Order Code RL34332
Engineered Nanoscale Materials and
Derivative Products: Regulatory Challenges
January 22, 2008
Linda-Jo Schierow
Specialist in Environmental Policy
Resources, Science, and Industry Division

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Engineered Nanoscale Materials and
Derivative Products: Regulatory Challenges
Summary
Scientists and engineers are rapidly learning how to examine, design, and
manipulate materials at the molecular level, termed “nanoscale,” between 1 and 100
billionths of a meter. The U.S. government has invested billions of dollars to ensure
that American industry remains a global leader in the field, because the products of
nanotechnology are seen to have great economic potential and offer possible
solutions to national problems ranging from energy efficiency to detection of agents
of biological warfare. Optimism about nanotechnology is tempered, however, by
concerns about the unknown potential of nanoscale materials to harm the
environment and human health. Some have called for federal regulation of potential
environmental, human health, and safety (EHS) risks, arguing that the lack of federal
EHS regulations increases the risks of unanticipated adverse consequences due to
human or environmental exposure to engineered nanomaterials. The cost of such
consequences would depend on their actual, as well as publically perceived, severity,
frequency, and reversibility. The cost to the nanotechnology industry could be great,
if consumers responded to a potential threat of harm by indiscriminately rejecting all
products of nanotechnology, rather than the offending nanomaterial or an individual
application. Others oppose federal regulatory requirements, arguing that they might
unnecessarily delay the environmental, health, and economic rewards expected from
nanotechnology.
Questions about the need for, and ideal form of, nanotechnology regulations are
exceedingly difficult to address, given the current state of scientific understanding of
engineered nanoscale materials. The purpose of this report is to consider certain
challenges faced by scientists, entrepreneurs, and government officials in the 25
agencies involved in the National Nanotechnology Program, as they strive to define
the characteristics of nanomaterials, the EHS risks they might pose, and how any
potential risks should be addressed. Challenges include the wide variety of
nanomaterials and applications; lack of basic information about their properties; lack
of conventions for naming, measuring and identifying nanomaterials; the proprietary
nature of some critical information; the need to prioritize federal resource needs; and
a possible lack of clear statutory authority or appropriate regulatory framework to
anticipate or respond to any identified risks.
These difficulties may be surmounted over time without significant legislative
action, or Congress may choose to intervene. If it does, it might choose any of
several approaches. Possible approaches include increasing funding for workshops
in standardization or other research relevant to identifying and possibly ameliorating
any environmental or human health and safety concerns associated with
nanomaterials; changing the allocation of research money among agencies or the
interagency research management structure; adopting a national or international
research strategy; or enacting legislation that authorizes, mandates, or constrains
agency actions to require information collection or to restrict production, sale, use,
or disposal of nanomaterials. Each risk management approach has potential positive
and negative consequences that Congress may want to consider.

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Contents
Introduction
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
The Nature of Nanotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Nanotechnology in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Federal Agencies in the National Nanotechnology Program . . . . . . . . . 3
Possible Risks of Nanotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Regulatory Challenges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Diversity of materials and applications . . . . . . . . . . . . . . . . . . . . . . . . . 6
Lack of data characterizing nanomaterials . . . . . . . . . . . . . . . . . . . . . . . 7
Lack of standardization in nomenclature, metrics, and materials . . . . . 8
Proprietary nature of information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Difficulty of communicating among academic disciplines . . . . . . . . . 10
Limited resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Possibly inadequate statutory authority . . . . . . . . . . . . . . . . . . . . . . . . 12
Voluntary Initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Legislative Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Increase and/or reallocate funding for health and safety research . . . . 17
Mandate/constrain reporting by manufacturers of nanotechnology . . . 21
Clarify, enlarge, or restrict agencies’ authority to regulate . . . . . . . . . 22
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
List of Tables
Table 1. FY2006 Actual Budget for the National Nanotechnology Initiative
(NNI) and Environmental, Health, and Safety (EHS) Research . . . . . . . . . . 4

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Engineered Nanoscale Materials and
Derivative Products: Regulatory Challenges
Introduction
U.S. scientists and engineers who are working at the molecular level, or
nanoscale, are developing novel materials and derivative products at a rapid pace.
The unique physical, chemical, and biological properties of engineered nanoscale
materials lend themselves to a huge array of applications that, some analysts believe,
will transform industries, foster sustainable economic growth, deliver more effective
treatments for chronic diseases, and vastly improve energy efficiency. Many nations,
including the United States, are eager to lead this nanotechnology revolution, and to
reap its benefits. The European Union has been particularly active, but there also is
intense activity in Japan, China, and other nations.
In the United States and some other nations, enthusiasm and investment in
nanotechnology are somewhat restrained, however, by questions about the possible
environmental, human health, and safety (EHS) risks associated with this new
technology. Does nanotechnology pose risks to human health or the environment
that are not being adequately controlled? If so, how will consumers here and abroad
react if possible hazards are identified? Should commerce in nanomaterials or
associated products be subjected to some level of government regulation? If so, do
federal agencies have sufficient statutory authority, expertise, and resources to
regulate potential EHS risks of engineered nanoscale materials and derivative
products? The answers to such questions may determine the nature, timing,
distribution, and extent of the social and economic costs and benefits associated with
nanotechnology.
Some groups are calling on Congress to regulate engineered nanoscale materials
and derivative products to control potential EHS risks, arguing that lack of federal
regulation might increase the risks of unanticipated adverse consequences. The cost
of such consequences would depend on their actual, as well as publically perceived,
severity, frequency, and reversibility. The cost to the nanotechnology industry also
could be great, if consumers responded by indiscriminately rejecting all products of
nanotechnology, rather than the offending nanomaterial or an individual application.
Others oppose federal regulatory requirements, arguing that they might unnecessarily
delay the environmental, health, and economic rewards expected from
nanotechnology.
Questions about the need for, and ideal form of, regulation for nanotechnology
are exceedingly difficult to address, given the current state of scientific understanding
of engineered nanoscale materials. The purpose of this report is to consider certain
challenges faced by federal EHS risk assessors, risk managers, and policy makers,
and to discuss possible legislative approaches to address those challenges.

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CRS-2
The Nature of Nanotechnology. “Nanotechnology” encompasses a broad
range of techniques for producing and manipulating tiny particles, thin films, and
other materials at such minute dimensions that quantum effects have a measurable
influence on the constituent atoms.1 At this scale, the basic chemical, physical, and
biological properties of materials can vary with slight increases and decreases in
dimensions between 1 and 100 billionths of a meter. For example, slightly smaller
or larger nanomaterials may be more or less magnetic or able to conduct electric
currents, or they may absorb and reflect different wavelengths of light. Thus, for
example, nanoparticles of gold can be red, yellow, or blue, depending on size and
shape. Even when the properties of nanoscale and bulk materials are similar, they
may be enhanced at the nanoscale because of the very high surface area of
nanoparticles relative to their total volume. Thus, for example, relatively small
doses of therapeutic drugs contained in nanoparticles may be more effective than
larger doses of the same drugs contained in larger particles.
Nanotechnology in the United States. The ability to manipulate
molecules to exploit particular properties promises a wealth of potential applications.
The United States is a leader in the field, with many patents for commercial
applications of nanotechnology granted and pending and hundreds of products
incorporating nanoengineered materials being marketed. Currently available
products that incorporate nanomaterials include certain cosmetics, sunscreen, tennis
balls, food additives, clothes washers, and odor-free clothing. According to experts,
anticipated products of nanotechnology range “from faster-burning rocket fuel
additives to new cancer treatments, filters to assist in cleaning the environment, and
remarkably accurate and simple-to-use detectors for biological toxins such as
anthrax.”2
To encourage and coordinate nanotechnology research and development in the
United States, the President established the interagency National Nanotechnology
Initiative (NNI). Launched in the President’s FY2001 budget request, the NNI was
codified and further defined when Congress enacted the 21st Century Nanotechnology
Research and Development Act (Public Law 108-153) in December 2003. In
accordance with the act, the President’s National Science and Technology Council,
through its Subcommittee on Nanoscale Science Engineering and Technology
(NSET), oversees planning, coordination, and management of the National
Nanotechnology Program (NNP).3 The law requires the NNP to set goals, priorities,
and means of measuring progress for nanotechnology research, and to authorize and
1 Quantum effects are the result of quantum physics, rules that predict the behavior of matter
and energy at the atomic level, where the more familiar laws of classical physics do not
apply.
2 Ratner, Mark, and Daniel Ratner. 2003. Nanotechnology: A Gentle Introduction to the
Next Big Idea. Prentice Hall: Upper Saddle River, NJ. p. 3.
3 The National Science and Technology Council (NSTC) is chaired by the President and
includes the Vice President, the Director of the Office of Science and Technology Policy,
Cabinet Secretaries and Agency Heads with significant science and technology
responsibilities, and other White House officials. According to its website, “It is the
principal means within the executive branch to coordinate science and technology policy
across the diverse entities that make up the Federal research and development enterprise.”

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CRS-3
coordinate funding by federal agencies that promotes nanotechnology research and
development (R&D). The NSET does not have budget authority or appropriations for
the NNP. Rather, each agency allocates part of its budget to nanotechnology and
reports its efforts to the NSET.
Federal Agencies in the National Nanotechnology Program.
According to the NNI, “Twenty-six federal agencies participate in the [National
Nanotechnology] Initiative, 13 of which have an R&D budget for nanotechnology.
Other Federal organizations contribute with studies, applications of the results from
those agencies performing R&D, and other collaborations.”4 The distribution of the
actual FY2006 total and EHS R&D budget among agencies and departments of the
NNI is shown in Table 1. The Environmental Protection Agency (EPA), the Food
and Drug Administration (FDA, within the Department of Health and Human
Services), the Consumer Product Safety Commission (CPSC), and the Occupational
Safety and Health Administration (OSHA, within the Department of Labor), are
actively exploring the EHS implications and possible risks of nanotechnology and
the possible need for regulations.5 Later sections of this report refer to these four
agencies as the regulatory agencies.
Possible Risks of Nanotechnology. While the potential economic gains
and beneficial uses for nanotechnology are exciting prospects, the potential risks
associated with nanoparticles are an issue for some scientists, policy makers, and
consumer and environmental groups. Congress directed the NNP to ensure that such
concerns would be considered as nanotechnology develops.
4 National Nanotechnology Initiative. About the NNI. [http://www.nano.gov/html/about/
home_about.html], visited January 10, 2008.
5 These agencies do not distinguish work conducted on nanotechnology from other work,
and do not report budget figures to the NNI. Moreover, OSHA and FDA do not conduct
toxicological research, although they do apply the results of such research in risk
assessments as a basis for regulatory decisions.
EPA Science Advisory Board, Board of Scientific Counselors. Meeting summary, October
19-20, 2006. p. 26.
National Science and Technology Council, Committee on Technology, Subcommittee on
Nanoscale Science, Engineering, and Technology. The National Nanotechnology Initiative:
Research and Development Leading to a Revolution in Technology and Industry.
Supplement to the President’s 2008 Budget, July 2007, pages 7 and 11. Hereafter cited as
the FY2008 Budget Supplement.

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Table 1. FY2006 Actual Budget for
the National Nanotechnology Initiative (NNI) and
Environmental, Health, and Safety (EHS) Research
(dollars in millions)
Agency/Department
NNI
EHSa
Department of Defense
$423.9
$1.0
National Science Foundation
359.7
21.0
Department of Energy
231.0
0.5
Department of Health and Human Services (National
195.4
9.0
Institutes of Health and National Institute for
Occupational Safety and Health)
Department of Commerce (National Institute of
77.9
2.4
Standards and Technology)
National Air and Space Administration
50.0
0.0
Department of Agriculture (Forest Service and
6.2
0.1
Cooperative State Research, Education, and Extension
Service)
Environmental Protection Agency
4.5
3.7
Department of Homeland Security
1.5
0.0
Department of Transportation
0.9
0.0
Department of Justice
0.3
0.0
TOTAL
$1,351.2
$37.7
Source: National Science and Technology Council, Committee on Technology, Subcommittee on
Nanoscale Science, Engineering, and Technology. The National Nanotechnology Initiative: Research
and Development Leading to a Revolution in Technology and Industry. Supplement to the President’s
2008 Budget, July 2007, pages 8 and 11.
a. EHS funding also is included in total NNI funding.
Scientific concern is based in part on some of the very properties that
researchers hope to exploit. For example, scientists hope to use certain nanoparticles
to deliver medicine to infected tissues where it can best fight disease with a minimum
of unintended side effects. The small size of nanoparticles may allow them to pass
easily through the skin and internal membranes. This raises questions, however, of
whether exposure to nanoparticles can be effectively confined to targeted tissues, or
whether environmental releases could be captured, removed from environmental
media, or rendered harmless. Similarly, while high surface-area-to-mass ratio may
allow nanoparticles to deliver potent doses of medicine in tiny packages, it also might
amplify any toxicity of particles inadvertently encountered.6
6 Science Policy Council, Nanotechnology Workgroup. 2007. U.S. Environmental
(continued...)

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It is too soon to know whether such questions are serious cause for concern, but
there is scientific evidence that some nanoparticles may be hazardous. For example,
certain nanoparticles are known to be toxic to microbes,7 and EPA has reported some
studies that have found nanoparticles generally (but not always) are more toxic than
larger particles of identical chemical composition.8 Other studies indicate that some
nanoparticles are toxic in a way that cannot be explained by differences in particle
size alone.9 Yet, such studies are rare, and nanoparticles are diverse, so that one
study with one kind of particle may not be informative with respect to the properties
of other kinds of particles. Moreover, scientists have demonstrated that toxic
nanoparticles may sometimes be made nontoxic by changing the surface chemistry
of the particles — for example, by oxidizing the exposed atoms.10
The unknown potential of individual nanomaterials to harm the environment or
human health might lead to consumer rejection of the entire range of consumer
products incorporating nanotechnology, especially if consumers perceive that there
is inadequate federal oversight. As explained by one witness who testified before the
House Committee on Science, “The perception that nanotechnology will cause
environmental devastation or human disease could itself turn the dream of a trillion-
dollar industry into a nightmare of public backlash.”11 To prevent a loss of
consumer confidence, academic researchers, policy analysts, and some entrepreneurs
in nanotechnology have been working with federal agencies that have responsibility
for protecting the environment, workers, and consumers. The remainder of this
report describes some of the challenges faced by these groups as they strive to define
the characteristics of nanomaterials, the risks they might pose, and how possible
risks might be addressed under existing statutory authorities.
Regulatory Challenges
The Environmental Protection Agency (EPA), Food and Drug Administration
(FDA), Consumer Product Safety Commission (CPSC), and Occupational Safety and
Health Administration (OSHA) are actively exploring the health and safety
6 (...continued)
Protection Agency Nanotechnology White Paper. EPA 100/B-07/001. U.S. EPA:
Washington DC, p. 14. Hereafter cited as EPA White Paper.
7 Silver, for example, is toxic to microbes, and some product manufacturers have made
antibacterial claims for their products containing nanosilver. In addition, research has
demonstrated the toxicity of C fullerenes to bacteria in water under laboratory conditions
60
(Fortner, J.D., D.Y. Lyon, C.M. Sayes, et al. “C60 in water: Nanocrystal formation and
microbial response,” Environmental Science & Technology, v. 39, (2005), p. 4307-4316.)
8 EPA White Paper, p. 54.
9 Ibid.
10 National Research Council. 2006. A Matter of Size. National Academies Press,
Washington, DC. p. 157. Hereafter cited as National Research Council 2006.
11 Colvin, Vicki L. Testimony before the Committee on Science, U.S. House of
Representatives. Hearing on “The Societal Implications of Nanotechnology.” 108th Cong.,
1st Sess., April 9, 2003. U.S. Govt. Print. Off., Washington, DC.

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implications of nanotechnology and the possible need for regulations. Other federal
agencies also are doing research on environmental, health, and safety applications or
implications of nanotechnology.12 They face many challenges, including those
discussed below.
Diversity of materials and applications. Nanomaterials vary widely in
size, structure, properties, and atomic or molecular identities (that is, chemical
composition). Some are relatively simple materials, composed primarily of a single
element in a particular crystal form, such as carbon nanotubes. But, even carbon
nanotubes may be of various lengths and thicknesses, and may be relatively pure,
containing few unneeded elements, or contaminated by unknown substances. The
properties being explored or exploited by researchers and developers of products may
result from any combination of these features, which may vary from batch to batch
supplied by carbon nanotube manufacturers or distributors.13 For example, carbon
nanotubes may be “doped” to deliberately include other substances to obtain a
particular electric charge or other property. Alternatively, a core nanomaterial may
be coated or covered by a nanoscale film, embedded in plastic, or otherwise
modified. Some carbon nanotubes are specifically treated to prevent agglomeration
into larger particles.
Many other elements and compounds may be used to produce materials through
nanoengineering, and some are considerably more complex than carbon nanotubes.
Currently, most commercial products fall into four categories: nanotubes (which may
be carbon, silicon, or another substance); metal oxides; quantum dots; and naturally
occurring clays.14 The physical, electrical, magnetic, and other properties of these
different materials vary due to chemical composition, but also due to overall
dimensions and shapes of particles. Some products of nanoengineering do not even
consist of nanoscale materials, but rather incorporate spaces that are nanoscale.
The risk associated with these diverse materials may depend more on the
application than on the material, and the potential uses of nanomaterials are
countless. For example, because risk varies with degree of exposure, risk posed by
nanomaterial is likely to vary depending on whether it is embedded in plastic or some
other substance that might reduce exposure, is free-standing and easily dispersed
through air or water, or is coated with a more biologically active organic molecule
in order to enhance exposure. Moreover, risks would be expected to vary throughout
the life cycle of a product, from manufacture through use, recycling, treatment, or
12 EPA Science Advisory Board, Board of Scientific Counselors. Meeting summary,
October 19-20, 2006. p. 26.
13 Busnaina, Ahmed. Director, National Science Foundation Nanoscale Science and
Engineering Center for High-rate Nanomanufacturing, Northeastern University. Comments
made at the EPA Peer Consultation on Materials Characterization of Nanoscale Materials,
September 6-7. 2007, at Arlington, Virginia.
14 Goldman, Lynn, and Christine Coussens, eds. 2005. Implications of Nanotechnology for
Environmental Health Research, Institute of Medicine, National Academies Press,
Washington, DC. pp. 6-7. These categories are not all inclusive, and there are other
categorization schemes, but this scheme accounts for the vast majority of commercial
applications in 2007.

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CRS-7
disposal. Thus, the potential risk from nanomaterial in cosmetics may be greater or
less than the risk of the same material washed into swimming pools or lakes. In
addition to the potential risks of routine manufacture, use, and disposal, risks
associated with accidental, even potentially catastrophic, releases should be
considered.
This diversity means that traditional regulatory toxicology and risk assessment,
which typically proceed chemical by chemical, would be prohibitively time-
consuming and expensive. Thus, Vicki Colvin, Executive Director of the
International Council on Nanotechnology (ICON) at Rice University, proposes a
different approach, which proceeds by correlating material properties with effects on
the environment and human health to determine the general factors that affect
toxicity. Colvin calls this risk forecasting.15
Lack of data characterizing nanomaterials. The structure and chemical
composition of a small sample of nanomaterials produced in a laboratory can be well
understood and defined, at least for relatively simple materials like buckyballs.
However, the consistency of structure and chemical composition within and between
batches of manufactured nanomaterials varies widely. It is possible to measure the
numerous properties of nanomaterials, but it is difficult and expensive, so properties
other than the ones of particular interest are not known. For example, researchers
generally do not investigate a nanomaterial to determine the temperature at which it
will melt or boil, or the degree to which it is soluble in water or any other solvent.
Even among researchers whose interest focuses on toxicity, there is no
agreement about which data might be useful, and therefore few data are collected.
Scientists have not yet determined which physical-chemical properties (for example,
size, shape, composition, stability, or electric charge) will be most important in
determining ecological and toxicological properties. For example, at a recent
meeting of researchers interested in studying toxicity, they agreed only that it is
probably most important to determine a material’s surface reactivity (a rather vague
notion of how readily surface molecules combine with other substances to which they
are exposed, that would be measured in various ways depending on the material).16
In addition, they generated a long list of properties of possible interest and a shorter
list of properties that definitely should be investigated before toxicity is assessed.17
15 Computational toxicology presumably is a form of risk forecasting. For more on
computational toxicology, see CRS Report RL34118, The Toxic Substances Control Act
(TSCA): Implementation and New Challenges, by Linda-Jo Schierow.
16 EPA Peer Consultation on Materials Characterization of Nanoscale Materials, September
6-7. 2007, at Arlington, Virginia.
17 EPA Peer Consultation on Materials Characterization of Nanoscale Materials, September
6-7. 2007, at Arlington, Virginia.
The shorter list was originally suggested by David Warheit of DuPont Haskell Laboratory
and, included particle size and size distribution (wet state) and surface area (dry state) in the
relevant media being utilized — depending upon the route of exposure; crystal
structure/crystallinity; aggregation status in the relevant media; composition/surface
(continued...)

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Until data are routinely collected on a basic set of physical and chemical properties,
there will be no basis for hypothesizing about relationships between size, structure,
chemical composition, and toxicity, or for predicting toxicity of similar, newly
created substances.
Lack of standardization in nomenclature, metrics, and materials.
A major obstacle to data collection is the absence of consensus on how the materials
should be named, how scientific tests should be conducted, or even what constitutes
a sample of a particular material. Naming conventions; standard, validated scientific
methods; and standard samples of materials must be developed and made available
to researchers, before the results of scientific tests will be accepted by others as valid
measures and comparable across researchers and materials. If such standards were
internationally accepted, it might permit international collaboration and data sharing,
and speed development of an adequate data set for generalizing about nanomaterials.
The U.S. approach to standards development is voluntary. The National
Institute of Standards and Technology (NIST), a non-regulatory federal agency within
the U.S. Department of Commerce, is facilitating the development of a measurement
system and nomenclature for use by nanotechnology scientists and engineers.18 The
NIST Center for Nanoscale Science and Technology (CNST) is
dedicated to partnering with interested parties from industry, academia, and
government to achieve common goals.... By offering collaborative opportunities,
the research program also offers access to nanoscale measurement and
fabrication capabilities not elsewhere available. The CNST also offers access to
the CNST Nanofab, operated by professionals dedicated to serving users and
offering access to state-of-the-art tools within an economical cost-sharing
model.19
EPA, the National Institute for Occupational Safety and Health, and other U.S.
agencies participating in the NNP also are working with the American National
Standards Institute (ANSI); ASTM International (an international organization that
uses a consensus approach to developing voluntary standards); the Nanotechnology
Characterization Laboratory (established by the National Cancer Institute (NCI),
NIST, and the U.S. Food and Drug Administration (FDA), to characterize
nanoparticles intended for cancer therapies and diagnostics); the International
Organization for Standardization (ISO); and other groups on these basic issues of
nomenclature, characterization, and measurement, which must be resolved prior to
17 (...continued)
coatings; surface reactivity; method of nanomaterial synthesis and/or preparation including
post-synthetic modifications (e.g., neutralization of ultrafine titanium dioxide particle-
types); and purity of sample.
18 Center for Nanoscale Science and Technology, National Institute of Standards and
Technology. About NIST’s Center for Nanoscale Science and Technology. [http://cnst.nist.
gov/about_cnst.html], visited January 9, 2008.
19 National Institute of Standards and Technology website. General Information.
[http://www.nist.gov/public_affairs/general2.htm], visited January 9, 2008.

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toxicity data development.20 The U.S. government is cooperating with its trading
partners in the Organization for Economic Cooperation and Development to ensure
development of standards that are consistent internationally.
Among the highest priorities for EHS risk assessment is development of
physical standards, that is, reference materials for each nanomaterial of interest.
Physical reference standards are needed to allow identification of materials being
examined. Without standard samples of materials for comparison, materials being
studied cannot be identified with precision, making research results impossible to
interpret.21
Vicki Colvin, executive director of ICON, has argued that experts repeatedly
identify the development of standards for conducting and reporting research as the
critical first step in EHS research for nanotechnology.22 They need protocols that
specify, for example, what constitutes a toxicologically relevant dose, or whether
chemical purity is a critical property, so that research reports will provide information
useful to EHS risk analysts. Such standards could be developed through workshops,
but there is no federal funding for such workshops, she contends.23 Others have
suggested that funding is necessary to permit travel to workshops by academics and
federal employees.24
Proprietary nature of information. Much of the on-going research and
development of nanomaterials is being conducted by private entities with an
economic interest in protecting information about their work. These entities
generally will not voluntarily reveal details about production processes or even the
chemical composition or physical structure of their nanomaterials, due to concerns
about competition, potential effect of regulatory decisions, and potential liability.
Furthermore, due to the very technical and often resource-intensive nature of
nanotechnology development, scientists working for private entities generally are
familiar with a limited set of nanomaterials: while one laboratory studies carbon
nanotubes, another might focus exclusively on metal oxides, or even on a single
metal oxide. This means that scientists generally do not have access to data that are
needed to detect patterns in the relationships between toxicity and other
20 EPA Peer Consultation on Materials Characterization of Nanoscale Materials. September
6-7, 2007, Arlington, Virginia.
EPA White paper, p. 32.
21 Small, John. Group Leader, Center for Nanoscale Science and Technology, NIST. EPA
Peer Consultation on Materials Characterization of Nanoscale Materials. September 6-7,
2007, Arlington, Virginia.
22 U.S. Congress. House. Committee on Science and Technology. Subcommittee on
Research and Science Education. Testimony on “Research on Environmental and Safety
Impacts of Nanotechnology: Current Status of Planning and Implementation under the
National Nanotechnology Initiative.” Hearing, 110th Cong., 1st Sess. October 31, 2007.
23 Ibid.
24 EPA Peer Consultation on Materials Characterization of Nanoscale Materials. September
6-7, 2007, Arlington, Virginia.

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characteristics of various nanomaterials. Without such data, there is no basis for
building theoretical models for hypothesis testing. In short, the proprietary nature of
nanotechnology arguably impedes the scientific study of nanoscale matter, and
nanotoxicology in particular, by discouraging data sharing.
Difficulty of communicating among academic disciplines. Only a few
laboratories have been able to generate data for diverse categories of nanomaterials,
and none has access to information about the full spectrum of materials in
development. There is some hope, however, that scientific understanding of
nanomaterials might be advanced by augmenting data on synthesized materials with
available data on naturally occurring or incidentally produced nanomaterials, such as
those found in dust or diesel exhaust. A few years ago, more than 500 peer-reviewed
publications were available on naturally occurring nanoparticles. In addition, there
were more than 10,000 peer-reviewed articles on incidental nanoparticles that result
largely as byproducts of human activities such as mining, cooking, and metal
working.25 On the other hand, synthesized nanomaterials vary in many ways from
those that are naturally occurring.26
Accessing data is one problem, but understanding the meaning of data across
academic disciplines is another. At an EPA workshop on characterizing
nanoparticles, toxicologists and physicists struggled to express their concerns to one
another, and admitted frankly their ignorance of the others’ areas.27 Agreement on
common terminology is likely to help, but the lack of commonality is deeper than
terminology. Perhaps in time, scientists collaborating routinely at interdisciplinary
research centers (and occasionally at workshops) may help to bridge the gap.
Limited resources. There are limited federal resources available to evaluate
EHS implications and regulate nanomaterials, because the overall budgets of the
executive agencies that are responsible for monitoring and regulating potential risks
to human health and the environment have been steady or declining in recent years,
while the agencies’ areas of responsibility have grown.28 For example, according to
an analysis by the Congressional Research Service of data provided by the
President’s Office of Management and Budget, EPA’s overall budget authority has
remained relatively flat for the past 20 years, and has declined slightly since 2003.
During the same period, Congress enacted legislation that expanded the agency’s
duties, and the Superfund tax authority expired. As the Superfund was depleted,
EPA’s budget absorbed the costs of cleaning up hazardous waste sites on the
National Priority List.
25 Goldman and Coussens, 2005, p. 7, citing Eva Oberdorster, unpublished.
26 Naturally occurring particles will vary in shape, size, and properties, while synthesized
nanomaterials are designed to be more uniform. Thus, synthesized materials often may be
redesigned and re-engineered to eliminate or ameliorate problems (such as toxicity) that
emerge.
27 EPA Peer Consultation on Materials Characterization of Nanoscale Materials. September
6-7, 2007, Arlington, Virginia.
28 However, the Administration has stated that the budget is adequate to the task.

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Recent hearing testimony reveals an equally constrained budget situation at the
Consumer Product Safety Commission (CPSC).29 “While the CPSC has thus far
been successful at facing these new and evolving challenges with diminishing
resources, the 2008 funding level will challenge the Commission’s ability to maintain
its existing level of standards development, enforcement, public information, and
international activities.”30
The Food and Drug Administration (FDA) also faces resource constraints.31 Its
funding issues have been summarized in the proceedings of a workshop addressing
FDA challenges generally that was convened by the Institute of Medicine.32
Workshop participants agreed that “the Administration should request and Congress
should approve substantially increased resources in both funds and personnel” for
FDA.33 Two organizations were formed in 2006 to advocate for more FDA funding
across the board (that is, not just for nanotechnology).34 A recent report by the
Subcommittee on Science and Technology of FDA’s Science Board concluded with
respect to all FDA programs (again, not just nanotechnology) “that science at the
FDA is in a precarious position: the Agency suffers from serious scientific
deficiencies and is not positioned to meet current or emerging regulatory
responsibilities.” According to the Subcommittee, those deficiencies stem from the
growth in demands on the agency without commensurate growth in resources.35 The
report states:
! The demands on the FDA have soared due to the extraordinary
advance of scientific discoveries, the complexity of the new
products and claims submitted to FDA for pre-market review and
approval, the emergence of challenging safety problems, and the
globalization of the industries that FDA regulates.
29 U.S. Consumer Product Safety Commission, 2008 Performance Budget Request,
submitted to Congress, February 2007, page vii. [http://www.cpsc.gov/CPSCPUB/PUBS/
REPORTS/2008plan.pdf], visited January 16, 2008.
30 Ibid.
31 Michael R. Taylor. 2006. Regulating the Products of Nanotechnology: Does FDA Have
the Tools It Needs? Project on Emerging Nanotechnologies, Woodrow Wilson International
Center for Scholars, Washington, DC. pp. 46-47.
32 Institute of Medicine. 2007. Challenges for the FDA: The Future of Drug Safety,
Workshop Summary. National Academies Press, Washington , DC, p. 2.
[http://books.nap.edu/catalog/11969.html], visited January 16, 2008.
33 Ibid. p. 13.
34 Each group has a website: the FDA Alliance site is at [http://www.StrengthenFDA.org],
while the Coalition for a Stronger FDA website is at [http://www.FDACoalition.org]. Both
sites were visited December 14, 2007.
35 FDA Science Board, Subcommittee on Science and Technology. November 2007. FDA
Science and Mission at Risk. Report. The report is marked “confidential” but is posted on
the website of the Science Board. [http://www.fda.gov/ohrms/dockets/ac/07/briefing/
2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf],
visited January 16, 2008.

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! The resources have not increased in proportion to the demands.
The result is that the scientific demands on the Agency far exceed
its capacity to respond. This imbalance is imposing a significant
risk to the integrity of the food, drug, cosmetic and device
regulatory system, and hence the safety of the public.36
On the other hand, within the constraints of the overall federal budget and
overall budgets of the 26 National Nanotechnology Initiative (NNI) agencies, the
President’s Office of Management and Budget and the Congress have been
encouraging agencies to allocate increasing portions of their budgetary authorities to
research related to nanotechnologies.37 A total of $1.3512 billion was appropriated
for these programs in FY2006, according to the President’s Office of Management
and Budget.38 However, less than three percent of that funding was allocated to
research on the potential “applications and implications of nanotechnology” for the
environment and human health and safety (EHS).39 40 The regulatory agencies are
responsible for a small fraction of this EHS research funding. EPA’s EHS budget for
nanotechnology in FY2006 was $3.7 million, and some of this funding was directed
toward development of environmentally beneficial applications of nanotechnology,
for example, to remove arsenic from surface water, rather than research relevant to
evaluating potential toxicity. EPA was the only regulatory agency identified as a
contributor to NNI funding in the President’s budget.41 However, it should be noted
that given the rudimentary understanding of nanomaterials, it is not surprising that
a relatively large portion of research funding goes to basic scientific studies. Such
research is funded by the National Science Foundation, which receives the bulk of
the EHS research budget, some $21 million in FY2006. In addition, substantial
research is conducted to develop standardized tools and measures of nanomaterials
and to understand their interactions with living things.
Possibly inadequate statutory authority. A final potential obstacle to
federal risk management for nanotechnology is a lack of clear statutory directives or
appropriate regulatory frameworks to guide federal risk managers. Although the
Bush Administration42 and several legal reviews of existing environmental, health,
36 Ibid., p. 2.
37 The NNI is coordinated through the White House National Science and Technology
Council’s Nanoscale Science, Engineering and Technology (NSET) subcommittee. NSET
does not have budget authority or appropriations. Rather, each agency allocates part of its
budget to nanotechnology and reports its efforts to the NNI.
38 FY2008 Budget Supplement.
39 Ibid.
40 For FY2007, estimated NNI and EHS funding levels are somewhat higher, and higher still
in the President’s FY2008 budget request.
41 The National Institute for Occupational Safety and Health informs regulatory activities
by the Occupational Safety and Health Administration (OSHA), but is not itself an agency
that issues EHS regulations.
42 Marburger, John H. III, and James L. Connaughton. Principles for Nanotechnology
Environmental, Health, and Safety Oversight, memorandum for the heads of Executive
(continued...)

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and safety statutes have concluded that they probably provide adequate authority for
federal regulators over nanotechnology, such laws were not written with
nanomaterials in mind.43 As a result, agencies would have to develop new policies,
produce guidance, and possibly issue regulations to translate statutory requirements
with respect to nanomaterials. These tasks almost certainly would be controversial,
because agencies would be making decisions that might, on the one hand, delay or
restrict commerce or, on the other hand, allow entrepreneurs to market products
whose effects on health or the environment are unknown or uncertain.
One concern about existing environmental, health, and safety statutes is that
most apply to a specific category of chemical products intended for a particular
application, for example, as a food additive, drug, cosmetic, pesticide, or consumer
product. This might lead to redundant or inconsistent regulation of a nanomaterial
under more than one federal law. For example, under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA),44 EPA must evaluate and regulate
commerce in, and use of, all products that are intended to control pests, including
bacteria. EPA already has stated its intent to regulate nanosilver under FIFRA when
it is released from certain washing machines and other products for which
manufacturers claim antibacterial properties. Other EPA program offices (the
Offices of Air and Radiation, and of Water, for example) also have responsibilities
for managing nanomaterials, including nanosilver, under certain conditions. To
address this challenge, EPA’s Science Policy Council, an internal policy group,
formed a Nanotechnology Workgroup in December 2004 and charged it with
describing “key science issues EPA should consider to ensure that society accrues the
important benefits to environmental protection that nanotechnology may offer, as
well as to better understand any potential risks from exposure to nanomaterials in the
environment.”45 The Toxic Substances Control Act (TSCA),46 which applies to all
categories of chemical uses not otherwise regulated, also allows coordination to
reduce any potential regulatory burden. TSCA Section 9(d) requires that the EPA
Administrator achieve “the maximum enforcement of [TSCA] while imposing the
least burdens of duplicative requirements on those subject to the Act.”
42 (...continued)
departments and agencies, November 8, 2007. [http://www.ostp.gov/html/Nano%20EHS%
20Principles%20Memo_OSTP-CEQ_FINAL.pdf], visited January 22, 2008.
43 Breggin, Linda K. 2005. Securing the Promise of Nanotechnology: Is U.S. Environmental
Law Up To the Job? Environmental Law Institute, Washington, DC. Hereafter cited as
Breggin 2005. [http://www.elistore.org/], visited October 11, 2007.
American Bar Association (ABA) Section of Environment, Energy, and Resources, Briefing
documents. [http://www.abanet.org/environ/nanotech/], visited October 11, 2007.
44 7 U.S.C. 136-136y
45 Science Policy Council, Nanotechnology Workgroup. 2007. U.S. Environmental
Protection Agency Nanotechnology White Paper. EPA 100/B-07/001. U.S. EPA:
Washington DC. 120 pp.
46 15 U.S.C. 2601 et seq.

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On the other hand, current laws sometimes exclude certain nanomaterials from
requirements. For instance, TSCA Section 8(b)(1) clearly excludes from its
requirements substances that are produced and used only in research laboratories.
This exclusion might apply to most of the various nanomaterials currently in
existence. Less clearly, TSCA excludes nanomaterials that are not “chemical
substances” as defined in the law.47 TSCA Section 2 defines a “chemical substance”
as “any organic or inorganic substance of a particular molecular identity” that is not
a mixture. Based on this definition, it is not clear whether any nanoparticle that
consists of a core inorganic material coated by an organic material would qualify as
a TSCA “chemical substance.” Other nanomaterials, like nanotubes or fullerenes,
have clear chemical identities in terms of chemical composition and crystal structure,
but have variable properties due to differences in size or shape of particular particles.
Size and shape are not normally considered in identifying molecular identity, or in
distinguishing one chemical substance from another. Therefore, EPA has indicated
that it does not consider size a relevant feature under TSCA.48 49 But, of course, size
is a central issue with nanomaterials.
In some cases, it is the regulations rather than the statute itself that complicate
agency decisions and actions with respect to nanomaterials. For example, laws often
direct agencies to exclude from regulatory requirements small quantities of
chemicals, particularly chemicals not yet in commerce. If the agencies define “small
quantities” in terms of weight, as EPA does for purposes of the periodic TSCA
inventory updates, nanomaterials may well be excluded, because few are produced
in large quantities by weight. Another example might be the exclusion of
nanomaterials from food additive regulations, if the Food and Drug Administration
were to decide that they fit into a category normally exempted, such as that for
substances “Generally Recognized As Safe” (GRAS). Under sections 201(s) and 409
of the Federal Food, Drug, and Cosmetic Act, this includes any substance that is
“generally recognized, among qualified experts, as having been adequately shown to
be safe under the conditions of its intended use.”50 For more information on the
possible limitations of existing laws, see reports issued by the Environmental Law
47 TSCA Sections 4 and 8 also authorize reporting requirements. For more information
about TSCA, see CRS Report RL34118, The Toxic Substances Control Act (TSCA):
Implementation and New Challenges.
48 EPA. TSCA Inventory Status of Nanoscale Substances — General Approach, p. 4.
Distributed at the EPA Peer Consultation on Materials Characterization of Nanoscale
Materials. September 6-7, 2007, Arlington, Virginia. Also available in the EPA docket
EPA-HQ-OPPT-2004-0122-0057 at [http://www.regulations.gov/], visited October 19, 2007.
49 However, according to J. Clarence Davies (2007, EPA and Nanotechnology: Oversight
for the 21st Century, Project on Emerging Nanotechnologies, Woodrow Wilson International
Center for Scholars, Washington, DC, p. 31), EPA did determine that carbon nanotubes have
properties different from other forms of carbon and did decide that it could be regulated
under TSCA.
50 U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition.
Guidance for Industry: Frequently Asked Questions About GRAS. December 2004.
[http://www.cfsan.fda.gov/~dms/grasguid.html#Q1], visited January 16, 2008.

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Institute, the American Bar Association, and the Woodrow Wilson International
Center for Scholars’ Project on Emerging Nanotechnologies.51
Voluntary Initiatives
As agencies consider the possible need for and shape of regulations, some
stakeholders are voluntarily engaging in what is called “responsible development”
of nanotechnologies. Professional organizations, industries, universities,
environmental organizations, and government have been involved in such efforts.
A few of the better known initiatives are described below.
The IEEE (formerly the Institute of Electrical and Electronics Engineers) is
developing standard methods needed to mass produce and market electronics and
photonics products while protecting workers and addressing environmental
concerns.52
Intel, DuPont, and other large companies voluntarily adhere to responsible
principles that have served in the past to minimize EHS problems associated with
production of materials that are not nanoscale. They complain, however, that the
adequacy of such practices with respect to nanotechnologies is unknown, and urge
the federal government to sponsor additional research to “shed more light on what
the best approach to protecting health and safety should be.” The National Institute
for Occupational Safety and Health (NIOSH) is working with industry to gather data
on exposure and worker health that should help guide the design of studies in
occupational settings.
In its 2007 White Paper, EPA expressed the view that
partnerships with industrial sectors will ensure that responsible development is
part of initial decision making. Working in partnership with producers, their
suppliers, and users of nanomaterials to develop best practices and standards in
the workplace, throughout the supply chain, as well as other environmental
programs, would help ensure the responsible development of the production, use,
and end of life management of nanomaterials.53
In that spirit, EPA has been working with stakeholder groups to develop a voluntary
Nanoscale Materials Stewardship Program. The program would pertain to engineered
nanoscale materials that are in commerce or about to enter commerce. A public
51 Breggin 2005.
J. Clarence Davies, 2007, EPA and Nanotechnology: Oversight for the 21st Century;
Breggin, Linda K., and John Pendergrass, Where Does the Nano Go? End-of-Life Regulation
of Nanotechnologies; and Michael R. Taylor, 2006, Regulating the Products of
Nanotechnology: Does FDA Have the Tools It Needs? Project on Emerging
Nanotechnologies, Woodrow Wilson International Center for Scholars, Washington, DC.
[http://www.nanotechproject.org/], visited January 16, 2008.
52 National Research Council 2006, p. 153.
53 EPA White paper, p. 63.

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meeting about risk management practices under this program was held October 19-
20, 2006. Possible elements of a stewardship program, according to EPA, include
! collection of existing data and information from manufacturers and
processors of existing chemical nanoscale materials;
! encouraging the development of test data needed to provide a firm
scientific foundation for future work and regulatory/policy decisions;
and
! identifying and encouraging use of a basic set of risk management
practices in developing and commercializing nanoscale materials.
The agency intends to use the information gained from the stewardship program to
guide development of its TSCA program for nanoscale materials. However, the
stewardship program is not yet launched, and there are few indications that launch
is imminent.54
Another voluntary initiative produced a guidebook for responsible corporate
behavior called the Nano Risk Framework. The six-point program was developed
by DuPont Corporation working in partnership with Environmental Defense, an
advocacy group, and was announced June 21, 2007, at a seminar sponsored by the
Woodrow Wilson International Center for Scholars, Project on Emerging
Nanotechnologies. The framework presents a process “for identifying, managing,
and reducing potential environmental, health, and safety risks of engineered
nanomaterials across all stages of a product’s ‘lifecycle.’”55
A final example of a voluntary initiative that aims to promote responsible
development of nanotechnology is spearheaded by the International Council on
Nanotechnology (ICON) at Rice University. As described on its website, “ICON is
a technically driven organization whose activities are broadly supported by industry,
non-profit foundations, and governments. Its multi-stakeholder partnerships and
governance, with members that span the globe, make it uniquely positioned to ensure
global coordination and cooperation in nanotechnology risk management.”56 Its
mission is “to develop and communicate information regarding potential
environmental and health risks of nanotechnology, thereby fostering risk reduction
while maximizing societal benefit.”57 ICON encourages close work between
developers of nanotechnology and toxicologists. As explained by Vicki Colvin,
executive director of ICON, “If we understand why a material is cytotoxic [that is,
toxic to cells], we should be able to make it less reactive and knock out its
54 Kinney, Jeff. 2007. EPA Expects Participation to Start in January For Nanotechnology
Stewardship Program. Daily Environment Report, November 14, 2007. p. A-1.
55 Nanorisk Framework. [http://nanoriskframework.com/page.cfm?tagID=1095], visited
January 16, 2008.
56 ICON website. Background. [http://icon.rice.edu/about.cfm?doc_id=4380], visited
January 16, 2008.
57 ICON website. Mission and Strategy. [http://icon.rice.edu/about.cfm?doc_id=4379],
visited January 16, 2008.

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toxicity....”58 Thus, she advises, “chemists making systematic changes in materials
must work with people who can measure their biological effects. Tight collaboration
between materials engineers, chemists, and toxicologists could provide the essential
data that can enable us to engineer safer nanomaterials from the beginning.”59
Legislative Options
The regulatory challenges posed by nanomaterials and nanotechnologies may
be resolved over time and to some extent without significant legislative action, as
stakeholders work together, scientists learn more about processes and properties on
the nanoscale, and federal regulators gradually adapt rules to implement existing
statutory authorities. Congress might, therefore, continue to take a wait-and-see
approach to nanotechnologies, perhaps combined with congressional oversight of
agencies’ activities. However, should Congress choose to intervene, a range of
legislative strategies is available, as described below.
Increase and/or reallocate funding for health and safety research.
The overall contribution from agencies’ budgets to the National Nanotechnology
Initiative (NNI) has grown substantially over the years.60 It is more difficult to
characterize trends in the allocation of funds devoted to research on the potential
EHS implications and applications of nanotechnologies, although it too appears to
have grown significantly.61 In some cases, however, this growth arguably has been
at the expense of agencies’ other programs. This is particularly likely for the
regulatory agencies, EPA, FDA, and the CPSC.62 For example, the National
Research Council observed that although there had been “pockets of increased
funding for EHS-related research,” including a proposed $4 million increase in the
FY2007 budget for nanotechnology research within EPA, “there was a 4 percent cut
in EPA’s overall FY2007 budget.”63
The National Research Council has recommended an increase in funding for
research relevant to evaluating the potential health and safety risks associated with
nanotechnologies, including work to develop requisite definitions, protocols, and
58 National Research Council. 2006. A Matter of Size. National Academies Press,
Washington, DC. p. 157.
59 Ibid.
60 FY2008 Budget Supplement.
61 Ibid.
National Research Council. 2006. A Matter of Size. National Academies Press,
Washington, DC. p. 151. Hereafter cited as National Research Council, 2006.
62 Although FDA does not conduct toxicological research, it does interpret research
conducted by manufacturers and apply the results of such research in risk assessments as a
basis for regulatory decisions.
63 National Research Council, 2006, p. 91.

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methodologies.64 Many companies, public interest groups, and the NanoBusiness
Alliance (a trade group) also have asked Congress for additional funding for EHS-
related research.65 According to the Chairman of the House Subcommittee on
Research and Science Education of the Committee on Science, “The basic position
of most outside observers from industry and non-governmental organizations is that
the funding level should be on the order of 10% of the initiative’s total funding,
rather than the current 4%.”66
Congress also might wish to consider whether to change the allocation of
research money among agencies. For example, it might wish to increase or decrease
basic research through the National Science Foundation relative to research that
might inform risk assessments at the National Institutes of Health. See Table 1,
above, for the distribution of the FY2006 actual budget among agencies and
departments of the NNI.
It is difficult to assess the need for additional federal funding or the adequacy
of its allocation among agencies without detailed information about research
priorities. Many policy analysts have argued that the foremost need with respect to
nanotechnology-related EHS research is a strategy or plan “to avoid duplication of
research and to set priorities.”67 The House Committee on Science has asked
repeatedly for the NNI to develop such a strategy. In September 2006, the NNI
delivered to the Committee a general framework for EHS research, which was
developed by the interagency Nanotechnology Environmental and Health
Implications (NEHI) Working Group.68 The report identified five research categories
and some specific needs within each, but it did not prioritize within or among
categories. The five research categories include

! instrumentation, metrology, and analytical methods;

! nanomaterials and human health;

! nanomaterials and the environment;

! health and environmental surveillance; and

! risk management methods.
64 Ibid., p. 6 - 8, 11-12, 38, 92.
65 Ibid., p. 91.
66 U.S. Congress. House. Committee on Science and Technology. Subcommittee on
Research and Science Education. Testimony on “Research on Environmental and Safety
Impacts of Nanotechnology: Current Status of Planning and Implementation under the
National Nanotechnology Initiative.” Hearing, 110th Cong., 1st Sess. October 31, 2007.
Opening statement of Chairman Brian Baird.
67 For example, Carol Henry of the American Chemistry Council: National Research
Council. 2006. A Matter of Size. National Academies Press, Washington, DC, p. 161.
68 National Nanotechnology Initiative. 2006. Environmental, Health, and Safety Research
Needs for Engineered Nanoscale Materials. Nanoscale Science, Engineering, and
Technology Subcommittee, Committee on Technology, National Science and Technology
Council, Washington DC. 62 p.

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Some experts who advocate for a stronger federal role in managing the risks of
nanotechnology argue that this NNI categorization provides insufficient direction for
managers, researchers, and research grant authorities. They would prefer a more “top-
down” approach to EHS research management, in order to ensure that the
information being collected is most useful for risk managers.69 Their priorities were
published in November 2006.70 Some of the same individuals co-authored a paper
published in November 2007 that was based on a workshop held in April 2006.71
That paper identified six critical information needs for evaluating and predicting the
toxicity of nanoparticles:
! extensive physico-chemical characterization;
! capacity for macromolecular perturbation (for example, for
interfering with repair of DNA or with proteins important to the
immune system);
! potential for unintended carriage of toxic molecules;
! translocation (for example, from the surface of skin into the blood
stream);
! agglomeration state; and
! chemical composition.
The Director of the National Nanotechnology Coordination Office and the Co-
Chair of the President’s Council of Advisors on Science and Technology (PCAST)
disagree that a top-down approach is needed, arguing that no single individual could
have the breadth of expertise necessary to adequately oversee all aspects of
nanotechnology EHS research.72 Rather, an interagency working group can “cast the
69 U.S. Congress. House. Committee on Science and Technology. Subcommittee on
Research and Science Education. Research on Environmental and Safety Impacts of
Nanotechnology: Current Status of Planning and Implementation under the National
Nanotechnology Initiative. Hearing, 110th Cong., 1st Sess. October 31, 2007. Testimony
of Andrew Maynard.
70 Maynard, Andrew D., Robert J. Aitken, Tilman Butz, Vicki Colvin, Ken Donaldson,
Günter Oberdörster, Martin A. Philbert, John Ryan, Anthony Seaton, Vicki Stone, Sally S.
Tinkle, Lang Tran, Nigel J. Walker, and David B. Warheit. 2006. Safe Handling of
Nanotechnology. Nature, v. 444, (16 November) pp. 267-269.
71 Balbus, John M., Andrew D. Maynard, Vicki L. Colvin, Vincent Castranova, George P.
Daston, Richard A. Denison, Kevin L. Dreher, Peter L. Goering, Alan M. Goldberg, Kristen
M. Kulinowski, Nancy A. Monteiro-Riviere, Günter Oberdörster, Gilbert S. Omenn, Kent
E. Pinkerton, Kenneth S. Ramos, Kathleen M. Rest, Jennifer B. Sass, Ellen K. Silbergeld,
and Brian A. Wong. 2007. Meeting Report: Hazard Assessment for Nanoparticles —
Report from an Interdisciplinary Workshop. Environmental Health Perspectives, v.115,
n.11, (November) p. 1654-1659.
72 U.S. Congress. House. Committee on Science and Technology. Subcommittee on
Research and Science Education. Research on Environmental and Safety Impacts of
Nanotechnology: Current Status of Planning and Implementation under the National
Nanotechnology Initiative. Hearing, 110th Cong., 1st Sess. October 31, 2007. Testimony
of Clayton Teague and Floyd Kvamme.

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wide net necessary to address the array of nanotechnology-related EHS issues,” and
this “interagency process will lead to a sound research strategy.”73
Proponents of the top-down approach have found these arguments
unconvincing, arguing instead that a top-down approach can involve many agencies
and other stakeholders. Environmental Defense, a group that advocates for
responsible development of nanotechnology, has suggested that NNI responsibilities
are potentially in conflict, because they include EHS oversight of research and
development on the one hand, and promotion of nanotechnology research and
development on the other. Thus, the group argues, some portion of the NNI should
be given “independent budgetary and management authority, responsibility,
accountability, and sufficient resources to develop and direct the overall Federal
nanomaterial risk research strategy.”74 Environmental Defense modeled this proposal
on the approach taken by the federal government with respect to nuclear power.75
In December 2007, the National Science and Technology Council (NSTC)
released an update of its strategic plan for the development of nanotechnology.76 It
noted that “A document that describes the NNI strategy for addressing the identified
priorities for nanotechnology-related EHS research is in preparation.”77
The Senate Committee on Appropriations expressed its desire for a research
strategy in S.Rept. 110-91, which accompanied S. 1696, a bill providing FY2008
appropriations for the Department of the Interior, environment, and related
agencies.78
The Committee is committed to ensuring that all Federal environmental, health
and safety research is prioritized and coordinated so that nanotechnology’s
potential benefits to the economy and environment are realized at the same time
73 Ibid. Testimony of Floyd Kvamme.
74 Environmental Defense. Potential model for restructuring National Nanotechnology
Initiative offered to better address nano risks. Press release. November 19, 2007.
[http://www.environmentaldefense.org/pressrelease.cfm?contentID=7346], visited January
16, 2008.
75 According to the Nuclear Regulatory Commission, “The NRC was created as an
independent agency by the Energy Reorganization Act, signed into law October 11, 1974,
which abolished the Atomic Energy Commission. The NRC, which took over the regulatory
functions of the AEC, formally came into being on January 19, 1975. The Energy Research
and Development Administration, also created by the Energy Reorganization Act, took over
the other functions of the AEC and is now part of the Department of Energy.”
76 Subcommittee on Nanoscale Science, Engineering, and Technology, Committee on
Technology, National Science and Technology Council. 2007. The National
Nanotechnology Initiative: Strategic Plan. 45p. [http://www.nano.gov/NNI_Strategic_Plan_
2007.pdf], visited January 11, 2008.
77 Ibid., p. 20.
78 U.S. Congress. Senate. Committee on Appropriations. Department of the Interior,
Environment, and Related Agencies Appropriations Bill, 2008. Report to Accompany S.
1696. S.Rept. No. 110-91, 110th Cong., 1st Sess. Washington, U.S. Govt. Print. Off., 2007.
p. 54.

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that human health and the environment are protected. To further these goals, the
Committee urges EPA to contract or enter into a cooperative agreement with the
National Academy of Sciences’ Board on Environmental Studies and Toxicology
within 90 days of enactment to develop and monitor implementation of a
comprehensive, prioritized research roadmap for all Federal agencies on
environmental, health and safety issues for nanotechnology.79
The Senate did not act on S. 1696, but in accord with the explanatory statement for
the Consolidated Appropriations Act, 2008, which became Public Law 110-161, the
report language for S. 1696 is being treated as approved.80 According to Celia
Merzbacher, who is co-chair of the NSTC Subcommittee on Nanoscale Science,
Engineering, and Technology, therefore, the National Academy review of the NNI
strategy will take place.81
Mandate/constrain reporting by manufacturers of nanotechnology.
Congress also might intervene to ensure an appropriate level of information
collection by regulatory agencies. If Congress wants to ensure that information about
the potential risks of nanotechnology and nanomaterials is collected and does not
want to rely on voluntary programs, or conversely, if Congress wants to prevent
agencies from imposing reporting requirements, legislation might be necessary.
Congress could direct or constrain agency action that would require manufacturers
of nanotechnology materials or products to determine physical and chemical
properties, to conduct toxicity tests, or to report information that already is
reasonably available and potentially relevant to EHS. Either requirements or
constraints could be phased into effect in order to ensure that requirements would be
commensurate with risk and investments by the regulated community. For example,
increasing demands for information could be tied to the introduction or marketing of
new applications, new products, or threshold quantities of products. Alternatively,
agencies might be instructed to refrain from requiring long-term and costly studies,
at least until a certain production threshold is attained.
For some chemical substances and applications, regulatory agencies already
have certain regulatory authorities. For example, under the Toxic Substances Control
Act (TSCA), Section 8(d), EPA requires that manufacturers submit lists of
unpublished health and safety studies known to have been conducted, and copies of
such studies, on request. If that authority is not sufficient, too broad, or not clear
with respect to nanomaterials, TSCA and other statutes could be amended.
Alternatively, reporting and testing requirements, limitations, or prohibitions could
be included in free-standing legislation. A third option might be to tie requirements
for reporting or testing to legislation authorizing research funding.
These options might have unintended consequences. For example, depending
on the specific provisions, new reporting or testing requirements might be considered
an impediment to innovation by small or medium-sized enterprises, or too
burdensome for manufacturers who embed nanomaterials in hard plastics or other
79 Ibid.
80 Congressional Record — House, December 17, 2007. p. H16122.
81 Personal communication, January 15, 2008.

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substances. A variety of methods are available to reduce unintended consequences.
For example, to reduce the burden imposed by a testing requirement, Congress might
allow manufacturers to share test data (and costs of testing), grant exclusive
production or marketing rights within the United States for a number of years to
manufacturers who conduct testing (to compensate them for their expenditures), or
exempt particular categories of products or manufacturers from requirements. Again,
existing law provides an example of how some requirements might be tailored. The
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) directs EPA to
promulgate testing and reporting requirements for pesticides, mechanisms for
simplifying requirements for relatively safe pesticides, and compensation rules, and
grants those who conduct tests a period of exclusive data use.
On the other hand, attempts to tailor requirements, limitations, or prohibitions
might be viewed as unfair by some regulated entities, if they are perceived to treat
manufacturers differently, conferring advantages on some but not others. Moreover,
any exemptions for small or medium-sized enterprises would reduce the amount of
information collected, information that might be important to risk assessors.
A potential benefit of requiring testing or reporting is that useful information
might become available to the regulatory agencies, allowing them to better evaluate
the significance of potential EHS risks or to assess the potential value of benefits.
This could lead to regulations that were more focused, reasonable, and economically
efficient, because agencies could target regulations toward technologies or products
posing greater relative risks (and perhaps smaller benefits).
Clarify, enlarge, or restrict agencies’ authority to regulate. Congress
also might legislate to ensure that nanotechnology would, or would not, be regulated
to manage any EHS risks that might be identified. Congress could either authorize
or restrict agencies’ authorities to regulate any stage in the lifecycle of nanomaterials:
production, sale, use, or disposal.
Imposing requirements on manufacturers might delay the environmental, health,
and economic rewards expected from nanotechnology. At the same time, EHS
regulations might reduce any risk of adverse consequences from exposure to
nanomaterials. The Bush Administration has issued guidelines for any regulations
that might be imposed under existing statutes.82
If, on the other hand, Congress chose to prohibit or restrict agencies’ authority
to regulate nanotechnology or products, the potential economic benefits of the new
technology might be more quickly realized, but the risks of unanticipated adverse
consequences might be greater. The cost of such consequences would depend on
their actual, as well as publically perceived, severity, frequency, and reversibility.
The cost to companies developing nanotechnology products also could be great, if
82 Marburger, John H. III, and James L. Connaughton. Principles for Nanotechnology
Environmental, Health, and Safety Oversight, memorandum for the heads of Executive
departments and agencies, November 8, 2007. [http://www.ostp.gov/html/Nano%
20EHS%20Principles%20Memo_OSTP-CEQ_FINAL.pdf], visited January 22, 2008.

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CRS-23
consumers responded by indiscriminately rejecting all products of nanotechnology,
rather than a single offending nanomaterial or application.
Conclusion
The need for additional research to identify the potential hazards that might be
associated with nanotechnology and to evaluate risks related to the environment and
human health and safety (EHS) is not in dispute. However, there is a range of views
about whether there is a need for increased federal intervention at this time. The
regulatory challenges posed by nanomaterials and nanotechnologies are many — the
diversity of nanomaterials, lack of data characterizing the materials, lack of
standardization in nomenclature and metrics, the proprietary nature of private
research results, limited resources in regulatory agencies, and possibly inadequate
statutory authority. These difficulties may be surmounted over time without
legislative action, or Congress may choose to intervene. If it does, it might choose
any of several approaches. Selected approaches include increasing funding for
workshops in standardization and other EHS research, changing the allocation of
research money among agencies, adopting and implementing a national and/or
international research strategy, or enacting legislation that authorizes, mandates, or
constrains agency actions to require information collection or to restrict production,
sale, use, or disposal of nanomaterials.
It is noteworthy that Congress is considering its options at this early stage of
technology development, when only a few nanomaterials are being manufactured on
a large scale. Risk management decisions nonetheless are pressing, as the rate of
nanotechnology development and commercialization is rapidly escalating.

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