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Report to the Chairman, Committee on Environment and Public Works,
U.S. Senate:
United States Government Accountability Office:
GAO:
May 2010:
Nanotechnology:
Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in
Regulating Risk:
GAO-10-549:
GAO Highlights:
Highlights of GAO-10-549, a report to Chairman, Committee on
Environment and Public Works, U.S. Senate.
Why GAO Did This Study:
Nanotechnology involves the ability to control matter at the scale of
a nanometer—one billionth of a meter. The world market for products
that contain nanomaterials is expected to reach $2.6 trillion by 2015.
In this context, GAO (1) identified examples of current and potential
uses of nanomaterials, (2) determined what is known about the
potential human health and environmental risks from nanomaterials, (3)
assessed actions EPA has taken to better understand and regulate the
risks posed by nanomaterials as well as its authorities to do so, and
(4) identified approaches that other selected national authorities and
actions U.S. states have taken to address the potential risks
associated with nanomaterials. GAO analyzed selected laws and
regulations, reviewed information on EPA’s Nanoscale Materials
Stewardship Program, and consulted with EPA officials and legal
experts to obtain their perspectives on EPA’s authorities to regulate
nanomaterials.
What GAO Found:
Companies around the world are currently harnessing the properties of
nanomaterials for use in products across a number of sectors and are
expected to continue to find new uses for these materials. GAO
identified a variety of products that currently incorporate
nanomaterials already available in commerce across the following eight
sectors: automotive; defense and aerospace; electronics and computers;
energy and environment; food and agriculture; housing and
construction; medical and pharmaceutical; and personal care, cosmetics
and other consumer products. Within each of these sectors, GAO also
identified a wide variety of other uses that are currently under
development and are expected to be available in the future.
The extent to which nanomaterials present a risk to human health and
the environment depends on a combination of the toxicity of specific
nanomaterials and the route and level of exposure to these materials.
Although the body of research related to nanomaterials is growing, the
current understanding of the risks posed by these materials is
limited. This is because the manner in which some studies have been
conducted does not allow for valid comparisons with newer studies or
because there has been a greater focus on certain nanomaterials and
not others. Moreover, the ability to conduct necessary research on the
toxicity and risks of nanomaterials may be further hampered by the
lack of tools to conduct such studies and the lack of models to
predict the characteristics of nanomaterials.
EPA has undertaken a multipronged approach to understanding and
regulating the risks of nanomaterials, including conducting research
and implementing a voluntary data collection program. Furthermore,
under its existing statutory framework, EPA has regulated some
nanomaterials but not others. Although EPA is planning to issue
additional regulations later this year, these changes have not yet
gone into effect and products may be entering the market without EPA
review of all available information on their potential risk. Moreover,
EPA faces challenges in effectively regulating nanomaterials that may
be released in air, water, and waste because it lacks the technology
to monitor and characterize these materials or the statutes include
volume based regulatory thresholds that may be too high for
effectively regulating the production and disposal of nanomaterials.
Like the United States, Australia, Canada, the United Kingdom, and the
European Union have begun collecting data to understand the potential
risks associated with nanomaterials and are reviewing their
legislative authorities to determine the need for modifications.
Australia and the United Kingdom have undertaken a voluntary data
collection approach whereas Canada plans to require companies to
submit certain types of information. Some U.S. states, like
California, have also begun to address the potential risks from
nanomaterials by, for example, collecting information from
manufacturers on a limited number of nanomaterials in use in those
states and making some of this information publicly available.
What GAO Recommends:
GAO recommends that EPA complete its plans to modify its regulatory
framework for nanomaterials as needed. EPA concurred with our
recommendations and provided technical comments, which we incorporated
as appropriate.
View [hyperlink, http://www.gao.gov/products/GAO-10-549] or key
components. For more information, contact Anu Mittal at (202) 512-3841
or mittala@gao.gov.
[End of section]
Contents:
Letter:
Background:
Nanomaterials Currently Enhance Products across a Number of Industry
Sectors, and New Uses Continue to Be Developed:
Potential Risks to Human Health and the Environment from Nanomaterials
Depend on Toxicity and Exposure, and Current Understanding of the
Risks Is Limited:
EPA Has Taken a Multipronged Approach to Managing the Potential Risks
of Nanomaterials but Faces Various Challenges in Regulating These
Materials:
Other National Authorities Are Collecting Information on Nanomaterials
and Are Evaluating Their Legislation to Ascertain if Changes Are
Needed:
Some State and Local Governments Have Begun to Address the Risks of
Nanomaterials:
Conclusions:
Recommendations for Executive Action:
Agency Comments:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Comments from the Environmental Protection Agency:
Appendix III: GAO Contact and Staff Acknowledgments:
Related GAO Reports:
Figures:
Figure 1: Examples of Nanomaterials as Raw Materials, Intermediates,
and Finished Products:
Figure 2: Examples of Current and Potential Nanotechnology Innovations
that May Be Used in an Automobile:
Figure 3: Examples of Current and Potential Nanotechnology Innovations
That May Be Used in a Mobile Phone:
Figure 4: Examples of Current and Potential Nanotechnology Innovations
That May Be Used in a Drink Bottle:
Figure 5: Examples of Current and Potential Nanotechnology Innovations
That May Be Used in a House:
Figure 6: Potential Exposure Routes throughout the Life Cycle of
Nanomaterials:
Figure 7: The Increase in Environment and Human Safety Research
Relating to Nanomaterials since 2005:
Abbreviations:
CERCLA: Comprehensive Environmental Response, Compensation, and
Liability Act:
EPA: Environmental Protection Agency:
FIFRA: Federal Insecticide, Fungicide, and Rodenticide Act:
ISO: International Organization for Standardization:
NICNAS: National Industrial Chemicals Notification and Assessment
Scheme:
NNI: National Nanotechnology Initiative:
OECD: Organisation for Economic Co-operation and Development:
RCRA: Resource Conservation and Recovery Act:
REACH: Regulation, Evaluation and Authorization of Chemicals:
SNUR: Significant New Use Rule:
TSCA: Toxic Substances Control Act of 1976:
UV: ultraviolet:
Wilson Center: Woodrow Wilson International Center for Scholars'
Project on Emerging Nanotechnologies:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
May 25, 2010:
The Honorable Barbara Boxer:
Chairman:
Committee on Environment and Public Works: United States Senate:
Dear Madam Chairman:
The term "nanotechnology" encompasses a wide range of innovations
based on the understanding and control of matter at the scale of
nanometers--the equivalent of one-billionth of a meter. For
illustration, a sheet of paper is about 100,000 nanometers thick, a
human hair is about 80,000 nanometers wide, and three gold atoms lying
side by side are about 1 nanometer long. Unusual properties can emerge
in materials manufactured at the nanoscale--including catalytic,
electrical, magnetic, mechanical, optical, and thermal properties--
that differ in important ways from the properties of conventionally
scaled materials. Some of these new properties can enhance products
and their applications across a number of sectors, including
electronics, medicine, and defense. The world market for
nanotechnology-related products is growing and is expected to total
between $1 trillion and $2.6 trillion by 2015.
Nanomaterials can occur naturally, be created incidentally, or be
manufactured intentionally. For example, naturally occurring
nanomaterials can be found in volcanic ash, forest fire smoke, and
ocean spray. Incidental nanomaterials are by-products of industrial
processes, such as mining and metal working, and combustion engines,
such as those used in cars, trucks, and some trains. In contrast,
manufactured nanomaterials (sometimes called engineered nanomaterials)
have been specifically designed for a particular function or property,
such as improved strength, decreased weight, or increased electrical
conductivity. Our review will focus on manufactured nanomaterials,
rather than nano-sized materials that occur naturally in the
environment or are incidentally produced, and for the remainder of
this report, we will call such materials "manufactured nanomaterials,"
or simply "nanomaterials." While the use of nanomaterials holds
promise for the future, their small size and unique properties raise
questions about potential risks to people or the environment that
might result from exposure to them during their manufacture, use, and
disposal. Risk is usually defined as the potential for harmful effects
to human health or the environment resulting from exposure to a
substance--in this case, nanomaterials. In general terms, risk depends
on a combination of the exposure a person or the environment has to
the substance as well as the inherent toxicity of the chemical. In
other words, the same exposure to two different substances each with
their own toxicity would result in different levels of potential risk.
The Environmental Protection Agency (EPA) administers several laws
that regulate chemicals, pesticides, pollutants in air or water, and
wastes that may be composed of or contain nanomaterials.[Footnote 1]
These laws include the following:
* the Toxic Substances Control Act of 1976 (TSCA), which authorizes
EPA to require chemical companies to report certain information about
chemicals used in commerce and authorizes EPA to require testing of
and control chemicals that pose an unreasonable risk to human health
or the environment, among other things;
* the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
which authorizes EPA to regulate the sale and use of pesticides and
prohibits marketing of pesticides that have not been registered with
EPA;[Footnote 2]
* the Clean Air Act, which requires EPA to set standards for common
air pollutants and to regulate industrial sources of hazardous air
pollutants;
* the Clean Water Act, which authorizes EPA to regulate discharges of
pollutants into federally regulated waters;
* the Resource Conservation and Recovery Act (RCRA), which establishes
a framework for regulation of hazardous and solid wastes and
authorizes EPA to issue administrative orders to address imminent
hazards; and:
* the Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA), commonly known as Superfund, which authorizes
EPA to compel parties responsible for contaminating sites to clean
them up or to conduct cleanups itself and then seek reimbursement from
responsible parties.
On the international level, other national authorities are also
concerned about the potential risks of nanomaterials and whether their
current regulatory framework authorities are sufficient to address
these risks. For example, Australia, Canada, the United Kingdom, and
the European Union have begun to review their regulatory approaches
for nanomaterials. Furthermore, the Organisation for Economic Co-
operation and Development--a forum in which the governments of 30
developed countries, including the United States, work together to
address economic, social, and environmental issues--has established a
"working party" on nanomaterials. In addition to the international
focus on this topic, some U.S. states have begun to explore ways to
address the potential risks of nanomaterials.
In this context, you asked us to (1) identify examples of current and
potential uses of nanomaterials, (2) determine what is known about the
potential human health and environmental risks from nanomaterials, (3)
specifically assess actions EPA has taken to better understand and
regulate the risks posed by nanomaterials as well as its authorities
to do so, and (4) identify approaches that selected other national
authorities have taken to address the risks associated with
nanomaterials. In addition, you asked us to identify any U.S. states
and localities that have begun to address the risks from nanomaterials.
To identify examples of current and potential uses of manufactured
nanomaterials, we analyzed documents and reports that discuss the
current and future uses of manufactured nanomaterials, such as market
research reports produced by Lux Research, an independent research
firm that conducts market analysis of nanotechnology, among other
things. In addition, we interviewed cognizant agency officials from
the six U.S. agencies that conduct the majority of nanotechnology-
related research.[Footnote 3] We also interviewed knowledgeable
stakeholders, including officials from the National Nanotechnology
Initiative, the Wilson Center, the National Academy of Sciences, Lux
Research, and the NanoBusiness Alliance--a nanotechnology-related
business association. We used an iterative process, often referred to
as "snowball sampling," to identify knowledgeable stakeholders, and we
selected for interviews those who would provide us with a broad range
of perspectives on the current and potential uses of nanomaterials.
To determine what is known about the potential human health and
environmental risks of manufactured nanomaterials, we reviewed
documents that had been published by peer-reviewed journals,
government agencies, and international nonprofit organizations. In
conducting this review, we searched databases, asked knowledgeable
stakeholders to identify relevant studies, and reviewed studies from
article bibliographies to identify additional sources of information
on the potential risks. Our review focused on 20 such studies,
selected in part because they provided a synthesis of available
research related to nanomaterials' risks and covered a variety of
nanomaterials. For the purposes of this report, all the documents,
studies, and synthesis studies we reviewed will be referred to as
"studies." We also spoke with a variety of knowledgeable stakeholders
representing industry, academia, nongovernmental organizations, and
the regulatory community. These knowledgeable stakeholders were also
selected using a snowball sampling method.
To assess actions EPA has taken to better understand and regulate
manufactured nanomaterials and its authorities to do so, we analyzed
selected laws and regulations, including TSCA, FIFRA, the Clean Air
Act, the Clean Water Act, RCRA, and CERCLA. We also reviewed data and
reports on EPA's Nanoscale Materials Stewardship Program, which EPA
developed to encourage companies to voluntarily develop and submit
information to the agency on the characteristics of nanomaterials.
Furthermore, we consulted with EPA officials and legal experts to
obtain their perspectives on EPA's available authorities to regulate
manufactured nanomaterials.
To identify the approaches that other selected national authorities-
Australia, Canada, the United Kingdom, and the European Union--have
used to address the potential risks associated with manufactured
nanomaterials, we analyzed these authorities' laws and regulations
that would be applicable to regulating manufactured nanomaterials. We
selected these authorities based on interviews with knowledgeable
stakeholders who identified them as having taken actions related to
better understanding, assessing, or regulating the potential risks of
nanomaterials. To identify any states that may be taking action with
regard to nanomaterials, we spoke with federal regulators; industry
and environmental groups; and other knowledgeable stakeholders,
including the Environmental Council of States.
A more detailed description of our scope and methodology is presented
in appendix I. We performed our work between May 2009 and May 2010, in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
Background:
In fiscal year 2009, federal support for nanotechnology research
totaled about $1.7 billion. Cumulatively from fiscal year 2001 through
fiscal year 2009, federal agencies have devoted over $10.5 billion to
nanotechnology research. To guide federal development of
nanotechnology, the National Nanotechnology Initiative (NNI) was
established in 2001 to support long-term research and development
aimed at accelerating the discovery, development, and deployment of
nanoscale science, engineering, and technology. The NNI is a mechanism
to coordinate the nanotechnology-related activities of the 25
currently participating federal agencies that fund nanoscale research
or have a stake in the outcome of this research, such as those
agencies that may regulate products containing nanomaterials. While
the NNI is designed to facilitate intergovernmental cooperation and
identify overarching goals and priorities for nanotechnology research,
it is not a research program and has no funding or authority to
dictate the nanotechnology research agenda for participating agencies
or to ensure that adequate resources are available to achieve specific
goals. Instead, participating agencies develop and fund their own
nanotechnology research agendas. In fiscal year 2009, six NNI agencies
accounted for over 95 percent of federal nanotechnology research
reported. These are the Department of Defense, the Department of
Energy, EPA, the Department of Health and Human Services' National
Institutes of Health, the Department of Commerce's National Institute
of Standards and Technology, and the National Science Foundation.
Nanomaterials can take a variety of forms and can generally be
organized into four types:
* Carbon-based materials. These nanomaterials are composed mostly of
carbon, and are most commonly spherical, elliptical, or tubular in
shape. Spherical and elliptical carbon shapes are referred to as
fullerenes, while tubular ones are called nanotubes.
* Metal-based materials. These nanomaterials include nanoscale gold,
nanoscale silver, and metal oxides, such as titanium dioxide. They
also include quantum dots, which are closely packed semiconductor
crystals comprised of hundreds or thousands of atoms, on the scale of
a few nanometers to a few hundred nanometers.
* Dendrimers. These nanomaterials are nanoscale polymers built from
branched units. The surface of a dendrimer has numerous branch ends,
which can be tailored to perform specific chemical functions. Also,
some dendrimers contain interior cavities into which other molecules
can be placed, such as for drug delivery.
* Composites. These materials combine nanoparticles with other
nanoparticles or with larger, conventional-scale materials. For
example, nanoparticles, such as nanoscale clay can be combined with
other materials to form a composite material.
EPA uses a risk assessment process to estimate the extent of harm, if
any, that can be expected from exposure to a given substance
throughout its life cycle and to help regulators determine whether the
risk meets the requirements for taking action under its statutory
authorities, such as banning the substance's production or limiting
its use. The basic risk assessment paradigm includes the following:
* an evaluation of scientific information on a substance's hazardous
properties--or toxicity--which may potentially affect human health or
the environment;
* the dose-response relationship--the relationship between the extent
of exposure (dose) and the resulting changes in health or body
function (response)--describes the toxic effect of a substance; and:
* exposure--the extent to which humans or the environment are expected
to be exposed to the chemical.
EPA is applying this risk assessment paradigm to assess the potential
risks from nanomaterials. EPA officials also told us that risk
assessment is not the only means of using scientific information to
inform decision making. For example, they said that by using green
chemistry and life cycle assessment approaches,[Footnote 4] a
material's properties may be modified or exposure controls
incorporated to minimize and manage potential risk.
Nanotechnology is an example of a fast-paced technology that poses
challenges to agencies' policy development and foresight efforts. We
have conducted past work looking at the challenges of exercising
foresight when addressing potentially significant but somewhat
uncertain trends,[Footnote 5] including technology-based trends that
proceed at a high "clockspeed," that is, a (1) faster pace than trends
an agency has dealt with previously or (2) quantitative rate of change
that is either exponential or exhibits a pattern of doubling or
tripling within 3 or 4 years, possibly on a repeated basis.[Footnote
6] As our prior work has noted, when an agency responsible for
ensuring safety faces a set of potentially significant high-clockspeed
technology-based trends, it may successfully exercise foresight by
carrying out activities such as:
* considering what is known about the safety impact of the trend and
deciding how to respond to it;
* reducing uncertainty as needed by developing additional evidence
about the safety of the trend; and:
* communicating with Congress and others about the trends, agency
responses, and policy implications.
Similarly, our 21st Century Challenges report raised concern about
whether federal agencies are poised to address fast-paced technology-
based challenges.[Footnote 7] Other foresight literature illustrates
the potential future consequences of falling behind a damaging trend
that could be countered by early action. These analyses suggest that
unless agencies and Congress can stay abreast of technological
changes, such as nanotechnology, they may find themselves "in a
constant catch-up position and lose the capacity to shape outcomes."
[Footnote 8]
Nanomaterials Currently Enhance Products across a Number of Industry
Sectors, and New Uses Continue to Be Developed:
Industries around the world are harnessing the properties of
nanomaterials for a variety of products across a number of sectors and
are expected to continue to find new uses for these materials.
Nanomaterials can enter the marketplace as materials themselves, as
intermediates that either have nanoscale features or incorporate
nanomaterials, and as final nano-enabled products (see figure 1). For
example, a manufacturer of clay nanoparticles can provide them to a
plastic manufacturer, who can use them to enhance a composite material
(an intermediate). The plastic manufacturer can then sell the
composite material to an automobile manufacturer, who can use the
material to mold parts for cars (nano-enabled products).
Figure 1: Examples of Nanomaterials as Raw Materials, Intermediates,
and Finished Products:
[Refer to PDF for image: illustration]
Nanomaterials: Nanoscale structures in unprocessed form:
Such as:
* Carbon nanotubes;
* Ceramic nanoparticles;
* Dendrimers;
* Fullerenes;
* Metal nanoparticles;
* Nanostructured metals;
* Nanowires.
Nanointermediates: Intermediate products with nanoscale features:
Such as:
* Catalysts;
* Coatings;
* Composites;
* Displays;
* Drug delivery systems;
* Energy storage;
* Sensors.
Nano-enabled products: Finished goods incorporating nanotechnology:
Such as:
* Automobiles;
* Bottles;
* Buildings;
* Cancer treatment;
* Mobile phones.
Source: Adapted by GAO from materials produced by Lux Research.
[End of figure]
As the uses of nanomaterials continue to evolve, the overall market
for them is growing, along with the degree to which they are
permeating our everyday lives. In 2009, the Woodrow Wilson
International Center for Scholars' Project on Emerging
Nanotechnologies (Wilson Center) identified a list of more than 1,000
nano-enabled products currently on the market, reflecting a 379
percent increase since this list was first compiled in 2006.[Footnote
9] The list contains information on products from over 20 countries
that can be purchased and used by consumers and provides a baseline
for understanding the extent to which nanotechnology is being used. As
the Wilson Center has reported, the trend of an increased number of
products and applications featuring nanomaterials is also reflected in
the number of nanotechnology patents issued by the U.S. Patent and
Trademark Office, growing from 125 in 1985 to 4,995 in 2005, which
represents a compound annual growth rate of 20 percent. The following
is a list of selected industry sectors and some examples of current
and potential uses of nanomaterials within each sector that illustrate
the ubiquitous nature of these materials in commerce. Because
assembling a complete catalog of uses would be difficult in an
evolving, dynamic industry, the list is not comprehensive, the
examples chosen are simply illustrative, and we have not verified the
claims made by the manufacturers of the products used in these
examples.
Automotive:
From car bodies to exterior coatings to engines on the market today,
cars contain numerous enhancements made possible by nanomaterials. In
the current marketplace, some bumpers and other auto parts incorporate
composite materials containing nanomaterials, such as nanoscale clays,
metals, and carbon nanotubes to make these parts stronger, and more
fire resistant.[Footnote 10] Many nano-enabled products in the
automotive sector involve the addition of nanoscale ceramic and metal
particles to a wide variety of coatings. These nanomaterials provide
advantages for coatings over conventional materials, such as the
ability to block ultraviolet (UV) light or promote self-cleaning
without altering the transparency of the coatings. For example,
coatings containing nanoparticles are currently dispersed in paints
and pigments to make surfaces stronger, smoother, more scratch and
stain resistant, waterproof, or some combination of these and other
properties. In addition, carbon nanotubes offer an especially high
tensile strength--the ability to withstand a stretching force without
breaking--of about 100 times greater than that of steel at one-sixth
the weight, and their electrical conductivity can be precisely
controlled, which helps prevent the build-up of static electricity. As
a result, when a manufacturer of fuel lines adds carbon nanotubes to
traditional engineering materials, it results in stronger, safer fuel
lines.
In the future, nanomaterials could be used to improve the performance
of cars, including reducing wear on engine parts and increasing
battery power and fuel efficiency. For example, lubricants that
contain certain nanomaterials could provide smaller, stronger, and
more stable alternatives to oil-based lubricants. In addition,
electrodes--electrical conductors that contain movable electric
charges--manufactured at the nanoscale could enable higher-performance
rechargeable batteries. For example, according to documents we
reviewed, one company that is developing a new lithium-ion battery for
electric vehicles uses nanoscale metal oxide materials to create
crystallized nanoparticles that may enable this nano-enabled battery
to deliver 20 percent more power. Moreover, fuel additives with
nanoparticles of cerium oxide could increase diesel engine fuel
efficiency.[Footnote 11] One British company has developed such an
application for a fuel-based additive that, due to the size-based
properties of cerium nanoparticles, creates a greater surface area for
catalyzing the combustion reactions between diesel and air.[Footnote
12] According to this company, the result is a cleaner burn that
converts more fuel to carbon dioxide, produces less noxious exhaust,
and deposits less carbon on the engine cylinder walls than other fuel
additives. Figure 2 shows examples of some current and potential
nanotechnology innovations that may be used in automobiles.
Figure 2: Examples of Current and Potential Nanotechnology Innovations
that May Be Used in an Automobile:
[Refer to PDF for image: illustration]
* Lubricating nanocoating on engine parts improves fuel economy;
* Carbon nanotube fuel line lessens risk of fire;
* Nanocomposite body moldings are lighter than conventional materials;
* Magnetic nanomaterial for memory chips may remove need for battery;
* Nanocoating improves scratch resistance;
* Nanoscale catalysts allow reduction in emissions.
Source: Adapted by GAO from materials produced by Lux Research.
Note: The photo is illustrative and not intended to imply that this
particular vehicle currently utilizes the nanotechnology innovations
depicted or will in the future.
[End of figure]
Defense and Aerospace:
Nanomaterials are beginning to be used in aerospace applications by
manufacturers seeking to take advantage of the electrical and
mechanical strength advantages they offer and by the Department of
Defense, which is seeking ways to enhance the tools available to its
soldiers and the effectiveness of its weapons systems. Nanomaterial
polymers are currently being used as sensors that detect very small
traces of explosives, which indicate the presence of buried landmines,
according to Department officials. In addition, according to documents
we reviewed, stronger and lighter planes that are better protected
against lightning and fire have been made possible by using carbon
nanotubes and other nanostructured materials. For example, one company
has created a nanolaminated material used for planes that is comprised
of layers of metal alloys that are stronger, lighter, and more energy
absorbent than steel. In addition, polymers with embedded silver
nanoparticles are helping to keep surfaces, including the interiors of
aircraft, free of microbes.[Footnote 13] The polymers contain
nanoscale silver particles that, when added to a product's surface,
release ions that kill bacteria existing on the surface.[Footnote 14]
Companies are also introducing nanostructured alternatives to standard
copper wiring. For example, one company has developed a process to
create highly conductive sheets of fabric and lengths of yarn
containing carbon nanotubes that can be used to create wiring and
cables for airplanes and satellites that weigh much less than
traditional copper wire.
In the future, nanomaterials may help enable the development of new
applications and products across a wide spectrum in the defense arena,
including surveillance devices, explosives and propellants, and
uniforms. For example, according to Department of Defense officials
and documents we reviewed, nearly "invisible" surveillance may be
possible through the incorporation and integration of different
nanotechnologies, including radio frequency identification chips;
integrated circuits; minute biosensors; and "intelligent" fabrics,
films, and surfaces. Miniaturized surveillance techniques under
research include using live insects ("spy" bees) tagged with
nanomaterials or tiny winged robots that emulate insects to fly into
an enemy situation to record data. In addition, more powerful
conventional explosives and faster moving missiles may be possible due
to the greater amounts of energy provided by nanostructured aluminum.
In combination with metal oxides, such as iron oxide, nanostructured
aluminum allows many more chemical reactions to occur in a given
surface area, increasing the explosive force. Also, nanomaterials such
as carbon nanotubes embedded in fabric could allow for lighter
uniforms and multifunctional combat suits for soldiers. The uniforms
could potentially, for example, change color to match the environment,
become rigid casts to protect injuries, or help block bullets and
chemical/biological agents. The material could even incorporate
sensors that monitor a soldier's condition, or function as drug
dispensers activated automatically via radio waves by a remote doctor.
Electronics and Computers:
Computers and consumer electronics have also begun to benefit from the
advantages nanomaterials offer, including improved display screens and
improved electrical conductivity. Carbon nanotubes, quantum dots,
[Footnote 15] and nanoscale layers of polymers can improve the
properties of displays. For example, one company has developed an
ultra-thin, layered system of polymers that, unlike conventional
liquid crystal displays, requires no backlights or filters. The images
are brighter and clearer, and the technology could make possible fully
bendable plastic displays, according to the company. In addition,
since nanomaterials often enhance electrical conductivity, metallic
nanoparticles and carbon nanotubes are being used in a growing number
of conductive coatings, such as those used for touchscreens and solar
cells. According to documents we reviewed, one company sells a
transparent conductive coating and a coated film, both incorporating
nanowires, which conduct electricity better than traditional
materials. The coating and film could eventually replace rare and
expensive indium tin oxide, currently the most widely used transparent
conductor in the display industry. Moreover, nanomaterials such as
lead-free, conductive adhesives could eliminate several steps in
manufacturing electronics and could lead eventually to elimination of
some or all of the 3,900 tons of toxic, leaded solder used every year
by the U.S. electronics industry, according to an EPA document.
In the future, computers and electronic devices could employ
nanomaterials to create more efficient data storage and longer-
lasting, rechargeable batteries. Memory storage devices could become
more powerful through a variety of nanotechnology applications. New
methods of storing information electronically are emerging from a
variety of applications aimed at increasing the amount of information
that can be stored on a given physical space. For example, one company
has demonstrated the potential to create high-density memory devices
with an estimated storage capacity of 1 terabyte per square inch--more
than 200 times higher than the storage density of a DVD--by storing
information mechanically using nanoscale probes to punch nanoscale
indentations into a thin plastic film.[Footnote 16] In addition,
companies, research institutions, and government labs are working to
develop nano-based technology that could perfect "microbatteries,"
which are smaller, cheaper, and more powerful than batteries currently
in use. The greater surface area of the nanowires used in these
batteries lowers the internal resistance of the battery and therefore
allows greater current flow. Figure 3 shows some examples of current
and potential nanotechnology innovations that may be used in a mobile
phone.
Figure 3: Examples of Current and Potential Nanotechnology Innovations
That May Be Used in a Mobile Phone:
[Refer to PDF for image: illustration]
* Nanocomposite plastics are lighter and stronger;
* Nanomaterials make batteries lighter and longer lasting;
* Nanomaterials enable faster memory;
* Nanostructured optical components allow better images;
* Nano-enabled light emitting diode or light emitting polymer displays
are lighter and cheaper;
* Antimicrobial nanocoating resists bacteria.
Source: Adapted by GAO from materials produced by Lux Research.
Note: The photo is illustrative and not intended to imply that this
particular phone currently utilizes the nanotechnology innovations
depicted or will in the future.
[End of figure]
Energy and Environment:
Companies are beginning to use nanomaterials to clean up waste,
substitute nonrenewable resources with renewable ones, reduce
pollution, and increase the efficiency of solar power. Because
nanoscale particles can be more chemically reactive than
conventionally scaled particles of the same substance due to their
large surface area to volume ratio, these materials can be useful for
environmental remediation. Specifically, the increased surface area of
various types of ceramic or metal nanomaterials can result in the
rapid reduction of contaminant concentrations in soil, water, and air,
as pollutants or toxins in these media react with the nanomaterials.
Similarly, nanoscale iron is being deployed in a growing number of
environmental remediation projects with results that are proving
successful so far, according to EPA officials. For example, at one
remediation project, researchers injected carbon infused with
nanoparticles of iron into contaminated soil and found that the
nanoparticles made the resulting material more effective at absorbing
contaminants than similar materials without the nanoparticles. In
addition, nanomaterials are being used to create packaging materials
made from waste. For example, one company produces nanoparticle paper
coatings made from renewable natural starches that can replace
conventional material in paper coatings, which is typically made from
nonrenewable petroleum. Nanomaterials are also being used to improve
automotive catalytic converters, which feature nano-enabled catalysts
that reduce air pollution more efficiently. One company is
manufacturing a catalyst consisting of nanostructures with surface
areas much higher than traditional materials and that allows catalytic
converters to remain effective under prolonged exposure to high
temperatures, resulting in more stable, durable, and cost-effective
products. In the energy arena, nano-enabled thin-film and photovoltaic
technologies are making solar power more efficient. For example, one
company has reported gains in the ability of its thin-film solar cell
materials to absorb light, because the structure of the nanomaterial
is much smaller than the wavelength of light, which allows it to act
like an antenna that concentrates, absorbs, and transfers energy with
high efficiency.
In the future, nanomaterials could help deliver alternative forms of
energy, cleaner water, and more efficient energy transmission. Using
nanoscale catalysts, hydrogen--an alternative form of energy--could be
produced from water more efficiently. For example, a company has
developed a photoelectrode that uses nanoscale material and converts
sunlight into hydrogen six times more efficiently than its
conventionally scaled equivalent.[Footnote 17] In addition,
nanotechnology-enabled water desalination and filtration systems may
offer affordable, scalable, and portable water filtration in the
future. Filters, comprised of nanoscale pores which incorporate a wide
variety of nanomaterials--including nanoparticles made of aluminum
oxide, iron, and gold, and carbon nanotubes--have the potential to
allow water molecules to pass through, but screen out larger
molecules, such as salt ions and other impurities such as bacteria,
viruses, heavy metals, and organic material. In addition,
nanoparticles could be used to improve the efficiency of energy
transmission by increasing the capacity and durability of insulation
for underground electrical cables, allowing cables of smaller diameter
to carry the same power as larger cables and to last longer. For
example, one company's research shows that cable insulation treated
with nanocomposites containing nanosilica have about 100 times longer
voltage endurance compared to untreated material. In addition,
researchers have demonstrated that carbon nanotube fiber bundles could
carry 100 times more electrical current than the leading transmission
wires, without as much energy loss. Moreover, one study predicts that
if energy transmission losses could be reduced from the current 7
percent using copper wires to 6 percent by using carbon nanotube
fibers, the annual energy savings in the United States would be equal
to 24 million barrels of oil.
Food and Agriculture:
Nanomaterials are currently appearing in food packaging and food
supplements.[Footnote 18] Specifically, nanomaterials are being used
in food packaging, where applications such as antimicrobial nanofilms--
thin layers of substances meant to hamper the growth of bacteria and
fungi--are intended to bolster food safety. Also, composite materials
made of nanoclays embedded in nylon can offer strong oxygen and carbon
dioxide barriers and have been used in plastic bottles and films for
packaging food and beverages. For example, one company produces a
nylon and clay nanocomposite used as a flexible, puncture-resistant
oxygen barrier for beer and carbonated beverage bottles; in packaging
for processed meats and cheeses; and in coatings for paper packaging
for juice or dairy products. Moreover, products such as cutting boards
and food containers have been infused with nanosilver--which is known
for its antimicrobial properties. In addition, encapsulation--the
process of using one material to deliver another material inside the
human body--has been in use for decades but is being improved with
nanomaterials. Nanoencapsulated food products and supplements can
target nutrients, release drugs on a controlled schedule, and mask
tastes. For example, some vitamins can be difficult to deliver in
beverages because they degrade and may not be easily absorbed by the
body. One company has developed nanoscale structures to deliver the
vitamin to the digestive system, making it easier for absorption to
occur. Another manufacturer has used nanocapsules to incorporate
certain fatty acids that have purported health benefits into bread.
The company claims the acids in the nanocapsules bypass the taste
buds, emerging only after the nanocapsules reach the stomach, thus
avoiding any unpleasant taste.
In the future, manufactured nanomaterials could be used to enhance
agriculture; monitor food quality and freshness; improve the ability
to track food products from point of origin to retail sale; and modify
the taste, texture, and fat content of food. Nanomaterials are being
developed to more efficiently and safely administer pesticides,
herbicides, and fertilizers by controlling more precisely when and
where they are released. In addition, researchers are developing a
nanoscale powder that can retain water better than other materials and
allows fertilizers to gradually release nutrients for crops or grass,
according to the Wilson Center. In addition, researchers have
developed nanobiosensors using nanoscale particles for detecting
bacteria, such as salmonella, in water and liquid food. Their work
could lead to nanosensors that could be used in fields to monitor for
bacterial contamination of crops, such as spinach, lettuce, and
tomatoes, potentially reducing the spread of food-borne illnesses. In
addition, electrically conductive inks containing nanomaterials could
be used to print radio-frequency identification tags, which could be
integrated into packaging for food products, potentially resulting in
improved food security and better inventory tracking and management.
Figure 4 shows some examples of current and potential nanotechnology
innovations that may be used in a drink bottle.
Figure 4: Examples of Current and Potential Nanotechnology Innovations
That May Be Used in a Drink Bottle:
[Refer to PDF for image: illustration]
* Nanoencapsulated carriers deliver food and dietary supplements;
* Nanosensors detect changes in food and beverage quality;
* Gas barrier nanocoatings keep food and beverages fresher;
* Coatings and plastics containing nanomaterials block ultraviolet
light;
* Nanosilver antimicrobial coating resists bacteria;
* Electrically conductive inks containing nanoparticles make radio
frequency identification tag printable.
Source: Adapted by GAO from materials produced by Lux Research.
Note: The photo is illustrative and not intended to imply that this
particular juice bottle currently utilizes the nanotechnology
innovations depicted or will in the future.
[End of figure]
Housing and Construction:
Materials and coatings are currently making buildings and homes
cleaner and stronger, and in the future will allow them to operate
with higher energy efficiency, according to documents we reviewed.
Protective coatings and materials that incorporate nanoparticles of
titanium dioxide are being used to manage heat and light by blocking
UV light from the sun's rays and are taking on self-cleaning
properties through a photocatalytic effect.[Footnote 19] For example,
titanium dioxide is being added to paints, cements, windows, tiles,
and other products for its sterilizing and deodorizing properties.
Additionally, as titanium dioxide is exposed to UV light, it becomes
increasingly hydrophilic--attractive to water--and is therefore being
used for antifogging coatings or self-cleaning windows. Nanomaterials
are also proving beneficial to the construction industry by, for
example, making steel tougher and concrete stronger, more durable, and
more easily placed. For example, one company has created a structural
material with a grain size reduced to the 100 nanometer scale, which
it claims has a strength-to-density ratio four times that of the
toughest titanium alloys and also resists corrosion. Inside the walls
of buildings, insulation made from nanomaterials is providing high
thermal performance at minimal weight and thickness. In addition,
nanomaterials are being incorporated into some air monitoring
technologies, air purification products, and energy-efficient air
conditioning systems for residential, commercial, and industrial
settings. For example, some air filters that are on the market use
nanomaterials to clean air better than conventional materials.
In the future, nanoparticle coatings on windows and buildings could
retain energy from the sun for later release. For example, researchers
working on phase change materials--materials which absorb and release
thermal energy--have found that when graphite nanofibers are blended
into these materials the nanofibers improve the material's thermal
performance. The result could be cheaper and more efficient uses of
these materials for solar energy storage. In addition, nanomaterials
may offer approaches that enable materials to "self-heal" by
incorporating, for example, nanocontainers of a repair substance
(e.g., an epoxy) throughout the material. When a crack or corrosion
reaches a nanocontainer, it could be designed to open and release its
repair material to fill the gap and seal the crack. Figure 5 shows
some examples of current and potential nanotechnology innovations that
may be used in a house.
Figure 5: Examples of Current and Potential Nanotechnology Innovations
That May Be Used in a House:
[Refer to PDF for image: illustration]
* Nanomaterials allow solar cells to be integrated into roof material;
* Nanoporous materials make insulation more efficient;
* Self-cleaning, nanostructured window coatings loosen dirt so windows
can self-clean;
* Nanocomposite materials make drywall stronger;
* Nanocoatings make bathroom surfaces easy to clean;
* Nanoparticles make paint durable and mildew resistant.
Source: Adapted by GAO from materials produced by Lux Research.
Note: The photo is illustrative and not intended to imply that this
particular house currently utilizes the nanotechnology innovations
depicted or will in the future.
[End of figure]
Medical and Pharmaceutical:
Nanotechnology is important to the medical and pharmaceutical industry
because the extremely small size of nanomaterials makes possible
medical interventions that can be directed to individual cell types,
allowing for better diagnosis, treatment, and prevention of cancer and
other deadly diseases.[Footnote 20] Current disease detection efforts
include the use of nanoscale sensors to identify biomarkers, such as
altered genes, that may provide an early indicator of cancer. Doctors
are also using nanomaterials as markers to enhance images from deep
inside human tissue, allowing them to track particles to the site of a
tumor, resulting in earlier detection of tumors. Certain nanomaterials
such as polymer nanoparticles are being used to treat cancer by
delivering medication directly to tumors while sparing healthy tissue.
In addition, silver nanocrystals are being used in antimicrobial wound
dressings, thereby requiring fewer dressing changes and causing
patients less pain.
In the future, nanomaterials could be used to help doctors better
diagnose and treat disease. In diagnosis, nanomaterials hold promise
for showing the presence, location, and contours of cardiovascular and
neurological disease, and small tumors. For example, researchers could
use metallic and magnetic nanoparticles to enhance imaging, the
results of which can be used to guide surgical procedures and to
monitor the effectiveness of nonsurgical therapies in reversing the
disease or slowing its progression. In the future, sensors implanted
or delivered with a drug could allow for continuous and detailed
health monitoring so disease might be managed better, turning a drug
into a multifunctional tool for diagnosis and treatment. For example,
bio-sensors could be attached to targeted drugs and linked to a
mechanism that reports the body's condition. Furthermore, according to
the National Institutes of Health, gold nanoshells are being developed
to simultaneously image and destroy cancer cells using infrared light.
Nanoshells can be designed to absorb light of different frequencies,
generating heat. Once the cancer cells take up the nanoshells,
scientists apply near-infrared light that is absorbed by the
nanoshells, creating an intense heat inside the tumor that selectively
kills tumor cells without disturbing neighboring healthy cells. Such a
targeted delivery approach could reduce the amount of chemotherapy
drug needed to kill cancer cells, potentially reducing the side
effects of chemotherapy. Medical researchers are also exploring the
use of nanomaterials to deliver molecules and growth factors to
promote better healing for burns and wounds that heal without scars.
For example, Department of Defense researchers have conducted tests in
animals using nanofiber mesh scaffolds to treat bone, nerve,
cartilage, and muscle injuries and have reported that preclinical data
from the studies indicate improved healing. Other nanofibers are being
developed for medical use as mesh barriers to stop the flow of blood
and other fluids more quickly and effectively.
Personal Care, Cosmetics, and Other Consumer Products:
Nanomaterials are currently being used in a variety of personal care
items, cosmetics, and other consumer products.[Footnote 21] These
products include sunscreens that contain nanoscale titanium dioxides
and zinc oxides, which act as physical filters that absorb UV light.
Because these nanomaterials are smaller than the wavelength of light,
they make sunscreens transparent instead of opaque, and they may also
adhere better when applied and absorb harmful ultraviolet rays more
effectively than conventional sunscreens, according to stakeholders
and documents we reviewed. In addition, nanomaterials are being
incorporated into cosmetics, such as an anti-aging cream, which allows
the active ingredients to penetrate deep into the skin where they can
be most effectively administered, according to the manufacturer.
Nanomaterials are also being used in a wide range of other consumer
products. For example, companies are using carbon nanotubes to
reinforce a variety of sporting goods, such as bicycle frames, tennis
rackets, baseball bats, and hockey sticks, because they offer greater
strength and reduced weight, while retaining, or even increasing,
stiffness. Companies are using other nanomaterials to improve the
performance of products such as ski wax and tennis balls. For example,
a nanomaterial coating decreases the gas permeability in tennis balls
and therefore allows the balls to maintain pressure for longer periods
of time, according to the company producing the coating. Nanomaterials
are also being used in coatings to make fabrics and clothing stain and
water resistant. For example, one company embeds nanomaterials on the
surface of fabric fibers, creating a cushion of air around them. The
fabric allows sweat to pass out, while also causing surface water to
bead up and roll off. Another company has developed socks treated with
nanosilver for its antimicrobial properties.
In the future, consumers may benefit from advanced applications that
could emerge from nanomaterial research occurring in a variety of
sectors. For example, developments in the health arena could lead to
new, beneficial pharmaceutical therapies designed to treat aging and
age-related disease. In addition, according to documents we reviewed,
researchers are working to make textiles functional by combining
manufactured nanomaterials with materials that react to light to
create power-generating clothing and nanosilver could be used in
textiles to treat skin conditions. Researchers are also developing
nano-enabled textile surfaces that can remove scratches and scuff
marks, as well as decolorize red wine spills.
Potential Risks to Human Health and the Environment from Nanomaterials
Depend on Toxicity and Exposure, and Current Understanding of the
Risks Is Limited:
The properties of nanomaterials affect their toxicity and, in turn,
their risks to human health and the environment. Furthermore, the risk
of nanomaterials also depends on the extent and route of exposure to
nanomaterials, but current understanding of nanomaterial toxicity and
exposure is limited, according to the studies we reviewed.
The Toxicity of Individual Nanomaterials May Vary According to Their
Properties and Affects Their Risks:
The toxicity of each nanomaterial may vary according to a combination
of the individual properties of these materials--including size,
shape, surface area, and ability to react with other chemicals--and
these properties affect the potential risks posed by nanomaterials,
according to some of the studies we reviewed. The properties of a
nanomaterial may differ from the properties of conventionally scaled
material of the same composition. For example, the properties of
conventionally scaled gold have been well characterized: gold is
metallic yellow in color and does not readily react with other
chemicals. As a nanoparticle, however, gold can vary in color from red
to black and become highly reactive. The following are examples of how
toxicity may be affected by the properties of nanomaterials as
compared with their conventionally scaled counterparts:
* Size. Research assessing the role of particle size on toxicity has
generally found that some nanoscale (<100 nanometers) particles are
more toxic and can cause more inflammation than conventionally scaled
particles of the same composition. Specifically, some research
indicates that the toxicity of certain nanomaterials, such as some
forms of carbon nanotubes and nanoscale titanium dioxide, may pose a
risk to human health because these materials, as a result of their
small size, may be able to penetrate cell walls, causing cell
inflammation and potentially leading to certain diseases. For example,
the small size of these nanomaterials may allow them to penetrate
deeper into lung tissue, potentially causing more damage, according to
some of the studies we reviewed. In addition, some nanomaterials may
disperse differently into the environment than conventionally scaled
materials of the same composition because of their size. However,
according to EPA, the small particle size may also cause the
nanomaterials to agglomerate, which may make it more difficult for
them to penetrate deep lung tissue.
* Shape. Nanomaterials may be produced in a wide variety of shapes,
including spheres, tubes, threads, and sheets, as well as more ornate
forms, such as dumb-bells. The shape of nanomaterials may be connected
to the type of health risks they may pose. For example, some carbon
nanotubes resemble asbestos fibers. When inhaled by people, asbestos
fibers are known to cause mesothelioma--which is a disease associated
with asbestos exposure. The similarity of these carbon nanotubes to
asbestos fibers has caused researchers to question if exposure to such
nanomaterials may lead to a similar disease. Furthermore, a study has
shown that exposing the abdominal cavity of mice to certain long
carbon nanotubes may be linked with inflammation of the abdominal
wall. The abdominal cavity in mice is often used as a surrogate for
understanding how the mesothelial lining of the human chest cavity
will react to substances.
* Surface area and reactivity. Nanomaterials may also be more reactive
with other chemicals than similar conventionally scaled materials
because nanomaterials have a higher surface area-to-mass ratio,
providing more area by weight for chemical reactions to occur. Some
studies have found that because of this increased reactivity, some
nanoscale particles may be potentially explosive and/or photoactive--
that is, sunlight triggers a chemical reaction in them. For example,
some nanomaterials--such as nanoscale titanium dioxide and silicon
dioxide--may explode if finely dispersed in the air and they come into
contact with a sufficiently strong ignition source. However, in
general, the extent to which such nanoscale dusts may be more
explosive than larger size dusts of the same composition is not fully
known, according to the National Institute for Occupational Safety and
Health. Other research has shown that particle surface area is a
better predictor of toxic response to inhaled particles than is
particle mass. For example, research into nanoscale titanium dioxide
in mice and rats has shown that particle surface area seems to be a
more appropriate measure for comparing the effects of different-sized
particles, provided they are of the same chemical structure.
Risk of Nanomaterials Is Also Affected by the Route and Extent of
Exposure:
In addition to toxicity, the risk that nanomaterials pose to humans
and the environment is also affected by the route and extent of
exposure to such materials. Nanomaterials can enter the human body
through three primary routes: inhalation, ingestion, and dermal
penetration.[Footnote 22]
* Inhalation is the most common route of exposure to airborne
nanoparticles, according to the National Institute of Occupational
Health and Safety. For example, workers may inhale nanomaterials while
producing them if the appropriate safety devices are not used, while
consumers may inhale nanomaterials when using products containing
nanomaterials, such as spray versions of sunscreens containing
nanoscale titanium dioxide. According to officials at the National
Institutes of Health, although the vast majority of inhaled particles
enter the pulmonary tract, evidence from studies on laboratory animals
suggest that some inhaled nanomaterials may travel via the nasal
nerves to the brain and gain access to the blood, nervous system, and
other organs, according to studies we reviewed.
* Ingestion of nanomaterials may occur from unintentional hand-to-
mouth transfer of nanomaterials or from the intentional ingestion of
nanomaterials.[Footnote 23] Ingestion may also accompany inhalation
exposure because particles that are cleared from the respiratory tract
can be swallowed. A large fraction of nanoparticles, after ingestion,
rapidly pass out of the body; however, according to some of the
studies we reviewed, a small amount may be taken up by the body and
then migrate into organs. The effect of these small amounts of
ingested nanomaterials is currently unknown, but concerns have arisen
from a growing body of evidence which indicates that certain types of
nanoparticles may cross cellular barriers.
* Nanomaterials may also be absorbed through the skin. For example,
one laboratory study has shown that certain nanomaterials have
penetrated layers of pig skin within 24 hours of exposure. In
addition, some cosmetics and sunscreens--among the first commercial
products to incorporate nanomaterials--contain nanoscale titanium
dioxide to increase the ultraviolet light-blocking power of the
product. The nano titanium dioxide is believed to be less toxic than
other chemicals that have been used to provide ultraviolet protection
in sunscreens. However, according to some of the studies we reviewed,
concerns have been raised that nanomaterials in sunscreens could
penetrate damaged skin. In contrast, according to officials at the
National Institutes of Health, there are several studies that have
found little dermal penetration from nanomaterials when applied to
undamaged skin. According to some stakeholders we spoke to, given the
known hazards of sun exposure, sunscreens containing nanomaterials may
be reasonable choices for the protection that they provide to
consumers from sun exposure.
In addition to the route of exposure, the extent of exposure--that is
the frequency and magnitude--to consumers and workers also affects the
risks posed by nanomaterials. Workers may be accidentally exposed to
nanomaterials during the production of nanomaterials or products
containing them, as well as during use, disposal or recycling of these
products. At present, there is insufficient information on the number
of workers exposed to nanomaterials in the work place or the effects
on human health of such exposure, according to the European Agency for
Safety and Health at Work. In addition, because nanomaterials have
applications in many consumer products and the use of such materials
in products is increasing, consumers have an increasing chance of
exposure to these materials. For example, consumers may now purchase
appliances such as washing machines coated with silver nanomaterials
purported to kill bacteria. When consumers purchase such a machine,
their clothing will be exposed to the silver nanomaterials, thus
increasing their exposure to nanomaterials. Similarly, consumers may
now purchase socks containing nanosilver, which exposes them to this
nanomaterial. According to EPA officials, occupational exposure is a
particular concern and warrants attention because the exposure and
risk to workers is potentially greater than the risk to consumers.
[Footnote 24]
In addition to humans, the environment may also be exposed to
nanomaterials through releases into the water, air, and soil, during
the manufacture, use, or disposal of these materials. For example,
nanomaterials could enter water through discharges from production
facilities. In addition, when nanomaterials are used in
pharmaceuticals, cosmetics, and sunscreens, the nanomaterials could
enter water via the sewage system during washing, showering, or
swimming after having been applied to the skin and may eventually end
up in a waste water treatment plant. These nanomaterials, if
antibacterial in nature and if released in sufficient amounts, could
potentially interfere with beneficial bacteria in sewage and waste
water treatment plants and could also contaminate water intended for
re-use, according to some of the studies that we reviewed. Moreover,
some researchers have raised serious concerns that antibacterial
nanomaterials will pose toxicity risks to human health and to
environmental systems into which waste products are released. In
addition, according to research, unused cosmetics are most likely to
be disposed of in household waste, which may be incinerated,
potentially putting nanomaterials into the air, or put in a landfill,
potentially leaching out of the landfill into the water. In addition,
nanomaterials that are currently being used to treat polluted water
will result in releases of the materials into water and soil. For
example, iron nanoparticles are being used to treat polluted water.
According to EPA officials, although little is known about how these
particles move through the environment, they are expected to react
with contaminants or with naturally occurring substances in water and
become iron oxides. Figure 6 shows the potential exposures to humans
and the environment throughout the lifecycle of nanomaterials.
Figure 6: Potential Exposure Routes throughout the Life Cycle of
Nanomaterials:
[Refer to PDF for image: illustration]
Life cycle:
Nanomaterial production;
Product manufacturing;
Consumer use;
End of life (disposal or recycling).
Worker and consumer exposure routes:
Dermal;
Ingestion;
Inhalation.
Environmental exposure routes:
Air;
Soil;
Water.
Source: Adapted by GAO from materials produced for the European
Parliament's Committee on the Environment, Public Health and Food
Safety.
[End of figure]
Currently, it is difficult to assess the risk of nanomaterials that
are released into the environment because these materials are so
varied and it is difficult to make generalizations about how they will
behave once they are released, according to EPA officials.
Specifically, it is unclear whether the nanomaterials will (1) stay
suspended, (2) aggregate or cluster together to form larger particles,
(3) dissolve or further break down, or (4) react with natural
materials found in the environment. For example, the release of carbon
nanotubes, nanoparticles of iron and titanium dioxide, or fullerenes--
which are nanoscale spheres of carbon--into water may result in their
aggregation, according to some of the studies we reviewed. These
larger aggregates may have different toxicological properties when
compared to those exhibited by the original nanomaterials. The risk
posed by some nanomaterials is presumed to decrease if they aggregate
because the nanomaterials may grow to the size of conventionally
scaled substances, according to some of the studies we reviewed.
However, the extent of aggregation may be limited because many
nanomaterials receive coatings to decrease the aggregation of these
materials. In addition, some nanomaterials may react with the
environment and eventually build up in the environment, according to
some of the studies we reviewed. Specifically, some nanomaterials may
become attached to and continue to build up in the soil, depending on
the nanomaterial characteristics and the characteristics of the soil.
Some nanomaterials may also bioaccumulate in organisms, according to
EPA.
Understanding of the Risks Posed by Nanomaterials Is Limited by
Several Factors:
Current understanding of the risks that nanomaterials may pose is
limited by several factors, including the limited amount of research
that has been conducted to date and a lack of tools and methods needed
to conduct additional research. As a result, predicting and assessing
the potential hazards, exposures, and resulting risks from
nanomaterials is difficult. Although the number of studies that have
focused on assessing the risks of nanomaterials has increased over the
past 5 years (see figure 7), the studies completed to date have
yielded limited risk information, according to EPA officials and other
stakeholders that we spoke with, and our review of these studies. Some
of these limitations include the following:
* The findings from completed toxicity studies of a nanomaterial
constructed in one manner may not be applicable to understanding the
risks posed by the same nanomaterial constructed in a different manner
and, therefore, studies of similar nanomaterials may not be
comparable. For example, carbon nanotubes may be produced in several
ways, each with its own potential level of toxicity so that the
results of a study for one type of carbon nanotube may not be
comparable to the results of a study of a different type of carbon
nanotube. Similarly, some early studies of carbon nanotubes did not
specify the length of the nanotubes being studied, making it difficult
to compare the results of those studies with subsequent carbon
nanotube studies, according to stakeholders. This is important because
researchers now know that different nanotube lengths may pose
different risks.
* The studies that have been conducted have focused more extensively
on some nanomaterials than others. For example, certain silica
nanoparticles and carbon black are among the best studied
nanomaterials, according to EPA. In contrast, less is known about
nanomaterials such as nanoscale aluminum oxide and nanoclays.
Therefore, little or no information is known about the risks of these
types of nanomaterials.
Figure 7: The Increase in Environment and Human Safety Research
Relating to Nanomaterials since 2005:
[Refer to PDF for image: vertical bar graph]
Year: 2005;
Number of publications: 128.
Year: 2006;
Number of publications: 197.
Year: 2007;
Number of publications: 377.
Year: 2008;
Number of publications: 462.
Year: 2009;
Number of publications: 721.
Source: GAO analysis of International Council on Nanotechnology data.
[End of figure]
Additional efforts to study the risks from nanomaterials will also be
hampered because certain tools necessary to conduct these studies are
lacking. Specifically, according to studies we reviewed, research on
nanomaterials depends on the availability of tools, such as models or
measurement technologies, to characterize or describe the
nanomaterials' main qualities. However, although some tools are
available, the scientific community does not currently possess all the
needed tools to do so, and it will require extensive research to
develop these tools. Additionally, lack of data and appropriate models
also limits our ability to study the risks posed by nanomaterials,
according to some of the studies we reviewed and stakeholders that we
spoke with. While researchers have developed models for conventionally
scaled chemicals that predict their characteristics based on the
characteristics of similar, or analogous, chemicals, no such models
exist yet for nanomaterials. For example, as mentioned earlier, free
nanoparticles may aggregate in the natural environment, forming larger
structures that may have different toxicological properties to those
exhibited by the original nanoform, but researchers lack models to
accurately predict how, when, and with which nanomaterials this
aggregation will occur. Moreover, according to stakeholders we spoke
to, small changes in the characteristics of some nanomaterials, such
as a 10 percent change in their size, may alter the toxicity of the
nanomaterials. The effect of such a small change compounds the
difficulty in creating predictive models of nanomaterial toxicity.
EPA Has Taken a Multipronged Approach to Managing the Potential Risks
of Nanomaterials but Faces Various Challenges in Regulating These
Materials:
EPA has taken a variety of actions to better understand and regulate
the risks of nanomaterials, including conducting research and asking
companies to voluntarily provide information about the nanomaterials
that they produce or use. Although EPA has taken some regulatory
action under its existing statutory framework with regard to
nanomaterials, its authority to do so varies depending on the statute
that it is using to regulate specific nanomaterials.[Footnote 25]
Moreover, the agency faces additional technical and informational
challenges that may impact its ability to regulate nanomaterials
effectively.
EPA Has Ongoing Research Efforts Related to Nanomaterials:
In June 2009, EPA issued its Nanomaterial Research Strategy, which
lays out the agency's plans for research to understand the potential
human health and environmental impacts from exposure to nanomaterials,
as well as how certain nanomaterials can be used in environmental
protection applications, such as remediating contaminated waste. The
strategy builds upon a body of research already conducted by EPA in
areas such as ultrafine particulate exposure and toxicity, fate and
transport modeling, life cycle assessment, and green chemistry.
[Footnote 26] EPA's strategy states that the agency's research efforts
will advance two key objectives: (1) develop approaches for
identifying and addressing any hazardous properties, while maintaining
beneficial properties, before a nanomaterial enters the environment
and (2) identify whether, once a nanomaterial enters the environment,
it presents environmental risks. EPA stated that it plans to pursue
these objectives from a life cycle perspective--from the production of
a nanomaterial, through its use in products, and as it is disposed of
or recycled. Ultimately, EPA plans to develop models and other tools
to enable it to predict the risks posed by various types of
nanomaterials. According to the strategy, EPA's research efforts will
be coordinated with those of other federal agencies. For example,
EPA's laboratories are collaborating with the National Institutes of
Health to conduct research on, among other things, the health effects
of carbon nanotubes. According to EPA, its research builds on and is
consistent with the scientific needs identified by the NNI's
Nanotechnology Environmental and Health Implications working group and
in EPA's 2007 Nanotechnology White Paper.
EPA is also coordinating with international organizations, such as the
Organisation for Economic Co-operation and Development (OECD) and the
International Organization for Standardization (ISO),[Footnote 27] on
nanomaterials research. Specifically, the OECD established the Working
Party on Manufactured Nanomaterials in September 2006, with EPA as a
member and the initial chair of the working party. This working party
is engaged in a variety of projects to further the understanding of
the properties and risks of nanoscale materials and how to mitigate
exposures and potential risks. For example, one project involves a
program for testing the safety of a set of 14 nanomaterials.
Specifically, member countries have agreed to develop certain data for
a group of 14 nanomaterials selected by the OECD working party, in
part, because they are in commerce or close to commercial use.
[Footnote 28] As part of this effort, EPA has the lead for the testing
of fullerenes, single-walled carbon nanotubes, multiwalled carbon
nanotubes, silver nanoparticles, and nano cerium oxide, among others.
In addition, EPA is participating in several ISO working groups for
nanomaterials. ISO has established a technical committee to develop
international standards for, among other things, nanotechnology
terminology, specifications for reference materials, and test
methodologies.
Under TSCA, EPA Has Regulated Some Nanomaterials as New Chemicals or
New Uses, but Some Nanomaterials May Be Entering the Market without
EPA Review:
Over the last 3 years, EPA's approach for regulating nanomaterials
under TSCA has been evolving as more information has become available
on the potential risks. In January 2008, EPA launched a voluntary
program called the Nanoscale Material Stewardship Program. Under this
program, EPA posted a notice in the Federal Register asking
manufacturers and processors of nanomaterials to submit existing
information on the nanomaterials they produce or use to help EPA
better understand the human health and environmental risks from these
substances. Thirty-one companies voluntarily provided information on
132 nanomaterials, according to EPA officials. In its interim report
on this program, issued in January 2009, EPA noted that although the
program provided useful information regarding certain nanomaterials in
commerce, a significant number of environmental health and safety data
gaps remain. For example, as part of the voluntary program, EPA
estimated that companies provided information on only about 10 percent
of the nanomaterials that are likely to be commercially available. In
addition, EPA reported that its review of data submitted through the
program revealed instances in which the details of the manufacturing,
processing, and use of the nanomaterials, as well as exposure and
toxicity data, were not provided. This further reduced the usefulness
of the information received because exposure and toxicity data are two
of the major categories of information that EPA had identified as
being needed to better inform its risk assessments of nanomaterials.
EPA concluded from the low response rate that most companies were not
inclined to voluntarily supply information on their nanomaterials.
In January 2008, EPA released a document entitled TSCA Inventory
Status of Nanoscale Substances--General Approach, which addressed
whether nanomaterials constituted new chemicals for the purpose of
regulation under TSCA. TSCA provides EPA with different authorities
for regulating new chemicals and existing chemicals. New chemicals are
those that are not already listed on the TSCA inventory, which is a
list of chemical substances manufactured or processed in the United
States. Existing chemicals are those already in commerce, including
about 62,000 which were already in commerce when EPA began reviewing
chemicals in 1979. In general, existing chemicals can be manufactured
or processed without any notification to EPA. By contrast, companies
intending to manufacture a new chemical must generally submit a notice
to EPA before manufacturing or producing the chemical. In its 2008
document, EPA stated that a nanomaterial is a new chemical for
purposes of regulation under TSCA only if it does not have the same
"molecular identity" as a chemical already on the inventory. Under
TSCA, a chemical is defined in terms of its particular molecular
identity. Although molecular identity is not defined in the statute,
EPA considers chemicals to have different molecular identities when,
for example, they represent different allotropes--a variant of a
substance consisting of only one type of atom--or isotopes. [Footnote
29] According to EPA officials, EPA generally does not consider the
properties--such as size, shape, and reactivity--of a chemical in
establishing its molecular identity. Thus, because titanium dioxide is
already listed on the TSCA inventory, nanoscale versions of titanium
dioxide, which have the same molecular formula, would not be
considered a new chemical under TSCA, despite having a different size
or shape, different physical and chemical properties, and potentially
different risks. However, fullerenes--a class of nanomaterials made of
spheres of carbon--would be considered a new chemical because they
represent a different allotrope, or molecular arrangement of carbon
atoms, than those chemicals already listed on the inventory.
If EPA makes certain findings, on the basis of information presented
in a premanufacture notice, it may control the manufacture,
processing, distribution in commerce, use, and disposal of the
chemical. The agency sometimes issues a consent order to the company
that places conditions on the use of the chemical or requires the
company to generate more information on the chemical's health and
environmental effects. Since 2005, the agency has received over 90
premanufacture notices for nanomaterials under TSCA, according to EPA
officials. EPA officials also told us that about 20 of these notices
were requests to be exempt from the full new chemical review process
based on regulatory exemptions for substances that met specific low
release and exposure criteria or which were produced at low volumes.
TSCA also authorizes EPA to issue rules addressing new uses of certain
materials--known as Significant New Use Rules (SNUR). These rules
identify new uses of existing chemicals that could affect the nature
of human and environmental exposure to the substance. If a company
wants to use a chemical in a way that has been designated as a
significant new use, it must submit a Significant New Use Notice to
EPA. For example, if EPA determines that manufacturing a chemical in a
powder form instead of a liquid form would be a significant new use of
that chemical, the company planning on manufacturing the chemical in a
powder form would have to notify EPA. Upon receipt of a notice, EPA
has 90 days to evaluate the intended use and, if warranted, to
prohibit or limit it before it occurs. In 2008, EPA issued two such
rules for nanomaterials. Specifically, having received premanufacture
notices for nanoscale versions of siloxane-modified silica and alumina
particles, EPA determined that certain uses of these chemicals,
including use without employing personal protective equipment, as a
powder, and uses different from those described in the premanufacture
notices, were significant new uses.
In 2008, EPA entered into consent orders with a manufacturer of a
specific type of carbon nanotubes that placed conditions on the use of
that manufacturer's carbon nanotubes. EPA was unable to determine the
potential for human health effects of these nanomaterials based on the
information available in the premanufacture notices and determined
that the uncontrolled manufacture, import, processing, distribution,
use, or disposal of these nanomaterials may present an unreasonable
risk to human health. Accordingly, EPA imposed exposure and release
controls on the manufacture of these nanomaterials in addition to
certain testing requirements. Subsequently, in November 2009, EPA
proposed SNURs for these nanomaterials, making the limitations
articulated in the consent orders applicable to all companies that
might seek to manufacture them, and in January extended the comment
period until February 2010.[Footnote 30] As of March 2010, no final
rule had been issued, but according to EPA, the agency is in the
process of issuing the final SNURs after considering public comment.
Until the SNURs are finalized, carbon nanotubes produced by
manufacturers other than those bound by the consent orders may be
entering the market without EPA review of available information on
their potential risk. However, according to EPA, no manufacturer or
importer has been able to demonstrate that their carbon nanotubes are
chemically identical to another manufacturer's carbon nanotubes; hence
the agency has treated all carbon nanotubes as unique chemical
substances for the purpose of listing them on the TSCA chemical
inventory.
In the fall of 2009, EPA announced it would reconsider the policy
described in its January 2008 document, TSCA Inventory Status of
Nanoscale Substances--General Approach, and subsequently announced it
planned to develop a SNUR to regulate nanoscale versions of
conventionally scaled chemicals that are already on the TSCA inventory
as a significant new use of that chemical. The agency intends to
propose this rule in December 2010. EPA stated the agency would
determine the existing uses of nanomaterials by using information
submitted through the voluntary Nanoscale Materials Stewardship
Program and other sources. EPA officials told us that issuing a SNUR
would allow the agency to regulate nano versions of chemicals already
on the TSCA inventory the same way it would regulate a new chemical.
One problem that EPA may face in issuing such a SNUR is that many uses
of nanomaterials are no longer new because nanomaterials are rapidly
entering the market, according to stakeholders we spoke with.
TSCA also gives EPA authority to issue rules requiring companies to
submit certain information about chemicals. EPA plans to issue one
such rule for nanomaterials that would require manufacturers to
provide information on production volume, methods of manufacture and
processing, and exposure and release, as well as available health and
safety studies.[Footnote 31] Evaluation of this information will
provide EPA with an opportunity to consider appropriate action under
TSCA to reduce unreasonable risks to human health or the environment,
according to EPA. This rule may also help them collect information on
nanomaterials not covered by the SNUR discussed above. EPA intends to
propose this rule in December 2010. This, however, raises the concern
that, in the meantime, nanomaterials may be entering the market
without the scrutiny these materials may merit. Furthermore,
stakeholders and EPA officials point out that the completeness of
information collected under a reporting rule may be limited because
the current definition of small manufacturers and processors may
exempt numerous manufacturers and processors of nanomaterials from
such rules. Some stakeholders told us this exemption may be
particularly limiting in the case of nanomaterials because much
nanomaterial development is being done by small startup companies.
Moreover, the reporting rule that EPA intends to propose will not
require periodic updates of the material reported.
EPA also collects data on chemicals through its Inventory Update Rule.
Under this rule, EPA requires companies to regularly report certain
information, including production volume and use information for
chemicals they produce in quantities over 25,000 pounds.[Footnote 32]
This reporting threshold is intended to capture information on
chemicals that account for most of the total U.S. production volume
covered by TSCA. EPA has not adjusted this threshold to capture the
production of nanomaterials, and thus EPA may be missing the
opportunity to collect important information on nanomaterials under
this rule.
Under TSCA, EPA can also issue rules that require chemical companies
to test chemicals for their health and environmental effects. To
require testing, EPA must find that a chemical (1) may present an
unreasonable risk of injury to human health or the environment or (2)
currently is or will be produced in substantial quantities and that
either (a) there is or may be significant or substantial human
exposure to the chemical or (b) the chemical enters or may reasonably
be anticipated to enter the environment in substantial quantities. EPA
must also determine that there are insufficient data to reasonably
determine or predict the effects of the chemical on health or the
environment and that testing is necessary to develop such data. EPA
officials told us they intend to propose a rule in December 2010 that
would require companies to generate test data on the health effects of
15 to 20 different nanomaterials, including carbon nanotubes,
nanoclays, and nano aluminum, and also on nanomaterials used in
aerosol-applied products.[Footnote 33] This information will help EPA
correlate the properties of these materials with specific health
effects, manage or minimize risk and exposure, and help EPA determine
the need for additional testing of these nanomaterials, according to
EPA. EPA officials told us they will be working with the National
Institute for Occupational Safety and Health, the Occupational Safety
and Health Administration, and the Consumer Product Safety Commission
on this effort. However, as we have noted in a prior report, EPA has
had difficulty in promulgating test rules in the past because, as
described above, it must demonstrate that chemicals may pose certain
health or environmental risks or meet volume and exposure thresholds
before it can require companies to establish such risks through
testing.[Footnote 34] Because relatively little is currently known
about the potential risks of nanomaterials and many of them have low
production volumes, EPA may have similar difficulties in making the
types of determinations necessary to promulgate a test rule for
nanomaterials.
EPA Has Not Developed a Clear Process under FIFRA for Regulating
Pesticides Containing Nanomaterials:
FIFRA requires companies to obtain a registration in order to
distribute or sell a pesticide. According to EPA, this authority
extends to pesticides containing nanomaterials. EPA must register a
pesticide if it determines, among other things, the pesticide will
perform its intended function without unreasonable adverse effects on
the environment.[Footnote 35] Under FIFRA, EPA is authorized to
require companies to submit or generate data that EPA needs to assess
the risks of the pesticide. EPA may publish and periodically revise
both data requirements and guidelines identifying the types of
information it generally requires to assess pesticides for
registration and the methods by which such data may be generated.
According to EPA, the agency may, on a case-by-case basis, modify data
requirements and guidelines for specific pesticides. In making its
registration decision, EPA can allow the pesticide to be distributed
and sold; allow it to be distributed and sold under certain
conditions, such as the need to develop further information; or
prohibit its distribution and sale altogether. However, according to
the agency, EPA's current guidelines do not require companies to
specify whether their pesticides contain nanoscale materials.
Officials told us that since 2007 they have received a few
applications for registration of various nanosilver pesticide
preparations. EPA officials told us that some of the companies that
have submitted registration applications for nanopesticides have told
EPA that the pesticide includes nanomaterials, while in other cases
EPA told us they were able to determine the pesticide contained
nanomaterials from the manufacturing processes. However, EPA officials
told us they registered at least one pesticide since 2007 without
being aware that it contained nanomaterials. A group of environmental
and consumer organizations has identified 260 products currently on
the market that claim to contain nanosilver. This group contends these
products should be regulated as pesticides due to the antimicrobial
effects of nanosilver, but that these products are not registered with
EPA under FIFRA.[Footnote 36] Because applicants do not have to
identify whether their pesticidal product contains nanomaterials, EPA
may not know that certain pesticides contain nanomaterials, and these
pesticides may be entering the market without EPA specifically
considering the potential risks their nanomaterials may pose.
EPA officials told us that if a company replaces a conventionally
sized active ingredient in a pesticide with a nanoscale version of
that ingredient, it is mandatory for the company to amend its
registration. Officials also noted, however, that the agency's
position on this point needs to be made explicit to the regulated
community and such a clarification could be made in EPA guidance.
According to stakeholders, manufacturers of nanopesticides are
required to obtain an amended registration in such a circumstance even
without new EPA guidance explicitly requiring it since the
registration requirement is based not only on questions of chemical
identity, but also on claims made about the pesticide; its
composition; and its chemistry, toxicology, and other information.
However, until EPA makes the requirement to obtain an amended
registration for pesticides that substitute a nanoscale ingredient for
a conventionally sized ingredient clear, such pesticides may be re-
engineered to include nanomaterials without EPA's knowledge and review.
EPA Believes It Has the Authority to Regulate Nanomaterials under Air,
Water, and Waste Statutes but Technology-related Limitations and
Volume-based Regulatory Thresholds Present Regulatory Challenges:
According to EPA officials and stakeholders, the agency can regulate
nanomaterials as it regulates other pollutants and waste under the
Clean Air Act, Clean Water Act, and RCRA, as well as undertake
cleanups of nanomaterials under CERCLA. Nanomaterials do not pose the
same definitional difficulties under the air, water, and waste
statutes as they do under TSCA and FIFRA because pollutants and wastes
are defined by their effects on humans and the environment rather than
by their composition. For example, EPA can list a nanomaterial as a
hazardous air pollutant if the agency can establish that the
nanomaterial may present a threat of adverse human health effects.
[Footnote 37] Similarly, EPA can list a nanomaterial as a toxic water
pollutant if exposure to the nanomaterial causes death, disease, and
genetic mutations, among other effects. Similarly under RCRA, a
material is characterized as a hazardous waste if it is specifically
listed as hazardous waste by EPA or it demonstrates any of four
hazardous characteristics--ignitability, corrosivity, reactivity, or
toxicity--based on testing or the knowledge of the manufacturer or
processor that generated the waste. Finally, under CERCLA, a material
is characterized as a hazardous substance if it is deemed hazardous
under CERCLA, RCRA, the Clean Water Act, the Clean Air Act, or TSCA.
EPA can designate additional substances as hazardous under CERCLA if
their release may present substantial danger to the public health or
welfare or the environment.
According to EPA officials and stakeholders, the agency faces
technical challenges to enforcing certain statutory provisions for
nanomaterials in air, water, and waste. For example, some stakeholders
told us that because fine particulates (particulates under 2.5
micrometers in diameter) are already defined as a conventional air
pollutant under the Clean Air Act,[Footnote 38] EPA could apply this
conventional air pollutant standard to nanomaterials. However, EPA
officials told us that while they could regulate nanomaterials under
this standard, they do not yet have the technology needed to monitor
particles of this size to enforce the standard. According to EPA and
stakeholders, the agency may need to reassess how it measures
pollutants under the Clean Air Act with respect to nanomaterials. This
is because given the relatively small weight associated with
nanomaterials, EPA may need to count particles or measure their
surface area rather than weigh them, as the current air pollutant
standard calls for.
Similarly, according to some stakeholders, in order to enforce any
technology-based effluent limitations for nanomaterials established
under the Clean Water Act in the future, EPA would need to identify
technology that can reliably and economically measure these materials
in effluents, which it does not currently have.[Footnote 39]
Similarly, EPA may face challenges in regulating nanomaterials in
waste under RCRA because the tests used to establish the hazards of
waste in general may be inadequate to characterize the hazards of
nanomaterials. For example, according to some stakeholders, to the
extent that nanoparticles behave in significantly different ways than
larger-scale particles in soil, groundwater, and drinking water, EPA's
assumptions under current testing procedures may not fully assess how
toxic wastes containing nanomaterials might affect groundwater.
In regulating nanomaterials, EPA also faces challenges attributable to
volume-based thresholds and special conditions, such as waste coming
from households, that trigger application of air, water, and waste
laws and regulations. For example, EPA exempts household waste from
RCRA hazardous waste regulation because it is impractical to regulate
individual households. Moreover, EPA officials told us that landfill
liners, as described in EPA's criteria for municipal solid waste
landfills under RCRA, are sufficient to handle the small amounts of
hazardous waste that end up in municipal landfills as a result of the
household hazardous waste exemption. However, some stakeholders argue
that until the risks of nanomaterials are better understood, it will
not be known whether the landfill liners are sufficient to address the
potential risks of nanomaterials that might be present in household
waste. An example of a volume-based threshold issue arises under the
Emergency Planning and Community Right to Know Act.[Footnote 40] EPA
has set thresholds in the regulations implementing hazardous chemical
inventory reporting requirements under these provisions that may not
establish a threshold that is appropriate for nanomaterials. For
example, the regulations include a default inventory reporting
threshold for releases of 500 pounds for extremely hazardous
substances and releases of 10,000 pounds for other hazardous
chemicals. Stakeholders question whether these thresholds may be too
high in the context of nanomaterials. EPA can set the thresholds lower
than the defaults and has, for example, reduced the default threshold
for some specific extremely hazardous substances to 1 pound. However,
it has not yet done so for any nanomaterials.
In addition to the challenges that EPA faces in regulating
nanomaterials under air, water, and waste statutes, the agency may
also be missing certain opportunities for gathering information on
nanomaterials under the Clean Water Act. For example, EPA may not be
collecting all available data on nanomaterials discharged into water.
EPA has authority under the Clean Water Act to require owners or
operators of facilities discharging pollutants to keep records, report
information, monitor and sample discharges, and provide other
information that EPA may reasonably require to carry out the act. The
act also gives EPA the authority to inspect facilities and review
records.[Footnote 41] According to stakeholders, at least one court
has interpreted this authority broadly, upholding as reasonable an EPA
permit requirement directing an applicant to disclose all toxic
pollutants used or produced in the facility.[Footnote 42] Thus,
stakeholders pointed out that EPA was able to obtain information not
only on toxic pollutants that were in fact being discharged from a
facility, but on those that had the potential to be discharged as
well. Stakeholders concluded that even if EPA cannot currently measure
nanomaterial discharges or cannot impose monitoring requirements on
facilities, the agency has the ability to obtain information on the
potential for nanomaterial discharge by a facility.
Other National Authorities Are Collecting Information on Nanomaterials
and Are Evaluating Their Legislation to Ascertain if Changes Are
Needed:
Australia and the United Kingdom have undertaken a voluntary approach
to collecting information on nanomaterials while Canada plans to
require companies to submit certain data. In contrast, the European
Union collects data on all chemicals being produced at a certain
volume as required by its basic chemicals legislation, which also
includes nanomaterials. All of these entities are reviewing their
existing legislation to determine the need for additional regulatory
authority to specifically address nanomaterials.[Footnote 43]
Australia Has Asked Companies to Voluntarily Provide Information on
Nanomaterials and Is Currently Reviewing Comments on Proposed
Legislative and Regulatory Changes:
Australia's National Industrial Chemicals Notification and Assessment
Scheme (NICNAS)--the government's regulatory body for chemicals--has
issued two requests for companies to voluntarily provide information
on nanomaterials but, like the U.S. experience, these requests have
produced limited results. In February 2006, NICNAS issued a voluntary
request for information from industry on the uses and quantities of
nanomaterials being manufactured or imported into the country.
Nanomaterials used exclusively in certain products, such as sunscreens
and food additives, among others, do not fall within the scope of
NICNAS and were consequently outside the request for information. Data
requested included chemical and trade name, molecular formula, and
estimates of total quantity imported or manufactured, and NICNAS did
not request data on nanomaterial toxicity. Companies supplied
information on 21 types of nanomaterials, 17 of which were available
for commercial use. The largest group of nanomaterials reported was
metal oxides, which are used in surface coatings, water treatment,
cosmetics, and catalysts. In October 2008, Australia expanded the
information requested in 2006 when it initiated a second request for
information that targeted all manufacturers or importers of
nanomaterials or products containing nanomaterials for commercial or
research and development purposes. The second request was for
companies to identify what data they have on their nanomaterials'
toxicological properties, while not requiring the data be provided to
NICNAS. The request also stipulated that no new data needed to be
generated. Although information was due to NICNAS by the end of
January 2009, the results of this request have not yet been made
public.
In addition to collecting information, NICNAS announced in fall 2009
that it is reviewing Australia's legislative framework and
administrative practices to ensure that any potential risks from
nanomaterials are adequately identified and appropriately managed. A
2008 review by an Australian university determined that Australia's
regulatory frameworks should be reviewed to ensure that the risks
posed by nanotechnology are better managed.[Footnote 44] The following
are areas, among others, that were identified for review by the report.
* Classification of nanomaterials as new or existing. Uncertainty
exists as to whether the nano-form of a chemical is considered new or
an existing chemical under current legislation. The NICNAS new
chemicals program--for chemicals not listed on the national inventory--
currently applies to nanomaterials and allows for them to be assessed
before commercial use. However, nanoscale versions of existing
chemicals--chemicals already on the national inventory--can legally be
introduced and used without notification to NICNAS.
* Weight or volume. Some Australian regulatory requirements are
currently triggered by weight or volume. For nanomaterials, weight or
volume thresholds may not be meaningful because current production
levels of nanomaterials are too low to trigger the threshold and not
enough is known about the appropriate threshold levels.
* Risk assessment protocols. It is uncertain whether risk assessment
methods currently being employed by various regulatory agencies are
suitable for goods that contain nanomaterials. Such uncertainties
reduce confidence in the results of assessments.
To address these areas of concern, Australia's NICNAS has proposed a
range of reforms, including removing nanomaterials from certain
exemptions and potentially requiring nanomaterials based on
conventionally scaled existing chemicals to go through the new
chemicals review program. Public comment on these proposals closed on
February 12, 2010, but the results of these comments have not yet been
made public.
The United Kingdom Has Asked Companies to Voluntarily Report Certain
Data on Nanomaterials and Is Currently Reviewing Whether Legislative
Changes Are Needed:
The United Kingdom launched a voluntary reporting scheme for
nanomaterials in 2006 that targeted manufacturers, importers, and
users and that also resulted in the collection of limited information.
This effort focused on free nanomaterials--nanomaterials not enclosed
in other materials--because they were identified as having greater
potential for environmental exposure. Information requested included
chemical identity; dimensions and shape; size range; predictions of
surface area; uses; available toxicological data; and certain physical
and chemical characteristics, such as water solubility, stability, and
flammability. As of July 2007, the United Kingdom had only received
nine responses to its voluntary reporting scheme.
Regarding legislation, the United Kingdom commissioned reviews of the
adequacy of existing legislation for each of its key regulatory
departments to assess whether current regulatory frameworks are
adequate to address the potential risks posed by nanomaterials. In
general, these reviews concluded that the current regulatory
framework, while broadly sufficient, has the potential for
nanomaterials to fall outside of regulatory controls in certain
circumstances, such as regulations with production volume or mass
thresholds developed in the context of macroscale materials. The
review also found that certain consumer products containing
nanomaterials may be found safe for consumer use, but that risk
assessments may not consider the full product life cycle, including
its disposal. Consequently, in June 2009, the United Kingdom
recognized that there may be a need to adjust existing systems to
create a more integrated approach to address risks from nanomaterials.
The United Kingdom is currently considering these issues as it
develops its strategy on nanotechnologies.
Canada Is Drafting a Requirement That Companies Provide Information on
Nanomaterials and Plans to Review the Data Collected before Proposing
Any Regulatory Changes:
Canadian officials have proposed but have not implemented a one-time
requirement for companies to provide information on nanomaterials
produced in or imported into Canada. Canadian importers and
manufacturers would be required to report their use of nanomaterials
produced or imported in excess of 1 kilogram. In 2009, Canadian
officials reported to the OECD that information required would include
chemical and trade name; molecular formula; and any available
information on the shape, size range, structure, quantity imported or
manufactured, and known or predicted uses. Also required would be any
available information on the nanomaterial's physical and chemical
properties--such as solubility in water and toxicological data, among
others. Under the proposal, companies could claim information as
confidential, but regulators would publish a summary of information
provided. Canada plans to use this information to help develop a
regulatory framework for nanomaterials and to determine which
information requirements would be useful for subsequent risk
assessments. Canadian officials stated they originally hoped to issue
this requirement in the spring of 2009 but could not predict when it
would be implemented.
With regard to current law, a report prepared for the government of
Canada in 2008 stated that Canada has no specific requirements for
nanomaterials and is considering whether they are needed. However,
Health Canada and Environment Canada--two agencies responsible for
health and the environment--have taken the first steps in recognizing
the potentially unique aspects of nanomaterials. These regulatory
agencies are currently relying on existing authority delegated to them
through legislation, such as the Canadian Environmental Protection
Act, to address nanomaterials. Specifically, in June 2007, Environment
Canada released a new substances program advisory announcing that
nanomaterials will be regulated under the act's new substances
notification regulations. Per this advisory, any nanomaterial not
listed on Canada's chemical inventory--the Domestic Substances List--
or with "unique structures or molecular arrangements" compared to
their non-nano counterparts, requires a risk assessment. A review
panel of the Canadian Academies found that, while it is not necessary
to create new regulatory mechanisms to address the unique challenges
presented by nanomaterials, the existing regulatory mechanisms could
and should be strengthened in a variety of ways, such as by creating a
specific classification for nanomaterials and by reviewing the
regulatory triggers that prompt review of the health and environmental
effects.
The European Union Is Considering Revising Its Chemicals Legislation
to Better Address Nanomaterials, and Is Requiring Labeling of
Nanomaterials in Certain Products:
The European Union passed its chemical legislation in 2007, known as
Regulation, Evaluation and Authorization of Chemicals (REACH),
[Footnote 45] under which the European Union generally collects
information on all chemicals. However because REACH requirements apply
to chemicals with a production volume of greater than 1 metric ton per
year, some stakeholders have expressed concern that the provisions of
REACH will not identify the risks of most nanomaterials because
companies do not produce these materials at this level or volume.
Because of this concern, the European Union is reviewing whether the
provisions of REACH need to be modified to take into consideration the
unique properties of nanomaterials by, for example, adjusting the
volume-based thresholds. This review is ongoing, according to official
EU reports, and is not scheduled for completion until 2012.
In addition to efforts under REACH, the European Union has developed a
regulation to require labeling on certain types of products containing
nanomaterials. For example, a European Union Cosmetics Regulation will
require cosmetic products that contain nanoscale ingredients to be
labeled as such. The regulation would also require the manufacturers
of new cosmetic products containing nanomaterials to notify regulators
and provide them with certain safety information. Manufacturers of
products containing nanoscale ingredients already being sold in the
European Union also would have to notify regulators and submit certain
safety information. In addition, the regulation requires all
nanomaterial ingredients be clearly indicated in the list of
ingredients and the names of such ingredients shall be followed by the
word "nano" in brackets. The regulation also calls for the European
Commission to compile a publicly available catalogue of all
nanomaterials used in cosmetic products placed on the market,
including those used as colorants, UV filters, and preservatives.
Although this regulation was published in November 2009, its
provisions are not scheduled to go into effect until July 2013.
In addition to the Cosmetics Regulation, the European Union has also
begun to regulate nanomaterials in food. Specifically, in January
2010, revised regulations on food additives went into effect. The
regulations clarify that when there is a change in the particle size
of a previously approved food additive, a new approval is required
before the additive goes to market. The European Union is also
considering an update to its regulations on novel foods--foods or
ingredients not widely consumed by people prior to 1997--that includes
measures to regulate manufactured nanomaterials in food. Specifically,
the proposed update would require that all foods containing
manufactured nanomaterials undergo premarket authorization.
Some State and Local Governments Have Begun to Address the Risks of
Nanomaterials:
Some U.S. states and localities have begun to address the potential
risks from nanomaterials by, for example, issuing requests for
information. Specifically, in January 2009, California required
companies that manufacture or import carbon nanotubes into the state
submit certain readily available data on these materials to the
California Department of Toxic Substances Control by January 22, 2010.
California officials told us that carbon nanotubes are an important
category of emerging nanomaterials for which data on toxicity,
physiochemical properties, and environmental fate and transport are
largely unavailable. California posted the 22 responses it received on
its Web site, as well as the names of companies that failed to
respond. In addition, California environmental officials said they are
now considering whether to conduct additional information requests on
nanoscale forms of metal oxides, including nano aluminum oxide, nano
silicon dioxide, nano titanium dioxide, and zinc oxide, as well as
nanosilver, nano zerovalent iron, and nano cerium oxide. According to
stakeholders we spoke with, environmental officials in other states
have also considered similar information requests. For example, in
2009, some Wisconsin state legislators called for a study on the
feasibility of creating a nanotechnology registry and the development
of subsequent legislation.
In addition to states, some municipalities have considered collecting
information on nanomaterials. For example, in December 2006, the City
of Berkeley, California, issued a hazardous materials ordinance that
requires companies to report the manufacture or use of nanomaterials.
According to stakeholders we spoke with, this was the first time a
U.S. city took such an approach. Berkeley's ordinance requires that
facilities that manufacture or use nanoparticles submit a separate
written disclosure of the material's known toxicology and how the
facility will safely handle, monitor, contain, dispose, track, and
mitigate the risks of such materials. Cambridge, Massachusetts, also
considered implementing a similar ordinance but has not done so yet.
Several state environmental officials told us they have considered
whether their states' current regulations provide enough authority to
address the risks of nanomaterials. For example, environmental
officials in California told us they planned to review the data
gathered under their requests for information to determine if
additional action is needed. According to a report issued by the
Environmental Council of the States, [Footnote 46] other states are
taking some preliminary actions with regard to nanomaterials.
Specifically,
* Maine officials developed an Air Toxics Priority List in July 2007
that includes particulate matter from nanotechnology,
* the Massachusetts Department of Environmental Protection identified
nanomaterials as an emerging contaminant of concern and established an
Interagency Nanotechnology Committee,
* the Washington State Department of Ecology considers nanomaterials
to be an emerging contaminant of concern and has revised its manual
for hazardous waste inspectors to include specific information on
nanomaterials, and:
* Pennsylvania and South Carolina have identified nanoparticles as
contaminants of concern.
The report identified nanomaterials, among other substances, as
emerging contaminants of concern.[Footnote 47] The report specifically
requested that federal agencies consider nanomaterials as a special
class of emerging contaminants due to properties that may make them
behave in ways that conventional-scale contaminants do not. In
addition, the report identified a number of states that are taking
some preliminary actions with regard to nanomaterials.
Conclusions:
The use of nanomaterials in products is growing faster than our
understanding of the risks these materials pose to human health and
the environment. While EPA has taken steps to improve our
understanding of these risks, such as by asking companies to
voluntarily provide information on the nanomaterials they produce, the
information gathered through these efforts has been limited and does
not provide a strong foundation for understanding the increasing
potential for exposure to these materials as their uses become more
prevalent. EPA has taken some regulatory action with regard to
nanomaterials under TSCA and has developed plans to take further
action with regard to information collection and testing of
nanomaterials. However, these changes have not yet gone into effect
and products may be entering the market without EPA review of
available information on their potential risk. Moreover, although EPA
requires chemical companies to periodically provide certain
information on many of the chemicals currently in commerce, EPA has
not extended this requirement to nanomaterials. Thus, EPA may be
missing the opportunity to gather some additional information on
nanomaterials from the regulated community. Furthermore, although EPA
is taking steps to regulate pesticides containing nanomaterials, it
has not clearly stated this to manufacturers, and the current data
requirements do not require companies to specify whether any materials
in their pesticides are nanoscaled.
EPA also may be missing the opportunity to gather some additional
information on potential discharges of nanomaterials from the
regulated community. We acknowledge that EPA faces technical
challenges in its research and regulatory efforts caused in part by a
lack of tools and models to help generate information on the potential
risks; however, better use of existing environmental statutes, such as
the Clean Water Act, may enable EPA to collect useful information on
nanomaterials.
Recommendations for Executive Action:
We recommend that the Administrator of EPA, take the following three
actions:
* Complete its plan to issue a Significant New Use rule for
nanomaterials.
* Modify FIFRA pesticide registration guidelines to require applicants
to identify nanomaterial ingredients in pesticides.
* Complete its plan to clarify that nanoscale ingredients in already
registered pesticides, as well as in those products for which
registration is being sought, are to be reported to EPA and that EPA
will consider nanoscale ingredients to be new.
In addition, the Administrator of EPA should make greater use of the
agency's authorities to gather information under existing
environmental statutes. Specifically, EPA should:
* complete its plan to use data gathering and testing authorities
under TSCA to gather information on nanomaterials, including
production volumes, methods of manufacture and processing, exposure
and release, as well as available health and safety studies; and:
* use information-gathering provisions of the Clean Water Act to
collect information about potential discharges containing
nanomaterials.
Finally, the Administrator of EPA should consider revising the
Inventory Update Rule under TSCA so that it will capture information
on the production and use of nanomaterials and so that the agency will
receive periodic updates on this material.
Agency Comments:
We provided EPA a draft of this report for review and comment. EPA
concurred with the report's recommendations and stated that the
recommendations are consistent with the agency's approach to
effectively managing nanoscale materials. EPA's comments are
reproduced in appendix II. In addition, EPA provided technical
comments, which we incorporated into the report as appropriate.
As agreed with your office, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the
appropriate congressional committees, the Administrator of EPA, and
other interested parties. The report will be available at no charge on
the GAO Web site at [hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-3841 or mittala@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. GAO staff who made key contributions
to this report are listed in appendix III.
Sincerely yours,
Signed by:
Anu K. Mittal:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
Our objectives for this review were to (1) identify examples of
current and potential uses of nanomaterials, (2) determine what is
known about the potential human health and environmental risks from
nanomaterials, (3) specifically assess actions the Environmental
Protection Agency (EPA) has taken to better understand and regulate
nanomaterials as well as its authorities to do so, and (4) identify
approaches that selected national authorities have taken to address
the risks associated with nanomaterials. In addition, you asked us to
identify any U.S. states and localities that may have begun to address
risks from nanomaterials.
To identify examples of current and potential uses of manufactured
nanomaterials, we analyzed documents and reports created by
stakeholders, including synthesis studies, databases of nanotechnology-
related products, and Web sites that compiled and analyzed
nanotechnology-related products from various sources. We identified
the documents and reports (1) through interviews with knowledgeable
stakeholders, (2) through open source research, and (3) from a
literature search. Because of the dynamic nature of nanotechnology, we
used only documents published since 2005. We also sought reports that
sorted the current and potential uses of nanomaterials into broad
categories, so that our report would not exclude any major industry
sectors. We analyzed the information, compared the sets of industry
sectors used in various reports to each other, and created a list of
eight industry sectors that in our estimation reflected the breadth
and depth of the commercial market for products enabled by
nanomaterials. We selected specific examples within each sector for
further analysis. Because assembling a comprehensive catalog of uses
would be difficult in an evolving, dynamic industry, our list of
examples is not comprehensive but rather was selected in a manner that
allowed us to convey the wide spectrum of materials in current use, or
which could be in use in the future, across a large range of products.
In addition, we interviewed cognizant agency officials from the top
six agencies conducting nanotechnology-related research. These six
agencies accounted for over 95 percent of federal nanotechnology
research reported in fiscal year 2009.[Footnote 48] We also
interviewed knowledgeable stakeholders, including officials from the
National Nanotechnology Initiative, the Woodrow Wilson International
Center for Scholars' Project on Emerging Nanotechnologies, Lux
Research--an independent research firm that conducts market analysis
of nanotechnology, among other things--and the NanoBusiness Alliance--
a nanotechnology related business association. To identify
knowledgeable stakeholders, we used an iterative process, often
referred to as "snowball sampling," in which we asked our initial
interviewees to identify others we should talk to, and we selected for
interviews those who would provide us with a broad range of
perspectives on the current and potential uses of nanomaterials.
To determine what is known about the potential human health and
environmental risks of nanomaterials, we reviewed documents that had
been published by peer-reviewed journals, government agencies, and
international nonprofit organizations. In conducting this review, we
searched databases, asked knowledgeable stakeholders to identify
relevant studies, and reviewed studies from article bibliographies to
identify additional sources of information on the potential risks.
Because of the importance of using the most current risk-related
research, the team used only documents published since 2005. Of the
over 700 documents we identified published between 2005 and 2010, we
narrowed our review to 140. Of these, we selected 20 for more detailed
analysis. We selected these documents in large part because they
provided a synthesis of available research related to nanomaterials
risks and they covered a variety of nanomaterials. To assess the
credibility, reliability, and methodological soundness of these
publications, a senior GAO technology analyst reviewed each of the
publications and considered such factors as the bibliographies of
evidence cited and the location of where the articles were published.
We did not examine the references cited by these studies as part of
our analysis. We concluded that all 20 reviews were sufficiently
reliable for the purposes of this report. For the purposes of this
review, all the documents, studies, and syntheses we reviewed will be
referred to in our report as "studies." We also spoke with a variety
of knowledgeable stakeholders representing government, industry,
academia, nongovernmental organizations, and the regulatory community.
These knowledgeable stakeholders were also selected using a snowball
sampling method.
To assess actions EPA has taken to better understand and regulate
nanomaterials and its authorities to do so, we analyzed selected laws
and regulations, including the Toxic Substances Control Act of 1976;
the Federal Insecticide, Fungicide, and Rodenticide Act; the Clean Air
Act; the Clean Water Act; the Resource Conservation and Recovery Act;
and the Comprehensive Environmental Response, Compensation, and
Liability Act. We also reviewed data and reports on EPA's Nanoscale
Materials Stewardship Program, which EPA developed to encourage
companies to voluntarily develop and submit information to EPA on the
characteristics of nanomaterials. We interviewed and obtained
documentation from agency officials responsible for implementing these
laws in EPA's Office of Air and Radiation, Office of Pollution
Prevention and Toxic Substances, Office of Pesticide Programs, Office
of Solid Waste and Emergency Response, and Office of Water. We also
interviewed and obtained documentation from staff in EPA's Office of
Research and Development. Furthermore, we consulted with knowledgeable
stakeholders and legal experts to obtain their perspectives on EPA's
available authorities to regulate nanomaterials.
To determine which national authorities had recently addressed
nanomaterials, we interviewed knowledgeable stakeholders, including
EPA officials who participated in working groups within the
Organisation for Economic Co-operation and Development to identify
candidate national authorities. We selected a judgmental sample of
four countries for our review based on the following criteria: (1) EPA
officials agreed that these countries have robust environmental
regulations that were comparable to US regulations and (2) the
countries had recently taken action with regard to nanomaterials,
including considering to regulate nanomaterials. Based on this, we
selected Australia, Canada, the United Kingdom, and the European
Union. To identify the approaches these national authorities have used
to address the potential risks associated with nanomaterials, we
analyzed these authorities' laws and regulations that would be
applicable to regulating nanomaterials, reviewed reports that other
organizations had conduced of these countries' laws as they pertain to
nanotechnology, and supplemented our understanding with interviews
with knowledgeable stakeholders and legal experts.
To identify any states or local governments that may be taking action
with regard to nanomaterials, we interviewed with knowledgeable
stakeholders including EPA officials, representatives from
environmental organizations, and the Environmental Council of States--
a nonpartisan association of state environmental officials. We
collected and analyzed documentation on these activities and
supplemented our analysis with interviews with selected state
officials.
[End of section]
Appendix II: Comments from the Environmental Protection Agency:
United States Environmental Protection Agency:
Office Of Chemical Safety And Pollution Prevention:
Washington, D.C. 20460:
May 4, 2010:
Anu Mittal, Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street, NW, Room HQ 2T31:
Washington, D.C. 20548:
Dear Ms. Mittal:
Thank you for the opportunity to review the U.S. Government
Accountability Office's (GAO's) draft report entitled Nanotechnolov:
Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in
Regulating Risk (GA0-10-549). We appreciate and concur with GAO's
recommendations, which are consistent with the Agency's approach to
effectively managing nanoscale materials.
We note GAO's acknowledgement that there are unanswered questions
about the potential risks of nanoscale materials to human health and
the environment. The same special properties that make nanoscale
materials useful are also properties that may cause some nanoscale
materials to pose potential risks to humans and the environment. At
this point, not enough information exists to fully assess these risks.
EPA will need a sound scientific basis for assessing and managing any
unforeseen future impacts resulting from the introduction of nanoscale
materials into the environment, as well as informing material design
and use decisions that avoid or reduce risk. A challenge for
environmental protection is to help fully realize the societal
benefits of nanotechnology while identifying and minimizing any
adverse impacts to humans or ecosystems from exposure to nanoscale
materials. The growing diversity and complexity of the types and uses
of nanoscale materials available and being developed presents
challenges in evaluating risks associated with the manufacture and use
of these materials.
As noted in the GAO report, this understanding will come from
environmental research and development activities. EPA is heavily
involved in efforts to understand the potential risks to humans,
wildlife, and ecosystems from exposure to nanomaterials. Through
innovation and discovery, scientists are studying the unique
properties of nanomaterials, determining their potential impacts, and
developing approaches to evaluate and prevent any risks. They are also
exploring how nanomaterials can be used effectively to clean up
contaminants released into the environment. With the use of
nanotechnology in the consumer and industrial sectors expected to
increase significantly in the future, nanotechnology offers society
the promise of major benefits. The challenge for environmental
protection is to ensure that, as nanomaterials are developed and used,
unintended consequences of exposures to humans and ecosystems are
prevented or minimized.
The recommendations contained in the GAO draft report are consistent
with the Agency's approach to effectively managing nanoscale materials
and we accept them. Below are comments on each of the recommendations
found in the draft report.
EPA Response to GAO's Recommendations for Executive Action:
We recommend the Administrator, EPA, take the following actions:
* Complete its plan to issue a Significant New Use Rule for
nanomaterials.
EPA agrees. EPA will continue to issue SNURs for nanoscale materials
that are new chemical substances on a case-by-case basis, as
appropriate, and intends to propose a SNUR for nanoscale materials
that are existing chemical substances by December 2010.
* Modify FIFRA pesticide registration guidelines to require applicants
to identify nanomaterial ingredients in pesticides.
EPA agrees and intends to clarify that, as part of the application for
registration, applicants for pesticide registrations which contain
nanomaterial ingredients need to specifically identify those
ingredients.
* Complete its plan to clarify the FIFRA guidelines to make clear that
already registered pesticides that have been reengineered to include
nanomaterials need to obtain an amended registration.
EPA agrees and is working on clarification of registrant's
responsibilities under FIFRA with respect to nanomaterials.
In addition, GAO recommends the EPA Administrator should make greater
use of its authorities to gather information under existing
environmental statutes. Specifically, GAO recommends EPA should:
* Complete its plan to use data gathering authorities under the Toxic
Substances Control Act (TSCA) to gather information on nanomaterials,
including production volumes, methods of manufacture and processing,
exposure and release, as well as available health and safety studies.
EPA agrees and intends to propose a section 8(a) information gathering
rule as described in the recommendation and also intends to propose a
section 4 test rule.
* Use information gathering provisions of the Clean Water Act to
collect information about potential discharges containing
nanomaterials.
The Agency agrees that collecting information about discharges is a
critical component of understanding potential environmental risks.
EPA's Office of Research and Development, and others, is conducting
research to determine whether nanomaterials may enter the water in
forms and levels of concern, as well as how to detect and monitor
nanomaterials in effluents and aquatic systems. Once we have these
capabilities, EPA will consider whether new reporting requirements
should be applied to companies who may be discharging nanomaterials
into the environment, including under the Clean Water Act.
* Finally, the EPA Administrator should consider revising the
Inventory Update Rule under TSCA so that it will capture information
on the production and use of nanomaterials and so that the Agency will
receive periodic updates on this material.
EPA agrees and will consider proposing periodic reporting under the
Inventory Update Rule for nanoscale materials.
Again, we appreciate the opportunity to review and comment on this
drag report. Should you have any questions or concerns regarding this
response, please contact Bob Trent, EPA's GAO Liaison Team Lead, at
202-566-0983.
Sincerely,
Signed by:
Stephen A. Owens:
Assistant Administrator:
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Anu Mittal, 202-512-3841 or mittala@gao.gov:
Staff Acknowledgments:
In addition to the contact person named above, Elizabeth Erdmann
(Assistant Director), David Bennett, Antoinette Capaccio, Nancy
Crothers, Cindy Gilbert, Gary Guggolz, Nicole Harkin, Kim Raheb, and
Hai Tran made key contributions to this report.
[End of section]
Related GAO Reports:
Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients
Determined to Be Generally Recognized as Safe (GRAS). [hyperlink,
http://www.gao.gov/products/GAO-10-246]. Washington, D.C.: February 3,
2010.
Chemical Regulation: Observations on Improving the Toxic Substances
Control Act. [hyperlink, http://www.gao.gov/products/GAO-10-292T].
Washington, D.C.: December 2, 2009.
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January 22,
2009.
Federal Research: Opportunities Exist to Improve the Management and
Oversight of Federally Funded Research and Development Centers.
[hyperlink, http://www.gao.gov/products/GAO-09-15]. Washington D.C.:
October 8, 2008.
Highway Safety: Foresight Issues Challenge DOT's Efforts to Assess and
Respond to New Technology-Based Trends. [hyperlink,
http://www.gao.gov/products/GAO-09-56]. Washington, D.C.: October 3,
2008.
Nanotechnology: Accuracy of Data on Federally Funded Environmental,
Health, and Safety Research Could Be Improved. [hyperlink,
http://www.gao.gov/products/GAO-08-709T]. Washington, D.C.: April 24,
2008:
Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting
of Federal Research Focused on Environmental, Health, and Safety
Risks. [hyperlink, http://www.gao.gov/products/GAO-08-402].
Washington, D.C.: March 31, 2008.
Chemical Regulation: Comparison of U.S. and Recently Enacted European
Union Approaches to Protect against the Risks of Toxic Chemicals.
[hyperlink, http://www.gao.gov/products/GAO-07-825]. Washington, D.C.:
August 17, 2007.
21st Century Challenges: Reexamining the Base of the Federal
Government. [hyperlink, http://www.gao.gov/products/GAO-05-325SP].
Washington, D.C.: February 2005.
[End of section]
Footnotes:
[1] EPA is one of four key agencies that administer laws that regulate
manufactured nanomaterials depending on how they are used. The other
regulatory agencies include the Consumer Product Safety Commission,
the Department of Health and Human Services' Food and Drug
Administration, and the Department of Labor's Occupational Safety and
Health Administration. We did not review these other agencies'
regulatory authorities as part of this work.
[2] In addition, EPA has authority under the Federal Food, Drug, and
Cosmetic Act to establish tolerances or exemptions for the requirement
of a tolerance for pesticide residues that remain in food. Food is
considered adulterated if, amongst other conditions, it contains any
residue of a pesticide chemical for which there is no tolerance or
exemption or which exceeds any established tolerance.
[3] These agencies are the Department of Defense, the Department of
Energy, EPA, the Department of Health and Human Services' National
Institutes of Health, the Department of Commerce's National Institute
of Standards and Technology, and the National Science Foundation.
These six agencies accounted for over 95 percent of federal
nanotechnology research reported in fiscal year 2009.
[4] Green chemistry, also known as sustainable chemistry, is the
design of chemical products and processes that reduce or eliminate the
use or generation of hazardous substances. Green chemistry can be
applied across the life cycle of a chemical product, including its
design, manufacture, and use.
[5] Exercising foresight consists of basing policies on an
understanding of forces shaping the future. In this context, a
potentially significant trend is one that, although somewhat
uncertain, may substantially affect progress toward basic goals across
a time horizon more than 5 years forward.
[6] GAO, Highway Safety: Foresight Issues Challenge DOT's Efforts to
Assess and Respond to New Technology-Based Trends, [hyperlink,
http://www.gao.gov/products/GAO-09-56] (Washington, D.C.: Oct. 3,
2008).
[7] GAO, 21st Century Challenges: Reexamining the Base of the Federal
Government, [hyperlink, http://www.gao.gov/products/GAO-05-325SP]
(Washington, D.C.: February 2005).
[8] Rejeski, David, and Carly Wobig. 2002. Long-term Goals for
Governments. Foresight 4, no. 6:14-22.
[9] The Wilson Center is a nonpartisan research institution
established by an act of Congress in 1968 and supported by public and
private funds. The products in the Wilson Center's consumer products
database are products identified as containing nanomaterials by their
manufacturers or another source, which can be readily purchased by
consumers, and for which the nanomaterials-based claims for the
product appear reasonable. The NanoBusiness Alliance, an industry
association representing the nanotechnology business community,
estimates that thousands of additional products using nanomaterials
are not publicized by their manufacturers. These products would
therefore most likely not be counted in databases like the Wilson
Center's database.
[10] Carbon nanotubes are basically tubes that consist of rolled-up
sheets of graphite. These materials have novel properties, including
extraordinary strength and unique electrical conductivity.
[11] Cerium oxide additives are already in use on a large scale in bus
fleets in a number of countries including the United Kingdom, but
their sale is not currently authorized in the United States.
[12] A catalyst is a substance that increases the rate of a chemical
reaction without being consumed by the reaction.
[13] A polymer is a material made of long, chain-like molecules.
[14] An ion is an atom or group of atoms that bears one or more
positive or negative electrical charges.
[15] A quantum dot is a nano-sized crystal that efficiently absorbs
light and emits either photons or electrons.
[16] A terabyte is about 1 trillion bytes or about 1,000 gigabytes.
[17] Photoelectrolysis is the splitting of water into hydrogen and
oxygen using light energy.
[18] The Food and Drug Administration is generally responsible for
overseeing the safety of color additives and foods, including food
additives and dietary supplements, as well as for safety of food
packaging.
[19] Photocatalysis is the acceleration of a photoreaction in the
presence of a photocatalyst.
[20] The Food and Drug Administration is generally responsible for
overseeing the safety and effectiveness of drugs and devices for
humans and animals, and of biological products for humans.
[21] The Food and Drug Administration is generally responsible for
overseeing the safety of cosmetics. In addition, the U.S. Consumer
Product Safety Commission is responsible for protecting the public
from unreasonable risks of serous injury or death from more than
15,000 types of consumer products, including some that may be
manufactured with nanomaterials.
[22] The routes of exposure listed are generally for incidental or
consumer exposures to nanomaterials. For medical applications, the
primary route of exposure is intravenous.
[23] Some consumer products containing edible nanomaterials are
available. Consumers may now purchase food containing nanomaterials
such as prepared milkshakes containing nanoscale vitamins used to
fortify the shakes.
[24] The Occupation Safety and Health Administration is responsible
for ensuring the safety and health of workers by setting and enforcing
standards and encouraging continual improvement in workplace safety
and health.
[25] We selected six key statutes administered by EPA--TSCA, FIFRA,
the Clean Air Act, the Clean Water Act, RCRA, and CERCLA--for the
purpose of assessing actions EPA has taken to better understand and
regulate the risks posed by nanomaterials as well as its authorities
to do so. Also, as noted previously, EPA is one of four agencies that
administers laws that regulate manufactured nanomaterials depending on
how they are used. We did not review the other three agencies'
regulatory authorities as part of this report, although we did
identify nanomaterial uses that may be regulated by them.
[26] EPA has been conducting research in ultrafine particulate matter,
particularly in the air. In this research, EPA defines ultrafine
particles as those less than 100 nanometers, making them nanoscaled.
[27] The OECD is a forum for the governments of 30 developed countries
to work together to address economic, social, and environmental issues.
[28] The 14 nanomaterials that the OECD has selected for further
review are aluminum oxide, carbon black, cerium oxide, dendrimers,
fullerenes, iron nanoparticles, multiwalled carbon nanotubes,
nanoclays, polystyrene, silicon dioxide, silver nanoparticles, single-
walled carbon nanotubes, titanium dioxide, and zinc oxide.
[29] Allotropes are different forms of the same element in which the
atoms are arranged differently. For example, graphite and diamond are
allotropes of carbon. Isotopes are different forms of the same element
that have different atomic weights because they have different numbers
of neutrons. For example, helium-3, which has two protons and one
neutron in its nucleus, is an isotope of helium.
[30] The SNURs were originally issued as direct final rules--that is,
they would go into effect without formal consideration of public
comment after a certain period if EPA did not receive any adverse
comments. Because EPA received a notice of intent to submit adverse
comments, however, EPA withdrew the SNURs. When EPA proposed these
rules again in November, it provided for a public comment period.
[31] EPA plans to propose this rule under section 8(a) of TSCA.
[32] Every 5 years, companies must report certain information on the
production volume for chemicals they produced over 25,000 pounds at
one location during that year. Companies must also report additional
use information on chemicals that they produce over 300,000 pounds at
one location.
[33] EPA plans to propose this rule under section 4 of TSCA.
[34] GAO, Chemical Regulation: Options Exist to Improve EPA's Ability
to Assess Health Risks and Manage Its Chemical Review Program,
[hyperlink, http://www.gao.gov/products/GAO-05-458] (Washington, D.C.:
June 13, 2005).
[35] The phrase "unreasonable adverse effects on the environment"
means (1) any unreasonable risk to man or the environment, taking into
account the economic, social, and environmental costs and benefits of
the use of any pesticide, or (2) a human dietary risk from residues
that result from a use of a pesticide in or on any food inconsistent
with the standard for tolerance under the Federal Food, Drug, and
Cosmetic Act. 7 U.S.C. § 136(bb) (2006).
[36] In November 2008, a group of environmental and consumer
organizations filed a petition asking EPA to regulate products
containing nanosilver as pesticides. Petitioners included the
International Center for Technology Assessment, the Center for Food
Safety, Friends of the Earth, Greenpeace, the Center for the Study of
Responsive Law, and the Consumers Union.
[37] EPA may promulgate a rule designating a given material as a
hazardous air pollutant if the material presents, or may present,
through inhalation or other routes of exposure, a threat of adverse
human health effects (including carcinogenicity, mutagenicity,
neurotoxicity, reproductive dysfunction, or acute or chronic toxicity)
or adverse environmental effects whether through ambient
concentrations, bioaccumulation, deposition, or otherwise. 42 U.S.C. §
7412(b)(2) (2006).
[38] A conventional air pollutant is one that causes or contributes to
air pollution that may reasonably be anticipated to endanger public
health or welfare. There are five other conventional air pollutants in
addition to particulates: they are ground-level ozone, carbon
monoxide, sulfur oxides, nitrogen oxides, and lead.
[39] An effluent limitation is a restriction on the discharge of
pollutants from, for example, a factory, into the waters of the United
States.
[40] Under this act, covered facilities must submit an emergency and
hazardous chemical inventory form to (a) the appropriate local
emergency planning committee; (b) the state emergency response
commission; and (c) the fire department with jurisdiction over the
facility. 42 U.S.C. § 11022(a) (2006).
[41] 33 U.S.C. § 1318 (2006).
[42] NRDC v. EPA, 822 F.2d 104, 119 (D.C. Cir. 1987).
[43] We selected a judgmental sample of four national authorities for
our review, based on criteria such as countries that have recently
taken action with regard to nanomaterials.
[44] Monash University, Review of the Possible Impacts of
Nanotechnology on Australia's Regulatory Frameworks (May 2008).
[45] REACH's requirements are being phased in and will not be in full
force until 2018.
[46] The Environmental Council of the States is the national non-
profit, non-partisan association of state and territorial
environmental agency leaders.
[47] Environmental Council of the States. State Experiences with
Emerging Contaminants: Recommendations for Federal Action, January
2010.
[48] These agencies are the Department of Defense, the Department of
Energy, EPA, the Department of Health and Human Services' National
Institutes of Health, the Department of Commerce's National Institute
of Standards and Technology, and the National Science Foundation.
[End of section]
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