS                                         500         3,300         1,000        5,200         1,500        8,500
   nIOSH                                        265         1,409                                     265         1,409
   Other            1,000        1,000         3,025          500         1,050          200         5,075        1,700

   Total           $8,165        18,200       $6,140        12,609       $3,850        12,800      $18,155       43,609

Notes: For abbreviations see list of acronyms. Dollar figures are given in millions. All figures are author’s approximations
based on current strength of agencies that would be included in the new department, except for the “other” category which
is based on need rather than on existing agencies.


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