Nanotechnology and Environmental, Health, and Safety: Issues for Consideration

Nanotechnology and Environmental, Health, and
Safety: Issues for Consideration
August 6, 2008
John F. Sargent
Specialist in Science and Technology Policy
Resources, Science, and Industry Division

Nanotechnology and Environmental, Health, and
Safety: Issues for Consideration
Summary
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.

Contents
In troduction ......................................................1
Opportunities and Challenges........................................3
Importance of Addressing EHS Issues..................................8
Selected Issues for Consideration....................................10
Federal Investment in EHS Research..............................11
Current Funding Level.....................................11
Alternative Approaches....................................14
Management of Federal EHS Research........................17
Federal Regulation............................................23
International Engagement......................................26
Concluding Observations...........................................28
Nanotechnology EHS-Related Legislation in the 110^th Congress............29
H.R. 5940 — National Nanotechnology Initiative Amendments
Act of 2008.............................................29
S. 3274 — National Nanotechnology Initiative Amendments
Act of 2008.............................................30
H.R. 3235 — Nanotechnology Advancement and New Opportunities
Act ....................................................32
H.R. 4040 — CPSC Reform Act.................................32
Appendix A. Selected Nanotechnology EHS Activities of Federal
Regulatory Agencies..........................................33
Appendix B. Selected International Engagement Efforts of NNI Agencies....41
List of Tables
Table 1. NNI Environmental, Health, and Safety Research Funding,
FY2006-2008 ................................................11
Table 2. FY2006 NNI Funding for EHS Research
by Research Needs Categories ..................................12

Nanotechnology and Environmental, Health,
and Safety: Issues for Consideration
Introduction
Nanotechnology — a term encompassing nanoscale science, engineering, and
technology — is focused on understanding, controlling, and exploiting the unique¹
properties of matter that can emerge at scales of one to 100 nanometers. 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 600³
nanotechnology products reportedly commercially available, 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

¹ Congress defined nanotechnology in the 21^st 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.

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 FY2008, the federal
government invested $8.4 billion in nanotechnology R&D. 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.

⁴ Profiting From International Nanotechnology, Lux Research, December 2006.

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 the NNI see, CRS Report RL34401, The National
Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues,
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.
Opportunities and Challenges
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.
[ ht t p: / / www.f oe.co.uk/ r esour ce/ br i e f i ngs/ gm_cr ops_f ood.pdf ]

^!offering new materials
that protect againstPotential Nanotechnology
impacts, self-repair toCancer Applications
prevent catastrophic
failure, or change in
ways that protect or aidThe NCI Cancer NanotechnologyPlan asserts that nanotechnology can
soldiers on theserve as an enabling technology for a
battlefield.variety of cancer-related applications:
For example, nanoscale materials imaging agents and diagnostics thatallow clinicians to detect cancer in
show promise for detecting, preventing,its earliest, most easily treatable,
and removing pollutants. According topre-symptomatic stage;
the Environmental Protection Agency systems that provide real-time
(EPA):assessments of therapeutic and
surgical efficacy;
nanoscale cerium oxide has been multifunctional, targeted devices
developed to decrease dieselcapable of bypassing biological
engine emissions; ironbarriers to deliver therapeutic agents
nanoparticles can removeat high local concentrations directly
contaminants from soil andto cancer cells and tissues that play
ground water; and nano-sizeda critical role in the growth and
sensors hold promise formetastasis of cancer;
improved detection and tracking⁶
of contaminants. agents capable of monitoring
predictive molecular changes and
In the area of human health,preventing precancerous cells frombecoming malignant;
scientists assert nanotechnology has the surveillance systems that detect
potential for improving diseasemutations that may trigger the
diagnostics, sensing, monitoring,cancer process and genetic markers
assessment, and treatment. In particular,that indicate a predisposition for
the National Cancer Institute (NCI) viewscancer;
nanotechnology as likely to provide novel methods for managing the
revolutionary tools to extend and improvesymptoms of cancer that adversely
lives. In July 2004, NCI launched aimpact quality of life; and
five-year, $145 million initiative focused research tools that enable
on applying nanotechnology to theinvestigators to quickly identify new
prevention, detection, and treatment oftargets for clinical development and
cancer and amelioration of its symptoms.predict drug resistance.
At the initiative’s launch, then-NCI^Source:^C^{ancer N}^anot^echnol^{ogy Pl}^{an: A}
Director Andrew von Eschenbach^S^t^ra^t^e^gⁱ^{c I}ⁿ^itia^{tive to}^Traⁿ^s^fo^{rm Clin}^ica^l
identified nanotechnology as a key^Oⁿ^col^{ogy and}^B^a^sⁱ^{c Res}^e^ar^{ch T}^h^r^{ough t}^h^e
component of the agency’s strategy for^Dⁱ^r^ect^{ed Appl}ⁱ^c^atⁱ^{on of}^N^anot^echnol^ogy^,
ending death and suffering from cancer^Natioⁿ^a^{l Ca}ⁿ^cer^Iⁿ^stitu^{te, Natio}ⁿ^a^{l I}ⁿ^stitu^tes^of^H^eal^t^h^{, D}^e^part^m^eⁿ^t^of^H^eal^t^h^an^{d H}^u^m^aⁿ
^S^e^rvⁱ^ces^{, Ju}^l^y^2004.

⁶ “Fact Sheet for Nanotechnology under the Toxic Substances Control Act,” Environmental
Protection Agency. [http://www.epa.gov/oppt/nano/nano-facts.htm]

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 unknown⁸
consequences, such as new toxicological and environmental effects.
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

⁷ “Cancer Nanotech Plan Gets Nod of Approval,” Science, Vol. 305, July 23, 2004.
[ ht t p: / / www.sci e ncemag.or g/ cont ent / vol 305/ i ssue5683/ s-scope.dt l #305/ 5683/ 461c]
⁸ A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National
Research Council, 2006. p. 148.
⁹ Nanosilver: A Threat to Soil, Water and Human Health? Friends of the Earth, March 2007.
[ h t t p : / / www.f o e.or g/ pdf / FoE_Aust r al i a _Nanosi l ver _r epor t .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.
[ ht t p: / / www.sci e ncedai l y.com/ r el eases/ 2008/ 05/ 080527091910.ht m]
¹² National Nanotechnology Initiative: Research and Development Supporting the Next
(continued...)

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

¹² (...continued)
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/nni 04_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/nalef d/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]

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^a
can cause lung tissue damage; that buckyballs (spherical fullerenes) caused brain damage in^b^c
fish; and that buckyballs can accumulate within cells and potentially cause DNA damage.
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^d
nanomaterials.
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^e
through simple chemical changes to the surface. 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.
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Importance of Addressing EHS Issues
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 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 EHS¹⁶
risks from nanomaterials.
Similarly, PCAST concluded that
it is premature to rigorously assess the levels of risk posed by engineered¹⁷
nanomaterials. Adequate tools are being developed but are not yet in place.
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,

¹⁵ The 21^st 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.

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, and¹⁸
accelerating and increasing our return on investment.
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
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 the²⁰
nanotech revolution.
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.

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 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]

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 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.
Selected Issues for Consideration
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.

Federal Investment in EHS Research
Current Funding Level. 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 and²¹
Health Implications (NEHI) working group and in OMB’s budget development
process, the decision process that establishes overall funding for nanotechnology
EHS research is highly decentralized.
In FY2008, NNI funding for EHS implications research²² is $58.6 million,
approximately 3.9% of the total NNI budget of $1.49 billion. This represents 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 has requested $76.4 million (5.0%) for EHS
research in FY2009. NNI EHS research funding for FY2006 through FY2008, and
the request for FY2009, is provided in Table 1.
Table 1. NNI Environmental, Health, and Safety Research
Funding, FY2006-2008
EHS research, EHS research’s share
in current dollarsof total NNI budget
FY2006 (actual)$ 37.7 million2.8%
FY2007 (actual)48.3 million3.4%
FY2008 (estimated)58.6 million3.9%
FY2009 (requested)76.4 million5.0%
^Sources^:^“^T^h^e^Natioⁿ^a^{l Nan}^o^techⁿ^o^lo^g^y^Iⁿ^itiativ^{e: Resear}^ch^an^d^Dev^e^lo^p^m^en^{t L}^eadⁱⁿ^g^to^a
^R^e^v^o^l^u^tⁱ^oⁿⁱⁿ^T^echⁿ^o^l^o^g^y^an^{d In}^du^s^t^ry^,^Su^ppl^em^en^t^t^o^t^h^{e Pres}ⁱ^d^en^t^’^s^F^Y^{2008 Bu}^dg^et^{,” N}^S^ET
^Su^bcom^m^{ittee, NST}^C^{, OST}^P^{, T}^h^{e W}^h^{ite Hou}^s^e,^J^u^ly^{2007; “}^N^ation^a^{l Nan}^o^t^e^c^hno^l^o^g^y^In^itiativ^e:
^{FY2009 B}^u^dg^{et an}^{d Hig}^h^lig^h^t^s^,^{” NSET}^Su^bcom^m^itt^{ee, NST}^C^{, T}^h^{e W}^h^{ite Hou}^s^{e, Febru}^a^ry²^008.
^[^h^t^t^p^:^/^/^www.ⁿ^aⁿ^o^.^g^o^v^/^N^N^I^_^F^Y^09_bu^dg^et^_s^u^m^m^a^ry^.pdf^]

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.
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.)

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 necessarily²³
critical to (and may actual hinder) overall prioritization and coordination.
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 for²⁴
Engineered Nanoscale Materials. Totals for EHS implications research spending
identified in each of the five categories is shown below 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
CategoryEstimated 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
^No^{te: Nu}^m^b^er^{s m}^a^yⁿ^o^{t ad}^d^d^u^{e to}^r^o^uⁿ^dⁱⁿ^g^.
^Source:^T^e^a^gue^,^E^.^C^l^a^y^t^o^n,^dⁱ^r^e^c^t^o^r^,^N^a^tⁱ^o^na^l^N^a^no^t^e^c^hno^l^o^gy^Co^o^r^dⁱ^na^tⁱ^o^{n O}^ffi^c^e^.^T^e^stⁱ^m^oⁿ^y
^bef^o^{re th}^{e Su}^bcom^m^{ittee on}^R^e^s^earch^an^{d Scien}^ce^E^d^uc^a^tⁱ^o^n,^Co^m^mⁱ^t^t^e^e^oⁿ^Scⁱ^e^nc^e^a^{nd T}^e^c^hno^l^o^gy^,
^{U.S. Hou}^s^{e of}^R^e^pres^en^tatⁱ^v^e^s^{. Hearin}^g^on^“^R^es^earch^on^En^vⁱ^ron^m^en^{tal an}^{d Saf}^e^ty^Im^pacts^of
^N^a^no^t^e^c^hno^l^o^gy^:^Cur^r^eⁿ^t^St^a^t^{us o}^f^P^l^aⁿⁿⁱ^{ng a}ⁿ^d^I^m^p^l^e^m^eⁿ^t^a^tⁱ^o^{n und}^e^r^t^h^e^N^a^tⁱ^o^na^l^N^a^no^t^e^c^hno^l^o^gy
^Iⁿ^itiativ^{e.” 1}¹⁰^th^C^oⁿ^g^{., 1}^st^S^e^s^s^{., O}^c^t^{ober 31, 2007.}

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.

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 potential²⁵
health and safety issues.
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 States²⁶
leads all other countries by a wide margin in support of such research.
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,²⁷
cross-agency approaches to the funding and execution of this research.

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.
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]

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] be²⁸
expanded.
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 for²⁹
nanotechnology EHS as well as the available capacity for quality research.
Alternative Approaches. 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:
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 vary³⁰

significantly across agencies.
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.
³⁰ Murdock, Sean, executive director, NanoBusiness Alliance. Testimony before the
Committee on Science and Technology, U.S. House of Representatives. Hearing on “The^th^nd
National Nanotechnology Initiative Amendments Act of 2008.” 110 Cong., 2 Sess., April

16, 2008.

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 than³²
arbitrary percentages or funding figures.
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 basic³³
research on nanomaterials.
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

³¹ Denison, Richard A. “A Proposal to Increase Federal Funding of Nanotechnology Risk
Research to at least $100 Million Annually,” Environmental Defense, April 2005.
[ h t t p : / / www.edf .or g/ document s / 4442_100mi l quest i onl .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^th^st
Implementation under the National Nanotechnology Initiative,” 110 Cong., 1 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^th
Status of Planning and Implementation under the National Nanotechnology Initiative,” 110^st
Cong., 1 Sess., October 31, 2007.

these groups argue for application of the “precautionary principle,”³⁵ which holds that
regulatory action 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 adequate³⁷
regulations have been put in place...
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 the³⁸
technology.
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 digestive³⁹

systems.
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 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]

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:
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 choice⁴¹
not to attempt to harness its power be anything other than unethical?
Management of Federal EHS Research. 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 risks⁴²
associated with exposure.
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 from⁴³
workplace exposure.
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:

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.
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.

environmental, health, and
safety risks in a wide range ofNNI EHS-focused Reports
settings must be identified and
the necessary researchEnvironmental Health and Safety
performed so that real risks can⁴⁴Research Needs for Engineered Nanoscale
be appropriately addressed.Materials, published in September 2006,
Some stakeholders have assertedidentified the research and informationneeded to enable sound risk assessment
that a comprehensive approach toand risk management decision making
federal EHS research has beenwith respect to nanoscale materials and
hampered by the lack of an NNI⁴⁵products that incorporate them.
roadmap for these efforts. In general,Prioritization of Environmental,
these stakeholders seek a multi-yearHealth, and Safety Research Needs for
roadmap with specific milestones,Engineered Nanoscale Materials,
metrics, and funding levels. Such apublished in August 2007, identified five
roadmap, they assert, would contributebroad categories of EHS research and
to a more coordinated approach amonginformation needs, and five specific
agencies and between the executiveresearch areas in each category.
branch and Congress on the magnitude,The National Nanotechnology
timing, prioritization, and managementInitiative: Strategy for Nanotechnology-
of federal EHS research. related Environmental, Health, and Safety
Research, published in February 2008,
NNI officials argue that the NSETdefined the NNI’s strategy for addressing
Subcommittee, the coordinating bodypriority research on EHS aspects of
for the NNI, has developed an EHSnanomaterials. The document reviewed
research strategy and articulated it incurrent agency research using thetaxonomy developed in the second report;
three reports (see text box, “NNI EHS-identified research gaps; and articulated a
focused Reports”), though theyframework for prioritizing research,
acknowledge that these documents doimplementing the strategy, and
not constitute a roadmap. At ancoordinating agency efforts.

October 2007 hearing of the House
Subcommittee on Research and
Education,⁴⁶ some Members of Congress expressed concerns about the time required
by the National Nanotechnology Coordination Office to produce a prioritized,
detailed implementation plan for NNI EHS research. While acknowledging the
challenges faced by the NNCO in developing consensus among the 25 NNI agencies,
some Members suggested that these challenges were emblematic of the need for a
more top-down approach to EHS research.
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.nanotechproj ect.org/ process/ files/5891/nehi_co mme nts_070912_final.pdf]
⁴⁶ Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current
Status of Planning and Implementation under the National Nanotechnology Initiative.” 110^th^st
Cong., 1 Sess., October 31, 2007.

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 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 safety⁴⁹

issues for nanotechnology.
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.

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^a
maximize resources and minimize inconsistent regulation of nanomaterials.
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^b
to help inform global dialogue on its potential risks.” 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;^c
and, (6) regularly review new information and adapt actions accordingly.
^a.^Envⁱ^r^onm^eⁿ^{tal D}^e^fe^ns^e^{and Ameri}^c^aⁿ^C^h^e^m^is^tr^y^C^ounc^{il N}^anote^c^hnology^Pane^l:^J^o^{int State}^m^eⁿ^{t of}
^P^rⁱⁿ^ci^p^l^es^{, C}^o^m^m^e^nts^{on EP}^A^’^s^N^o^tic^e^of^a^P^ublic^Me^e^ting^{on N}^a^nos^c^a^l^e^Ma^te^rⁱ^a^l^s^,^J^une^{23, 2005.}
^{b. “}^D^uP^{ont a}^{nd Env}ⁱ^r^onm^eⁿ^ta^{l D}^e^f^e^ns^e^L^a^unc^{h C}^o^m^p^r^e^he^ns^iv^e^T^{ool f}^o^r^Ev^a^l^ua^tin^g^aⁿ^d^A^d^d^r^e^s^sⁱⁿ^g^Po^t^eⁿ^t^ia^l
^Rⁱ^s^k^s^of^N^a^nos^c^a^l^e^Ma^te^rⁱ^a^l^s^,^”^pr^e^s^s^r^e^le^a^s^e^,^{E. I}^.^{du P}^{ont de}^N^e^m^our^s^aⁿ^d^C^o^m^p^aⁿ^y^,^J^une^{21, 2007.}
^[^h^ttp://v^oc^u^s^p^r^.^v^o^c^us.c^om^/V^oc^usP^R^30/Ne^w^s^room^/Que^ry^.a^spx^?^Site^Na^m^e⁼
^D^upontN^e^w^&^Entity⁼^P^R^A^s^s^e^t^&^S^F^_^PR^A^s^s^e^t^_^PR^A^s^s^e^t^I^D^_^E^Q⁼¹^06677&^X^S^L⁼^P^r^e^s^s^R^e^l^e^a^s^e^&^Ca^c^h^e⁼^F^a^l^s^e^]
^c.^N^anor^is^k^Fr^am^e^w^or^k^{, Env}ⁱ^r^onm^eⁿ^ta^{l D}^e^f^e^ns^e^-^D^u^P^{ont N}^a^{no P}^a^r^t^ne^r^s^{hip, J}^une^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 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,⁵⁰
and the mechanisms to ensure that resources are used effectively.
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 tax⁵¹

dollars and not optimizing progress.
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_Nanotechnol o gy_ M a
yn ard_NNCO_Comme nts.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^th^st
the National Nanotechnology Initiative.” 110 Cong., 1 Sess., October 31, 2007.

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:^R^e^j^e^s^kⁱ^,^D^a^vⁱ^{d, di}^rect^{or, Proj}^ect^on^Em^er^gi^{ng N}^a^no^t^e^c^hno^l^o^gi^e^s^.^“N^aⁿ^o^t^e^c^h^Sa^fe^t^y¹⁰¹
^o^r^H^o^w^to^A^v^oⁱ^d^th^{e Nex}^t^L^{ittle A}^ccid^eⁿ^t^{,” p}^a^p^e^r^,^W^o^r^k^sh^o^p^oⁿ^Disaster^P^r^ev^en^tioⁿ^,^Har^v^ar^d
^Uⁿⁱ^v^ersⁱ^t^y^{, A}^p^ri^l^{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 each⁵²
other.
Federal Regulation
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.
Broadly, market forces have increased the pace of global innovation, challenging
institutions’ ability to identify and cope
with the societal implications of rapid
change. Speed-to-market has become
a driving factor in competition forUnique Properties Emerge
many industries as a result of the entryat the Nanoscale
of new and nimble competitors in the
global marketplace, increased publicScientists have discovered that elements
and private investments in R&D,and materials with the same chemistry canexhibit fundamentally different properties
global models of innovation, increasedat the nanoscale. For example, platinum,
flows of scientific and technicalwhich exhibits no magnetism in its bulk
knowledge, and greater numbers ofform, shows significant magnetic
scientists and engineers around theproperties in nanoscale clusters of 13
world. In addition, growing globalatoms. The optical properties of gold also
markets enable companies to recoupcan change with particle size. At 10
their investments faster and enablenanometers, gold particles absorb green
earlier investments in subsequentlight and appear red, not gold.
generations of technology, further
accelerating the pace of innovation.Not only can nanoscale particles differ
The increased pace, scope, andin properties from bulk material with thesame chemical composition, they may also
complexity of technological innovationdiffer from other nanoscale materials with
may pose challenges to the existingthe same chemical composition. For
regulatory system. While these factorsexample, the melting point of an element
may affect a broad range of— which was believed to be constant
technologies, nanotechnology may beregardless of the element’s particle size —
especially affected due to the rapidcan change with particle size.
growth in public and private R&DNanotechnology research has demonstrated
investments in the field since the yearthat the melting temperature of gold
2000 and the potential fordecreases when the particle’s radius drops
nanomaterials to be used in a widebelow 10 nanometers (from a meltingtemperature of approximately 1,000^oC at
array of products.10 nanometers to approximately 500^oC at

2 nanometers).

Nanotechnology also may pose
unique challenges to the regulatory^Source:^R^oduⁿ^e^r^,^E^mⁱ^l^.^“^N^an^os^copi^c
system. For example, historically,^Materials^:^Size-^Depen^d^en^t^P^h^en^om^en^a,”
regulatory agencies have defined a^Uⁿⁱ^v^e^r^si^t^y^o^f^St^ut^t^g^a^r^t^,^G^e^r^m^aⁿ^y^,^A^ugust^2006.

⁵² E-mail communication, November 21, 2007.

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; establish metrics and standards that can be used⁵³
to characterize nanomaterials; conduct ongoing research; and more.
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.

⁵³ “Nanotechnology Leaders to Converge in Washington, D.C., This Week for NanoBusiness
Alliance Public Policy Tour,” article, nanotechwire.com, February 16, 2006.
[http://nanotechwi re.com/news.asp?nid=2929]

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 that⁵⁴
the product will not present an unacceptable risk.
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 approach⁵⁵
nanoparticles.
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 environment campaigner for Friends of the⁵⁶
Earth. 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 and⁵⁷

workers assured of their safety.
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 ]
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.j s p?press_release_K EY=248]
⁵⁷ Ibid.

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.
International Engagement
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 duplication⁵⁹
and to leverage investments, characterizing such work as “non-competitive.”
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.
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

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.

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.
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 governments⁶⁰
and countries might catch up.
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.
Concluding Observations
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, S. 3274 and H.R. 5940, that would
reauthorize and amend the 21^st Century Nanotechnology Research and Development
Act, the appropriations bills that fund the NNI agencies’ nanotechnology EHS
research, and two other bills (H.R. 3235, H.R. 4040) with nanotechnology EHS
provisions. 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.

Nanotechnology EHS-Related Legislation in the
110^th Congress
Four bills introduced in the 110^th Congress contain provisions that seek to address
nanotechnology EHS concerns. The following section summarizes selected EHS-
related provisions of these bills.
H.R. 5940 — National Nanotechnology Initiative Amendments
Act of 2008
H.R. 5940, the National Nanotechnology Initiative Amendments Act of 2008, was
introduced on May 1, 2008. This act would revise the 21^st 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.
On June 5, 2008, the House of Representatives passed the bill by a vote of 407-6.
The bill has been referred to the Senate Committee on Commerce, Science, and
Transportation.
S. 3274 — National Nanotechnology Initiative Amendments
Act of 2008
S. 3274, the National Nanotechnology Initiative Amendments Act of 2008, was
introduced on July 16, 2008, and referred to the Senate Committee on Commerce,^st
Science, and Transportation. The act would reauthorize and amend the 21 Century
Nanotechnology Research and Development Act. The legislation includes a variety
of provisions that address nanotechnology EHS issues. The legislation:
^!expands the scope of the NNI by identifying as specific missions: (1)
support for the development of standard reference materials,
instrumentation, measurement science, and computational tools to
measure, characterize, and predict the properties of nanoscale
materials, and (2) participation in national and international efforts
to develop regulatory guidelines, plans, and standards for the safe
use of nanotechnology;
^!requires, as part of the NNI’s triennial strategic plan, a review of
efforts to encourage joint interagency solicitations of grant
applications for instrumentation and metrology equipment to detect,
measure and characterize nanomaterials;
^!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;
^!directs the National Nanotechnology Coordination Office to develop
and maintain a public database of NNI EHS projects, including a
project description, 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 on
societal, ethical, legal, environmental, and workforce concerns;

^!directs that the National Research Council, as part of its triennial
review of the NNI, assess the adequacy of the NNI’s activities to
address ethical, legal, environmental, and human health 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; providing oversight of the coordination, planning, and
budget prioritization of the NNI’s EHS activities; and encouraging
agencies to engage in public-private partnerships to support EHS
research;
^!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;
^!directs the NNAP to periodically review the level of funding for the
NNI’s Environmental, Health, and Safety program component area;
determine whether it is sufficient to address the research needs
identified in the annual EHS research plan; and, recommend an
appropriate level of funding to the Coordinator for Societal
Dimensions of Nanotechnology if the current level is found to be
insufficient or excessive;
^!requires certain interdisciplinary research centers supported under
the NNI to include EHS research to conduct research on 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;
^!requires certain interdisciplinary research centers supported under
the NNI to include research on methods to develop characterization
and metrology capabilities relevant to the NNI’s Environmental,
Health, and Safety program component area, and to foster the
transfer of results to industry;
^!directs the Government Accountability Office (GAO) to conduct,
within two years, a study of federal codes, standards, and regulations
as they pertain to the safe production, use, and disposal of
engineered nanomaterials and products that incorporate them; to
evaluate comparable international efforts; identify gaps in the ability
of federal agencies to enforce cost-effective safety procedures using
current codes, standards, and regulations; and develop
recommendations for changes to such codes, standards, and
regulations to remedy identified gaps; and

^!authorizes $2 million for the NNCO to convene a national
discussion, including at least two large-scale deliberative forums, to
engage U.S. citizens, increase their awareness of nanotechnology,
and seek to identify collective priorities and concerns; a report to
Congress summarizing the national discussion is required one year
from the date of enactment of the legislation.
H.R. 3235 — Nanotechnology Advancement and New
Opportunities Act
H.R. 3235, the Nanotechnology Advancement and New Opportunities Act, was
introduced on July 31, 2007. 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 July 31, 2007, H.R. 3235 was referred to the House Science and Technology
Committee’s Subcommittee on Research and Science Education; the House Ways
and Means Committee; the House Energy and Commerce Committee’s
Subcommittee on Commerce, Trade, and Consumer Protection; and the House
Homeland Security Committee’s Subcommittee on Emerging Threats, Cybersecurity,
and Science and Technology.
H.R. 4040 — CPSC Reform Act
H.R. 4040, the CPSC Reform Act, was introduced November 1, 2007. Among its
provisions, the bill authorizes $1 million for the Consumer Product Safety
Commission for fiscal years 2009 and 2010 for research, in cooperation with the
National Institute of Standards and Technology, the Food and Drug Administration,
and other relevant federal agencies, on safety issues related to the use of
nanotechnology in consumer products.
H.R. 4040 was passed by the House of Representatives on December 19, 2007, by
a vote of 407-0, and subsequently passed by the Senate on March 6, 2008, by a vote
of 79-13. The bill is in conference. For additional information, see CRS Report
RL34399, Consumer Product Safety Improvement Act of 2008: H.R. 4040, by
Margaret Mikyung Lee.

Appendix A. Selected Nanotechnology EHS
Activities of Federal Regulatory Agencies
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.
Environmental Protection Agency. 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 risks⁶¹
that may result from the introduction of nanoscale materials into the environment.
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.

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 ]

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 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 the⁶⁶
nanotechnology revolution, [the NMSP is] simply ‘too little, too late.’
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 start⁶⁷
the voluntary program, much less institute an adequate regulatory system.
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

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.
[ h t t p : / / www.epa.go v/ oppt / n ano/ nmspf r .ht m]
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]

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.
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”

⁶⁸ Berger, Michael. “Implementing successful voluntary nanotechnology environmental
programs appears to be a 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), coordinated
by Susan R. Fletcher.
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.

chemicals that are nanoscale materials. EPA is also developing an umbrella approach⁷²
for evaluating both new and existing chemicals in NMs.
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 of⁷³
pesticides, regardless of the use.
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 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.
Food and Drug Administration. 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

⁷² “New Nanotechnology Products,” Environmental Protection Agency.
[ h t t p : / / www.epa.go v/ oppt / a r / 20052006/ ma nagi ng/ n ew_nano.ht m]
⁷³ “EPA Regulates Nano Product, Not Nano Industry,” Small Times, January 2007.
⁷⁴ For additional information, see CRS Report RL34334, The Food and Drug
Administration: Budget and Statutory History, FY1980-FY2007, by Judith A. Johnson,
Donna V. Porter, Susan Thaul, and Erin D. Williams.
⁷⁵ “FDA and Nanotechnology Products,” Food and Drug Administration.
[ h t t p : / / www.f d a.go v/ nanot echnol ogy/ f a qs.ht ml ]

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 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
National Institute of Environmental Health Sciences/National
Toxicology Program. 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

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.
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 ]

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.
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.
Occupational Safety and Health Administration/National Institute for
Occupational Safety and Health. 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.

⁷⁹ “Toxicology in the 21^st Century: The Role of the National Toxicology Program,” Update,
National Toxicology Program, January 2004. [http://ntp.niehs.nih.gov/ntp/htdocs/Liaison/

2004J anLO_News.pdf]

⁸⁰ Toxicology in the 21^st Century: The Role of the National Toxicology Program, Department
of Health and Human Services, February 2004. [http://ntp.niehs.nih.gov/ntp/
ma in_page s/NT PV ision.pdf]

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
Consumer Product Safety Commission. The Consumer Product Safety
Commission (CPSC) is charged with protecting the public from unreasonable risks⁸³
of serious injury or death from certain types of consumer products. CPSC 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

⁸¹ “Nanotechnology at NIOSH,” National Institute for Occupational Safety and Health.
[ h t t p : / / www.c d c . go v/ ni os h/ t opi c s / n a not e c h/ ]
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 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.

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

⁸⁴ “CPSC Nanomaterial Statement,” Consumer Product Safety Commission, August 2005.
[http://www.cpsc.gov/library/cpscnanostatement.pdf]

Appendix B. Selected International Engagement
Efforts of NNI Agencies
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

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
(continued...)

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 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.

⁸⁶ (...continued)
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]
⁸⁷ “ANSI Establishes Nanotechnology Standards Panel,” American National Standards
Institute, August 5, 2004. [http://www.ansi.org/news_publications/
news_story.aspx?me nuid=7&articleid=735]