Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges
Congressional research reportJul 18, 2008
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Prepared for Members and Committees of Congress
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Scientists and engineers can now 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 heavily 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 publicly 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. This report considers certain challenges faced by scientists, entrepreneurs, and
government officials involved with nanotechnology research, as they strive to define the
characteristics of nanomaterials, the potential EHS risks, and how they might 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. For more information about the national nanotechnology
research agenda, appropriations, and authorizing legislation, see CRS Report RL34401, The
National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues, by
(name redacted)
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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Introduction ..................................................................................................................................... 1
The Nature of Nanotechnology ................................................................................................. 1
Nanotechnology in the United States ........................................................................................ 2
Federal Agencies in the National Nanotechnology Program .................................................... 2
Possible Risks of Nanotechnology............................................................................................ 3
Regulatory Challenges .................................................................................................................... 5
Diversity of Materials and Applications.................................................................................... 5
Lack of Data Characterizing Nanomaterials ............................................................................. 6
Lack of Standardization in Nomenclature, Metrics, and Materials........................................... 7
Proprietary Nature of Information............................................................................................. 8
Difficulty of Communicating Among Academic Disciplines ................................................... 9
Limited Resources..................................................................................................................... 9
Possibly Inadequate Statutory Authority..................................................................................11
Voluntary Initiatives ...................................................................................................................... 13
Legislative Options........................................................................................................................ 15
Increase and/or Reallocate Funding for Health and Safety Research ..................................... 15
Mandate/Constrain Reporting by Manufacturers of Nanotechnology .................................... 19
Clarify, Enlarge, or Restrict Agencies’ Authority to Regulate ................................................ 20
Conclusion..................................................................................................................................... 20
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Table 1. FY2007 Actual Budget for the National Nanotechnology Initiative (NNI) and
Environmental, Health, and Safety (EHS) Research.................................................................... 4
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Author Contact Information .......................................................................................................... 21
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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 publicly 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. For more information about the national nanotechnology research
agenda, appropriations, and authorizing legislation, see CRS Report RL34401, The National
Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues, by (name re
dacted)
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“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
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.
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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.
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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 (P.L. 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 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.
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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
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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other collaborations.”4 The distribution of the actual FY2007 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.
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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. FY2007 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
National Science Foundation
Department of Energy
Department of Health and Human Services (National Institutes of Health and National
Institute for Occupational Safety and Health)
Department of Commerce (National Institute of Standards and Technology)
National Air and Space Administration
Environmental Protection Agency
Department of Agriculture (Forest Service and Cooperative State Research, Education, and
Extension Service)
Department of Homeland Security
Department of Justice
Department of Transportation
$450
389
236
222
0.0
26.9
0.0
13.3
88
20
8
7
0.9
0.0
7.1
0.1
2
2
1
$1,425
0.0
0.0
0.0
$48.3
Total
National Science and Technology Council, Committee on Technology, Subcommittee on Nanoscale
Science, Engineering, and Technology. National Nanotechnology Initiative: FY2009 Budget & Highlights, page 2.
Source:
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
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
6
Science Policy Council, Nanotechnology Workgroup. 2007. U.S. Environmental 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 C60 fullerenes to bacteria in water
under laboratory conditions (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.
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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.
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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 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.
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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
9
Ibid.
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.
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
(continued...)
10
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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 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
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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
(...continued)
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.
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 (name red
acted).
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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 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.
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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
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 coatings; surface reactivity; method of nanomaterial synthesis and/or preparation including postsynthetic 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.
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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 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 This concern is addressed in bills to reauthorize the NNI (H.R. 5940, as passed by
the House, and S. 3274, as introduced).
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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
19
National Institute of Standards and Technology website. General Information. http://www.nist.gov/public_affairs/
general2.htm, visited January 9, 2008.
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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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 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.
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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.
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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,
25
Goldman and Coussens, 2005, p. 7, citing Eva Oberdorster, unpublished.
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.
26
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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.
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.3132 Its funding issues
have been summarized in the proceedings of a workshop addressing FDA challenges generally
that was convened by the Institute of Medicine.33 Workshop participants agreed that “the
Administration should request and Congress should approve substantially increased resources in
both funds and personnel” for FDA.34 Two organizations were formed in 2006 to advocate for
more FDA funding across the board (that is, not just for nanotechnology).35 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.36 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.
•
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.37
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
For a CRS analysis of the budget situation at FDA, see CRS Report RL34334, The Food and Drug Administration:
Budget and Statutory History, FY1980-FY2007, coordinated by (name redacted).
33
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.
34
Ibid. p. 13.
35
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.
36
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.
37
Ibid., p. 2.
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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.38 A total of $1.3512 billion was
appropriated for these programs in FY2006, according to the President’s Office of Management
and Budget.39 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).4041 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.42 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.
¢ȱ ȱ¢ȱ¢ȱ
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 Administration43 and several legal reviews of existing environmental, health,
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.44 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.
38
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.
39
FY2008 Budget Supplement.
40
Ibid.
41
For FY2007, estimated NNI and EHS funding levels are somewhat higher, and higher still in the President’s FY2008
budget request.
42
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.
43
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/galleries/default-file/Nano%20EHS%20Principles%20Memo_OSTP-CEQ_FINAL.pdf, visited
January 22, 2008.
44
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.
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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),45 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.”46 The Toxic Substances Control Act (TSCA),47
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.”
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.48 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 might not be clear whether certain nanoparticles consisting of
a core inorganic material coated by an organic material would qualify as a TSCA “chemical
substance” or a mixture. 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.4950 But,
of course, size is a central issue with nanomaterials.
45
7 U.S.C. 136-136y
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.
47
15 U.S.C. 2601 et seq.
48
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, by (name redacted).
49
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.
50
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.
46
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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.”51 For more information on
the possible limitations of existing laws, see reports issued by the Environmental Law Institute,
the American Bar Association, and the Woodrow Wilson International Center for Scholars’
Project on Emerging Nanotechnologies.52
¢ȱ ȱ
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.53
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
51
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.
52
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.
53
National Research Council 2006, p. 153.
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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.54
In that spirit, EPA worked with stakeholder groups to develop a voluntary Nanoscale Materials
Stewardship Program (NMSP). The program, which pertains to engineered nanoscale materials
that are in commerce or about to enter commerce, was launched January 28, 2008.55
The NMSP allows two levels of participation, basic and in-depth. Under the basic program, EPA
will collect available data and information from manufacturers and processors of existing
chemical nanoscale materials. In addition, EPA will ask participants to identify their risk
management practices and to develop a risk management plan.56 Participants in the in-depth
program will develop new test data needed to provide a firm scientific foundation for future work
and regulatory/policy decisions. The agency intends to use the information gained from the
stewardship program to guide development of its TSCA program for nanoscale materials.
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.’”57
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 multistakeholder partnerships and governance, with members that span the globe, make it uniquely
positioned to ensure global coordination and cooperation in nanotechnology risk management.”58
Its mission is “to develop and communicate information regarding potential environmental and
health risks of nanotechnology, thereby fostering risk reduction while maximizing societal
benefit.”59 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 toxicity.... ”60 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.”61
54
EPA White paper, p. 63.
73 Federal Register 4861-4866.
56
EPA. Nanoscale Materials Stewardship Program. http://www.epa.gov/oppt/nano/stewardship.htm, visited February
14, 2008.
57
Nanorisk Framework. http://nanoriskframework.com/page.cfm?tagID=1095, visited January 16, 2008.
58
ICON website. Background. http://icon.rice.edu/about.cfm?doc_id=4380, visited January 16, 2008.
59
ICON website. Mission and Strategy. http://icon.rice.edu/about.cfm?doc_id=4379, visited January 16, 2008.
60
National Research Council. 2006. A Matter of Size. National Academies Press, Washington, DC. p. 157.
61
Ibid.
55
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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.
ȱȦȱȱȱȱ ȱȱ¢ȱȱ
The overall contribution from agencies’ budgets to the National Nanotechnology Initiative (NNI)
has grown substantially over the years.62 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.63 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.64 For example, the National
Research Council observed that although there had been “pockets of increased funding for EHSrelated 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.”65
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 methodologies.66 Many companies, public interest
groups, and the NanoBusiness Alliance (a trade group) also have asked Congress for additional
funding for EHS-related research.67 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%.”68 H.R.
5940, as passed by the House, and S. 3274, as introduced, would reauthorize the National
Nanotechnology Initiative and require an official in the Office of Science and Technology to
62
FY2008 Budget Supplement.
Ibid.National Research Council. 2006. A Matter of Size. National Academies Press, Washington, DC. p. 151.
Hereafter cited as National Research Council, 2006.
64
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.
65
National Research Council, 2006, p. 91.
66
Ibid., p. 6 - 8, 11-12, 38, 92.
63
67
Ibid., p. 91.
68
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.
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oversee planning and budget requests for EHS research, but would not require that participating
agencies allocate a set percentage of nanotechnology funding for EHS research.
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 FY2007 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 for several years 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.”69 The House
Committee on Science 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.70 The report identified five research categories and some specific needs within
each. 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.
Some experts who have advocated for a stronger federal role in managing the risks of
nanotechnology argued that this NNI categorization provided insufficient direction for managers,
researchers, and research grant authorities. They preferred a more “top-down” approach to EHS
research management, in order to ensure that the information being collected is most useful for
risk managers.71 Their priorities were published in November 2006.72 Some of the same
individuals co-authored a paper published in November 2007 that was based on a workshop held
in April 2006.73 That paper identified six critical information needs for evaluating and predicting
the toxicity of nanoparticles:
69
For example, Carol Henry of the American Chemistry Council: National Research Council. 2006. A Matter of Size.
National Academies Press, Washington, DC, p. 161.
70
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.
71
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.
72
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.
73
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
(continued...)
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•
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.74 Rather, an
interagency working group can “cast the wide net necessary to address the array of
nanotechnology-related EHS issues,” and this “interagency process will lead to a sound research
strategy.”75
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.”76
Environmental Defense modeled this proposal on the approach taken by the federal government
with respect to nuclear power.77
(...continued)
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.
74
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.
75
Ibid. Testimony of Floyd Kvamme.
76
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.
77
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.”
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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 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 P.L. 110-161, the report language for S.
1696 is being treated as approved.80 According to Celia Merzbacher, who formerly was 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 The NAS will review the final
version of the NNI strategy.
The National Science and Technology Council (NSTC) released the final NNI Strategy for
Nanotechnology-Related Environmental, Health, and Safety Research in mid-February 2008.82
The strategy builds on the five research categories described above, but also identifies and
prioritizes specific research needs within each category. Research under way in FY2006 was
matched to the five research categories, and timelines were developed to guide future activities.
Timelines reflect the agencies’ immediate needs as well as their views of research capacities and
prerequisites. Research in the area of instrumentation, metrology, and analytical methods is
considered cross-cutting and of highest priority. This research will be coordinated by the National
Institute for Standards and Technology. The National Institutes of Health will coordinate research
related to human health, and the EPA will coordinate research related to the environment. NIOSH
is assigned responsibility for coordinating research related to human and environmental exposure
assessment. Research related to risk management will be coordinated by the Food and Drug
Administration (FDA) and EPA. Finally, NSET noted that the research strategy is expected to be
reviewed and updated as research progresses and needs and priorities evolve.83
H.R. 5940, as passed by the House, and S. 3274, as introduced, would require the Director of the
President’s Office of Science and Technology Policy (OSTP) to designate an associate director of
OSTP as Coordinator for Societal Dimensions of Nanotechnology. The Coordinator would be
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.
79
Ibid.
80
Congressional Record—House, December 17, 2007. p. H16122.
81
Personal communication, January 15, 2008.
82
Subcommittee on Nanoscale Science, Engineering, and Technology, Committee on Technology, National Science
and Technology Council. 2008. National Nanotechnology Initiative Strategy for Nanotechnology-Related
Environmental, Health, and Safety Research. 90 p. http://www.nano.gov/NNI_EHS_Research_Strategy.pdf, visited
February 15, 2008.
83
Ibid.
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responsible for 1) ensuring that a research plan for environmental, health, and safety research
activities is developed, updated, and implemented; 2) “encouraging and monitoring” agencies
participating in the NNI “to allocate the level of resources and management attention necessary to
ensure that the ethical, legal, environmental, and other appropriate societal concerns related to
nanotechnology, including human health concerns, are addressed;” and 3) encouraging agencies
to identify, assess, and implement suitable mechanisms for establishing public-private
partnerships to support EHS research. The bill would require the plan to 1) specify near-term
research objectives and long-term research objectives; 2) specify milestones, and the time and
resources needed for achieving near-term objectives; 3) describe the roles of the agencies in
achieving the objectives; 4) specify the funding allocated to each objective and the sources of
funding by agency; and 5) estimate the funding required and the source of funding by agency for
each major objective for three future years.
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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 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,
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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 mediumsized 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).
¢ǰȱǰȱȱȱȂȱ¢ȱȱȱ
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.84
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 consumers responded by indiscriminately rejecting all products of
nanotechnology, rather than a single offending nanomaterial or application.
ȱ
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
84
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/galleries/default-file/Nano%20EHS%20Principles%20Memo_OSTP-CEQ_FINAL.pdf, visited
January 22, 2008.
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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. H.R. 4040, as passed by the House, and S. 3274, as introduced,
would require appointment of an official who would be required to oversee development and
implementation of an EHS research plan.
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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(name redacted)
Specialist in Environmental Policy
[redacted]@crs.loc.gov, 7-....
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