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Nanotechnology—a term encompassing nanoscale science, engineering, and technology—is
focused on understanding, controlling, and exploiting the unique properties of matter that can
emerge at scales of one to 100 nanometers. A key issue before Congress regarding
nanotechnology is how best to protect human health, safety, and the environment as nanoscale
materials and products are researched, developed, manufactured, used, and discarded. While the
rapidly emerging field of nanotechnology is believed by many to offer significant economic and
societal benefits, some research results have raised concerns about the potential adverse
environmental, health, and safety (EHS) implications of nanoscale materials.
Some have described nanotechnology as a two-edged sword. On the one hand, some are
concerned that nanoscale particles may enter and accumulate in vital organs, such as the lungs
and brains, potentially causing harm or death to humans and animals, and that the diffusion of
nanoscale particles in the environment might harm ecosystems. On the other hand, some believe
that nanotechnology has the potential to deliver important EHS benefits such as reducing energy
consumption, pollution, and greenhouse gas emissions; remediating environmental damage;
curing, managing, or preventing diseases; and offering new safety-enhancing materials that are
stronger, self-repairing, and able to adapt to provide protection.
Stakeholders generally agree that concerns about potential detrimental effects of nanoscale
materials and devices—both real and perceived—must be addressed to protect and improve
human health, safety, and the environment; enable accurate and efficient risk assessment, risk
management, and cost-benefit trade-offs; foster innovation and public confidence; and ensure that
society can enjoy the widespread economic and societal benefits that nanotechnology may offer.
Congressionally-mandated reviews of the National Nanotechnology Initiative (NNI) by the
National Research Council and the President’s Council of Advisors on Science and Technology
have concluded that additional research is required to make a rigorous risk assessment of
nanoscale materials.

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Introduction ..................................................................................................................................... 1
Opportunities and Challenges.......................................................................................................... 3
Importance of Addressing EHS Issues ............................................................................................ 6
Selected Issues for Consideration.................................................................................................... 9
Federal Investment in EHS Research........................................................................................ 9
Current Funding Level........................................................................................................ 9
Alternative Approaches..................................................................................................... 12
Management of Federal EHS Research ............................................................................ 15
Federal Regulation .................................................................................................................. 19
International Engagement ....................................................................................................... 22
Concluding Observations .............................................................................................................. 24
Nanotechnology EHS-Related Legislation in the 111th Congress ................................................. 25
H.R. 554—National Nanotechnology Initiative Amendments Act of 2009............................ 25
H.R. 820—Nanotechnology Advancement and New Opportunities Act ................................ 26

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Table 1. NNI Environmental, Health, and Safety Research Funding, FY2006-2008,
FY2009 Request......................................................................................................................... 10
Table 2. FY2006 NNI Funding for EHS Research by Research Needs Categories ......................11

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Appendix A. Selected Nanotechnology EHS Activities of Federal Regulatory Agencies ............ 27
Appendix B. Selected International Engagement Efforts of NNI Agencies.................................. 34

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Author Contact Information .......................................................................................................... 35

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Nanotechnology—a term encompassing nanoscale science, engineering, and technology—is
focused on understanding, controlling, and exploiting the unique properties of matter that can
emerge at scales of one to 100 nanometers.1 These properties are believed by many to offer
substantial economic and societal benefits.
A key issue before Congress regarding nanotechnology is how best to protect human health,
safety, and the environment as nanoscale materials and products are researched, developed,
manufactured, used, and discarded. While the rapidly emerging field of nanotechnology is
believed by many to offer significant economic and societal benefits, some research results have
raised concerns about the potential environmental, health, and safety (EHS) implications of
nanoscale materials. Potential tools the Federal government might use to address these concerns
include research and development, regulation, and international engagement.
Some of the properties of nanoscale materials (e.g., small size, high surface area-to-volume ratio)
that have given rise to great hopes for beneficial applications have also given rise to concerns
about their potential adverse implications for the environment, and human health and safety.2
There are more than 600 nanotechnology products reportedly commercially available,3 and with
this number of products concerns have been raised about the health and safety of the scientists
working with nanoscale materials, workers who manufacture the products, consumers who use
the products, and members of the general public who may be exposed to nanoparticles, as well as
the environmental impact of nanomanufacturing processes and the use and disposal of
nanotechnology products.
Nanoscale particles can result from a variety of different processes. While nanoscale particles can
occur naturally (e.g., some particles produced by forest fires, sea spray, volcanoes) and as an
incidental by-product of human activities (e.g., some particles contained in welding fumes, diesel
exhaust, industrial effluents, cooking smoke), EHS concerns have focused primarily on nanoscale
materials that are intentionally designed and produced, often referred to as engineered
nanomaterials.
Issues surrounding the potential EHS implications of nanotechnology emerged with the launch in
2000 of the National Nanotechnology Initiative (NNI). The NNI is a multi-agency federal effort
to coordinate and expand federal nanotechnology research and development (R&D) efforts.
Between FY2001 and FY2009, the federal government invested $9.9 billion in nanotechnology

1 Congress defined nanotechnology in the 21st Century Nanotechnology Research and Development Act (P.L. 108-153)
as, “the science and technology that will enable one to understand, measure, manipulate, and manufacture at the atomic,
molecular, and supramolecular levels, aimed at creating materials, devices, and systems with fundamentally new
molecular organization, properties, and functions.” ASTM International, one of the largest voluntary standards
development organizations, has defined nanotechnology as, “A term referring to a wide range of technologies that
measure, manipulate, or incorporate materials and/or features with at least one dimension between approximately 1 and
100 nanometers. Such applications exploit those properties, distinct from bulk or molecular systems, of nanoscale
components.” One nanometer is about the width of 10 hydrogen atoms placed side-by-side, or approximately
1/100,0000 of the thickness of a sheet of paper.
2 Nanotechnology EHS applications refers to the beneficial use of nanotechnology to improve health, safety and the
environment; EHS implications refers to known and potential adverse effects of nanoscale materials on health, safety
and the environment.
3 Project on Emerging Nanotechnologies. Figure as of April 2008.
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R&D, including approximately $1.5 billion in FY2009. Many governments around the world
have followed the U.S. lead and established their own national nanotechnology programs. The
private sector has invested heavily as well. Global nanotechnology R&D investments—public
and private—are estimated to have totaled $12.4 billion in 2006 alone.4
Such large investments and intensified efforts to capitalize on these public and private
investments have caused some observers (as detailed later in this report) to suggest that there is
insufficient information about the potential effects nanotechnology products and manufacturing
processes may have on human health, safety, and the environment. They assert a variety of
uncertainties, including: how nanoscale particles might be transported in air, water, and soil; how
they might react with the environment chemically, biologically, or through other processes; how
they might be distributed and deposited; and whether they might accumulate in plants or animals.
Others express the view that concerns about nanotechnology EHS implications are often
overgeneralized and overstated. Among the arguments they put forth are that nanoscale materials
are frequently embedded in other materials as part of the manufacturing process; that some
nanotechnology products, such as semiconductors, have nanoscale features but do not contain
nanoscale particles; that nanotechnology materials may replace other materials that have
significant and known risks; that some nanoscale particles tend to aggregate or agglomerate in the
environment into larger particles that no longer have nanoscale dimensions; and that people are
regularly exposed to nanoscale particles produced naturally and as incidental by-products of
human activities.
Congressionally-mandated reviews of the NNI by the National Research Council (NRC) and the
President’s Council of Advisors on Science and Technology (PCAST) have concluded that
additional research is required to make a rigorous risk assessment of nanoscale materials. In
addition, the NRC warned that, until such information is available, precautionary measures
should be taken to protect the health and safety of workers, the public, and the environment.
Nevertheless, most stakeholders agree that these concerns about the potential detrimental effects
of nanoscale materials and devices—both real and perceived—must be addressed. Among the
issues these stakeholders have identified are characterizing the toxicity of nanoscale materials;
developing methods for assessing and managing the risks of these materials; and understanding
how these materials move in, and interact with, the environment.
This report identifies the potential environmental, health, and safety opportunities and challenges
of nanotechnology; explains the importance of addressing nanotechnology EHS concerns;
identifies and discusses nanotechnology EHS issues; and summarizes options for Congressional
action, including the nanotechnology EHS-related provisions of selected legislation. The report
also includes two appendices. Appendix A provides an overview of selected nanotechnology
EHS activities of federal regulatory agencies. Appendix B provides an overview of selected
EHS-related international engagement efforts of NNI agencies.
For more information on nanotechnology and the NNI see, see CRS Report RL34401, The
National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues, CRS
Report RL34493, Nanotechnology and U.S. Competitiveness: Issues and Options, and CRS
Report RL34614, Nanotechnology and Environmental, Health, and Safety: Issues for

4 Profiting From International Nanotechnology, Lux Research, December 2006.
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Consideration, all by John F. Sargent. For additional information on nanotechnology-related
regulatory challenges, see CRS Report RL34332, Engineered Nanoscale Materials and
Derivative Products: Regulatory Challenges, by Linda-Jo Schierow.
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Historically, many new technologies have delivered general societal benefits while presenting
EHS challenges. For example, automobiles increased personal mobility and provided faster, less
expensive transportation of goods, but soon became a leading cause of accidental deaths and
injuries, as well as a source of emissions that can damage air quality and may contribute to global
climate change. Similarly, genetically-modified (GM) plants have traits such as greater resistance
to pests, pesticides, or cold temperatures that contribute to higher crop yields, while critics argue
some GM foods contribute to food allergies and antibiotic resistance.5
Like other new technologies, nanotechnology offers potential economic and societal benefits, and
presents potential EHS challenges as well. Nanotechnology advocates assert, however, that
nanotechnology provides the opportunity to reduce or eliminate known risks by engineering
around them. Proponents maintain that nanotechnology also offers the potential for significant
EHS benefits, including:
• reducing energy consumption, pollution, and greenhouse gas emissions;
• cleaner, more efficient industrial processes;
• remediating environmental damage;
• curing, managing, or preventing deadly diseases; and

5 “Genetically Modified Crops and Foods,” Friends of the Earth, January 2003. http://www.foe.co.uk/resource/
briefings/gm_crops_food.pdf
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• offering new materials that protect
Potential Nanotechnology Cancer
against impacts, self-repair to prevent
Applications
catastrophic failure, or change in ways
The NCI Cancer Nanotechnology Plan asserts that
that protect or aid soldiers on the
nanotechnology can serve as an enabling technology for a
battlefield.
variety of cancer-related applications:
For example, nanoscale materials show
• imaging agents and diagnostics that allow clinicians
to detect cancer in its earliest, most easily treatable,
promise for detecting, preventing, and
pre-symptomatic stage;
removing pollutants. According to the
Environmental Protection Agency (EPA):
• systems that provide real-time assessments of
therapeutic and surgical efficacy;
nanoscale cerium oxide has been developed
• multifunctional, targeted devices capable of
to decrease diesel engine emissions; iron
bypassing biological barriers to deliver therapeutic
nanoparticles can remove contaminants
agents at high local concentrations directly to
from soil and ground water; and nano-sized
cancer cells and tissues that play a critical role in the
sensors hold promise for improved
growth and metastasis of cancer;
detection and tracking of contaminants.6
• agents capable of monitoring predictive molecular
changes and preventing precancerous cells from
In the area of human health, scientists assert
becoming malignant;
nanotechnology has the potential for
• surveillance systems that detect mutations that may
improving disease diagnostics, sensing,
trigger the cancer process and genetic markers that
monitoring, assessment, and treatment. In
indicate a predisposition for cancer;
particular, the National Cancer Institute (NCI)
• novel methods for managing the symptoms of
views nanotechnology as likely to provide
cancer that adversely impact quality of life; and
revolutionary tools to extend and improve
• research tools that enable investigators to quickly
lives. In July 2004, NCI launched a five-year,
identify new targets for clinical development and
$145 million initiative focused on applying
predict drug resistance.
nanotechnology to the prevention, detection,
Source: Cancer Nanotechnology Plan: A Strategic Initiative
and treatment of cancer and amelioration of its
to Transform Clinical Oncology and Basic Research Through
symptoms. At the initiative’s launch, then-NCI
the Directed Application of Nanotechnology, National
Director Andrew von Eschenbach identified
Cancer Institute, National Institutes of Health,
nanotechnology as a key component of the
Department of Health and Human Services, July 2004.
agency’s strategy for ending death and
suffering from cancer by 2015 (see text box, “Potential Nanotechnology Cancer Applications”).7
Some characteristics of nanoscale particles could produce both positive and negative
consequences. According to E. Clayton Teague, director of the National Nanotechnology
Coordination Office (NNCO),
the unique properties of these [nanotechnology] materials are a double-edged sword: they
can be tailored for beneficial properties, but also have unknown consequences, such as new
toxicological and environmental effects.8

6 “Fact Sheet for Nanotechnology under the Toxic Substances Control Act,” Environmental Protection Agency.
http://www.epa.gov/oppt/nano/nano-facts.htm
7 “Cancer Nanotech Plan Gets Nod of Approval,” Science, Vol. 305, July 23, 2004. http://www.sciencemag.org/
content/vol305/issue5683/s-scope.dtl#305/5683/461c
8 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
148.
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The following examples illustrate how the same nanotechnology material may be both potentially
beneficial and potentially harmful:
• Nanoscale silver is highly effective as an antibacterial agent in wound dressings,
clothing, and washing machines, but some have expressed concerns that
widespread dispersion of nanoscale silver in the environment could kill microbes
that are vital to waste water treatment plants and to ecosystems. Some beneficial
bacteria, for example, break down organic matter, remove nitrogen from water,
aid in animal digestion, protect against fungal infestations, and even aid some
animals in defense against predators.9
• Some nanoscale particles may have the potential to penetrate the blood-brain
barrier, a structure that protects the brain from harmful substances in the blood
but also hinders the delivery of therapeutic agents. The characteristics of certain
nanoscale materials may allow pharmaceuticals to be developed to purposefully
and beneficially cross this barrier and deliver medicine directly to the brain to
treat, for example, a brain tumor.10 Some critics are concerned, however, that
nanoscale particles might unintentionally pass through the blood-brain barrier
causing harm to humans and animals.11
• Certain nanoscale materials are highly chemically reactive due to their high
surface-to-volume ratio.12 This is a property that might be positively exploited in
catalysis, treatment of groundwater contamination, and site remediation. This
property also is being explored for use in protective masks and clothing as a
defense against chemical and biological agents. However, some research results
indicate that the reactivity of some nanoparticles potentially can result in cell
damage in animals.13
• Carbon nanotubes (CNTs) have potential uses in a wide range of applications
(e.g., materials, batteries, memory devices, electronic displays, transparent
conductors, sensors, medical imaging). However, some scientists have expressed
concerns that some CNTs exhibit properties similar to asbestos fibers, and might
become lodged in organs (e.g., lungs), harming humans and animals.14

9 Nanosilver: A Threat to Soil, Water and Human Health? Friends of the Earth, March 2007. http://www.foe.org/pdf/
FoE_Australia_Nanosilver_report.pdf
10 “Blood-Brain Barrier Breached by New Therapeutic Strategy,” press release, National Institutes of Health, June
2007. http://www3.niaid.nih.gov/news/newsreleases/2007/bloodbrainbarrier.htm
11 “Nanotechnology Risks: How Buckyballs Hurt Cells,” Science Daily, May 27, 2008. http://www.sciencedaily.com/
releases/2008/05/080527091910.htm
12 National Nanotechnology Initiative: Research and Development Supporting the Next Industrial Revolution,
Supplement to the President’s FY2004 Budget, Nanoscale Science, Engineering and Technology Subcommittee,
Committee on Technology, National Science and Technology Council, The White House, October 2003.
http://www.nano.gov/nni04_budget_supplement.pdf
13 Magrez, A., Kasas, S., Salicio, V., Pasquier, N., Seo, J.W., Celio, M., Catsicas, S., Schwaller, B., and Forro, L.
“Cellular Toxicity of Carbon-Based Nanomaterials,” Nano Letters, 6(6):1121-1125, American Chemical Society, May
2006. http://pubs.acs.org/cgi-bin/abstract.cgi/nalefd/2006/6/i06/abs/nl060162e.htmll
14 Nanotechnology: The Future is Coming Sooner Thank You Think, Joint Economic Committee, U.S. Congress, March
2007. p. 13. http://www.house.gov/jec/publications/110/nanotechnology_03-22-07.pdf
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EHS Concerns About Carbon Nanotubes and Other Fullerenes
Much of the public dialogue about potential risks associated with nanotechnology has focused on carbon nanotubes
(CNTs) and other fullerenes (molecules formed entirely of carbon atoms in the form of a hollow sphere, ellipsoid, or
tube) since they are currently being manufactured and are among the most promising nanomaterials. These concerns
have been amplified by some research on the effects of CNTs on animals and on animal and human cells. For example,
researchers have reported that carbon nanotubes inserted into the trachea of mice can cause lung tissue damage;a
that buckyballs (spherical fullerenes) caused brain damage in fish;b and that buckyballs can accumulate within cells and
potentially cause DNA damage.c
There are scientists who have argued that experiments indicating CNT/fullerene toxicity are not conclusive. They
suggest that toxicity reported by researchers may have resulted from uncharacterized contaminants in the samples
resulting from the synthesis, purification, and post-processing methods used in the manufacture of CNTs. Thus, they
assert, the experiments could be measuring the toxicity of non-nanoscale materials and, therefore, unfairly indicting
nanoscale materials. They also contend that such non-nanoscale contaminants, if identified as toxic, potentially could
be eliminated or controlled in the manufacturing process. The issue of contaminants is often cited by advocates for
improved standards, reference materials, sensors, instrumentation, and other technologies for the characterization of
nanoscale materials.
Some experiments have produced results that indicate CNTs/fullerenes are non-toxic. Research on single-walled
carbon nanotubes (SWCNTs) by the Institute of Toxicology and Genetics in Karlsruhe, Germany, reported that, in
three of four different types of tests conducted, SWCNTs did not show toxicity. In the fourth test, which appeared
to indicate SWCNT toxicity, the researchers concluded that the results were a “false positive” and explained how the
SWCNTs interacted with the materials in the assay to produce a misleading result. These researchers concluded that
this result points to the need for careful selection of assays and the need for the establishment of standards for
toxicity testing of CNTs and other nanomaterials.d
Work at Rice University’s Center for Biological and Environmental Nanotechnology conducted in 2005 found cell
toxicity of CNTs to be low, and that it could be reduced further through simple chemical changes to the surface.e
Earlier research demonstrated that similar surface modifications of buckyballs reduced their toxicity. Nanotechnology
may offer the potential to engineer around known and potential hazards by changing the size, molecular construction,
or other property of a nanoscale material to make it safe or less hazardous. Experts advise that the potential to do so
will require a thorough understanding of the properties of the various nanoparticles and their effects on humans and
other organisms.
a Lam, C.W., James, J.T., McCluskey, R., and Hunter, R.L. “Pulmonary toxicity of single-wall carbon nanotubes in mice
7 and 90 days after intratracheal instillation,” September 2003. http://www.ncbi.nlm.nih.gov/sites/
entrez?cmd=Retrieve&db=PubMed&list_uids=14514958
b Oberdörster, Eva. “Manufactured Nanomaterials (Fullerenes, C60) Induce Oxidative Stress in the Brain of Juvenile
Largemouth Bass,” April 2004. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1247377
c Magrez, A., Kasas, S., Salicio, V., Pasquier, N., Seo, J.W., Celio, M., Catsicas, S., Schwaller, B., and Forro, L. “Cellular
Toxicity of Carbon-Based Nanomaterials,” Nano Letters, 6(6):1121-1125, American Chemical Society, May 2006.
http://pubs.acs.org/cgi-bin/abstract.cgi/nalefd/2006/6/i06/abs/nl060162e.html
d Wörle-Knirsch, J.M., Pulskamp, K., and Krug, H. F. “Oops They Did It Again! Carbon Nanotubes Hoax Scientists in
Viability Assays,” American Chemical Society, Nano Letters, Vol.6, April 2006.
e “Modifications render carbon nanotubes nontoxic,” press release, Rice University, October 2005.
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Nanotechnology covers a wide swath of scientific fields, engineering disciplines, and
technological applications. Sufficient knowledge has been developed about the useful properties
of certain nanomaterials, how they can be manufactured, and how they can be applied in useful
ways to enable commercial product development. In other areas of nanotechnology, fundamental
research on nanoscale phenomena and processes is under way that may lead to greater
understanding and beneficial applications in the years ahead. In general, however,
nanotechnology is still an emerging field and there is a dearth of information about how
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nanoscale particles and devices might adversely affect human health, safety, and the environment.
Accordingly, there is widespread agreement on the need for more research to better understand
such implications.
In reviews of the NNI,15 both the National Research Council and the President’s Council of
Advisors on Science and Technology (PCAST) concluded that assessment of potential
nanotechnology EHS risks is not possible due to the absence of information and tools. According
to the NRC,
it is not yet possible to make a rigorous assessment of the level of risk posed by [engineered
nanomaterials]. Further risk assessment protocols have to be developed, and more research is
required to enable assessment of potential EHS risks from nanomaterials.16
Similarly, PCAST concluded that
it is premature to rigorously assess the levels of risk posed by engineered nanomaterials.
Adequate tools are being developed but are not yet in place.17
Leaders of the NNI have argued strongly that to achieve the economic, societal, and EHS benefits
of nanotechnology the nation must concurrently address its potential adverse effects. According
to then-Under Secretary of Commerce for Technology Phillip J. Bond, a leading Administration
advocate for the NNI,
Addressing societal and ethical issues is the right thing to do and the necessary thing to do. It
is the right thing to do because as ethically responsible leaders we must ensure that
technology advances human well-being and does not detract from it. It is the necessary thing
to do because it is essential for speeding technology adoption, broadening the economic and
societal benefits, and accelerating and increasing our return on investment.18
This is a view shared by many in the business community. A 2006 survey of business leaders in
the field of nanotechnology indicated that nearly two-thirds believe that “the risks to the public,
the workforce, and the environment due to exposure to nano particles are ‘not known,’” and 97%
believe that it is very important or somewhat important for the government to address potential
health effects and environmental risks that may be associated with nanotechnology.19

15 The 21st Century Nanotechnology Research and Development Act (P.L. 108-153) requires a triennial assessment of
the National Nanotechnology Program (in practice, of the NNI) by the NRC and a biennial assessment by PCAST,
serving in its capacity as the National Nanotechnology Advisory Panel (NNAP). The act requires each assessment to
include a review of the NNI’s EHS activities. Three such assessments have been conducted, one by the NRC (A Matter
of Size: Triennial Review of the National Nanotechnology Initiative, 2006) and two by PCAST (The National
Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National Nanotechnology Advisory
Panel, May 2005; The National Nanotechnology Initiative: Second Assessment and Recommendations of the National
Nanotechnology Advisory Panel, April 2008).
16 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
90.
17 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. p. 7.
18 Bond, Phillip J., Under Secretary for Technology, U.S. Department of Commerce. “Preparing the Path for
Nanotechnology: Addressing Legitimate Societal and Ethical Issues,” keynote address, Nanoscale Science,
Engineering, and Technology Subcommittee Workshop on Societal Implications of Nanoscience and Nanotechnology,
December 3, 2003.
19 “Survey of U.S. Nanotechnology Executives,” Small Times Magazine and the Center for Economic and Civic
(continued...)
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The Project on Emerging Nanotechnologies (PEN) has warned that bad practices in
nanotechnology research or production may result in a nanotechnology accident that would
chill investment, galvanize public opposition, and generally lead to a lot of hand wringing on
the part of governments who are betting large sums of money on the nanotech revolution.20
Successfully addressing EHS issues is seen as vital for those potentially exposed to nanoscale
materials (e.g., consumers, researchers, manufacturing workers, the general public), businesses,
and investors for a variety of reasons:
• protecting and improving human health, safety, and the environment;
• enabling accurate and efficient risk assessments, risk management, and cost-
benefit trade-offs;
• ensuring public confidence in the safety of nanotechnology research,
engineering, manufacturing, and use;
• preventing a problem in one application area of nanotechnology from having
negative consequences for the use of nanotechnology in unrelated application
areas due to public fears, legislative interventions, or an overly-broad regulatory
response; and
• ensuring that society can enjoy the widespread economic and societal benefits
that nanotechnology is believed by many to offer.
In addition, the U.S. regulatory environment for nanotechnology could be an enabler for
innovation and contribute to a strong, sustainable economy by creating predictability, accurately
assessing risks and benefits, and fostering the swift movement of safe products into the market.
Such an environment is likely to favor nanotechnology-related investments and innovative
activities in the United States by domestic and foreign stakeholders, as opposed to nations where
such regulatory conditions do not exist.
Conversely, if the U.S. regulatory environment is not handled effectively (i.e., if it lacks
predictability, if regulatory approaches do not accurately assess risks and benefits, or if approval
processes are too long or expensive) it could prove a major impediment to innovation, economic
growth, and job creation, as well as posing a potential threat to health, safety, and the
environment. In such a regulatory environment, investment capital may be driven away from
nanotechnology, potentially beneficial products may not be developed, safe products may be
denied regulatory approval, or unsafe products may be allowed to enter the market.
Alternatively, nanotechnology investments, research, and production may be driven to other
nations with preferable regulatory environments. On the one hand, such a regulatory system
might be more desirable to investors and companies because it is more predictable, more
efficient, and less costly. In such a case, the United States might miss out on nanotechnology’s
potential economic benefits. On the other hand, if other nations’ regulatory systems are more

(...continued)
Opinion at the University of Massachusetts-Lowell, Fall 2006.
20 Rejeski, David, Director, Project on Emerging Nanotechnologies. “Nanotech Safety 101 or How to Avoid the Next
Little Accident,” paper, Workshop on Disaster Prevention, Harvard University, April 27, 2006.
http://www.nanotechproject.org/file_download/files/nanotechsafety101paper.pdf
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attractive to investors and producers because those systems under-regulate or do not regulate at
all, then nanotechnology research, development, and production could present increased EHS
risks worldwide.
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Given the widespread agreement that nanotechnology EHS concerns must be addressed,
discourse on how best to do so has focused on three main issues:
• federal investment in EHS research;
• federal regulation; and
• international engagement.
These issues are closely interrelated. For example, reliable EHS research is required by regulatory
bodies to determine whether and how to regulate nanotechnology products. Since all nations face
the same fundamental health, safety, and environmental issues, international coordination on EHS
research could help accelerate development of a common body of knowledge through the sharing
of results and reduction in redundant research. This shared knowledge could, in turn, inform
regulatory decision making and perhaps improve the consistency of regulations among nations.
Regulations, standards, and enforcement might need to be coordinated worldwide to protect
workers and consumers as intermediate and final products are frequently produced along global
supply chains and sold in industrial and commercial markets around the world. In addition, one
nation’s policies governing nanotechnology production, use, and disposal may have implications
for nearby nations and, perhaps, for all nations.
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There is not a single, centralized source of EHS research funds that is allocated to individual
agencies. Agency nanotechnology budgets are developed internally as part of each agency’s
overall budget development process. These budgets are subjected to review, revision, and
approval by the Office of Management and Budget (OMB) and become part of the President’s
annual budget submission to Congress. The NNI budget—and the EHS component—is then
calculated by aggregating the nanotechnology components of the appropriations provided by
Congress to each federal agency. While there is some coordination of EHS-research budget
requests through the Nanotechnology Environmental and Health Implications (NEHI) working
group21 and in OMB’s budget development process, the decision process that establishes overall
funding for nanotechnology EHS research is highly decentralized.

21 NEHI is a working group of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the
White House National Science and Technology Council (NSTC). The NSET Subcommittee is the coordinating body
for the NNI. For additional information about the structure of the NNI, see CRS Report RL34401, The National
Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues.
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In FY2008, NNI funding for EHS implications research22 was $58.6 million, approximately 3.9%
of the total NNI budget of $1.49 billion. This represented an increase over the FY2007 EHS
research level of $48.3 million (3.4% of the total NNI budget), and the FY2006 level of $37.7
million (2.8%), both in dollars and in share of total NNI funding. President Bush requested $76.4
million (5.0%) for EHS research in FY2009. NNI EHS research funding for FY2006 through
FY2008, and the request for FY2009, is provided in Table 1.
Table 1. NNI Environmental, Health, and Safety Research Funding, FY2006-2008,
FY2009 Request

EHS research,
EHS research’s share
in current dollars
of total NNI budget
FY2006 (actual)
$ 37.7 million
2.8%
FY2007 (actual)
48.3 million
3.4%
FY2008 (estimated)
58.6 million
3.9%
FY2009 (requested)
76.4 million
5.0%
Sources: “The National Nanotechnology Initiative: Research and Development Leading to a Revolution in
Technology and Industry, Supplement to the President’s FY2008 Budget,” NSET Subcommittee, NSTC, OSTP,
The White House, July 2007; “National Nanotechnology Initiative: FY2009 Budget and Highlights,” NSET
Subcommittee, NSTC, The White House, February 2008. http://www.nano.gov/NNI_FY09_budget_summary.pdf
NNI officials assert that the initiative also conducts EHS research as a part of its other research
activities, but that these EHS investments are not easily quantified and thus are not reflected in
the NNI’s reported figure for EHS funding. PCAST agreed with this assertion in its 2008
assessment, arguing that
In many instances, nanotechnology EHS research cannot be separated from the particular
application(s) research and from the context for which a specific nanomaterial is intended.
Such division is unproductive and neglects the whole benefit of research. Consequently,
[PCAST] expects that a substantial fraction of nanotechnology research related to EHS will
continue to take place under the auspices of agencies that fund applications R&D and may
not be uniquely or exclusively identified as nanotechnology EHS research.... Furthermore,
detailed reporting on the degree of relevance to EHS of such research is not necessarily
critical to (and may actual hinder) overall prioritization and coordination.23
In 2007, OMB issued a one-time request to all NNI research agencies to report funding data on
research related to the five categories identified in the NSET document, Prioritization of
Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials.24 Totals
for EHS implications research spending identified in each of the five categories is shown below

22 According to the NNCO, EHS research funding data included in Tables 1 and 2 of this report are for implications
research only. The NNCO also states that the figures reported in Table 1 may understate the NNI’s EHS implications
research by excluding funding for instrument research, metrology, and standards that support EHS implications
research but are reported separately. (Source: Private communication between the NNCO and CRS.)
23 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. p. 34.
24 Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale
Science, Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology
Council, The White House, August 2007.
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in Table 2. Preliminary analysis of this data by the NEHI working group indicated that $67
million was spent on EHS research in FY2006, in contrast to the reported figure of $37.7.
Table 2. FY2006 NNI Funding for EHS Research
by Research Needs Categories
Category Estimated
Funding
Instrumentation, Metrology, and Analytical Methods
$27 million
Nanomaterials and Human Health
$24 million
Nanomaterials and the Environment
$13 million
Health and Environmental Exposure Assessment
$ 1 million
Risk Management Methods
$ 3 million
TOTAL
$67 million
Source: Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the
Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of
Representatives. Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current Status
of Planning and Implementation under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October
31, 2007.
Note: Numbers may not add due to rounding.
Critics (as detailed in the following section) assert that the current level of federal
nanotechnology EHS research is too low and represents too small a share of the overall NNI
budget. These critics argue that the current allocation of NNI funding may produce a flood of
products for which there is inadequate information to assess and manage their EHS risks.
However, executive branch officials stress that the United States leads the world in EHS funding
and, by inference, that the current funding level is adequate. White House Office of Science and
Technology Policy (OSTP) director John Marburger asserted that the United States
leads the world not only in spending for nanotechnology development, but also, by an even
larger margin, in its investment in research to understand the potential health and safety
issues.25
Similarly, NNCO director E. Clayton Teague asserted U.S. leadership in nanotechnology EHS
research:
During fiscal years 2005 through 2008, it is estimated that NNI agencies will have invested
nearly $180 million in research whose primary purpose is to address the EHS implications of
nanomaterials. With these investments, the United States leads all other countries by a wide
margin in support of such research.26

25 Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science,
Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council,
The White House, September 2006. Cover letter.
26 Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on
Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on
“Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation
under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October 31, 2007.
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Dr. Teague maintains that EHS research has been a top priority of the Administration and the
NNI, citing, as an example, the annual R&D budget guidance memorandum sent by the directors
of OMB and OSTP to departments and agencies. This memorandum identifies Administration
priorities and is intended to help guide agency budget development for the following fiscal year.
The OMB/OSTP memorandum to guide FY2006 agency budget development stated that
In order to ensure that nanotechnology research leads to the responsible development of
beneficial applications, agencies also should support research on the various societal
implications of the nascent technology. In particular, agencies should place a high priority on
research on human health and environmental issues related to nanotechnology and develop,
where applicable, cross-agency approaches to the funding and execution of this research.27
The OMB/OSTP memorandum has included similar language in each succeeding year.
In their reviews of the NNI, both the NRC and PCAST concluded that federal EHS research
funding should be expanded. According to the NRC assessment,
To help ensure the responsible development of nanotechnology ... research on the
environmental, health, and safety effects of nanotechnology [should] be expanded.28
PCAST acknowledged potential EHS risks in its first review of the NNI but found the federal
government was “directing appropriate attention” and “adequate resources” to EHS research. In
its second assessment, PCAST termed the current federal investment level in EHS “appropriate,”
but added that
expanded EHS research, broad-based protocol development, and particularly standardization
are necessary.... the funding level for EHS [should] continue to grow consistent with the
needs identified in the NNI research strategy for nanotechnology EHS as well as the
available capacity for quality research.29
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Various alternatives have been suggested for addressing the perceived shortcoming in EHS
funding. One recommendation is requiring a fixed percentage of the NNI’s total funding be
devoted to EHS research. A figure of 10% has been proposed for this purpose by organizations
such as the NanoBusiness Alliance and the Project on Emerging Nanotechnologies. If this
proposal had been in effect in FY2008, the NNI would have been required to spend $149 million
on EHS research, more than twice as much as the NSET-reported level of $58.6 million. In
testimony before the House Committee on Science and Technology, Sean Murdock, executive
director of the NanoBusiness Alliance, agreed with the level of funding represented by the 10%
figure but argued the need for cross-agency flexibility in achieving it:

27 “Updated Administration Research and Development Budget Priorities,” memorandum, Office of Management and
Budget and Office of Science and Technology Policy, The White House, August 12, 2004. http://www.whitehouse.gov/
omb/memoranda/fy04/m04-23.pdf
28 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
92.
29 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. pp. 7, 27.
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The NanoBusiness Alliance believes that environmental, health, and safety research should
be fully funded and based on a clear, carefully-constructed research strategy. While we
believe that 10 percent of the total funding for nanotechnology research and development is a
reasonable estimate of the resources that will be required to execute the strategic plan, we
also believe that actual resource levels should be driven by the strategic plan as they will
vary significantly across agencies.30
Others have suggested a different approach, proposing fixed dollar amounts or minimum levels.
For example, the Environmental Defense Fund has called for $100 million or more in federal
nanotechnology EHS research funding.31
In its 2008 assessment, PCAST disagreed with both approaches:
growing research in nanotechnology EHS must be strategic, guided by ... a comprehensive
set of scientifically determined priorities and needs rather than arbitrary percentages or
funding figures.32
By establishing a 10 percent requirement (or setting a figure of $100 million for total EHS
funding), the United States could greatly accelerate the growth in EHS research spending. In
testimony before Congress in 2007, PCAST co-chair Floyd Kvamme warned against such a rapid
increase:
In general, increasing funding too rapidly does not lead to equivalent increases in high
quality research. It is crucial to note that EHS research also depends on advances in non-EHS
areas, such as instrumentation development and basic research on nanomaterials.33
Some non-governmental organizations (NGOs) have advocated for a more restrained approach to
nanotechnology research and development. They assert that the federal government is pushing
ahead too quickly in developing nanotechnology and encouraging its commercialization and use
without sufficient knowledge and understanding of EHS implications and how they might be
mitigated.34 They argue that the very characteristics that make nanotechnology promising also
present significant potential risks to human health and safety and the environment. Some of these
groups argue for application of the “precautionary principle,”35 which holds that regulatory action

30 Murdock, Sean, executive director, NanoBusiness Alliance. Testimony before the Committee on Science and
Technology, U.S. House of Representatives. Hearing on “The National Nanotechnology Initiative Amendments Act of
2008.” 110th Cong., 2nd Sess., April 16, 2008.
31 Denison, Richard A. “A Proposal to Increase Federal Funding of Nanotechnology Risk Research to at least $100
Million Annually,” Environmental Defense, April 2005. http://www.edf.org/documents/4442_100milquestionl.pdf
32 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. pp. 7, 27.
33 Kvamme, Floyd, co-chair, President’s Council of Advisors on Science and Technology. Testimony before the
Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of
Representatives. Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current Status of
Planning and Implementation under the National Nanotechnology Initiative,” 110th Cong., 1st Sess., October 31, 2007.
34 Maynard, Andrew, chief science advisor, Project on Emerging Nanotechnologies, a joint venture of the
congressionally-chartered Woodrow Wilson Center for International Scholars and the Pew Charitable Trusts.
Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S.
House of Representatives. Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current
Status of Planning and Implementation under the National Nanotechnology Initiative,” 110th Cong., 1st Sess., October
31, 2007.
35 The precautionary principle has been used in other countries on some issues and is the official policy in the European
Union. For international agreements a precautionary approach is sometimes embraced. For example, the Biosafety
(continued...)
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may be required to control potentially hazardous substances even before a causal link has been
established by scientific evidence.36 In 2006, Friends of the Earth warned that
The early warning signs surrounding nanotoxicity are serious and warrant a precautionary
approach to the commercialization of all products containing nanomaterials ... . there should
be a moratorium on the further commercial release of sunscreens, cosmetics and personal
care products that contain engineered nanomaterials, and the withdrawal of such products
currently on the market, until adequate public, peer-reviewed safety studies have been
completed, and adequate regulations have been put in place ... 37
The Action Group on Erosion, Technology, and Concentration (ETC Group) has called for a
moratorium on the conduct of nanotechnology R&D and use of commercial products
incorporating man-made nanoparticles:
Given the concerns raised over nanoparticle contamination in living organisms, Heads of
State ... should declare an immediate moratorium on commercial production of new
nanomaterials and launch a transparent global process for evaluating the socio-economic,
health and environmental implications of the technology.38
In 2003, the ETC Group expanded the breadth of its proposed moratorium:
In the absence of toxicology studies, ETC Group believes that governments must also
urgently consider extending the moratorium to products that place consumers in direct
contact with synthetic nanoparticles through their skin, lungs or digestive systems.39
In contrast to these views, a report prepared by the NSET Subcommittee concluded that
conducting EHS research in parallel with the development of nanomaterials and their applications
will help to ensure the full, safe, and responsible realization of the promise of nanotechnology.40
In 2003, then-Under Secretary of Commerce for Technology Phillip J. Bond addressed calls for a
moratorium or slowdown in nanotechnology R&D, casting the issue in ethical terms:

(...continued)
Protocol to the 1992 Convention on Biological Diversity incorporates provisions applying the precautionary principle
to the safe handling, transfer, and trade of genetically modified organisms. For further information, see CRS Report
RL30594, Biosafety Protocol for Genetically Modified Organisms: Overview, by Alejandro E. Segarra and Susan R.
Fletcher.
36 “NGOs urge precautionary principle in use of nanomaterials,” EurActiv.com, June 14, 2007,
http://www.euractiv.com/en/environment/ngos-urge-precautionary-principle-use- nanomaterials/article-164619; Sass,
Jennifer, “Nanotechnology and the Precautionary Principle,” presentation, Natural Resources Defense Council, 2006.
http://docs.nrdc.org/health/hea_06121401A.pdf
37 Nanomaterials, Sunscreens, and Cosmetics: Small Ingredients, Big Risks, Friends of the Earth, May 2006.
http://www.foe.org/camps/comm/nanotech/nanocosmetics.pdf
38 “No Small Matter,” Communique, ETC Group, May/June 2002. http://www.etcgroup.org/upload/publication/
pdf_file/192 The ETC group is a non-governmental organization focused on the global societal impacts of emerging
technologies.
39 “No Small Matter II: The Case for a Global Moratorium,” Occasional Paper Series, ETC Group, April 2003.
http://www.etcgroup.org/upload/publication/pdf_file/165
40 Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science,
Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council,
The White House, September 2006. p. vii.
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Those who would have us stop in our tracks argue that it is the only ethical choice. I
disagree. In fact, I believe a halt, or even a slowdown, would be the most unethical of
choices.... Given the promise of nanotechnology, how can our attempt to harness its power at
the earliest opportunity—to alleviate so many of our earthly ills—be anything other than
ethical? Conversely, how can a choice not to attempt to harness its power be anything other
than unethical?41
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In order to manage the Federal EHS portfolio, policymakers will need to establish research
priorities. In this regard, the NRC recommended that
Assessing the effects of engineered nanomaterials on public health and the environment
requires that the research conducted be well defined and reproducible and that effective
methods be developed and applied to (1) estimate the exposure of humans, wildlife, and
other ecological receptors to source material; (2) assess effects on human health and
ecosystems of both occupational and environmental exposure; and (3) characterize, assess,
and manage the risks associated with exposure.42
In 2005, PCAST concluded that EHS research should give highest priority to workplace
exposure. PCAST noted
the greatest likelihood of exposure to nanomaterials is during manufacture, and therefore
[we] agree with the prioritization of research on potential hazards from workplace
exposure.43
Several years later, in its 2008 assessment, PCAST reiterated this point stating, “the greatest risk
of exposure to nanomaterials at present is to workers who manufacture or handle such material,”
but also acknowledged a broader range of risks:
environmental, health, and safety risks in a wide range of settings must be identified and the
necessary research performed so that real risks can be appropriately addressed.44
Some stakeholders have asserted that a comprehensive approach to federal EHS research has
been hampered by the lack of an NNI roadmap for these efforts.45 In general, these stakeholders
seek a multi-year roadmap with specific milestones, metrics, and funding levels. Such a roadmap,
they assert, would contribute to a more coordinated approach among agencies and between the

41 Bond, Phillip J., Under Secretary for Technology, U.S. Department of Commerce. “Nanotechnology: Economic
Opportunities, Societal and Ethical Challenges,” keynote address, NanoCommerce 2003, December 9, 2003.
42 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
92.
43 The National Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National
Nanotechnology Advisory Panel, President’s Council of Advisors on Science and Technology, May 2005. p. 35.
44 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. p. 2.
45 Rejeski, David, director, Project on Emerging Nanotechnologies. Public comments on the Nanoscale Science,
Engineering, and Technology Subcommittee’s report, Prioritization of Environmental, Health, and Safety Research
Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, September 12, 2007.
http://www.nanotechproject.org/process/files/5891/nehi_comments_070912_final.pdf
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executive branch and Congress on the magnitude, timing, prioritization, and management of
federal EHS research.
NNI officials argue that the NSET
NNI EHS-focused Reports
Subcommittee, the coordinating body for the
Environmental Health and Safety Research Needs for
NNI, has developed an EHS research strategy
Engineered Nanoscale Materials, published in September
and articulated it in three reports (see text box,
2006, identified the research and information needed to
enable sound risk assessment and risk management
“NNI EHS-focused Reports”), though they
decision making with respect to nanoscale materials and
acknowledge that these documents do not
products that incorporate them.
constitute a roadmap. At an October 2007
Prioritization of Environmental, Health, and Safety Research
hearing of the House Subcommittee on
Needs for Engineered Nanoscale Materials, published in
Research and Education,46 some Members of
August 2007, identified five broad categories of EHS
Congress expressed concerns about the time
research and information needs, and five specific
required by the National Nanotechnology
research areas in each category.
Coordination Office to produce a prioritized,
The National Nanotechnology Initiative: Strategy for
detailed implementation plan for NNI EHS
Nanotechnology-related Environmental, Health, and Safety
research. While acknowledging the challenges
Research, published in February 2008, defined the NNI’s
strategy for addressing priority research on EHS aspects
faced by the NNCO in developing consensus
of nanomaterials. The document reviewed current
among the 25 NNI agencies, some Members
agency research using the taxonomy developed in the
suggested that these challenges were
second report; identified research gaps; and articulated a
emblematic of the need for a more top-down
framework for prioritizing research, implementing the
approach to EHS research.
strategy, and coordinating agency efforts.
Opposition to an EHS roadmap stems
primarily from doubts of the practicality and efficacy of such an approach. Some argue that it is
unlikely that OMB would commit to a multi-year, multi-agency roadmap accompanied by
specific funding levels. Such an approach would depart from the current executive branch annual
budget development process and reduce OMB’s flexibility in future years. In addition, agencies
often have to respond to new requirements based on emergent circumstances, Congressional
direction, or other factors. Agency funding is often redirected from planned efforts to new, often
imminent, priorities. The need for such redirection of funding could impede the achievement of
roadmap milestones and metrics or, conversely, impede the movement of funding to new
priorities.
To overcome the obstacles associated with the development of a roadmap by the agencies, some
have suggested the National Academies produce such a roadmap. Some assert that this approach
worked well with respect to the development of a federal research roadmap to reduce EHS
uncertainties associated with airborne particulate matter. Others argue that the particulate matter
effort focused only a narrow field and covered research conducted by only a single agency (EPA);
in contrast, nanotechnology spans a broad range of materials and applications across many fields,
and requires EHS research efforts by several agencies.
In February 2007, 19 environmental and business organizations, large and small companies, and
research organizations signed a letter to the Senate Appropriations Subcommittee on Interior,
Environment, and Related Agencies requesting $1 million be appropriated for the development of

46 Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and
Implementation under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October 31, 2007.
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a federal roadmap and research strategy. The letter recommended that this work be done by the
National Institute of Environmental Health Sciences (NIEHS).47
The Senate Appropriations Committee report (S.Rept. 110-91) accompanying the Department of
the Interior, Environment, and Related Agencies Appropriations Act, 200848 urged the
Environmental Protection Agency (EPA) to
contract or enter into a cooperative agreement with the National Academy of Sciences’
Board on Environmental Studies and Toxicology within 90 days of enactment to develop and
monitor implementation of a comprehensive, prioritized research roadmap for all Federal
agencies on environmental, health and safety issues for nanotechnology.49
A Cooperative Approach to Addressing EHS Concerns
Some organizations have taken a cooperative approach to promote EHS research. For example, the Environmental
Defense Fund, an environmental advocacy group, partnered with the American Chemistry Council, a trade group, to
issue a Joint Statement of Principles in June 2005 that recognizes the “significant societal and sustainable development
benefits” expected from nanotechnology, while calling for a multi-stakeholder dialogue to achieve the timely
development of nanomaterials “in a way that minimizes potential risks to human health and the environment.” The
statement also called for increased federal investments in EHS research and
development of an international effort to standardize testing protocols, hazard and exposure
assessment approaches, and nomenclature and terminology ... to maximize resources and minimize
inconsistent regulation of nanomaterials.a
There is general agreement among stakeholders that these activities can contribute to creating an environment where
research results can be reliably shared and compared, to protecting human health and safety, and to creating a
common language about nanotechnology that increases clarity in the sharing of ideas and information. However
international standardization efforts are often time- and resource-consuming, and can divert resources from more
pressing needs. In addition, such efforts can be used by nations and other organizations for competitive advantage
(e.g., by securing the adoption of a favorable standard, slowing others’ progress).
In June 2007, the Environmental Defense Fund and DuPont issued a Nano Risk Framework “to assist with the
responsible development and use of nanotechnology and to help inform global dialogue on its potential risks.”b The
framework is a six-step process to identify, address, and manage potential risks: (1) describe the material and the
intended application; (2) profile the material’s lifecycle in the application; (3) evaluate associated risks; (4) assess risk
management options; (5) decide on and document actions; and, (6) regularly review new information and adapt
actions accordingly.c
a Environmental Defense and American Chemistry Council Nanotechnology Panel: Joint Statement of Principles, Comments on
EPA’s Notice of a Public Meeting on Nanoscale Materials, June 23, 2005.
b “DuPont and Environmental Defense Launch Comprehensive Tool for Evaluating and Addressing Potential Risks of
Nanoscale Materials,” press release, E. I. du Pont de Nemours and Company, June 21, 2007.
http://vocuspr.vocus.com/VocusPR30/Newsroom/
Query.aspx?SiteName=DupontNew&Entity=PRAsset&SF_PRAsset_PRAssetID_EQ=106677&XSL=PressRelease&Cac
he=False
c Nanorisk Framework, Environmental Defense-DuPont Nano Partnership, June 2007.
The process used to develop research priorities and the federal EHS budget has also raised
management concerns. As discussed earlier, the federal nanotechnology EHS research portfolio
results from research funding requests made by individual agencies pursuing their missions and

47 An electronic copy of this letter, dated February 22, 2007, was provided to the Congressional Research Service
(CRS) by the American Chemistry Council.
48 Incorporated as division F of the Consolidated Appropriations Act, 2008 (P.L. 110-161).
49 S.Rept. 110-91, p. 54.
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by decisions made in the Congressional appropriations process. Informal research coordination
among EHS funding agencies occurs through the NEHI working group and more formally
through the OMB budget development process. Some proponents for an integrated federal EHS
research effort have called for a more top-down approach. The Woodrow Wilson Center’s Project
on Emerging Nanotechnologies (PEN) has been a leading advocate on this issue. PEN’s chief
science advisor, Andrew Maynard, asserted that
to realize nanotechnology’s benefits ... the federal government needs a master plan for
identifying and reducing potential risks. This plan should include a top-down risk research
strategy, dedicated and sufficient funding to do the job, and the mechanisms to ensure that
resources are used effectively.50
PEN has recommended increasing the authorities of the NEHI working group to empower it to
develop and implement the top-down research plan, a minimum of $100 million over two years to
fund the research, and a full-time director to support the NEHI working group.
Responding to the PEN recommendation, E. Clayton Teague, director of the NNCO, testified
before Congress that there was a consensus among NNI agencies that a centralized office with
budgetary authority to oversee the NNI’s EHS research program would have significant
detrimental effects. According to Dr. Teague,
No one agency or centralized organization would have the breadth of scientific expertise and
knowledge of regulatory authorities and needs currently represented by the 20 agencies
participating in the NEHI working group.
Creation of a new central authority would undermine the existing successful interagency
coordination.
Moving the management of all nanotechnology EHS research into a single office would
likely decouple such research from related efforts within NNI agencies and from the
knowledge base in the agencies that is currently networked into the NNI’s EHS research
effort.
Creating a separate office would, on the one hand, give mission agencies a disincentive for
doing nanotechnology-related EHS research. They would reasonably assume that another
agency is responsible, and they therefore could redirect their limited resources to address
other priorities. A likely result could be that the level of research would actually decrease.
Conversely, creating a separate office could lead to duplicative work being funded, thereby
wasting tax dollars and not optimizing progress.51

50 Maynard, Andrew, chief science advisor, Project on Emerging Nanotechnologies. “Public Meeting on Research
Needs and Priorities Related to Environmental, Health, and Safety Aspects of Engineered Nanoscale Materials,”
comments, January 4, 2007. http://www.nano.gov/html/meetings/ehs/uploads/
20070103_1505_Nanotechnology_Maynard_NNCO_Comments.pdf
51 Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on
Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on
“Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation
under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October 31, 2007.
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Project on Emerging Nanotechnologies Recommendations
The Project on Emerging Nanotechnologies (PEN), a joint venture of the congressionally-chartered Woodrow
Wilson Center for International Scholars and the Pew Charitable Trusts, has produced inventories of both
nanotechnology-based products and government-funded EHS research. PEN has asserted the need for more EHS
research, more aggressive oversight, and a more centralized federal government approach to funding EHS research.
In addition, PEN contends that the increasing complexity of systems incorporating nanoparticles with multiple
functions will make the behaviors more complex and difficult to predict. To minimize the likelihood of a
nanotechnology accident, PEN made the following recommendations:
• Creating a Nano Safety Reporting System where people working with nanotechnology can anonymously report
safety issues and concerns. PEN states that the information gleaned from this system could be used to inform the
design of educational materials, better structure technical assistance programs, and provide an early indicator of
emerging safety issues.
• Creating technologies that provide an early-warning system to allow for risk to be assessed early in research
efforts. Such a technology might enable low-cost, fast-screening for novel properties that would allow for risk
assessment integrated and concurrent with the R&D process.
• Pushing information out to small businesses, start-ups, and laboratories that, due to their size and resources, are
unlikely to be able to devote significant resources to EHS issues. PEN states that existing assistance programs
could be used to deliver this information, as well as the development of peer-to-peer mentoring programs within
industrial supply chains.
• Application of lessons learned in other technology areas to make nanotechnology more inherently safe, using
strategies such as multiple levels of protection, learning from failures, not oversimplifying the complex, awareness
of operations, and building in resilience to prevent cascading of errors.
Source: Rejeski, David, director, Project on Emerging Nanotechnologies. “Nanotech Safety 101 or How to Avoid
the Next Little Accident,” paper, Workshop on Disaster Prevention, Harvard University, April 27, 2006.
Dr. Maynard counters that “it should be possible to develop a functional structure that enables
agencies to work within a broader plan.” According to Maynard, while a centralized office is not
necessary,
top-down leadership with authority and the ability to ensure resources get to where they are
needed is necessary.... [Such] leadership does not take away from agencies’ expertise and
missions, but rather empowers agencies to do the best they can, while coordinating and
partnering as effectively as possible with each other.52
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Some have raised concerns about whether current laws, regulations, and authorities are adequate
to protect human health, safety, and the environment from potential adverse implications of
nanotechnology. Several factors may affect the ability of the regulatory system to keep pace with
advances in technology, both broadly and specifically with respect to nanotechnology.

52 E-mail communication, November 21, 2007.
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Broadly, market forces have increased the
Unique Properties Emerge
pace of global innovation, challenging
at the Nanoscale
institutions’ ability to identify and cope with
Scientists have discovered that elements and materials
the societal implications of rapid change.
with the same chemistry can exhibit fundamentally
Speed-to-market has become a driving factor
different properties at the nanoscale. For example,
in competition for many industries as a result
platinum, which exhibits no magnetism in its bulk form,
of the entry of new and nimble competitors in
shows significant magnetic properties in nanoscale
the global marketplace, increased public and
clusters of 13 atoms. The optical properties of gold also
can change with particle size. At 10 nanometers, gold
private investments in R&D, global models of
particles absorb green light and appear red, not gold.
innovation, increased flows of scientific and
Not only can nanoscale particles differ in properties from
technical knowledge, and greater numbers of
bulk material with the same chemical composition, they
scientists and engineers around the world. In
may also differ from other nanoscale materials with the
addition, growing global markets enable
same chemical composition. For example, the melting
companies to recoup their investments faster
point of an element—which was believed to be constant
and enable earlier investments in subsequent
regardless of the element’s particle size—can change
with particle size. Nanotechnology research has
generations of technology, further accelerating
demonstrated that the melting temperature of gold
the pace of innovation. The increased pace,
decreases when the particle’s radius drops below 10
scope, and complexity of technological
nanometers (from a melting temperature of
innovation may pose challenges to the existing
approximately 1,000oC at 10 nanometers to
regulatory system. While these factors may
approximately 500oC at 2 nanometers).
affect a broad range of technologies,
Source: Roduner, Emil. “Nanoscopic Materials: Size-
nanotechnology may be especially affected
Dependent Phenomena,” University of Stuttgart,
Germany, August 2006.
due to the rapid growth in public and private
R&D investments in the field since the year
2000 and the potential for nanomaterials to be used in a wide array of products.
Nanotechnology also may pose unique challenges to the regulatory system. For example,
historically, regulatory agencies have defined a chemical by its chemical composition, usually
without regard to its particle size. In contrast, the essence of nanotechnology is that a material
may exhibit different properties at the nanoscale than it does at a bulk, molecular, or atomic scale.
(See text box, “Unique Properties Emerge at the Nanoscale.”) Accordingly, questions are being
raised by representatives of the scientific, advocacy, and regulatory communities about how an
EHS research portfolio might be structured when particle size may affect a material’s properties,
whether it may be necessary to incorporate particle size into regulatory regimes, and how this
might be accomplished given the vast spectrum of particle sizes that might affect the
characteristics of a particular material.
Some argue that EHS concerns about nanotechnology products can be handled under existing
laws and regulations, while others see legal obstacles to adequate EHS regulation. In both of its
assessments of the NNI, PCAST concluded that existing regulatory authorities were adequate for
the current activities; that appropriate regulatory mechanisms should be used to address instances
of harmful human or environmental effects of nanotechnology; and that new regulatory policies
related to nanotechnology should be rational, science-based, and consistent across the federal
government. Similarly, Sean Murdock, executive director of the NanoBusiness Alliance, asserted
that
The apparatus for effective nanotechnology regulation is largely in place through various
statutes and agencies, but it lacks data and resources. To enable these agencies and for the
nanotech regulation effort to succeed we must increase the level of funding available to them
for nanotech environmental, health and safety research; coordinate efforts between agencies;
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establish metrics and standards that can be used to characterize nanomaterials; conduct
ongoing research; and more.53
Others believe that new laws and regulations, or modifications to existing ones, may be required.
J. Clarence Davies, senior advisor to the Project on Emerging Nanotechnologies and former EPA
Assistant Administrator for Policy, Planning, and Evaluation argued that
Nanotechnology is difficult to address using existing regulations. There are a number of
existing laws—notably the Toxic Substances Control Act; the Occupational Safety and
Health Act; the Food, Drug and Cosmetic Act; and the major environmental laws (Clean Air
Act, Clean Water Act, and Resource Conservation and Recovery Act)—that provide some
legal basis for reviewing and regulating [nanotechnology] materials. However, all of these
laws either suffer from major shortcomings of legal authority, or from a gross lack of
resources, or both. They provide a very weak basis for identifying and protecting the public
from potential risk, especially as nanotechnologies become more complex in structure and
function and the applications become more diverse.
A new law may be required to manage potential risks of nanotechnology. The law would
require manufacturers to submit a sustainability plan which would show that the product will
not present an unacceptable risk.54
Davies further asserts that new mechanisms and institutional capabilities—including research
programs, tax breaks, acquisition programs, and regulatory incentives—are needed to encourage
beneficial applications of nanotechnology.
In developing the regulatory structure, some in the business and financial communities assert that
stability and predictability are key characteristics for attracting investment and spurring
commercial applications. According to Matthew Nordan, vice president of Lux Research, the
ambiguity surrounding environmental, health, and safety regulation of nanoparticles is
hampering commercialization. Firms do not want to play a game whose rules may change at
any time.... That doesn’t mean they want more regulations or more onerous regulations.
They’re just looking for a roadmap on how federal agencies such as the EPA or OSHA
[Occupational Safety and Health Administration] plan to approach nanoparticles.55
Some tension exists between the goals of promoting the development of nanotechnology,
ensuring the global competitive position of the United States, addressing potential EHS
implications of nanotechnology, and coping with the unique challenges nanotechnology poses to
the current regulatory regime. To prevent health and safety concerns from becoming an
impediment to innovation, some suggest that health and safety research and regulation must be
done near-concurrently with product development, keeping pace with the speed of innovation.
Alternatively, others argue that the potential health, safety, and environmental implications are
either unknown or of such significance that EHS research and regulation must precede
nanotechnology development and commercialization. “By the time monitoring catches up to
commerce the damage will already have been done,” asserted Ian Illuminato, health and

53 “Nanotechnology Leaders to Converge in Washington, D.C., This Week for NanoBusiness Alliance Public Policy
Tour,” article, nanotechwire.com, February 16, 2006. http://nanotechwire.com/news.asp?nid=2929
54 Davies, J. Clarence. Managing the Effects of Nanotechnology, Project on Emerging Nanotechnologies, January 2006.
p. 3. http://www.nanotechproject.org/process/assets/files/2708/30_pen2_mngeffects.pdf
55 “U.S. Risks Losing Nano Lead,” article, physorg.com, July 6, 2005. http://www.physorg.com/news4963.html
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environment campaigner for Friends of the Earth.56 AFL-CIO industrial hygienist Bill Kojola
warned that
Even though potential health hazards stemming from exposure have been clearly identified,
there are no mandatory workplace measures that require exposures to be assessed, workers to
be trained, or control measures to be implemented. [Nanotechnology] should not be rushed
to market until these failings are corrected and workers assured of their safety.57
The National Research Council assessment of the NNI acknowledged the need for additional
reproducible, well-characterized EHS data to inform risk-based guidelines and best practices and
warned that until such information is available precautionary measures should be taken to protect
the health and safety of workers, the public, and the environment.58
In its 2008 assessment of the NNI, PCAST asserted that risk research must not be considered in
isolation, but rather in the context of the overall risks and benefits of a particular material or
technology. This perspective is shared by many industry advocates who argue that regulatory
decisions must balance the potential risks associated with a nanotechnology product against the
benefits it delivers and the risk it displaces. Further, they maintain that nanotechnology products
should not be held to a higher standard than non-nanotechnology products. PCAST also noted
that manufacturers and sellers of nanotechnology products had responsibilities for ensuring
workplace and product safety, and asserted that the NNI has a vital role in supporting federal
regulatory agencies by providing them with EHS research results.
A description of selected nanotechnology EHS activities of federal regulatory agencies is
provided in Appendix A.
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International engagement on EHS issues is believed by many to be important to the responsible
development and successful commercialization of nanotechnology. NNI officials assert that the
United States has played a central role in convening international efforts to address EHS
concerns. In its 2008 assessment, PCAST encouraged the NNI to coordinate its efforts with other
nations to avoid duplication and to leverage investments, characterizing such work as “non-
competitive.”59
Federal agencies have engaged internationally (e.g., with agencies of other nations, international
organizations, standards organizations) across a wide range of nanotechnology-related areas,
including standards, nomenclature, and EHS research. Appendix B provides an overview of
selected international engagement efforts of NNI agencies related to environmental, health, and
safety issues.

56 “International Coalition Calls for Oversight of Nanotechnology,” press release, Friends of the Earth, July 31, 2007.
http://action.foe.org/dia/organizationsORG/foe/pressRelease.jsp?press_release_KEY=248
57 Ibid.
58 A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006.
p.11.
59 The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. p. 33.
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Advocates for international engagement assert a variety of potential benefits. For example,
transparency and/or harmonization of standards and regulations may contribute to assurance of
global supply chains and market confidence in nanotechnology products. Increased globalization
of production and markets means that companies and consumers around the world are
increasingly part of a common network. Manufacturers of final products generally rely on inputs
from multiple suppliers in their global supply chains. The reliability of a final product often
depends on the reliability of inputs, such as materials or components. Transparent and common
standards and regulations may help to ensure the integrity of supply chains and final products.
While this is an issue for a variety of non-nanotechnology products (e.g., the recent discovery of
lead-tainted toys and other products imported from China), nanotechnology may present a unique
challenge in that at least some nanoscale particles can be incorporated into materials and products
in ways that cannot be easily detected or detected at all. Thus, producers and the consumers they
serve must rely, in large measure, on standards and regulatory systems to ensure that nanoscale
materials are properly produced and represented throughout the supply chain. In the absence of
such standards and regulatory systems, producers may not be able to rely on inputs or may incur
additional costs for testing and verification; substandard inputs may be incorporated in final
products making them underperform or unsafe, and possibly resulting in loss of market
confidence and/or potential litigation; or nanotechnology materials may be incorporated without
disclosure.
Internationally agreed upon standards could also contribute to greater comparability of research
results, improving understanding of EHS-related aspects of nanotechnology, and promoting
regulations that help protect human health and the environment. Common standards and
nomenclature also may contribute to more effective global collaboration in nanoscale science,
engineering, and technology R&D, accelerating the realization of nanotechnology’s economic and
societal potential.
Global engagement may help to establish a common environment for the development and
production of nanotechnology products and to promote access to global markets. In the absence
of such an environment, some nations may seek to attract investments in their markets by
adopting lower environmental, health, and safety standards and regulations.
Finally, while much remains unknown about the transport and fate of nanoscale materials released
into the environment, it is possible that countries and populations other than those where research
and production activities take place may be affected. Efforts to promote the adoption of best
practices in nanotechnology research, production, use, disposal, and recycling may protect human
health and the environment worldwide.
International engagement on EHS research may pose problems, including the time, cost,
difficulty, and alleged ineffectiveness of such collaborations. For example, while some advocates
assert the need for swift action in advancing EHS research, international engagements often entail
slow processes. Also, given the strong U.S. position in nanotechnology, broadly, and in
nanotechnology EHS research, specifically, some may argue that other countries have little to
contribute, that such efforts tax limited federal EHS financial and human resources, and that such
diffusion of resources may slow overall EHS progress. Others might assert that international
engagement efforts focused explicitly on nanotechnology are unnecessary given the wide variety
of existing mechanisms and pathways for sharing academic research and environmental, health,
and safety information across national borders.
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Some may oppose international engagement efforts because they lack faith in the goodwill of
some participating parties due to the potentially strong national interests at stake (e.g., military
applications, economic growth, job creation). In 2003, then-Under Secretary of Commerce for
Technology Phillip J. Bond questioned whether global calls for a slowdown in nanotechnology
R&D to address environmental, health, and safety concerns are intended to allow other nations to
close the nanotechnology leadership gap with the United States:
I wonder very often if there are really calls for a slow-down so that other governments and
countries might catch up.60
Others assert that the research required to understand and address EHS implications may be
closely linked to applications-related R&D to create nanotechnology materials, products, or
processes. In such cases, companies and countries may be reluctant to reveal EHS concerns and
efforts, to cooperate in EHS research, or to share results as such actions may reveal competitive
strategies, provide information others might use to compete against them (e.g., insights into
promising materials or manufacturing processes), or result in unwanted scrutiny by regulators.
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Advocates and critics agree that potential environmental, health, and safety implications of
nanotechnology must be addressed if the full economic and societal benefits of nanotechnology
are to be achieved. There is also general agreement that the current body of knowledge of how
nanoscale materials might affect humans and the environment is insufficient to assess, address,
and manage the potential risks. While there is agreement on the need for more EHS research,
there are differing views on the level of funding required, how it should be managed, and related
issues.
Congress is currently considering legislation, H.R. 554, that would reauthorize and amend the 21st
Century Nanotechnology Research and Development Act, the appropriations bills that fund the
NNI agencies’ nanotechnology EHS research, and H.R. 820, the Nanotechnology Advancement
and New Opportunities Act. Congress may use these opportunities to further address
nanotechnology EHS implications issues, including: How much should the federal government
appropriate for EHS research? How can the federal EHS research investment be better accounted
for? How should the research be prioritized? Should the research be more centrally managed?
How can EHS research results and best practices be shared more broadly? Can voluntary
programs effectively provide needed information about industrial nanotechnology production
activities? How can efforts to develop common nomenclature and standards be improved? Are
existing laws, regulations, guidelines, and regulatory structures adequate? Is there sufficient
coordination among federal regulatory agencies? What types of international engagement on
nanotechnology research and regulatory issues could best foster responsible development of
nanotechnology?

60 Regional, State, and Local Initiatives in Nanotechnology, Nanoscale Science, Engineering, and Technology
Subcommittee, Committee on Technology, National Science and Technology Council, The White House, 2005. p. 33.
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Two bills introduced in the 111th Congress contain provisions that seek to address nanotechnology
EHS concerns. The following section summarizes selected EHS-related provisions of these bills.
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H.R. 554, the National Nanotechnology Initiative Amendments Act of 2008, was introduced on
January 15, 2009, and referred to the House Committee on Science and Technology. This act
would revise the 21st Century Nanotechnology Research and Development Act in a variety of
ways, several of which specifically address nanotechnology EHS concerns. The legislation:
• directs the National Nanotechnology Coordination Office to develop and
maintain a public database of NNI EHS projects, including the agency funding
source and funding history;
• requires the National Nanotechnology Advisory Panel (NNAP) to be established
as a “distinct entity” (the NNAP’s functions are currently performed by the
President’s Council of Advisors on Science and Technology), and requires the
establishment of a subpanel to assess whether societal, ethical, legal,
environmental, and workforce concerns are adequately addressed by the NNI;
• directs that the National Research Council, as part of its triennial review of the
NNI, evaluate the adequacy of the NNI’s efforts to address ethical, legal,
environmental, human health, and other appropriate societal concerns;
• requires the designation of an associate director of the White House Office of
Science and Technology Policy to serve as Coordinator for Societal Dimensions
of Nanotechnology with responsibility for developing an annual research plan for
federal nanotechnology EHS activities, monitoring and encouraging agency EHS
efforts, and for encouraging agencies to engage in public-private partnerships to
support EHS research;
• requires certain interdisciplinary research centers supported under the NNI to
include EHS research to develop methods for developing environmentally benign
nanoscale products and processes, to foster the transfer of research results to
industry, and to provide interdisciplinary study programs to educate scientists and
engineers in these methods;
• directs NNI agencies to support the activities of standards setting bodies involved
in the development of standards for nanotechnology, including authorizing
agency reimbursement of travel costs of scientists and engineers participating in
these activities; and
• requires activities supported under the NNI’s Education and Societal Dimensions
program component area to include environmental, health, and safety education
in its informal, pre-college, and undergraduate nanotechnology education efforts.
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H.R. 820, the Nanotechnology Advancement and New Opportunities Act, was introduced on
February 3, 2009. Among its provisions, the bill would require the NNCO to produce an annual
research strategy that establishes priorities for the development and responsible stewardship of
nanotechnology, as well as providing recommendations regarding the funding required to
implement the strategy.
On February 3, 2009, H.R. 820 was referred to the House Science and Technology Committee;
the House Ways and Means Committee; the House Energy and Commerce Committee; and the
House Homeland Security Committee.
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Several federal regulatory agencies have begun to grapple with the EHS issues raised by
nanotechnology in their spheres of responsibility. Some critics argue that there is a potential
conflict of interest among some regulatory agencies that are, on the one hand, conducting and
promoting nanotechnology research and that are, on the other hand, responsible for regulating
nanotechnology applications. The following section provides an overview of selected EHS-
related nanotechnology activities of federal regulatory agencies.
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The Environmental Protection Agency (EPA) co-chairs the NEHI working group of the NSET,
along with the National Institute for Occupational Safety and Health (NIOSH), a research
institute within the Department of Health and Human Services. EPA, which has both a research
function and a regulatory function, has asserted a need for more information to assess the
potential EHS impacts of most engineered nanoscale materials. According to EPA, this
information is needed
... to establish a sound scientific basis for assessing and managing unreasonable risks that
may result from the introduction of nanoscale materials into the environment.61
EPA is supporting research on the toxicology, fate, transport, transformation, bioavailability, and
exposure of humans and other species to nanomaterials to obtain information for use in risk
assessment, a central aspect of EPA’s mission.62
EPA reports it is working collaboratively with stakeholders both domestically and internationally
to address industrial chemical nanoscale materials. (International EHS collaboration is discussed
in Appendix B.) One example of EPA’s domestic work is its effort to establish a Nanoscale
Materials Stewardship Program (NMSP). The purpose of the NMSP is to engage industry in a
process that will foster effective federal government decision-making through the sharing of
otherwise proprietary information about the characteristics, development, and manufacture of
nanoscale materials. As envisioned by EPA, the program is designed primarily to engage
manufacturers of nanoscale materials that would be considered existing chemical substances
under the Toxic Substances Control Act (TSCA), but also encourages the participation of
individuals and organizations working at a variety of stages of product development. EPA says
that NMSP is intended to help provide a firmer scientific foundation for regulatory decisions by
encouraging the development of key scientific information and appropriate risk management
practices for nanoscale chemical substances.
According to EPA, the data acquired through NMSP will be used to gain an understanding of
which nanoscale materials are produced, in what quantities, how they are used, and the data that

61 “Fact Sheet for Nanotechnology under the Toxic Substances Control Act,” Environmental Protection Agency.
http://www.epa.gov/oppt/nano/nano-facts.htm
62 “Exploratory Research: Nanotechnology Research Grants Investigating Fate, Transport, Transformation, and
Exposure of Engineered Nanomaterials: A Joint Research Solicitation - EPA, NSF, & DOE,” Environmental Protection
Agency. http://es.epa.gov/ncer/rfa/2007/2007_star_nanotech.html
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are available for such materials. EPA maintains that its scientists will use data collected through
this program, where appropriate, to aid in determining how and whether certain nanoscale
materials or categories of nanoscale materials may present risks to human health and the
environment. EPA states that NMSP is also intended to assist in the identification and adoption of
risk management practices in the development and commercialization of nanoscale materials, to
encourage the development of test data needed to provide a firmer scientific foundation for future
work and regulatory/policy decisions, and to promote responsible development.63
EPA solicited comments on the NMSP from stakeholders in a July 2007 Federal Register
Notice.64 The business community has been supportive of the use of voluntary programs to
address EHS risks of nanotechnology. The NanoBusiness Alliance states in its EHS research
policy statement that “EPA and NIOSH should receive adequate funding to develop and
implement their voluntary programs.”65 Other organizations have expressed frustration with the
speed at which EPA is moving to implement the NMSP. At an EPA public meeting held in August
2007, Richard Denison, senior scientist for the Environmental Defense Fund, testified that
As a government response to addressing the possible downsides of the nanotechnology
revolution, [the NMSP is] simply ‘too little, too late.’66
The Project on Emerging Nanotechnologies’ J. Clarence Davies testified at the same meeting that
while NMSP is
... potentially a useful initiative ... The delay in starting the NMSP is discouraging. It gives a
signal that there really is no urgency, that the agency is in no hurry to start the voluntary
program, much less institute an adequate regulatory system.67
Some observers say that past experience with other voluntary environmental programs shows that
such efforts can produce benefits for both industry and government. For industry, voluntary
programs may provide an opportunity to provide input into the regulatory process, to delay costly
and constraining mandatory regulations, and to improve corporate goodwill. For government,
voluntary programs may increase access to real-world data and information, may reduce the cost
of data creation and/or collection, provide insights into new problems and about emerging
industries, and provide a mechanism to control pollutants that are currently unregulated and for
which jurisdiction may be hard to obtain.68 Others maintain that voluntary programs can be
counterproductive if they delay implementation of an adequate oversight system.

63 EPA notes that the National Research Council described “responsible development” in its first triennial review of the
NNI as “the balancing of efforts to maximize the technology’s positive contributions and minimize its negative
consequences. Thus, responsible development involves an examination both of applications and of potential
implications. It implies a commitment to develop and use technology to help meet the most pressing human and
societal needs, while making every reasonable effort to anticipate and mitigate adverse implications or unintended
consequences.”
64 “Nanoscale Program Approach for Comment,” Environmental Protection Agency. http://www.epa.gov/oppt/nano/
nmspfr.htm
65 “Nanotech Environmental, Health and Safety: Progress and Priorities,” NanoBusiness Alliance.
http://www.nanobusiness.org/ehspolicy.php
66 “EPA’s Actions on Health Risks of Nanomaterials Called ‘Too Little, Too Late,’” press release, Environmental
Defense Fund, August 2, 2007.
67 Davies, J. Clarence, testimony, EPA Public Meeting on Nanoscale Materials Stewardship Program, August 2, 2007.
http://www.nanotechproject.org/file_download/212
68 Berger, Michael. “Implementing successful voluntary nanotechnology environmental programs appears to be a
(continued...)
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Multiple statutes govern EPA’s authority to regulate nanotechnology materials and devices,
including the Clean Air Act (CAA, 42 U.S.C. 7401 et seq); Clean Water Act (CWA, codified
generally as 33 U.S.C. §§1251-1387); Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA, 7 U.S.C.136-136y); and Toxic Substances Control Act (15 U.S.C. 2601 et seq.).69
Important issues have been raised about the application of EPA’s authorities to regulate
nanotechnology.
Key issues revolve around TSCA, which authorizes regulation of chemical commerce.70 Under
the provisions of TSCA, producers of a “new” material must provide EPA with a premanufacture
notification (PMN). EPA then has 90 days to approve manufacture, to require information from
manufacturers, or to restrict chemical use. Other TSCA provisions permit EPA regulation of
existing chemicals already in commerce, but these rely on EPA fact-finding and rulemaking
before EPA can require testing or restrict uses. Several NGOs have urged EPA to consider all
nanoscale materials “new” regardless of whether the material is on the EPA inventory list in its
bulk form.71 However, some nanotechnology materials have the same chemical composition as
materials that are already in commerce, raising the question of whether the nanotechnology
materials are “new” and thus subject to PMN requirements. With respect to this issue, EPA stated
that
EPA is considering how best to evaluate and, where appropriate, manage the risks associated
with engineered nanoscale materials (NMs).... Nanoscale materials are “chemical
substances” as defined under TSCA and are subject to the law unless otherwise excluded.
Thus premanufacture notifications (PMNs) are required under TSCA prior to manufacturing
a NM “new” chemical substance. To assist potential submitters, EPA is developing a general
approach to the TSCA inventory status of nanoscale substances in making the distinction
between “new” and “existing” chemicals that are nanoscale materials. EPA is also
developing an umbrella approach for evaluating both new and existing chemicals in NMs.72
When nanomaterials are intended to control pests, including microbes, FIFRA may offer EPA
more authority to regulate nanotechnology than TSCA, according to Lynn Bergeson, chair of the
American Bar Association’s Section on Environment, Energy, and Resources:
Under TSCA, once a substance is on the approved inventory list, any use is legitimate, but
FIFRA is use-specific. The EPA always has the authority to assess the risk of pesticides,
regardless of the use.73
Applicability of FIFRA to nanotechnology products was one aspect of a November 2006 EPA
ruling that a device that “incorporates a substance intended to prevent, destroy or mitigate pests”
is considered a pesticide and is required to be registered under FIFRA. While the ruling is not

(...continued)
challenge,” Nanowerk LLC, November 29, 2007. http://www.nanowerk.com/spotlight/spotid=3476.php
69 For additional information, see CRS Report RL30798, Environmental Laws: Summaries of Major Statutes
Administered by the Environmental Protection Agency (EPA), by Susan R. Fletcher et al.
70 For more information about TSCA and nanotechnology, see CRS Report RL34118, The Toxic Substances Control
Act (TSCA): Implementation and New Challenges, by Linda-Jo Schierow.
71 “The EPA’s Toxic Substances Control Act: What you must know,” Small Times, September/October 2007.
72 “New Nanotechnology Products,” Environmental Protection Agency. http://www.epa.gov/oppt/ar/20052006/
managing/new_nano.htm
73 “EPA Regulates Nano Product, Not Nano Industry,” Small Times, January 2007.
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unique to nanomaterials, it came in the context of advertising claims for a washing machine
containing nanoscale silver ions that kill microbes. EPA’s ruling made this appliance the first
nanotechnology product to be regulated under FIFRA. However, claims for the pesticidal
effectiveness of the washing machine have been removed from advertisements, possibly limiting
EPA’s ability to regulate the device as a pesticide under FIFRA.
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A variety of current and future products that incorporate nanotechnology fall, or may fall, under
the regulatory auspices of the Food and Drug Administration (FDA), including cosmetics,
medical devices, foods, drugs, biological products, and combination products.74 FDA anticipates
that many of the nanotechnology products that the agency is likely to regulate will be
combination products, such as drug-device, drug-biological, or device-biological products.
According to FDA, it regulates products based on their statutory classification rather than the
technology they employ, thus the agency may not provide regulatory consideration to a
nanotechnology product until well after its initial development.75 Also, some critics maintain that
FDA’s limited regulatory authority over certain categories of products may limit its authority to
regulate nanotechnology products.
With respect to the need for unique tests or requirements for regulating nanotechnology products,
FDA states that its existing requirements may be adequate for most nanotechnology products it
expects to regulate. FDA has asserted that nanotechnology products are in the same size-range as
the cells and molecules its reviewers and scientists deal with every day. The agency says that
every degradable medical device and injectable pharmaceutical generates particulates that pass
through the nanoscale size range during the processes of their absorption and elimination by the
body. According to FDA, it has no knowledge of reports of adverse reactions related to the
“nano” size of resorbable drug or medical device products. New tests or other requirements may
be needed, according to FDA, if new risks are identified arising from new materials or
manufacturing techniques. FDA has established a Nanotechnology Interest Group (NTIG)
comprised of representatives from each of its centers to facilitate the regulation of
nanotechnology products.76 Others, in particular consumer groups, counter that FDA’s resources
are insufficient to adequately address the safety of emerging technologies in general, and that the
agency’s regulatory approach, particularly for cosmetics, dietary supplements, and other products
for which pre-market review is not required, would not detect any problems until such products
had been in use.77
FDA does not provide grants for nanotechnology research but does conduct research in several of
its centers to understand the characteristics of nanomaterials and nanotechnology processes. FDA

74 For additional information, see CRS Report RL34334, The Food and Drug Administration: Budget and Statutory
History, FY1980-FY2007, coordinated by Judith A. Johnson.
75 “FDA and Nanotechnology Products,” Food and Drug Administration. http://www.fda.gov/nanotechnology/faqs.html
76 Ibid.
77 See, for example, Michael Taylor, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?
The Project on Emerging Nanotechnologies, October 2006, at http://www.nanotechproject.org/news/archive/
is_fda_nanotech-ready. The FDA Science Board, Subcommittee on Science and Technology, designated
nanotechnology as one of eight emerging technologies that are most challenging for FDA. See FDA Science Board,
Subcommittee on Science and Technology, FDA Science and Mission at Risk, November 2007, p. 4, at
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA Report on Science and Technology.pdf.
The FDA Science Board is the advisory board to the FDA Commissioner.
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is also collaborating with NIEHS on studies, as part of the interagency National Toxicology
Program (NTP), examining the skin absorption and phototoxicity of nano-sized titanium dioxide
and zinc oxide preparations used in sunscreens.
FDA says that there currently is no international regulation of nanoproducts or the underlying
nanotechnology. FDA participates in multinational organizations where cooperative work on
nanotechnology has been proposed, including the Organization for Economic Cooperation and
Development (OECD), ASTM International, and the International Organization for
Standardization (ISO). FDA plans to work with its foreign regulatory counterparts to share
perspectives and information on regulation of nanotechnology.78
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While not a regulatory agency, NIEHS is conducting nanotechnology EHS research that will
support the missions of regulatory agencies. In particular, NIEHS serves as home to the
interagency National Toxicology Program. The NTP’s mission is to coordinate toxicological
testing programs, develop and validate improved testing methods, develop approaches and
generate data to strengthen scientific knowledge about potentially hazardous substances, and
communicate with stakeholders.79 In 2006, the NTP established the Nanotechnology Safety
Initiative (NSI), a broad-based research program to address potential human health hazards
associated with the manufacture and use of nanoscale materials. The goal of this research
program is to evaluate the toxicological properties of major nanoscale materials that represent a
cross-section of composition, size, surface coatings, and physical and chemical properties, and to
use these as model systems to investigate fundamental questions concerning whether nanoscale
materials can interact with biological systems and how they might do so.80
According to NTP, the NSI is focused on three areas of research with respect to specific types or
groups of nanoscale materials:
• non-medical, commercially relevant and available nanoscale materials to which
humans are intentionally being exposed, such as cosmetics and sunscreens;
• nanoscale materials representing specific classes (e.g., fullerenes and metal
oxides) so that information can be extrapolated to other members of those
classes; and
• subsets of nanomaterials to test specific hypotheses about a key characteristic
(such as size, composition, shape, or surface chemistry) that might be related to
biological activity.
Current NSI research activities are focused on metal oxides, fluorescent crystalline
semiconductors (also known as quantum dots), fullerenes, and carbon nanotubes.

78 FDA and Nanotechnology Products: Frequently Asked Questions, Food and Drug Administration, U.S. Department
of Health and Human Services. http://www.fda.gov/nanotechnology/faqs.html
79 “Toxicology in the 21st Century: The Role of the National Toxicology Program,” Update, National Toxicology
Program, January 2004. http://ntp.niehs.nih.gov/ntp/htdocs/Liaison/2004JanLO_News.pdf
80 Toxicology in the 21st Century: The Role of the National Toxicology Program, Department of Health and Human
Services, February 2004. http://ntp.niehs.nih.gov/ntp/main_pages/NTPVision.pdf
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NTP has also established a Nanotechnology Working Group (NWG) to serve as a technical
advisory body to provide a structured and formal mechanism for bringing stakeholders together to
learn about NTP nanotechnology research related to public health, address issues related to that
research, and promote dissemination of those discussions to other federal agencies,
nanotechnology stakeholders, and the public. Another function of the NWG is to provide a
mechanism for the public and interested parties to provide advice to the NTP Board of Scientific
Counselors.
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The mission of the Occupational Safety and Health Administration (OSHA), an agency of the
Department of Labor, is to ensure the safety and health of America’s workers by setting and
enforcing standards; providing training, outreach, and education; establishing partnerships; and
encouraging continual improvement in workplace safety and health. OSHA has not yet taken any
regulatory actions with respect to nanotechnology.
The National Institute for Occupational Safety and Health (NIOSH), a part of the Department of
Health and Human Services, is the lead federal agency conducting research and providing
guidance on the occupational safety and health implications and applications of nanotechnology.
NIOSH co-chairs the NSET’s NEHI working group. NIOSH is not a regulatory agency, but its
work directly supports OSHA and other regulatory agencies.
NIOSH states that its nanotechnology efforts are building on its experience in defining the
characteristics, properties, and effects of ultrafine particles—such as welding fumes and diesel
particulates—as well as its experience in conducting advanced health effects laboratory studies
and in fostering industrial hygiene policies and practices. NIOSH has developed interim
guidelines for working with nanomaterials. The agency asserts that these guidelines are consistent
with the best scientific knowledge of nanoparticle toxicity and control. NIOSH also maintains a
Nanoparticle Information Library with information on the health and associated properties of
nanomaterials as an online resource for occupational health professionals, industrial users, worker
groups, and researchers.81
NIOSH and OSHA are considering risk management approaches that do not rely on traditional
exposure- and time-limits. These new approaches seek to maximize flexibility for innovation
while ensuring the health and safety of workers.82
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The Consumer Product Safety Commission (CPSC) is charged with protecting the public from
unreasonable risks of serious injury or death from certain types of consumer products.83 CPSC

81 “Nanotechnology at NIOSH,” National Institute for Occupational Safety and Health. http://www.cdc.gov/niosh/
topics/nanotech/
82 Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science,
Engineering, and Technology Subcommittee, Committee on Technology, National Science and Technology Council,
The White House, September 2006.
83 CPSC’s regulatory authorities are provided by the Consumer Product Safety Act; Federal Hazardous Substances Act
of 1960, as amended by the Toy Safety Acts of 1969 and 1984 and the Child Protection Amendments of 1966; Poison
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asserts that potential safety and health risks of nanomaterials can be assessed under existing
CPSC statutes, regulations and guidelines. Since the Consumer Product Safety Act (15 U.S.C.
2051 et seq.) and the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) do not require
pre-market registration or approval of products, CPSC does not evaluate a product’s risk to the
public until it has been distributed in commerce.
In August 2005, CPSC commissioners approved a nanotechnology statement which notes that
nanotechnology presents challenges that “may require unique exposure and risk assessment
strategies.” The CPSC statement identified regulatory challenges, including identification of the
specific nanomaterial in a product; the need to characterize the materials to which a consumer is
exposed during product use, including an assessment of the size distribution of the materials
released; and the application of toxicological data of appropriate particle sizes to assess health
risks. However, the CPSC takes the position that it is unable to make any general statements
about potential consumer exposure to nanomaterials or the health effects that may result from
exposure to nanomaterials during consumer use and disposal due to the wide variation in potential
health effects and the dearth of exposure and toxicity data for specific nanomaterials.84

(...continued)
Prevention Packaging Act of 1970; Flammable Fabrics Act of 1953; and Refrigerator Safety Act of 1956. For
additional information, see CRS Report RS22821, Consumer Product Safety Commission: Current Issues, by Bruce K.
Mulock.
84 “CPSC Nanomaterial Statement,” Consumer Product Safety Commission, August 2005. http://www.cpsc.gov/library/
cpscnanostatement.pdf
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Federal agencies have engaged internationally (e.g., with agencies of other nations, international
organizations, standards organizations) on a host of nanotechnology-related issues, with a focus
on EHS-related efforts such as scientific research, standards, nomenclature and terminology. The
following section provides an overview of some of these activities.
In June 2004, the U.S. government initiated and hosted the first International Dialogue on
Responsible Research and Development of Nanotechnology in Alexandria, Virginia. The meeting
was attended by representatives from 25 countries and the European Union. The following year
the NSET Subcommittee established the Global Issues in Nanotechnology (GIN) working group.
In addition to monitoring foreign nanotechnology programs and promoting U.S. commercial and
trade interests in nanotechnology, GIN was chartered to broaden international collaboration on
nanotechnology R&D, including research on safeguarding the environment and human health.
GIN representatives participated in the second International Dialogue on Responsible Research
and Development of Nanotechnology hosted by the European Community (EC) in Brussels in
July 2005. These meetings focused on clarifying issues and concerns of scientists, engineers, and
policymakers working in nanotechnology around the world.
GIN representatives have also participated in nanotechnology-related activities of the
Organization for Economic Cooperation and Development (OECD). In June 2005, chemical
experts from 30 OECD countries participated in the Joint Meeting of Chemicals Committee and
Working Party on Chemicals, Pesticides, and Biotechnology. Participants agreed to launch an
international effort to coordinate assessment procedures for chemicals manufactured with
nanotechnologies, to work toward linking national databases on high production-volume
chemicals, and to establish a harmonized template for reporting hazard data needed for the
notification and registration of new and existing chemicals, biocides, and pesticides. In December
2005, EPA hosted and chaired a second meeting of this group in Washington, D.C., on the safety
of manufactured nanomaterials.
In October 2005, the United States proposed the creation of a Working Party on Nanotechnology
within the OECD’s Committee for Scientific and Technological Policy. Established in March
2007, the objective of this working party is to promote international co-operation that facilitates
research, development, and responsible commercialization of nanotechnology in member
countries and in non-member economies.85 EPA is also participating in the OECD’s Working
Party on Manufactured Nanomaterials which was established in September 2006 to facilitate
international collaboration on EHS issues related to manufactured nanomaterials.86
Another focus of U.S. international cooperation efforts has been in the development of
nanotechnology standards. In response to a request from the White House Office of Science and
Technology Policy, the American National Standards Institute (ANSI) established the

85 “OECD Work on Nanotechnology,” Organization for Economic Cooperation and Development.
http://www.oecd.org/sti/nano
86 “Fact Sheet for Nanotechnology Under the Toxic Substances Control Act,” Environmental Protection Agency.
http://www.epa.gov/oppt/nano/nano-facts.htm; “OECD Work on Nanotechnology,” Organization for Economic
Cooperation and Development. http://www.oecd.org/sti/nano
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Nanotechnology Standards Panel (NSP) in June 2004 to facilitate and coordinate nanotechnology
standards development in the United States, focusing its initial work on nomenclature and
terminology.87 Subsequently, the International Organization for Standardization (ISO) established
the Nanotechnologies Technical Committee, a parallel organization to ANSI’s NSP. E. Clayton
Teague, director of the NNI NNCO, chairs the ANSI-accredited Technical Advisory Group (TAG)
to the ISO and leads the U.S. delegation.
The United States was selected to lead the ISO Technical Committee’s Working Group on Health,
Safety, and Environmental Aspects of Nanotechnologies. The Working Group has forwarded the
NIOSH document “Approaches to Safe Nanotechnology,” incorporating additional input from
five other countries, to the ISO Technical Committee on Nanotechnologies (ISO TC 229) for a
full review. If approved by the ISO Technical Committee, the document (re-titled “Health and
Safety Practices in Occupational Settings Relative to Nanotechnologies”) will be issued as an
international Publicly Available Specification, an informational document available to all
countries. NSET reports that significant progress on nanotechnology terminology and
nomenclature has also been made by the TC 229 working group.
Federal government funding also contributed to the establishment of the International Council on
Nanotechnology (ICON), a non-profit organization. ICON was established as an affiliate program
of the NSF-funded, Rice University-based Center for Biological and Environmental
Nanotechnology (CBEN), and has received funding from the National Science Foundation, the
National Institutes of Health, and other private and non-profit organizations. ICON characterizes
its purpose as seeking to catalyze global activities that lead to sound and responsible
nanotechnology risk assessment, management, and communications. ICON has held EHS
workshops, produced EHS reports, developed an online database of scientific findings related to
the benefits and risks of nanotechnology, and designed and executed a survey of corporate
nanotechnology EHS practices. In March 2007, ICON and CBEN jointly launched The Virtual
Journal of Nanotechnology Environment, Health, and Safety, which contains citations and links
to articles on the EHS impacts of nanotechnology.

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John F. Sargent Jr.

Specialist in Science and Technology Policy
jsargent@crs.loc.gov, 7-9147

87 “ANSI Establishes Nanotechnology Standards Panel,” American National Standards Institute, August 5, 2004.
http://www.ansi.org/news_publications/news_story.aspx?menuid=7&articleid=735
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