Professional Documents
Culture Documents
Effects Nano Tech Final
Effects Nano Tech Final
Effects Nano Tech Final
Nanotechnologies
T 202.691.4000
F 202.691.4001
www.wilsoncenter.org/nano
www.nanotechproject.org
I. Characteristics of Nanotechnology
David A. Metzner, Vice Chair
7
1. Defining NT PUBLIC MEMBERS
2. Rapid Development James H. Billington, The Librarian of Congress; Bruce Cole, Chairman, National
3. Lack of Effects Data Endowment for the Humanities; Michael O. Leavitt, The Secretary, U.S. Department of
16 The PROJECT ON EMERGING NANOTECHNOLOGIES was launched in April 2005 by the Wilson
1. Coordinating Mechanisms Center and The Pew Charitable Trusts. It is dedicated to helping business, governments, and
2. Amending Existing Laws the public anticipate and manage the possible human and environmental implications of
3. Strengthening Existing Laws nanotechnology.
IV. A New Law 18 THE PEW CHARITABLE TRUSTS serves the public interest by providing information, advancing
1. Description policy solutions and supporting civic life. Based in Philadelphia, with an office in
2. Advantages and Disadvantages Washington, D.C., the Trusts will invest $204 million in fiscal year 2006 to provide organi-
3. Other Options zations and citizens with fact-based research and practical solutions for challenging issues.
V. Incentives for Environmentally Beneficial Technology 24 The WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS is the living, national memo-
1. Research rial to President Wilson established by Congress in 1968 and headquartered in
2. Tax Breaks Washington, D.C. The Center establishes and maintains a neutral forum for free, open and
3. Acquisition Programs informed dialogue. It is a nonpartisan institution, supported by public and private funds and
4. Regulatory Advantages engaged in the study of national and international affairs.
Bibliography 31
Managing the Effects
of NANOTECHNOLOGY
J. Clarence Davies
Senior Advisor, Project on Emerging Nanotechnologies
and Senior Fellow, Resources for the Future
The opinions expressed in this report are those of the author and do not necessarily reflect
views of the Woodrow Wilson International Center for Scholars or The Pew Charitable Trusts.
1
Preface
This paper has two purposes.The first is to describe the menu of possibilities for government
action to deal with the adverse effects of nanotechnology (NT). If there are important alter-
natives that are not described here it is because of inadvertence or ignorance.
The second purpose is to provide evidence relevant for determining what needs to be
done to manage NT. When I began this work, my initial assumption was that there was no
need for new statutory authority. As I learned more about the unique aspects of NT and
thought more about the weaknesses of existing statutes, I was increasingly led to the conclu-
sion that a new law is needed.This paper, however, is not an advocacy piece for a new law. It
would have been written quite differently if that were its purpose. Rather, it is a policy analy-
sis, intended to give the reader the information relevant for thinking about a course of action.
In short, the paper is intended to inform, not persuade.
A word needs to be said about the paper’s title. In the coming decades, NT is likely to
change many aspects of our lives, hopefully for the better. New materials and products will
revolutionize the way we do many things. I do not address these kinds of effects. The time
frame of the paper is the next five-to-ten years, and the primary focus is on managing poten-
tial adverse effects of NT.
I am grateful to the Project on Emerging Nanotechnologies for its generous support and
encouragement, and also to Resources for the Future for its continuing support.A number of
individuals have been generous in giving their time to read the paper and answer stupid ques-
tions from the author. I am particularly grateful to Julia Moore, who initiated this project, and
to Dave Rejeski, Andrew Maynard, Barbara Karn and Evan Michelson, all of the Wilson
Center.Among others who gave generously of their time were William K. Reilly, Mike Taylor,
Mark Greenwood and Michael Rodemeyer. Jeff Porro did an excellent job editing the man-
uscript.The input of all these people has greatly improved this paper, but all responsibility for
what it contains remains solely with the author.
3
Executive Summary
Nanotechnology (NT) is the production and use of materials at the smallest possible scale—
100 nanometers or less. One hundred nanometers is approximately 1/800th the width of a
human hair and 1/70th the diameter of a red blood cell. Materials at the nanoscale often
exhibit very different physical, chemical, and biological properties than their normal size
counterparts. While we know little about possible adverse effects of nanotechnology, we
know enough to recognize that there needs to be some type of governmental oversight to
ensure that public health and safety are not adversely affected.This paper reviews the options
currently available to provide oversight, looking at the entire suite of federal government reg-
ulations, and concludes that:
Nanotechnology is difficult to address using existing regulations. There are a number of
existing laws—notably the Toxic Substances Control Act; the Occupational Safety and
Health Act; the Food, Drug and Cosmetic Act; and the major environmental laws (Clean Air
Act, Clean Water Act, and Resource Conservation and Recovery Act)—that provide some
legal basis for reviewing and regulating NT materials. However, all of these laws either suf-
fer from major shortcomings of legal authority, or from a gross lack of resources, or both.
They provide a very weak basis for identifying and protecting the public from potential risk,
especially as nanotechnologies become more complex in structure and function and the
applications become more diverse.
A new law may be required to manage potential risks of nanotechnology. The law would
require manufacturers to submit a sustainability plan which would show that the product will
not present an unacceptable risk, a term that is further discussed in the paper. The political
obstacles to passing new legislation are very large, though not impossible, and the drawbacks
of trying to fit NT under existing laws make the attempt worthwhile.
New mechanisms and institutional capabilities are needed. The paper describes several
mechanisms to encourage beneficial applications of NT. These include research, tax breaks,
acquisition programs, and regulatory incentives. It then outlines institutional needs in four
areas: international harmonization, foresight capability, research on adverse health and envi-
ronmental effects, and public participation.
If nothing specific is done to manage nanotechnology’s possible adverse effects, a range of
undesirable developments could emerge. The public potentially would be left unprotected,
the government would struggle to apply existing laws to a technology for which they were
not designed, and industry would be exposed to the possibility of public backlash, loss of
markets, and potential financial liabilities.The challenges presented by nanotechnology are as
many and varied as the promises that NT holds for a better life. If nanotechnology is to ful-
fill its promise, society must openly face the issues of whether the technology has or could
have adverse effects, what these effects are, and how to prevent them in the future.
5
Dr. Davies, a senior advisor to the Project on Emerging Nanotechnologies and a senior fel-
low 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 pollution, the
tendency of pollutants to move across boundaries, from air to water to land, revealing short-
comings in the legal and regulatory framework.
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
Executive Vice President of The Conservation Foundation, a non-profit think tank on envi-
ronmental policy; Executive Director of the National Commission on the Environment; and
a senior staff member at the Council on Environmental Quality, where among other activi-
ties, 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 Decision 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 (AAAS) 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,
Pollution Control in the United States, and several other books and monographs addressing envi-
ronmental 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.
Managing the Effects of Nanotechnology 7
Characteristics of Nanotechnology
Nanotechnology (NT) is the production and new uses. The third is NT’s possible adverse
use of materials with purposely engineered effects. Right now, we know very little about
features close to the atomic or molecular scale. these effects.
NT deals with putting things together atom-
by-atom and with structures so small they are 1. Defining NT
invisible to the naked eye. It provides the abil- The definition of NT is subject to some con-
ity to create materials, devices and systems with fusion and controversy, and is complicated by
fundamentally new functions and properties. the fact that there are naturally occurring
The promise of NT is enormous. It has nano-size materials and other nano-size parti-
implications for almost every type of manufac- cles that occur as byproducts of combustion or
turing process and product. Potential NT industrial processes. Size is critical in any defi-
applications in the next few decades could pro- nition of NT, but there are a variety of defini-
duce huge increases in computer speed and tions in circulation. Some of the differences
storage capacity, therapies for several different over definition are of only academic interest,
types of cancer, much more efficient lighting but the way NT is defined in a regulatory con-
and battery storage, a major reduction in the text can make a significant difference in what
cost of desalinating water, clothes that never is regulated, how it is regulated, and how well
stain and glass that never needs cleaning.While a regulatory program works.
the benefits are almost limitless, they will be The U.S. National Nanotechnology
realized only if the potential adverse effects of Initiative (NNI) defines NT as “the under-
NT are examined and managed. standing and control of matter at dimensions of
NT is new, but the effort to understand and roughly 1 to 100 nanometers … nanotechnol-
manage its effects will be long-term. As the ogy involves imaging, measuring, modeling,
world community tries to reduce the adverse and manipulating matter at this length scale”
effects of the technology, our understanding of (www.nano.gov accessed 10/6/05). The
these effects will steadily increase. At the same Europeans tend to define it more simply as the
time, as the technology advances and commer- technology dealing with applications and
cial applications multiply, new challenges and products with engineered structures smaller
problems will arise.The topics covered in this than 100 nanometers (Swiss RE 2004 p.11;
paper will be with us for decades. The Royal Society 2004, p.5). For comparison,
Three aspects of the technology are relevant a single human hair is approximately 80,000
to questions of how to manage it.The first is its nanometers wide, and a red blood cell is
definition. NT covers a wide variety of approximately 7,000 nanometers wide (Royal
processes and materials. One must consider Society 2004, p. 5).
whether it makes any more sense to talk about In the context of this paper, the question of
regulating or managing NT than it does to talk definition raises at least two important further
about regulating or managing things that are questions: 1) Does it make sense to regulate or
blue or things that are very large.The second is manage a collection of processes or materials
the rapid development of the technology. It has on size alone? 2) Can a definition be formulat-
quickly found new applications and it will ed that allows both manufacturers and regula-
continue to expand into new materials and tors to know what is included and what is not?
8
The basic reason that it makes sense to This does not necessarily mean that existing
regulate NT as a separate category is that NT statutes cannot be used, but, at a minimum,
materials behave differently from convention- they will require adjustment and adaptation.
al materials. The properties of NT materials Sections II and III of this paper discuss the
are often not predictable from the laws of application of existing authorities to NT.
classical physics and chemistry. The laws of When discussing the management of NT
electricity that apply to bigger things may not as a separate category, it may be useful to dis-
hold for NT materials. A material that con- tinguish between NT processes and NT
ducts electricity at normal size may be an materials. The latter almost certainly will
electrical insulator at NT size, and vice versa. require basic changes in government regula-
We do not know enough about the toxicity tory programs. NT processes, on the other
and environmental effects to know whether hand, may be more amenable to regulation
NT materials are also different in these under the Occupational Safety and Health
respects, but it is likely, for example, that the Act (OSHAct) and existing environmental
toxicity of NT materials is more related to laws. Section II discusses this in more detail.
their surface area than to their weight The answer to the definitional question—
(Oberdorster 2005, Maynard 2005). Certainly whether regulators and those regulated will
the direct relationship between volume of be able to make a clear demarcation between
material and exposure—assumed in most what is and what isn’t considered NT—will
chemical regulation—is not a useful guide depend on the details of the definition and
for dealing with NT. the technical capability for applying it. These
Another factor that differentiates NT issues cannot be resolved at the present time,
materials is the importance of structure in but it is relevant that manufacturers across
determining their physical and biological various industries seem to be in general
behavior. Some experts prefer to talk about agreement about what is considered NT.
“nanostructured materials” rather than nano-
materials. In many cases, NT products start 2. Rapid Development
with some molecule or atom—carbon, titani- The current age is characterized by accelerat-
um or gold, for example—shaped into a basic ing technological development, and NT is
form such as a nanodot or nanotube. These developing extraordinarily rapidly. The field
forms are then combined into larger struc- was not identified until 1959, when Nobel
tures, and/or combined with other material physicist Richard Feynman called attention to
such as textile, resin or glass. The behavior of the opportunities in the realm of the “stagger-
the NT product cannot be predicted from the ingly small” (Ratner and Ratner 2002, p.38).
starting chemical, or often even from the basic In 2001, Science magazine named NT the
NT form, because the structure of the mate- “breakthrough of the year.” Currently, there
rial will be a major determinant. In this are several hundred different commercial
respect, chemical polymers are similar and, applications of NT. The National Science
interestingly, the Toxic Substances Control Act Foundation predicts that nano-related goods
(see section II) exempts polymers. and services could be a $1 trillion market by
Given the above differences, the existing 2015. (Roco and Bainbridge 2001, p.3. This
regulatory and management programs are not often-repeated figure seems to have little ana-
likely to be very useful in dealing with NT. lytical basis. See Miller et al 2005, p.175.)
Managing the Effects of Nanotechnology 9
(sec. 26(c)) provides that any action that can be Regulations, Title 40, Ch.1, part 723.5). This
taken with respect to individual chemicals also is equivalent to anything less than about 11
can be taken with respect to “categories” of tons a year, and would exclude almost all NT
chemicals. Categories are defined to include a products. It clearly does not make sense if
group of chemicals that are similar in “physical TSCA is to be applied to NT. EPA would
properties” (sec. 26(c)(2)(A)), a definition that need to amend the low-volume exemption to
would seem adequate to cover NT materials exclude NT materials, but crafting the exclu-
because NT materials share similar physical sion would be challenging.
properties, such as size. TSCA is a law with dramatic strengths and
Perhaps the most challenging problem weaknesses. Its strengths are the flexible
raised by trying to include NT materials broadness of its coverage (see above) and the
under TSCA is the importance of structure wide range of measures it allows to be taken
discussed in Section I-1 above. Even assuming to deal with chemical risks (TSCA sec. 6).The
that NT materials are within TSCA’s jurisdic- measures include almost any conceivable
tion at the stage when a chemical is shaped requirement the EPA Administrator would
into a basic NT form (e.g., nanodot, nan- want to impose.
otube), the exposure and toxicity from the TSCA’s strengths are, not coincidentally,
ultimate product cannot be predicted at that balanced by hedges and obstacles that make it
point. Thus, efforts to deal with the adverse difficult for EPA to take action.The entire law
effects of NT must focus on the stage of the is premised on the balancing of risks and ben-
ultimate product. However, it may be unrea- efits (see especially TSCA 6(c)(1)). Such bal-
sonable and impractical to expect the manu- ancing invites controversy and litigation. The
facturers of basic NT forms to keep track of act stacks the deck against EPA in litigation in
all possible uses. Furthermore, by the next at least three important ways.
stage in the process when the NT material is First, the technical standard of judicial
combined into larger structures and/or other review in the act is: “supported by substantial
materials, it may have lost the molecular iden- evidence in the rulemaking record” (TSCA
tity that defines what TSCA covers. Labeling 19(c)(B)(i)). This standard is very difficult to
on the basic NT form that requires reporting meet, and it contrasts with the much easier
of uses—as well as tracking of the NT supply “arbitrary and capricious” standard applied to
chain—may provide a partial solution to this the Clean Air Act, Clean Water Act and most
difficulty. But this is a clear example of the other environmental statutes (see Corrosion
problems that arise when trying to apply Proof Fittings v. EPA, 947 F.2d 1201, para.15).
existing legal categories to NT products. The result is that it is very difficult for EPA to
Currently, TSCA’s new chemical notifica- defend rules promulgated under TSCA.
tion requirements exempt several categories A second weakness is that TSCA implicit-
of chemicals. The law (sec. 5(h)) authorizes ly assumes that no knowledge about a chem-
the EPA Administrator to make exemptions, ical means that there is no risk.The most rel-
but what is exempted is defined by rules evant section (5(e)) is the epitome of a “Catch
promulgated by the Administrator. The 22.” It states that if EPA does not have enough
exemption most relevant to NT exempts information “to permit a reasoned evaluation
chemicals produced in volumes of 10,000 of the health and environmental effects of a
kilograms or less per year (Code of Federal chemical,” it can delay or prohibit its manu-
12
facture only if it can show that the chemical occupational health functions exercised by
“may present an unreasonable risk”—which the Department of Health, Education and
is precisely the thing that it cannot show. Welfare (now Health and Human Services).
There is another criterion that in theory can The Department of Labor was given respon-
be used for EPA action.This is that the chem- sibility for administering the OSHAct.
ical will be produced in “substantial quanti- The OSHAct’s basic mechanism is for the
ties” and that there will be significant envi- Occupational Safety and Health
ronmental or human exposure. In practice, Administration (OSHA) in the Department of
this criterion only rarely can be used, because Labor to set standards and to enforce the stan-
most new chemicals initially are produced in dards through inspections and penalties for
small volumes, and because the likelihood of noncompliance. An occupational safety and
significant exposure is difficult to establish. health standard is defined in the act (sec. 3(8))
The problem is even greater for NT materi- as “ a standard which requires conditions, or
als because quantity or volume may not be a the adoption or use of one or more practices,
relevant indicator of potential risk. means, methods, operations or processes, rea-
A third problem is that the act requires sonably necessary or appropriate to provide
EPA to meet a variety of requirements before safe or healthful employment and places of
it can regulate a chemical. The difficulty of employment.”This language is certainly broad
these requirements was illustrated dramatical- enough to cover NT.
ly by the Corrosion Proof Fittings case that The difficulties with using the OSHAct to
struck down EPA’s proposed regulation of deal with NT are the same that arise with most
asbestos, in part because of inadequate analy- of the environmental statutes. Detection of NT
sis—even though EPA had spent 10 years products requires expensive and sophisticated
doing the analysis to support the regulation. equipment (Ratner and Ratner, 2002,
For example, because TSCA requires that a pp.39–42), and it is often unclear which
proposed regulation be the “least burden- parameters are the relevant ones to measure
some” regulation, the court criticized EPA for from the standpoint of toxicity. For practical
not analyzing the costs and benefits of all purposes, whether in the setting of a factory or
other possible ways of regulating asbestos. the ambient environment, detection and con-
These and other shortcomings contained trol methods (e.g., filters) may not be currently
in the act are sufficient to make TSCA a weak available or may be too expensive or too cum-
regulatory instrument. Furthermore, as with bersome. (For a discussion, see Maynard 2005.)
most government regulatory programs, there One further OSHA weakness should be
simply are not enough people in the toxic noted. Like EPA, OSHA traditionally has been
substances office to perform the tasks starved for resources. In FY 1980 there were
required by the law. 2,950 OSHA employees. Twenty-five years
later, with a greatly expanded economy and a
2.. Occupational Safety and Health larger number of workplaces, there were 2,208
Act (OSHAct) OSHA employees (Dudley and Warren 2005,
The OSHAct was passed in 1970 and has Table A-3, p.21). EPA has been able to per-
been amended frequently since. The act com- form its basic functions because state agencies
bined the occupational safety programs do most of the labor-intensive work, such as
housed in the Department of Labor with the inspections and enforcement. However, for
Managing the Effects of Nanotechnology 13
implementing the OSHAct, only 21 states Cosmetics are quite a different story.
have OSHA-approved plans that allow them Although the FDCA has a lot of language
to enforce OSHA standards. Three additional devoted to cosmetics, it is not much of an
states have approved state plans for protecting exaggeration to say that cosmetics in the
state and local government employees only United States are essentially unregulated.
(www.osha.gov, accessed 9/7/05). There are The FDCA prohibits the marketing of
millions of workplaces in the United States, “adulterated or misbranded” cosmetics in
and the chance of being visited by an OSHA interstate commerce. “Adulterated” is
inspector is not high. roughly defined as injurious to health.
“Misbranded” means that the label is false or
3. Food, Drug, and Cosmetic Act misleading or does not contain required
(FDCA) information. However, manufacturers of
The FDCA is a one-hundred-year-old act cosmetics are not required to register with
originally passed to prevent poisonings from FDA, are not required to file data on prod-
quack patent medicines and to clean up gross- uct ingredients, and are not required to
ly unsanitary conditions in food processing report cosmetic-related injuries to FDA. If
plants. Over the years, it has been frequently by some chance FDA discovers a cosmetic
amended, its scope expanding to cover an that is adulterated or misbranded, it has no
increasing number of areas. authority to recall the product or take
Five types of NT applications are within action against the manufacturer. All FDA
the purview of the FDCA: drugs, medical can do is ask the Justice Department to
devices, biologics, cosmetics and food. bring suit to have the product removed
(Medical devices are, roughly, any mechanical from the market. (see www.cfsan.fda.gov,
thing used for treatment or diagnosis of dis- accessed 9/17/2005.)
ease.) Drugs, biologics and medical devices are FDA regulation of food focuses on pack-
regulated quite differently from cosmetics. (For aging and food additives. As with FDA’s reg-
a discussion of FDA and NT from an industry ulation of drugs, there have been some
perspective, see Miller et al 2005, pp.83–102.) intense food-related controversies (e.g., sac-
Drugs, biologics and medical devices must charin). FDA’s determination not to regulate
receive approval from the Food and Drug genetically modified food as a food additive
Administration (FDA) before they can be has been harshly criticized and the agency
sold.The approval process is time-consuming has been faulted for its inadequate monitor-
and rigorous. The burden of proof is on the ing of pesticide residues on food. However,
manufacturer to show that the product is safe. FDA’s legal authority under FDCA is ade-
The process has been criticized by some as quate, and there is not a gross disparity
too time-consuming, and by others as not between resources available and the regula-
sufficiently rigorous. Recently, there have tory tasks to be performed.
been instances of political interference in In light of these facts, it appears that NT-
FDA decisions, notably the decision to delay based drugs, biologics and medical devices—
approval of the morning-after birth control and probably NT-based food additives and
pill. However, overall, the process for approv- packaging—are best regulated under the
ing drugs, biologics and medical devices FDCA authorities. On the other hand,
works reasonably well. although it would be neater legally and
14
There also are releases of nanoparticles that ticides, then the Federal Insecticide,
are not related to NT products. For example, Fungicide, and Rodenticide Act (FIFRA)
the burning of diesel fuel creates nano-sized comes into play. If NT materials are used to
particles (Goldman and Coussens 2005, p.30). filter drinking water, the Safe Drinking Water
These sources will have to be regulated under Act may apply. Some NT applications could
the environmental laws, although detection involve radioactive materials, in which case the
and control will be difficult. The focus of this laws regulating nuclear and atomic energy
paper, however, is on engineered nanoscale matters are relevant. If NT is used in relation
materials, not on natural or incidental to food, there are several laws in addition to
nanoparticles. FDCA that deal with food safety and purity.
The one environmental law provision that As its name indicates, The Consumer
has been considered in the NT context is the Product Safety Act, administered by the
CAA standard for fine particulates. This stan- Consumer Product Safety Commission
dard sets limits on the amount of particulates (CPSC) is responsible for ensuring consumer
less than 2.5 micrometers in diameter that can products are safe. It is, however, a law with
be present in the ambient air. (2.5 microme- mostly hortatory powers. The total staff of
ters is equal to 2.5 thousand nanometers. In CPSC is 446, less than half the number of
other words, a 100-nanometer-wide particle, people it had in 1980. And even in 1980, its
the largest NT particle by the usual definition staff was inadequate to keep track of the mil-
of NT (see above), is 1/25 of the small parti- lions of consumer products (Staff numbers
cle CAA standard.) The CAA standard, like from Dudley and Warren 2005, table A-3,
almost all environmental standards, is premised p.21). Applications of NT in consumer elec-
on a direct relationship between volume or tronics equipment, or in other items like ten-
concentration on the one hand, and risk on nis balls, would come under the purview of
the other. This relationship may not be valid the CPSC.
for NT. In any case, volume and concentration None of these laws has the central impor-
may not be useful measures if NT is lumped tance in NT regulation that TSCA, OSHAct
together with larger-sized matter, because the and FDCA have. As we have discussed, there
volume and concentration will be dominated are major problems even with TSCA,
by the larger-sized material. OSHAct and FDCA. The next section will
consider whether some of these problems can
5. Other Laws be addressed within the NT context.
There are a number of other laws that are rel-
evant for NT. If NT materials are used in pes-
16
the nanotubes behave quite differently in the another manufacturer makes a textile that
environment, and probably in the human body incorporates the tubes, do you regulate both? If
as well.The same is true of other types of NT the nanotubes are used in a medical device,
products.This means that an effective regulato- what role would FDA play? What happens in
ry mechanism must involve internal changes the future when NT is combined with genet-
within each of the agency programs and not ic engineering? While it might be possible to
just allocate responsibilities among agencies. arrive at reasonable answers to these kinds of
The current federal coordinating mecha- questions, it would require a lot of time, effort
nism for NT is the Nanoscale Science and foresight.
Engineering and Technology (NSET) sub-
committee of the National Science and 3. Strengthening Existing Laws
Technology Council Committee on Even assuming that existing laws could be
Technology (see www.nano.gov). NSET has amended to clarify and make explicit their
established a Nanotechnology Environmental coverage of NT—and that the patchwork of
and Health Implications Working Group. The existing laws could be stitched together in a
subcommittee and the working group have coordinated framework that would perform
focused on research and development. NSET better than it has for biotech—one still would
could evolve to deal with regulatory and poli- be left with the weaknesses contained in these
cy issues as well as research, but it does not have laws. Section II delineated some of these weak-
the membership or authority to do so now. nesses. TSCA still would lack authority to
require risk data. FDA still would not be able
2. Amending Existing Laws to review and regulate the ingredients of cos-
Some of the aforementioned problems—and metics. OSHA still would lack resources.
questions about whether particular laws (e.g., In the current political climate, it is incon-
TSCA) cover NT—could be addressed by ceivable that these weaknesses could be reme-
amending individual statutes to make clear died. It would be easier, politically and sub-
that they do cover NT. While this would stantively, to draft and enact a new law
avoid a lot of litigation, winning the approval focused on NT. I turn to an outline of such a
of numerous congressional committees and law in the next section.
the executive branch for such legislation Even if there is agreement that there should
would be a formidable challenge. be a new law, it will take months—and prob-
There also would be the major substantive ably years—before a new law is enacted. In the
problem of deciding how to define what is interim, regulators would have to use existing
covered. Is it possible to define NT just by the laws in the best possible way. Thus, how the
size of the material? What if the NT material is current laws can be applied to NT, and what
combined with a non-NT material? If one resources will be required to effectively apply
manufacturer makes carbon nanotubes and them, are inescapable and important issues.
18
A New Law
Given all the difficulties of using existing laws (see Swiss Re 2004), and the European
to address the potential adverse effects of NT, Union, which has been more active about
there is much to be said for considering a regulation than the United States, are con-
completely new law. New legislation could be stantly pressing for action on NT. The NT
tailored specifically to take account of the industry might endorse legislation as a way of
current characteristics of NT as well as char- assuring the public about the safety of NT.
acteristics we expect to emerge in the next Because of these possibilities, and because
decade or two. A new law also could take thinking about NT legislation is itself a
advantage of what we have learned about reg- mechanism for reaching agreement about
ulation in the past four decades. what should be done, this section of the paper
The wide spectrum of products and mate- outlines what a new NT legislative initiative
rials included in NT means that the law might look like.
would have to be broad enough to cover all of
these products and materials.At the same time, 1. Description
the law would have to allow for broad cate- I begin with the assumption that a new law
gories of exemptions—perhaps up to 80 or would focus on products, not on the environ-
90 percent of NT products—if resource ment, because once NT materials get into the
demands were not to become prohibitive.The environment, it is probably too late to take
rapid development of NT would require a remedial measures. The law should focus on
regulatory structure that is flexible and that prevention, not cleanup, for the same reason.
does not unduly impede development of the Thus, the general framework looks something
technology.The lack of data about the adverse like TSCA or FIFRA, or the drug part of
effects of NT means that the law would have FDCA.
to be structured to provide incentives for Given the lack of NT effects data, it would
developing effects data and making it available. be necessary to place the burden on the man-
Section II noted the near impossibility of ufacturer to show that the proposed product is
passing new regulatory legislation (including safe. As more is learned about classes of NT
strengthening of existing laws) in the current products, it may be possible to carve out cate-
political climate. However, this could change. gories of exemptions, or types of products that
The political climate could shift because of require less information.
changes in the nation or the global competi- The process that the law would prescribe
tive climate. A dramatic event or crisis affect- can be envisioned in four stages: ground rules,
ing some aspect of the environment—or sustainability plan, review and follow-up.
involving NT directly — could create an In the first stage, EPA (assuming EPA is the
opportunity or a demand for new legislation lead agency) would have to define the law’s
(see Kingdon 1984). A broad consensus, per- coverage. Providing a workable definition of
haps fed by disparate state and local regulato- NT products will not be easy. It does seem
ry action, could emerge to favor NT legisla- clear that all products containing NT materi-
tion. The insurance companies, concerned als will have to be covered, not just the basic
about the liability of their industry customers NT materials.The reason is that both exposure
Managing the Effects of Nanotechnology 19
and toxicity are not predictable from the NT testing requirements also could be tiered over
material alone.The exposure and toxicity of a time, although it is not clear what the basis of
carbon nanotube or a titanium nanoparticle, the tiers would be. Current EU chemicals law
for example, will depend on what structure it requires more testing as the volume of the
is shaped in, what other materials it is used chemical produced increases. However, this is
with, and how it is used. Regulations probably probably not a good basis for tiering the test-
should require labels on NT materials stating ing of NT materials.
that any product using the material must be The reporting requirements, which also
registered with and reviewed by EPA. could be coordinated with other nations,
There are at least two further definitional should place as small a burden as possible on
issues. The first is: Should the coverage the manufacturer, but provide enough contin-
exclude products covered by other laws? I uing information to alert the government if a
think the answer is yes, provided that the cov- problem arises. At a minimum, the manufac-
erage of the law is really adequate to protect turer should be required to report results of any
the public. Thus, drugs, biologics, medical tests conducted on adverse effects, as well as
devices, food additives, pesticides and nuclear any information received about adverse effects
materials all would be excluded. However, occurring. Less information could be required
cosmetics, for example, would not be exclud- of companies with good health and environ-
ed because there is no regulatory review of mental records.
cosmetic products. The second issue is: What In the second stage, the manufacturer
do we do about NT products already on the would submit a sustainability plan (SP) to EPA,
market? Should the law be applied retroac- preferably in electronic format.The SP would
tively? I think probably not, because the have six components: 1) a life cycle analysis of
resource burden on both the regulating the material or product; 2) testing results; 3)
agency and the manufacturers would be proposed future reporting requirements; 4)
unmanageable. However, the law should con- proposed labeling of the product; 5) proposed
tain provisions for restricting products already restrictions, if any, on the product; and 6) an
on the market if it is discovered that they are explanation of why the product risk, if any, is
having an adverse effect. acceptable. The burden of proof for showing
EPA also would have to establish testing and that the product does not pose unacceptable
reporting requirements. The requirements risks belongs to the manufacturer.
should be coordinated internationally and, ide- In the third stage, the government would
ally, would be the same in all nations. This initiate a review process, the endpoint of which
would benefit manufacturers as well as govern- is to approve the SP, approve it with changes, or
ments.The International Life Sciences Institute disapprove it.The criterion for approval is that
(ILSI) has developed the elements of a detailed the product will not create any “unacceptable
screening strategy for human health effects of risks,” a term which the law would have to
nanomaterials (ILSI 2005). define with great care. (In my view, unaccept-
The testing requirements would build on a able risk is no more or less stringent than
set of protocols that describe how each type of “unreasonable risk.” I have avoided the latter
test should be done. What tests are required term because I would like to encourage a more
would be based on the type of product and the flexible definition than has been given to
results of previous tests (a decision tree). The unreasonable risk.)
20
There are several, not necessarily mutually However, if this were the case, other countries
exclusive, approaches that could be taken to might have to be given enough time to review
defining unacceptable risk. First, and most the SP themselves. Protection of confidential
obvious, the manufacturer might have to antic- business information is another important
ipate likely risks from the product and show consideration that must be incorporated into
either that they would not occur if reasonable the review process.
steps were taken to prevent them, or that, if There is a need for coordination among
they occurred, the actual damage would be U.S. agencies for all decisions regarding a par-
very small. A second possibility is to take a ticular material or product, as well as for gen-
rough cost-benefit approach.That is, some risks eral policies on matters such as risk assessment
would be deemed acceptable if the benefits of and labeling. Any new statute should mandate
the product clearly outweighed the risks. If the coordinated policies and decisions and should
product cured cancer, for example, some risk of establish an interagency group to implement
death in unusual cases would be acceptable. A the mandate.
third approach is based on comparative risk. A The review stage may provide companies
product’s risk might be acceptable if it could be additional incentives for developing environ-
shown clearly that it would substitute for a mentally beneficial products (see Section V
material that had greater risks. Some combina- below). If there were tax incentives for devel-
tion of these approaches, as well as other possi- oping such products (see Section V-2), EPA
bilities, needs to be considered. could decide whether the product qualified for
A review stage should strike a balance a tax benefit, or could provide input for such a
between allowing a sufficient amount of con- determination by the Treasury Department.
sultation with interested parties and minimiz- Also, the approval process could be speeded up
ing the time taken to approve or disapprove the in various ways for products that had major
SP.The general public needs to have an oppor- health or environmental benefits.
tunity to comment, and administrative law The follow-up stage would have to
usually requires that the public be given at least include provisions for dealing with new uses
60 or 90 days to make comments. If a public of a product, and for requiring further testing
hearing is requested or required, however, the if new evidence comes to light.Again, the law
time consumed by public review will be con- would need to be balanced between giving
siderably greater. And while other nations also the government the information it would like
should be consulted, this could be very time but not imposing on manufacturers burdens
consuming, even when aided by electronic that would stifle entrepreneurship. Another
communications. tradeoff involves enforcement and judicial
At present, there is no institutional struc- review.TSCA has been rendered almost inop-
ture to formulate or facilitate international erative because of the difficulties of enforcing
regulation.The amount of time and degree of the law and defending against attacks in the
detail necessary for international consultation courts. However, the rights of the regulated
will depend on how much agreement there is parties and the general public also need pro-
on the basic regulatory framework. Ideally, tection. A balance should be struck. Any new
there would be complete consistency among law would have to deal with a variety of other
major nations, so that approval of a product in issues such as imports, exports, national
one country constituted approval globally. defense and citizen lawsuits.
Managing the Effects of Nanotechnology 21
EPA proposed a voluntary program for NT pants “an opportunity to help determine the
in September 2005 (U.S. EPA 2005).The pro- best ways to evaluate and address the potential
gram would ask producers of engineered risks” of NT (US EPA 2005). Many companies
nanoscale materials to submit to EPA, for involved in NT fear a public reaction against
materials chosen by the producer, information NT, which might be fed by a lack of regula-
on: 1) material characterization; 2) hazard tion.They also fear the possibility of over-reg-
information; 3) use and exposure potential; and ulation by EPA and other regulatory agencies.
4) risk management practices. If basic informa- Thus, the incentives offered by the EPA pro-
tion on material characterization (such as sur- gram have some appeal, and may be sufficient
face area, solubility or chemical composition) to motivate companies to participate. Because
were missing, the voluntary program partici- the demands of the proposed program are fair-
pant would be expected to generate the infor- ly modest, non-compliance from those who
mation, but there is no expectation that any do participate should not be a problem. An
other information would be generated for the exception may be the withholding of existing
program.A separate “in-depth” program would negative risk information.
focus on a more limited number of materials, A major disadvantage of voluntary pro-
and would ask participants to generate and grams is that they may leave out the people
report risk information specified by EPA.That who most need to be included. In the case of
information is intended to allow the agency to NT, small firms making risky products and
conduct a full risk assessment of the identified large firms with small consciences are not
materials and associated uses. Both programs likely to volunteer to do health testing or to
are designed to help EPA develop a permanent give EPA information that might indicate a
(and, presumably, non-voluntary) regulatory significant risk.
program for NT. The other major option to new legislation
A key question to ask about any voluntary is a ban either on commercialization of NT
program is:What incentives are there for peo- products or on NT research. ETC, the Action
ple to join the program and comply with its Group on Erosion, Technology, and
requirements? (See the essays by Mazurek and Concentration, a Canadian-based organiza-
by Harrison in Dietz and Stern 2002.) For tion, has stated: “Given the concerns raised
example, the 33–50 program, one of the first over nanoparticle contamination in living
major voluntary efforts initiated by EPA, asked organisms, Heads of State … should declare
companies to volunteer to make major reduc- an immediate moratorium on commercial
tions in toxic air emissions. Many companies production of new nanomaterials and launch
voluntarily made the reductions, but they were a transparent global process for evaluating the
encouraged to do so by the fact that in a few socio-economic, health and environmental
years they almost certainly would be forced to implications of the technology (ETC
do so by enforcement of the Clean Air Act. Communique, Issue 76, May/June 2002).
The primary incentives for joining the vol- This is, as far as I know, the only organization
untary EPA NT program are that it would that has called for a ban on NT. Focus groups
provide companies “a concrete means to convened by the Project on Emerging
demonstrate their individual and collective Nanotechnologies indicate that only a small
commitment to responsible nanotechnology minority of the general public support a ban
development,” and that it would give partici- (Macoubrie 2005, p.17).
Managing the Effects of Nanotechnology 23
The British Royal Society (2004, p.8) did made retroactive, products already on the mar-
recommend that:“Until more is known about ket might be labeled to indicate that they had
environmental impacts … the releases of man- not been reviewed by the government.There
ufactured nanoparticles and nanotubes into the is not a lot of empirical evidence about the
environment should be avoided as far as possi- effectiveness of labeling, although the available
ble.” It also recommended prohibiting “the use evidence indicates that labels often do not
of free (that is, not fixed in a matrix) manufac- have much impact on consumer behavior (see
tured nanoparticles in environmental applica- Lutzenhiser and also Thogersen in Dietz and
tions such as remediation” until more is known Stern 2002).
about the risks and benefits of such use (ibid.). State pilot programs are yet another
A ban is consistent with the “precautionary option. NT development is concentrated in
principle” which, in one of its simplest forms, fewer than a dozen states, and, in theory, a
says you will not undertake any action unless state could initiate a program at least to col-
you know that it will not have any unaccept- lect data on NT uses and effects. Given the
able consequences. (There are many versions intense interstate competition to attract
of the precautionary principle and many dis- high-tech industry, it seems doubtful that any
cussions of it. For a good overview, see Durant state would have much incentive to take such
in Durant et al 2004.) The wisdom of a ban an initiative. Several states have initiated pro-
depends on weighing the potential benefits of grams to encourage NT as part of their eco-
continued development of NT against the nomic development efforts (see, for exam-
severity and likelihood of any adverse conse- ples, www.watechcenter.org; www.ccst.us).
quences resulting from the technology. Most Washington State has called the competition
knowledgeable observers believe that the ben- to attract nano companies “one of the most
efits of NT will outweigh the adverse conse- intensely competitive technological races in
quences, especially if steps are taken to mini- history” (www.watechcenter.org, p.1,
mize adverse effects. accessed 11/2/05).
Another option is labeling. Some have Some would say that the most likely option
argued that consumers are entitled to know if always is to do nothing, taking no initiatives to
products contain nanomaterials. Labeling also deal with NT’s adverse effects. But that would
can benefit manufacturers by allowing them serve no one’s interest. The public would be
to determine the contents of supplied goods left unprotected, the government would strug-
and/or the supplier’s conformance with good gle to apply existing law to a technology for
practices. While labeling is a supplement, which it was not designed, and industry would
rather than a substitute, for the broader pro- be exposed to the possibility of public fear and
grams outlined above, it could be important. outrage over a powerful, mysterious, and
For example, if NT product review were not potentially dangerous new technology.
24
tists in the United States, and China now ranks tax-writing committees in Congress, especially
third behind the United States and Japan in the powerful House Ways and Means
NT patents (Hassan 2005). A recent survey Committee, most frequently have taken the
(Choi 2005) found the United States, Japan, position that taxes should be used only to raise
Germany and South Korea to be the dominant general funds for running the government and
nations in NT research and development. have opposed using taxes for social purposes.
The effectiveness of this research for The Treasury Department usually has support-
encouraging environmentally beneficial NT is ed the committees in this opposition.The fact
unknowable now and may never be known. that some large corporations are engaged in
(Miller et al 2005, pp. 115–130, analyze the NT research and development does provide a
NNI program and consider it successful.) potential base of support for tax subsidies.
Dramatic successes and failures of government The other obstacle lies in defining which
R&D programs are widely publicized, but expenditures would be eligible for tax subsi-
overall evaluations of such programs are rare. In dies or tax penalties.The definition of which
the United States, it is hard to know what por- products or processes are NT is not altogeth-
tion of government R&D funds go to NT er clear, and defining which NT efforts are
technologies that are directly or indirectly ben- environmentally desirable is much more
eficial to health and the environment. This problematic.The need to make economically
should be a continuing concern of the NNI. important decisions about poorly delineated
categories leads to confusion at best, and to
2. Tax Breaks corruption at worst.
Tax benefits have been an important tool for
protecting the environment. The Byzantine 3. Acquisition Programs
U.S. tax code contains a variety of incentives The federal and state governments are major
for environmentally beneficial behavior such as consumers of a broad variety of goods and
energy conservation. services. This characteristic has occasionally
Tax penalties to discourage pollution or been used to promote social goals. For exam-
other socially undesirable behavior have been ple, the Clean Air Act (section 248) says that
used in the United States, but are more com- the General Services Administration (GSA)
mon in European countries. For example, gas should underwrite the incremental cost of
taxes are much higher in most OECD purchasing clean fuel vehicles for use in feder-
(Organization for Economic Cooperation and al agency fleets. In theory, the government
Development) countries than in the United could be required to purchase environmental-
States (Davies and Mazurek, 1998, p.211). ly beneficial NT products. Such a mandate
Although one can argue that any imagina- would raise the same definitional problems as
ble provision can find its way into the U.S. tax tax breaks. More fundamentally, it would raise
code, there are at least two significant obstacles a dilemma that has characterized most acquisi-
to using taxes to encourage environmentally tion proposals, one of cost versus social goal.
beneficial NT. Government agencies generally behave like
One obstacle is that there has never been rational consumers, searching for the lowest
strong support for such use of the tax system. price for a given product. If the products man-
In particular, environmental groups have been dated to be purchased are less expensive than
cool to economic incentives of any kind.The comparable products, agencies will buy them
26
in any case and the legislation is unnecessary. If and medical devices if this were considered
the mandated products are more expensive, the desirable. It also would be possible to do this
agencies will be reluctant to spend their budg- under new legislation dealing with NT, such as
et money to fulfill a purpose that is not part of the proposal outlined in Section IV above.
their mission, and the acquisition program gets TSCA does not lend itself to such incentives
quietly undermined by the resistance of pur- because there is a set time limit (90 days,
chasing agents in individual agencies. To the extendable to 180 days) for EPA to make a
extent that government purchasing is done decision about a chemical. At the end of the
centrally by the GSA, the chances of acquisi- time period, the chemical can be manufac-
tion programs succeeding are slightly better, tured unless the agency has taken steps to ban
but the basic dynamic remains. or limit its manufacture.
How much of an incentive a regulatory
4. Regulatory Incentives provision is depends on how much capital has
There have been a few instances of using reg- been invested in the product before the regu-
ulatory incentives to encourage particular latory decision, and on how much time is saved
types of technologies. For example, FDA accel- by the regulatory advantage. In the case of
erates the review and approval of certain types something like a new drug, where the devel-
of drugs that address unmet medical needs (see opment expense typically is large and the reg-
www.accessdata.fda.gov). It would be possible ulatory delay could be lengthy, a regulatory leg
for FDA to give some advantage to NT drugs up can be an important incentive.
Managing the Effects of Nanotechnology 27
There has been a long, on-going debate foresight capability is essential if the legisla-
about the ability to do forecasting. If the goal is ture is to operate effectively in the modern
accurate prediction of the future, then most world (see Morgan and Peha 2003; Goldman
forecasting is doomed to failure. However, and Coussens 2005, p.10).
thinking about the future allows one to con-
sider likely options, identify important deter- 3. Research
minants of the future of a technology, and get Section V-1 discussed the role of research in
a jump on creating relevant policies.The rapid encouraging environmentally beneficial NT.
pace of NT makes improved foresight capabil- However, there is also a need for research
ity a necessity. focusing on adverse effects of NT, monitoring
Several kinds of initiatives are needed. First, instruments, and control methods to prevent
EPA and other agencies should establish adverse effects. Much of the research on effects
offices explicitly charged with forecasting— is either done or paid for by the government.
and with encouraging their agency to use NT presents a variety of unique challenges.
forecast results. Second, NSF, EPA and others It is not clear whether there are good ways to
should fund academic centers dedicated to detect NT materials in the ambient environ-
research that will improve forecasting ability.A ment, or, if they cannot be detected, whether
lot of research on how to improve forecasting there are ways environmental controls can be
is needed (Brewer & Stern 2005, pp.230–245; imposed. It is not clear which, if any, of the
Ascher 1978), but forecasting is inherently usual control methods will be effective in deal-
interdisciplinary, and for this and other rea- ing with NT materials. Following these
sons, it has been almost entirely neglected by avenues often leads back to the primary
academics. The availability of funding for importance of prevention. The only way to
research —and the existence of institutions deal with potential adverse effects of NT in
that would use the results—would help rem- most cases will be to design the product or tai-
edy this neglect. As the NRC has said, many lor the use of the material so that the NT
reasons exist to motivate forecasting activities. material does not get into the environment or
Among them is the desire to increase the lead the human body in the first place.
time for making decisions in order to allow Rejeski has suggested that EPA needs an
more careful analysis of various options, and to advanced research capability similar to the mil-
increase the chance for broad public participa- itary’s Defense Advanced Research Projects
tion in decision making (Brewer and Stern, Agency (DARPA) to develop breakthrough
2005 p.104). In managing NT’s effects, these solutions for the “really hard problems” (Olson
reasons are particularly relevant. and Rejeski 2005, p.172). EPA’s track record
Congress also needs to have the ability to with research of this kind is not good, but cre-
foresee and evaluate new technological devel- ation of a new office with incentives to attract
opments. In 1995, the Republican Congress outstanding researchers could change this.
eliminated the Congressional Office of It will remain a continuing challenge to
Technology Assessment (OTA), the only identify and analyze the adverse effects of NT.
effective institution it had for fulfilling these With government funds, some new institutions
tasks. It eliminated OTA as a budget-cutting at universities already have been established to
measure, although the total OTA budget was do research on these effects. Much of the
a modest $22 million. Rebuilding Congress’ research on effects is cross-disciplinary—a
Managing the Effects of Nanotechnology 29
major handicap in enlisting the discipline-ori- effects in two different ways. First, as the Royal
ented universities to undertake the research. It Society (2004, p.62) states, “some of the social
also is a handicap in enlisting individual and ethical concerns that certain applications
researchers who may not get academic rewards of nanotechnologies are likely to raise stretch
for working on interdisciplinary, applied prob- well beyond the basic science or engineering
lems.The question of how to create incentives of the matter” (see also Roco and Bainbridge
for the private sector to conduct testing and do 2001). Social values, apart from scientific ques-
research on NT adverse effects is a different tions, are an inextricable part of assessing risks
kind of institutional challenge. Holding manu- (Stern and Fineberg 1996), and the public
facturers responsible for the adverse effects of needs to be involved in assessing NT’s risks, as
their products is clearly a major incentive for well as in defining the measures to be taken to
such testing and research. deal with the risks.
There is broad agreement that current gov- The social value questions that NT is likely
ernment spending to determine the health and to raise transcend the risks of individual tech-
safety effects of NT is inadequate.At a Nov. 17, nologies or applications. A study comparing
2005, hearing before the House Committee the controversy over biotechnology with what
on Science, industry, environmental and might be expected in relation to NT noted
research organizations called for federal spend- that the issues many people saw as being
ing of at least $100 million annually—more involved in the biotechnology controversy
than three times current expenditures —on included “Global drives towards new forms of
health and safety research (Couillard 2005). proprietary knowledge; shifting patterns of
Some witnesses also called for a more actively ownership and control in the food chain; issues
managed, strategically targeted, and carefully of corporate responsibility and corporate
coordinated approach to determine what closeness to governments; intensifying rela-
adverse effects, if any, NT may create. tionships of science and scientists to the worlds
Recently, the Project on Emerging of power and commerce; unease about hubris-
Nanotechnologies at the Woodrow Wilson tic approaches to limits in human understand-
Center released a comprehensive inventory of ing; conflicting interpretations of what might
NT-related environmental, health and safety be meant by sustainable development…”
research (Maynard 2005b).The inventory cov- (Grove-White 2004, p.19). As the authors
ered information on 208 research projects, in 6 point out, these kinds of concerns cannot be
countries and regions, accounting for $38 mil- accommodated within a framework of risk
lion of research annually. 169 projects, account- assessment of individual NT products.
ing for $27 million, were in the United States. The second way the public needs to be
However, within the United States, only $6 involved is as consumers both of information
million of federal research was considered to be about NT and of NT products. The tremen-
of “high relevance” to determining the envi- dous potential of the technology will not
ronmental, health and safety implications of develop without the public having a realistic
engineered nanomaterials. view of the intended and unintended effects of
NT. In its scope and diversity of applications,
4. Public Participation NT often has been compared with biotech-
The involvement of members of the general nology.The lessons learned from biotechnolo-
public is crucial for dealing with NT’s adverse gy about the consequences of a poorly
30
informed public should not be lost on those more information to support informed con-
dealing with NT. Some institutions have risen sumer choices (ibid. p.19).
to this challenge. For example, DuPont has New and better institutions for public par-
joined with the non-governmental organiza- ticipation are needed (Beierle and Cayford
tion Environmental Defense to define a 2002, p.74; Brewer and Stern 2005, p.37).
process for identifying and reducing potential Going through the motions of a public hear-
health, safety and environmental risks of ing where nobody listens, or launching a slick
nanoscale materials, and to test the process on public relations campaign will not suffice.The
specific DuPont materials or applications. public needs to be educated, not brainwashed.
A study by the Woodrow Wilson Center’s It needs to be seriously listened to, not tolerat-
Project on Emerging Nanotechnologies ed. And there needs to be real participation.
(Macoubrie 2005) showed more trust in regu- New forms of participation are being tried, for
latory agencies than might have been expect- example, using the Internet, and NT provides
ed. Almost half the sample believed that EPA, a good opportunity to use and experiment
OSHA and other regulatory agencies would with these new methods.
effectively manage risks from nanotechnology,
while about 40 percent believed the agencies
could not be trusted. Of the 177 participants in The challenges presented by NT are as many
the study, 55 percent said that voluntary stan- and varied as the promises that it holds for a
dards applied by industry would not be suffi- better life. If the new technology is to fulfill its
cient to deal with NT risks. When asked for promise, society must openly face the issues of
their top choice of how government and whether the technology has or could have
industry could increase public trust, 34 percent adverse effects, what these effects are, and how
selected increased safety tests before products to prevent them. I hope that this paper will
are marketed, and 25 percent chose supplying move that effort forward.
Managing the Effects of Nanotechnology 31
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Publishers
Preface 1 WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS
Lee H. Hamilton, President and Director
Executive Summary 3
BOARD OF TRUSTEES
About the Author 5 Joseph B. Gildenhorn, Chair
I. Characteristics of Nanotechnology
David A. Metzner, Vice Chair
7
1. Defining NT PUBLIC MEMBERS
2. Rapid Development James H. Billington, The Librarian of Congress; Bruce Cole, Chairman, National
3. Lack of Effects Data Endowment for the Humanities; Michael O. Leavitt, The Secretary, U.S. Department of
16 The PROJECT ON EMERGING NANOTECHNOLOGIES was launched in April 2005 by the Wilson
1. Coordinating Mechanisms Center and The Pew Charitable Trusts. It is dedicated to helping business, governments, and
2. Amending Existing Laws the public anticipate and manage the possible human and environmental implications of
3. Strengthening Existing Laws nanotechnology.
IV. A New Law 18 THE PEW CHARITABLE TRUSTS serves the public interest by providing information, advancing
1. Description policy solutions and supporting civic life. Based in Philadelphia, with an office in
2. Advantages and Disadvantages Washington, D.C., the Trusts will invest $204 million in fiscal year 2006 to provide organi-
3. Other Options zations and citizens with fact-based research and practical solutions for challenging issues.
V. Incentives for Environmentally Beneficial Technology 24 The WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS is the living, national memo-
1. Research rial to President Wilson established by Congress in 1968 and headquartered in
2. Tax Breaks Washington, D.C. The Center establishes and maintains a neutral forum for free, open and
3. Acquisition Programs informed dialogue. It is a nonpartisan institution, supported by public and private funds and
4. Regulatory Advantages engaged in the study of national and international affairs.
Bibliography 31
Project on Emerging
Nanotechnologies
T 202.691.4000
F 202.691.4001
www.wilsoncenter.org/nano
www.nanotechproject.org