Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Congressional research reportJan 20, 2011
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Nanotechnology and Environmental, Health,
and Safety: Issues for Consideration
(name redacted)
Specialist in Science and Technology Policy
January 20, 2011
Congressional Research Service
7-....
www.crs.gov
RL34614
CRS Report for Congress
Prepared for Members and Committees of Congress
Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Summary
Nanotechnology—a term encompassing nanoscale science, engineering, and technology—is
focused on understanding, controlling, and exploiting the unique properties of matter that can
emerge at scales of one to 100 nanometers. A key issue before Congress regarding
nanotechnology is how best to protect human health, safety, and the environment as nanoscale
materials and products are researched, developed, manufactured, used, and discarded. While the
rapidly emerging field of nanotechnology is believed by many to offer significant economic and
societal benefits, some research results have raised concerns about the potential adverse
environmental, health, and safety (EHS) implications of nanoscale materials.
Some have described nanotechnology as a two-edged sword. On the one hand, some are
concerned that nanoscale particles may enter and accumulate in vital organs, such as the lungs
and brains, potentially causing harm or death to humans and animals, and that the diffusion of
nanoscale particles in the environment might harm ecosystems. On the other hand, some believe
that nanotechnology has the potential to deliver important EHS benefits such as reducing energy
consumption, pollution, and greenhouse gas emissions; remediating environmental damage;
curing, managing, or preventing diseases; and offering new safety-enhancing materials that are
stronger, self-repairing, and able to adapt to provide protection.
Stakeholders generally agree that concerns about potential detrimental effects of nanoscale
materials and devices—both real and perceived—must be addressed to protect and improve
human health, safety, and the environment; enable accurate and efficient risk assessment, risk
management, and cost-benefit trade-offs; foster innovation and public confidence; and ensure that
society can enjoy the widespread economic and societal benefits that nanotechnology may offer.
Congressionally-mandated reviews of the National Nanotechnology Initiative (NNI) by the
National Research Council and the President’s Council of Advisors on Science and Technology
have concluded that additional research is required to make a rigorous risk assessment of
nanoscale materials.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Contents
Introduction...................................................................................................................................... 1
Opportunities and Challenges .......................................................................................................... 3
Importance of Addressing EHS Issues............................................................................................. 7
Selected Issues for Consideration .................................................................................................. 10
Federal Investment in EHS Research ...................................................................................... 10
Current Funding Level ...................................................................................................... 10
Alternative Approaches ..................................................................................................... 14
Management of Federal EHS Research............................................................................. 16
Federal Regulation................................................................................................................... 24
International Engagement ........................................................................................................ 27
Concluding Observations............................................................................................................... 29
Nanotechnology EHS-Related Legislation in the 111th Congress.................................................. 30
Title I, Subtitle A, H.R. 5116 (111th Congress)—National Nanotechnology Initiative
Amendments Act of 2010 ..................................................................................................... 30
H.R. 554 (111th Congress)—National Nanotechnology Initiative Amendments Act of
2009 ...................................................................................................................................... 30
S. 1482 (111th Congress)—National Nanotechnology Amendments Act of 2009 ................... 31
S. 2942 (111th Congress)—Nanotechnology Safety Act of 2010 ............................................ 32
H.R. 820 (111th Congress)—Nanotechnology Advancement and New Opportunities
Act ........................................................................................................................................ 32
Tables
Table 1. NNI EHS Research Funding, FY2006-2010, FY2011 Request ....................................... 11
Table 2. FY2006 NNI Funding for EHS Research by Research Needs Categories...................... 12
Appendixes
Appendix. Overview of Selected Federal Agencies’ Roles in the Regulation of
Nanotechnology .......................................................................................................................... 33
Contacts
Author Contact Information........................................................................................................... 37
Congressional Research Service
Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Introduction
Nanotechnology—a term encompassing nanoscale science, engineering, and technology—is
focused on understanding, controlling, and exploiting the unique properties of matter that can
emerge at scales of one to 100 nanometers.1 These properties are believed by many to offer
substantial economic and societal benefits.
A key issue before Congress regarding nanotechnology is how best to protect human health,
safety, and the environment as nanoscale materials and products are researched, developed,
manufactured, used, and discarded. While the rapidly emerging field of nanotechnology is
believed by many to offer significant economic and societal benefits, some research results have
raised concerns about the potential environmental, health, and safety (EHS) implications of
nanoscale materials. Potential tools the Federal government might use to address these issues
include research and development, regulation, and international engagement.
Some of the properties of nanoscale materials (e.g., small size, high surface area-to-volume ratio)
that have given rise to great hopes for beneficial applications have also given rise to concerns
about their potential adverse implications for the environment, and human health and safety.2
With more than 1,000 nanotechnology products reportedly commercially available,3 there is great
interest in protecting the health and safety of the scientists working with nanoscale materials,
workers who manufacture the products, consumers who use the products, and members of the
general public who may be exposed to nanoparticles, as well as in understanding the
environmental impact of nanomanufacturing processes and the use and disposal of
nanotechnology products.
Nanoscale particles can result from a variety of different processes. While nanoscale particles can
occur naturally (e.g., some particles produced by forest fires, sea spray, volcanoes) and as an
incidental by-product of human activities (e.g., some particles contained in welding fumes, diesel
exhaust, industrial effluents, cooking smoke), EHS concerns have focused primarily on nanoscale
materials that are intentionally designed and produced, often referred to as engineered
nanomaterials.
Issues surrounding the potential EHS implications of nanotechnology emerged with the launch in
2000 of the National Nanotechnology Initiative (NNI). The NNI is a multi-agency federal effort
to coordinate and expand federal nanotechnology research and development (R&D) efforts.
Between FY2001 and FY2011, the federal government has invested approximately $14.2 billion
1
Congress defined nanotechnology in the 21st Century Nanotechnology Research and Development Act (P.L. 108-153)
as, “the science and technology that will enable one to understand, measure, manipulate, and manufacture at the atomic,
molecular, and supramolecular levels, aimed at creating materials, devices, and systems with fundamentally new
molecular organization, properties, and functions.” ASTM International, one of the largest voluntary standards
development organizations, has defined nanotechnology as, “a wide range of technologies that measure, manipulate, or
incorporate materials and/or features with at least one dimension between approximately 1 and 100 nanometers. Such
applications exploit those properties, distinct from bulk or molecular systems, of nanoscale components.” One
nanometer is about the width of 10 hydrogen atoms placed side-by-side, or approximately 1/100,0000 of the thickness
of a sheet of paper.
2
Nanotechnology EHS applications refers to the beneficial use of nanotechnology to improve health, safety, and the
environment; EHS implications refers to known and potential adverse effects of nanoscale materials on health, safety,
and the environment.
3
Project on Emerging Nanotechnologies. Figure as of June 2010.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
in nanotechnology R&D, including approximately $1.8 billion in FY2011 funded under the
current continuing resolution (P.L. 111-322). In addition, by one estimate, U.S. private investment
in nanotechnology—$2.7 billion in corporate R&D and $1.0 billion in venture capital
investments—exceeded U.S. government funding of $1.9 billion in 2008. Many governments
around the world have followed the U.S. lead and established their own national nanotechnology
programs. The private sector has invested heavily as well. Global nanotechnology R&D
investments—public and private—are estimated to have totaled more than $17 billion in 2008
alone.4
Such large investments and intensified efforts to capitalize on these public and private
investments have caused some observers (as detailed later in this report) to suggest that there is
insufficient information about the potential effects nanotechnology products and manufacturing
processes may have on human health, safety, and the environment. They assert a variety of
uncertainties, including: how nanoscale particles might be transported in air, water, and soil; how
they might react with the environment chemically, biologically, or through other processes; how
they might be distributed and deposited; and whether they might accumulate in plants or animals.
Others express the view that concerns about nanotechnology EHS implications are often
overgeneralized and overstated. Among the arguments they put forth are that nanoscale materials
are frequently embedded in other materials as part of the manufacturing process; that some
nanotechnology products, such as semiconductors, have nanoscale features but do not contain
nanoscale particles; that nanotechnology materials may replace other materials that have
significant and known risks; that some nanoscale particles tend to aggregate or agglomerate in the
environment into larger particles that no longer have nanoscale dimensions; and that people are
regularly exposed to nanoscale particles produced naturally and as incidental by-products of
human activities.
Congressionally-mandated reviews of the NNI by the National Research Council (NRC) and the
President’s Council of Advisors on Science and Technology (PCAST) have concluded that
additional research is required to make a rigorous risk assessment of nanoscale materials. In
addition, the NRC warned that, until such information is available, precautionary measures
should be taken to protect the health and safety of workers, the public, and the environment.
Nevertheless, most stakeholders agree that these concerns about the potential detrimental effects
of nanoscale materials and devices—both real and perceived—must be addressed. Among the
issues these stakeholders have identified are characterizing the toxicity of nanoscale materials;
developing methods for assessing and managing the risks of these materials; and understanding
how these materials move in, and interact with, the environment.
This report identifies the potential environmental, health, and safety opportunities and challenges
of nanotechnology; explains the importance of addressing nanotechnology EHS concerns;
identifies and discusses nanotechnology EHS issues; and summarizes several options for
congressional action, including the nanotechnology EHS-related provisions of selected
legislation. The Appendix provides an overview of selected federal agencies’ roles in the
regulation of nanotechnology.
4
Lux Research, as cited by Report to the President and Congress on the Third Assessment of the National
Nanotechnology Initiative, President’s Council of Advisors on Science and Technology, The White House, March 12,
2010, p. 25.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
For more information on nanotechnology and the NNI see, see CRS Report RL34401, The
National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues, CRS
Report RL34493, Nanotechnology and U.S. Competitiveness: Issues and Options, and CRS
Report RL34614, Nanotechnology and Environmental, Health, and Safety: Issues for
Consideration, all by John F. Sargent. For additional information on nanotechnology-related
regulatory challenges, see CRS Report RL34332, Engineered Nanoscale Materials and
Derivative Products: Regulatory Challenges, by (name redacted).
Opportunities and Challenges
Historically, many new technologies have delivered general societal benefits while presenting
EHS challenges. For example, automobiles increased personal mobility and provided faster, less
expensive transportation of goods, but soon became a leading cause of accidental deaths and
injuries, as well as a source of emissions that can damage air quality and may affect the global
climate. Similarly, genetically-modified (GM) plants have traits such as greater resistance to
pests, pesticides, or cold temperatures that contribute to higher crop yields, while critics argue
some GM foods contribute to food allergies and antibiotic resistance.5
Like other new technologies, nanotechnology offers potential economic and societal benefits, and
presents potential EHS challenges as well. Nanotechnology advocates assert, however, that
nanotechnology provides the opportunity to reduce or eliminate known risks by engineering
around them. Proponents maintain that nanotechnology also offers the potential for significant
EHS benefits, including:
•
reducing energy consumption, pollution, and greenhouse gas emissions;
•
cleaner, more efficient industrial processes;
•
remediating environmental damage;
•
curing, managing, or preventing deadly diseases; and
•
offering new materials that protect against impacts, self-repair to prevent
catastrophic failure, or change in ways that protect or aid soldiers on the
battlefield.
For example, nanoscale materials show promise for preventing, detecting, tracking, and removing
pollutants. According to the Environmental Protection Agency (EPA):
nanoscale cerium oxide has been developed to decrease diesel engine emissions; iron
nanoparticles can remove contaminants from soil and ground water; and nano-sized sensors
hold promise for improved detection and tracking of contaminants.6
In the area of human health, scientists assert nanotechnology has the potential for improving
disease diagnostics, sensing, monitoring, assessment, and treatment. In particular, the National
Cancer Institute (NCI) views nanotechnology as likely to provide revolutionary tools to extend
5
“Genetically Modified Crops and Foods,” Friends of the Earth, January 2003. http://www.foe.co.uk/resource/
briefings/gm_crops_food.pdf
6
“Fact Sheet for Nanotechnology under the Toxic Substances Control Act,” Environmental Protection Agency.
http://www.epa.gov/oppt/nano/nano-facts.htm
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
and improve lives. In July 2004, NCI launched a five-year, $145 million initiative focused on
applying nanotechnology to the prevention, detection, and treatment of cancer and amelioration
of its symptoms. At the initiative’s launch, then-NCI Director Andrew von Eschenbach identified
nanotechnology as a key component of the agency’s strategy for ending death and suffering from
cancer by 2015 (see text box, “Potential Nanotechnology Cancer Applications”).7 The NCI has
reissued the program for an additional five years and expects to complete an updated plan by the
end of 2010.
Some characteristics of nanoscale particles
could produce both positive and negative
consequences. According to E. Clayton
Teague, director of the National
Nanotechnology Coordination Office
(NNCO),
the
unique
properties
of
these
[nanotechnology] materials are a doubleedged sword: they can be tailored for
beneficial properties, but also have
unknown consequences, such as new
toxicological and environmental effects.8
The following examples illustrate how the
same nanotechnology material may be both
potentially beneficial and potentially harmful:
•
•
Nanoscale silver is highly effective as
an antibacterial agent in wound
dressings, clothing, and washing
machines, but some have expressed
concerns that widespread dispersion
of nanoscale silver in the environment
could kill microbes that are vital to
waste water treatment plants and to
ecosystems. Some beneficial bacteria,
for example, break down organic
matter, remove nitrogen from water,
aid in animal digestion, protect against
fungal infestations, and even aid some
animals in defense against predators.9
Potential Nanotechnology Cancer
Applications
The NCI Cancer Nanotechnology Plan asserts that
nanotechnology can serve as an enabling technology for a
variety of cancer-related applications:
•
imaging agents and diagnostics that allow clinicians
to detect cancer in its earliest, most easily treatable,
pre-symptomatic stage;
•
systems that provide real-time assessments of
therapeutic and surgical efficacy;
•
multifunctional, targeted devices capable of
bypassing biological barriers to deliver therapeutic
agents at high local concentrations directly to
cancer cells and tissues that play a critical role in the
growth and metastasis of cancer;
•
agents capable of monitoring predictive molecular
changes and preventing precancerous cells from
becoming malignant;
•
surveillance systems that detect mutations that may
trigger the cancer process and genetic markers that
indicate a predisposition for cancer;
•
novel methods for managing the symptoms of
cancer that adversely impact quality of life; and
•
research tools that enable investigators to quickly
identify new targets for clinical development and
predict drug resistance.
Source: Cancer Nanotechnology Plan: A Strategic Initiative
to Transform Clinical Oncology and Basic Research Through
the Directed Application of Nanotechnology, National
Cancer Institute, National Institutes of Health,
Department of Health and Human Services, July 2004.
Some nanoscale particles may have the potential to penetrate the blood-brain
barrier, a structure that protects the brain from harmful substances in the blood
but also hinders the delivery of therapeutic agents. The characteristics of certain
7
“Cancer Nanotech Plan Gets Nod of Approval,” Science, Vol. 305, July 23, 2004. http://www.sciencemag.org/
content/vol305/issue5683/s-scope.dtl#305/5683/461c
8
A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
148.
9
Nanosilver: A Threat to Soil, Water and Human Health? Friends of the Earth, March 2007. http://www.foe.org/pdf/
FoE_Australia_Nanosilver_report.pdf
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
nanoscale materials may allow pharmaceuticals to be developed to purposefully
and beneficially cross this barrier and deliver medicine directly to the brain to
treat, for example, a brain tumor.10 Some critics are concerned, however, that
nanoscale particles might unintentionally pass through the blood-brain barrier
causing harm to humans and animals.11
•
Certain nanoscale materials are highly chemically reactive due to their high
surface-to-volume ratio.12 This is a property that might be positively exploited in
catalysis, treatment of groundwater contamination, and site remediation. This
property also is being explored for use in protective masks and clothing as a
defense against chemical and biological agents. However, some research results
indicate that the reactivity of some nanoparticles potentially can result in cell
damage in animals.13
•
Carbon nanotubes (CNTs) have potential uses in a wide range of applications
(e.g., materials, batteries, memory devices, electronic displays, transparent
conductors, sensors, medical imaging). However, some scientists have expressed
concerns that some CNTs exhibit properties similar to asbestos fibers and might
become lodged in organs (e.g., lungs, kidneys, livers), harming humans and
animals.14
10
“Blood-Brain Barrier Breached by New Therapeutic Strategy,” press release, National Institutes of Health, June
2007. http://www3.niaid.nih.gov/news/newsreleases/2007/bloodbrainbarrier.htm
11
“Nanotechnology Risks: How Buckyballs Hurt Cells,” Science Daily, May 27, 2008. http://www.sciencedaily.com/
releases/2008/05/080527091910.htm
12
National Nanotechnology Initiative: Research and Development Supporting the Next Industrial Revolution,
Supplement to the President’s FY2004 Budget, Nanoscale Science, Engineering and Technology Subcommittee,
National Science and Technology Council, The White House, October 2003. http://www.nano.gov/
nni04_budget_supplement.pdf
13
Magrez, A., Kasas, S., Salicio, V., Pasquier, N., Seo, J.W., Celio, M., Catsicas, S., Schwaller, B., and Forro, L.
“Cellular Toxicity of Carbon-Based Nanomaterials,” Nano Letters, 6(6):1121-1125, American Chemical Society, May
2006. http://pubs.acs.org/cgi-bin/abstract.cgi/nalefd/2006/6/i06/abs/nl060162e.htmll
14
Nanotechnology: The Future is Coming Sooner Thank You Think, Joint Economic Committee, U.S. Congress, March
2007. p. 13. http://www.house.gov/jec/publications/110/nanotechnology_03-22-07.pdf
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
EHS Concerns About Carbon Nanotubes and Other Fullerenes
Much of the public dialogue about potential risks associated with nanotechnology has focused on carbon nanotubes
(CNTs) and other fullerenes (molecules formed entirely of carbon atoms in the form of a hollow sphere, ellipsoid, or
tube) since they are currently being manufactured and are among the most promising nanomaterials. These concerns
have been amplified by some research on the effects of CNTs on animals and on animal and human cells. For example,
researchers have reported that carbon nanotubes inserted into the trachea of mice can cause lung tissue damage;a
that buckyballs (spherical fullerenes) caused brain damage in fish;b and that buckyballs can accumulate within cells and
potentially cause DNA damage.c
There are scientists who have argued that experiments indicating CNT/fullerene toxicity are not conclusive. They
suggest that toxicity reported by researchers may have resulted from uncharacterized contaminants in the samples
resulting from the synthesis, purification, and post-processing methods used in the manufacture of CNTs. Thus, they
assert, the experiments could be measuring the toxicity of non-nanoscale materials and, therefore, unfairly indicting
nanoscale materials. They also contend that such non-nanoscale contaminants, if identified as toxic, potentially could
be eliminated or controlled in the manufacturing process. The issue of contaminants is often cited by advocates for
improved standards, reference materials, sensors, instrumentation, and other technologies for the characterization of
nanoscale materials.
Some experiments have produced results that indicate CNTs/fullerenes are non-toxic. Research on single-walled
carbon nanotubes (SWCNTs) by the Institute of Toxicology and Genetics in Karlsruhe, Germany, reported that, in
three of four different types of tests conducted, SWCNTs did not show toxicity. In the fourth test, which appeared
to indicate SWCNT toxicity, the researchers concluded that the results were a “false positive” and explained how the
SWCNTs interacted with the materials in the assay to produce a misleading result. These researchers concluded that
this result points to the need for careful selection of assays and the need for the establishment of standards for
toxicity testing of CNTs and other nanomaterials.d
Work at Rice University’s Center for Biological and Environmental Nanotechnology conducted in 2005 found cell
toxicity of CNTs to be low, and that it could be reduced further through simple chemical changes to the surface.e
Earlier research demonstrated that similar surface modifications of buckyballs reduced their toxicity. Nanotechnology
may offer the potential to engineer around known and potential hazards by changing the size, molecular construction,
or other property of a nanoscale material to make it safe or less hazardous. Experts advise that the potential to do so
will require a thorough understanding of the properties of the various nanoparticles and their effects on humans and
other organisms.
a Lam, C.W., James, J.T., McCluskey, R., and Hunter, R.L. “Pulmonary toxicity of single-wall carbon nanotubes in mice
7 and 90 days after intratracheal instillation,” September 2003. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=
Retrieve&db=PubMed&list_uids=14514958
b Oberdörster, Eva. “Manufactured Nanomaterials (Fullerenes, C60) Induce Oxidative Stress in the Brain of Juvenile
Largemouth Bass,” April 2004. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1247377
c Magrez, A., Kasas, S., Salicio, V., Pasquier, N., Seo, J.W., Celio, M., Catsicas, S., Schwaller, B., and Forro, L. “Cellular
Toxicity of Carbon-Based Nanomaterials,” Nano Letters, 6(6):1121-1125, American Chemical Society, May 2006.
http://pubs.acs.org/cgi-bin/abstract.cgi/nalefd/2006/6/i06/abs/nl060162e.html
d Wörle-Knirsch, J.M., Pulskamp, K., and Krug, H. F. “Oops They Did It Again! Carbon Nanotubes Hoax Scientists in
Viability Assays,” American Chemical Society, Nano Letters, Vol.6, April 2006.
e “Modifications render carbon nanotubes nontoxic,” press release, Rice University, October 2005.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Importance of Addressing EHS Issues
Nanotechnology covers a wide swath of scientific fields, engineering disciplines, and
technological applications. Sufficient knowledge has been developed about the useful properties
of certain nanomaterials, how they can be manufactured, and how they can be applied in useful
ways to enable commercial product development. In other areas of nanotechnology, fundamental
research on nanoscale phenomena and processes is under way that may lead to greater
understanding and beneficial applications in the years ahead. In general, however,
nanotechnology is still an emerging field and there is a dearth of information about how
nanoscale particles and devices might adversely affect human health, safety, and the environment.
Accordingly, there is widespread agreement on the need for more research to better understand
such implications.
In reviews of the NNI,15 both the 2006 National Research Council and the 2008 President’s
Council of Advisors on Science and Technology (PCAST) reports concluded that assessment of
potential nanotechnology EHS risks was not possible due to the absence of information and tools.
According to the NRC,
it is not yet possible to make a rigorous assessment of the level of risk posed by [engineered
nanomaterials]. Further risk assessment protocols have to be developed, and more research is
required to enable assessment of potential EHS risks from nanomaterials.16
Similarly, PCAST found that
it is premature to rigorously assess the levels of risk posed by engineered nanomaterials.
Adequate tools are being developed but are not yet in place.17
Subsequently, in its third assessment of the NNI, the NRC alluded to potential EHS risks, stating:
Research to date suggests that some products of nanotechnology have the potential to present
new or unusual risks to human health and the environment. For instance, nanoscale particles
may penetrate to places in the body that are inaccessible to larger particles; radical changes
in behavior at the nanoscale may render harmful materials considered to be safe in largerscale and more conventional forms.18
15
The 21st Century Nanotechnology Research and Development Act (P.L. 108-153) requires a triennial assessment of
the National Nanotechnology Program (in practice, of the NNI) by the NRC and a biennial assessment by PCAST,
serving in its capacity as the National Nanotechnology Advisory Panel (NNAP). The act requires each assessment to
include a review of the NNI’s EHS activities. Four such assessments have been conducted, one by the NRC (A Matter
of Size: Triennial Review of the National Nanotechnology Initiative, 2006) and three by PCAST (The National
Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National Nanotechnology Advisory
Panel, May 2005; The National Nanotechnology Initiative: Second Assessment and Recommendations of the National
Nanotechnology Advisory Panel, April 2008; and Report to the President and Congress on the Third Assessment of the
National Nanotechnology Initiative, March 2010). In addition, in 2009 the NRC produced a report at the request of the
National Nanotechnology Coordination Office entitled, Review of Federal Strategy for Nanotechnology-related
Environmental, Health, and Safety (EHS) Research.
16
A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
90.
17
The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, April 2008. p. 7.
18
Report to the President and Congress on the Third Assessment of the National Nanotechnology Initiative, President’s
(continued...)
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Leaders of the NNI have argued strongly that to achieve the economic, societal, and EHS benefits
of nanotechnology the nation must concurrently address its potential adverse effects. According
to then-Under Secretary of Commerce for Technology Phillip J. Bond, a leading Bush
Administration advocate for the NNI,
Addressing societal and ethical issues is the right thing to do and the necessary thing to do. It
is the right thing to do because as ethically responsible leaders we must ensure that
technology advances human well-being and does not detract from it. It is the necessary thing
to do because it is essential for speeding technology adoption, broadening the economic and
societal benefits, and accelerating and increasing our return on investment.19
The NRC’s third assessment of the NNI reinforces the perspective that EHS-related uncertainty
may stymie nanotechnology innovation and commercialization:
In the absence of more detailed scientific evidence—and effective assessment and
communication of the evidence that does exist—the distinction between plausible and
implausible risks remains unclear. The resulting uncertainty threatens to undermine
confidence and trust amongst investors, businesses, and consumers, and could jeopardize the
success of nanotechnology. This is not a hypothetical threat. Consumer and advocacy groups
already have raised concerns over the use of engineered nanomaterials in products as diverse
as clothing, fuel additives, and sunscreens. Businesses have been hampered by regulatory
uncertainty. A number of industries have shied away from nanotechnology for fear of
consumer rejection in the face of speculative concerns.20
According to the NRC, the nanotechnology industry and a variety of environmental and publichealth interest groups agree that an adequate evaluation of the potential health and environmental
effects of engineered nanomaterials is necessary
to ensure that the future of nanotechnology is not burdened by uncertainties and innuendo
about potential adverse health and environmental effects of engineered nanoscale materials.21
A 2006 survey of business leaders in the field of nanotechnology indicated that nearly two-thirds
believed that “the risks to the public, the workforce, and the environment due to exposure to nano
particles are ‘not known,’” and 97% believed that it is very important or somewhat important for
the government to address potential health effects and environmental risks that may be associated
with nanotechnology.22
(...continued)
Council of Advisors on Science and Technology, The White House, March 12, 2010, p. 38.
http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-nano-report.pdf
19
Bond, Phillip J., Under Secretary for Technology, U.S. Department of Commerce. “Preparing the Path for
Nanotechnology: Addressing Legitimate Societal and Ethical Issues,” keynote address, Nanoscale Science,
Engineering, and Technology Subcommittee Workshop on Societal Implications of Nanoscience and Nanotechnology,
December 3, 2003.
20
Report to the President and Congress on the Third Assessment of the National Nanotechnology Initiative, President’s
Council of Advisors on Science and Technology, The White House, March 12, 2010, p. 38.
21
Review of Federal Strategy for Nanotechnology-related Environmental, Health, and Safety (EHS) Research, National
Research Council, Washington, DC, December 2008.
22
“Survey of U.S. Nanotechnology Executives,” Small Times Magazine and the Center for Economic and Civic
Opinion at the University of Massachusetts-Lowell, Fall 2006.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
The Project on Emerging Nanotechnologies (PEN) has warned that bad practices in
nanotechnology research or production may result in a nanotechnology accident that would
chill investment, galvanize public opposition, and generally lead to a lot of hand wringing on
the part of governments who are betting large sums of money on the nanotech revolution.23
Successfully addressing EHS issues is seen as vital for those potentially exposed to nanoscale
materials (e.g., consumers, researchers, manufacturing workers, the general public), businesses,
and investors for a variety of reasons:
•
protecting and improving human health, safety, and the environment;
•
enabling accurate and efficient risk assessments, risk management, and costbenefit trade-offs;
•
ensuring public confidence in the safety of nanotechnology research,
engineering, manufacturing, and use;
•
preventing a problem in one application area of nanotechnology from having
negative consequences for the use of nanotechnology in unrelated application
areas due to public fears, legislative interventions, or an overly-broad regulatory
response; and
•
ensuring that society can enjoy the widespread economic and societal benefits
that nanotechnology is believed by many to offer.
In addition, the U.S. regulatory environment for nanotechnology could be an enabler for
innovation and contribute to a strong, sustainable economy by creating predictability, accurately
assessing risks and benefits, and fostering the swift movement of safe products into the market.
Such an environment is likely to favor nanotechnology-related investments and innovative
activities in the United States by domestic and foreign stakeholders, as opposed to nations where
such regulatory conditions do not exist.
Conversely, if the U.S. regulatory environment is not handled effectively (i.e., if it lacks
predictability, if regulatory approaches do not accurately assess risks and benefits, or if approval
processes are too long or expensive) it could prove a major impediment to innovation, economic
growth, and job creation, as well as posing a potential threat to health, safety, and the
environment. In such a regulatory environment, investment capital may be driven away from
nanotechnology, potentially beneficial products may not be developed, safe products may be
denied regulatory approval, or unsafe products may be allowed to enter the market.
Alternatively, nanotechnology investments, research, and production may be driven to other
nations with preferable regulatory environments. On the one hand, such a regulatory system
might be more desirable to investors and companies because it is more predictable, more
efficient, and less costly. In such a case, the United States might miss out on nanotechnology’s
potential economic benefits. On the other hand, if other nations’ regulatory systems are more
attractive to investors and producers because those systems under-regulate or do not regulate at
23
Rejeski, David, Director, Project on Emerging Nanotechnologies. “Nanotech Safety 101 or How to Avoid the Next
Little Accident,” paper, Workshop on Disaster Prevention, Harvard University, April 27, 2006.
http://www.nanotechproject.org/file_download/files/nanotechsafety101paper.pdf
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
all, then nanotechnology research, development, and production could present increased EHS
risks worldwide.
Selected Issues for Consideration
Given the widespread agreement that nanotechnology EHS concerns must be addressed,
discourse on how best to do so has focused on three main issues:
•
federal investment in EHS research;
•
federal regulation; and
•
international engagement.
These issues are closely interrelated. For example, reliable EHS research is required by regulatory
bodies to determine whether and how to regulate nanotechnology products. Since all nations face
the same fundamental health, safety, and environmental issues, international coordination on EHS
research could help accelerate development of a common body of knowledge through the sharing
of results and reduction in redundant research. This shared knowledge could, in turn, inform
regulatory decision making and perhaps improve the consistency of regulations among nations.
Regulations, standards, and enforcement might need to be coordinated worldwide to protect
workers and consumers as intermediate and final products are frequently produced along global
supply chains and sold in industrial and commercial markets around the world. In addition, one
nation’s policies governing nanotechnology production, use, and disposal may have implications
for nearby nations and, perhaps, for all nations.
Federal Investment in EHS Research
Current Funding Level
There is not a single, centralized source of EHS research funds that is allocated to individual
agencies. Agency nanotechnology budgets are developed internally as part of each agency’s
overall budget development process. These budgets are subjected to review, revision, and
approval by the Office of Management and Budget (OMB) and become part of the President’s
annual budget submission to Congress. The NNI budget—and the EHS component—is then
calculated by aggregating the nanotechnology components of the appropriations provided by
Congress to each federal agency. While there is some coordination of EHS-research budget
requests through the Nanotechnology Environmental and Health Implications (NEHI) working
group24 and in OMB’s budget development process, the decision process that establishes overall
funding for nanotechnology EHS research is highly decentralized.
In FY2010, NNI funding for EHS implications research25 was an estimated $91.6 million,
approximately 5.1% of the total NNI budget of $1.781 billion. This represented an increase over
24
NEHI is a working group of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the
White House National Science and Technology Council (NSTC). The NSET Subcommittee is the coordinating body
for the NNI. For additional information about the structure of the NNI, see CRS Report RL34401, The National
Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues.
25
According to the NNCO, EHS research funding data included in Tables 1 and 2 of this report are for implications
(continued...)
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
the FY2009 EHS research level of $74.5 million26 (4.4% of the total NNI budget), and the
FY2008 level of $67.9 million (4.4%), both in dollars and in share of total NNI funding. President
Obama requested $116.9 million (6.6%) for EHS research in FY2011. NNI EHS research funding
for FY2006 through FY2010, and President Obama’s request for FY2011, is provided in Table 1.
Table 1. NNI EHS Research Funding, FY2006-2010, FY2011 Request
EHS research,
in current dollars
EHS research’s share
of total annual NNI budget
FY2006 (actual)
$ 37.7 million
2.8%
FY2007 (actual)
48.3 million
3.4%
FY2008 (actual)
67.9 million
4.4%
FY2009 regular (actual)
74.5 million
4.4%
FY2009 ARRA (actual)
12.0 million
N/A
FY2010 (actual)
91.6 million
5.1%
FY2011 (request)
116.9 million
6.6%
Source: CRS analysis of data from the FY2008, FY2010, and FY2011 editions of “The National Nanotechnology
Initiative: Research and Development Leading to a Revolution in Technology and Industry,” NSET Subcommittee,
NSTC, The White House, July 2007, and “National Nanotechnology Initiative: FY2009 Budget and Highlights,”
NSET Subcommittee, NSTC, The White House, February 2008.
NNI officials assert that the initiative also conducts EHS research as a part of its other research
activities, but that these EHS investments are not easily quantified and thus are not reflected in
the NNI’s reported figure for EHS funding. PCAST agreed with this assertion in its 2008
assessment, arguing that
In many instances, nanotechnology EHS research cannot be separated from the particular
application(s) research and from the context for which a specific nanomaterial is intended.
Such division is unproductive and neglects the whole benefit of research. Consequently,
[PCAST] expects that a substantial fraction of nanotechnology research related to EHS will
continue to take place under the auspices of agencies that fund applications R&D and may
not be uniquely or exclusively identified as nanotechnology EHS research.... Furthermore,
detailed reporting on the degree of relevance to EHS of such research is not necessarily
critical to (and may actual hinder) overall prioritization and coordination.27
This undercounting was evidenced in part by a one-time OMB request in 2007 to all NNI
research agencies to report FY2006 funding data on research related to the five categories
identified in the NSET document, Prioritization of Environmental, Health, and Safety Research
Needs for Engineered Nanoscale Materials.28 Totals for EHS implications research spending
(...continued)
research only. The NNCO also states that the figures reported in Table 1 may understate the NNI’s EHS implications
research by excluding funding for instrument research, metrology, and standards that support EHS implications
research but are reported separately. (Source: Private communication between the NNCO and CRS.)
26
Regular FY2009 appropriations only; does not include supplemental funding provided under the American Recovery
and Reinvestment Act of 2009 (P.L. 111-5).
27
The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, April 2008. p. 34.
28
Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale
(continued...)
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
identified in each of the five categories is shown below in Table 2. Preliminary analysis of this
data by the NEHI working group indicated that NNI agencies spent nearly twice as much on EHS
research in FY2006 than was previously reported ($67 million identified by the OMB data-call
versus $37.7 million in the President’s budget.
Table 2. FY2006 NNI Funding for EHS Research
by Research Needs Categories
Category
Estimated Funding
Instrumentation, Metrology, and Analytical Methods
$27 million
Nanomaterials and Human Health
$24 million
Nanomaterials and the Environment
$13 million
Health and Environmental Exposure Assessment
$ 1 million
Risk Management Methods
$ 3 million
TOTAL
$67 million
Source: Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the
Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of
Representatives. Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current Status
of Planning and Implementation under the National Nanotechnology Initiative.” 110th Congress, 1st Session,
October 31, 2007.
Note: Numbers may not add due to rounding.
Critics (as detailed in the following section) assert that the current level of federal
nanotechnology EHS research is too low and represents too small a share of the overall NNI
budget. These critics argue that the current allocation of NNI funding may produce a flood of
products for which there is inadequate information to assess and manage their EHS risks.
However, executive branch officials stress that the United States leads the world in EHS funding
and, by inference, that the current funding level is adequate. White House Office of Science and
Technology Policy (OSTP) director John Marburger asserted that the United States
leads the world not only in spending for nanotechnology development, but also, by an even
larger margin, in its investment in research to understand the potential health and safety
issues.29
Similarly, NNCO director E. Clayton Teague asserted U.S. leadership in nanotechnology EHS
research:
During fiscal years 2005 through 2008, it is estimated that NNI agencies will have invested
nearly $180 million in research whose primary purpose is to address the EHS implications of
(...continued)
Science, Engineering, and Technology Subcommittee, National Science and Technology Council, The White House,
August 2007.
29
Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science,
Engineering, and Technology Subcommittee, National Science and Technology Council, The White House, September
2006. Cover letter.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
nanomaterials. With these investments, the United States leads all other countries by a wide
margin in support of such research.30
In early reviews of the NNI, both the NRC and PCAST concluded that federal EHS research
funding should be expanded. According to the NRC assessment,
To help ensure the responsible development of nanotechnology ... research on the
environmental, health, and safety effects of nanotechnology [should] be expanded.31
PCAST acknowledged potential EHS risks in its first review of the NNI but found the federal
government was “directing appropriate attention” and “adequate resources” to EHS research. In
its second assessment, PCAST termed the current federal investment level in EHS “appropriate,”
but added that
expanded EHS research, broad-based protocol development, and particularly standardization
are necessary.... the funding level for EHS [should] continue to grow consistent with the
needs identified in the NNI research strategy for nanotechnology EHS as well as the
available capacity for quality research.32
Under President Obama, PCAST struck a different tone. In its third assessment of the NNI,
PCAST acknowledged the importance of adequate funding and appropriate accounting, but
emphasized that
appropriate and targeted funding for strategic nanotechnology EHS research is more
important than absolute dollar amounts. To ensure that emerging EHS issues are addressed
effectively and in a way that yields useful information for regulators and policymakers, the
NNI needs to help the scientific community establish a substantial core of exploratory
research into biological and environmental interactions with nanomaterials. In addition, the
Federal Government needs to ensure sufficient funds are available to mission-driven
agencies to address specific issues that are arising.33
In this regard, PCAST credits the NNI’s “substantial funding increases for nanotechnology EHS
research” for agencies such as the National Institute for Occupational Safety and Health,
Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and Consumer
Product Safety Commission (CPSC), noting that:
Significantly, this will be the first time that FDA and CPSC will have had a specific
allocation of funds to cover nanotechnology, a welcome move and one that the NNAP hopes
is sustained over a number of years.34
30
Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on
Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on
“Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation
under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October 31, 2007.
31
A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
92.
32
The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, April 2008. pp. 7, 27.
33
The National Nanotechnology Initiative: Third Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, March 12, 2010. p. 45.
34
Ibid.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Alternative Approaches
Various alternatives have been suggested for addressing the perceived shortcoming in EHS
funding. One recommendation is requiring a fixed percentage of the NNI’s total funding be
devoted to EHS research. A figure of 10% has been proposed for this purpose by organizations
such as the NanoBusiness Alliance and the Project on Emerging Nanotechnologies. If this
proposal had been in effect in FY2010, the NNI would have been required to spend $178.1
million on EHS research, nearly twice as much as the NSET-reported level of $91.6 million. In
testimony before the House Committee on Science and Technology, Sean Murdock, executive
director of the NanoBusiness Alliance, agreed with the level of funding represented by the 10%
figure but argued the need for cross-agency flexibility in achieving it:
The NanoBusiness Alliance believes that environmental, health, and safety research should
be fully funded and based on a clear, carefully-constructed research strategy. While we
believe that 10 percent of the total funding for nanotechnology research and development is a
reasonable estimate of the resources that will be required to execute the strategic plan, we
also believe that actual resource levels should be driven by the strategic plan as they will
vary significantly across agencies.35
Others have suggested a different approach, proposing fixed dollar amounts or minimum levels.
For example, the Environmental Defense Fund has called for $100 million or more in federal
nanotechnology EHS research funding.36
In its 2008 assessment, PCAST disagreed with both approaches:
growing research in nanotechnology EHS must be strategic, guided by ... a comprehensive
set of scientifically determined priorities and needs rather than arbitrary percentages or
funding figures.37
By establishing a 10 percent requirement (or setting a specific dollar figure), the United States
could accelerate the growth in EHS research spending. However, in testimony before Congress in
2007, then-PCAST co-chair Floyd Kvamme warned against a rapid increase:
In general, increasing funding too rapidly does not lead to equivalent increases in high
quality research. It is crucial to note that EHS research also depends on advances in non-EHS
areas, such as instrumentation development and basic research on nanomaterials.38
Some non-governmental organizations (NGOs) have advocated for a more restrained approach to
nanotechnology research and development. They assert that the federal government is pushing
35
Murdock, Sean, executive director, NanoBusiness Alliance. Testimony before the Committee on Science and
Technology, U.S. House of Representatives. Hearing on “The National Nanotechnology Initiative Amendments Act of
2008.” 110th Cong., 2nd Sess., April 16, 2008.
36
Denison, Richard A. “A Proposal to Increase Federal Funding of Nanotechnology Risk Research to at least $100
Million Annually,” Environmental Defense, April 2005. http://www.edf.org/documents/4442_100milquestionl.pdf
37
The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, April 2008. pp. 7, 27.
38
Kvamme, Floyd, co-chair, President’s Council of Advisors on Science and Technology. Testimony before the
Subcommittee on Research and Science Education, Committee on Science and Technology, U.S. House of
Representatives. Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current Status of
Planning and Implementation under the National Nanotechnology Initiative,” 110th Cong., 1st Sess., October 31, 2007.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
ahead too quickly in developing nanotechnology and encouraging its commercialization and use
without sufficient knowledge and understanding of EHS implications and how they might be
mitigated.39 They argue that the very characteristics that make nanotechnology promising also
present significant potential risks to human health and safety and the environment. Some of these
groups argue for application of the “precautionary principle,”40 which holds that regulatory action
may be required to control potentially hazardous substances even before a causal link has been
established by scientific evidence.41 In 2006, Friends of the Earth warned that
The early warning signs surrounding nanotoxicity are serious and warrant a precautionary
approach to the commercialization of all products containing nanomaterials ... there should
be a moratorium on the further commercial release of sunscreens, cosmetics and personal
care products that contain engineered nanomaterials, and the withdrawal of such products
currently on the market, until adequate public, peer-reviewed safety studies have been
completed, and adequate regulations have been put in place.... 42
The Action Group on Erosion, Technology, and Concentration (ETC Group) has called for a
moratorium on the conduct of nanotechnology R&D and use of commercial products
incorporating man-made nanoparticles:
Given the concerns raised over nanoparticle contamination in living organisms, Heads of
State ... should declare an immediate moratorium on commercial production of new
nanomaterials and launch a transparent global process for evaluating the socio-economic,
health and environmental implications of the technology.43
In 2003, the ETC Group expanded the breadth of its proposed moratorium:
In the absence of toxicology studies, ETC Group believes that governments must also
urgently consider extending the moratorium to products that place consumers in direct
contact with synthetic nanoparticles through their skin, lungs or digestive systems.44
39
Maynard, Andrew, chief science advisor, Project on Emerging Nanotechnologies, a joint venture of the
congressionally-chartered Woodrow Wilson Center for International Scholars and the Pew Charitable Trusts.
Testimony before the Subcommittee on Research and Science Education, Committee on Science and Technology, U.S.
House of Representatives. Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current
Status of Planning and Implementation under the National Nanotechnology Initiative,” 110th Cong., 1st Sess., October
31, 2007.
40
The precautionary principle has been used in other countries on some issues and is the official policy in the European
Union. For international agreements a precautionary approach is sometimes embraced. For example, the Biosafety
Protocol to the 1992 Convention on Biological Diversity incorporates provisions applying the precautionary principle
to the safe handling, transfer, and trade of genetically modified organisms. For further information, see CRS Report
RL30594, Biosafety Protocol for Genetically Modified Organisms: Overview, by (name redacted) and (name red
acted).
41
“NGOs urge precautionary principle in use of nanomaterials,” EurActiv.com, June 14, 2007,
http://www.euractiv.com/en/environment/ngos-urge-precautionary-principle-use- nanomaterials/article-164619; Sass,
Jennifer, “Nanotechnology and the Precautionary Principle,” presentation, Natural Resources Defense Council, 2006.
http://docs.nrdc.org/health/hea_06121401A.pdf
42
Nanomaterials, Sunscreens, and Cosmetics: Small Ingredients, Big Risks, Friends of the Earth, May 2006.
http://www.foe.org/camps/comm/nanotech/nanocosmetics.pdf
43
“No Small Matter,” Communique, ETC Group, May/June 2002. http://www.etcgroup.org/upload/publication/
pdf_file/192 The ETC group is a non-governmental organization focused on the global societal impacts of emerging
technologies.
44
“No Small Matter II: The Case for a Global Moratorium,” Occasional Paper Series, ETC Group, April 2003.
http://www.etcgroup.org/upload/publication/pdf_file/165
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
In contrast to these views, a report prepared by the NSET Subcommittee concluded that
conducting EHS research in parallel with the development of nanomaterials and their applications
will help to ensure the full, safe, and responsible realization of the promise of nanotechnology.45
In 2003, then-Under Secretary of Commerce for Technology Phillip J. Bond addressed called for
a moratorium or slowdown in nanotechnology R&D, casting the issue in ethical terms:
Those who would have us stop in our tracks argue that it is the only ethical choice. I
disagree. In fact, I believe a halt, or even a slowdown, would be the most unethical of
choices.... Given the promise of nanotechnology, how can our attempt to harness its power at
the earliest opportunity—to alleviate so many of our earthly ills—be anything other than
ethical? Conversely, how can a choice not to attempt to harness its power be anything other
than unethical?46
Management of Federal EHS Research
Research Priorities and Strategies
In order to manage the Federal EHS portfolio, policymakers will need to establish research
priorities. In its first review of the NNI, the NRC recommended that
Assessing the effects of engineered nanomaterials on public health and the environment
requires that the research conducted be well defined and reproducible and that effective
methods be developed and applied to (1) estimate the exposure of humans, wildlife, and
other ecological receptors to source material; (2) assess effects on human health and
ecosystems of both occupational and environmental exposure; and (3) characterize, assess,
and manage the risks associated with exposure.47
In 2005, PCAST concluded that EHS research should give highest priority to workplace
exposure, noting
the greatest likelihood of exposure to nanomaterials is during manufacture, and therefore
[we] agree with the prioritization of research on potential hazards from workplace
exposure.48
In its 2008 assessment, PCAST reiterated this point stating, “the greatest risk of exposure to
nanomaterials at present is to workers who manufacture or handle such material,” but also
acknowledged a broader range of risks:
45
Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science,
Engineering, and Technology Subcommittee, National Science and Technology Council, The White House, September
2006. p. vii.
46
Bond, Phillip J., Under Secretary for Technology, U.S. Department of Commerce. “Nanotechnology: Economic
Opportunities, Societal and Ethical Challenges,” keynote address, NanoCommerce 2003, December 9, 2003.
47
A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006. p.
92.
48
The National Nanotechnology Initiative at Five Years: Assessments and Recommendations of the National
Nanotechnology Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, May
2005. p. 35.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
environmental, health, and safety risks in a wide range of settings must be identified and the
necessary research performed so that real risks can be appropriately addressed.49
In February 2008, the NSET published its much-awaited Federal Strategy for Environmental,
Health, and Safety (EHS) Research Needs for Engineered Nanoscale Materials. The report
describes the NNI’s EHS research strategy, identifies lead agencies for each of five research
categories, and asserts that it provides “a framework to guide and inform agency efforts to
address prioritized research areas and to sustain a diverse program to advance knowledge and
support risk decision-making.”50
Subsequently, the NSET requested the NRC independently review this strategy document. In
2009, the NRC published the results of its review, Review of Federal Strategy for
Nanotechnology-related Environmental, Health, and Safety (EHS) Research.51 While
complimentary of the widespread collaboration and coordination required to produce the report
and its potential usefulness in “communicating the breadth of federally supported research
associated with developing a more comprehensive understanding of the environmental, health,
and safety implications of nanotechnology,” the NRC review asserted that:
•
research needs in risk management and exposure assessment were “poorly
defined and incomplete;”
•
research needs were not presented as “concrete, measurable objectives” and that
no explanation was provided of how success would be measured or the amount
of resources required to achieve them;
•
the NSET overstates federal funding specifically addressing nanotechnologyrelated EHS issues and that funding may be inadequate;
•
the approach used by the NSET for its gap analysis is “flawed and is neither
accurate nor complete in laying a foundation for a research strategy”; and
•
federal EHS nanotechnology funding is dominated by agencies traditionally
focused on exploratory and investigator-driven research (such as NIH and NSF)
and that if these agencies are to continue to lead, their approaches may need to be
modified “to ensure that the research they support feeds into an effective EHS
risk research strategy based on appropriate, targeted research.”
The NRC concluded that what was needed was an effective “national strategy” that involves a
range of stakeholders beyond the federal government, including academia, industry, consumer
and environmental groups, and others. Such a plan, according to the NRC, would
identify research needs clearly and estimate the financial and technical resources needed to
address identified research gaps. A national strategic plan would be focused on providing
solutions to challenges that do not necessarily fit neatly into disciplinary and institutional
49
The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, April 2008. p. 2.
50
Federal Strategy for Environmental, Health, and Safety (EHS) Research Needs for Engineered Nanoscale Materials,
Nanoscale Science, Engineering, and Technology Subcommittee, National Science and Technology Council, The
White House, February 2008.
51
Review of Federal Strategy for Nanotechnology-related Environmental, Health, and Safety (EHS) Research, National
Research Council, Washington, DC, December 2008.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
silos, and ensure important research does not fall between the gaps. Such a plan would also
provide specific, measurable objectives and a timeline for meeting them.52
Proposals for a Research Roadmap: Differing Perspectives
Some stakeholders assert that a comprehensive approach to federal EHS research has been
hampered by the lack of an NNI roadmap for these efforts.53 In general, these stakeholders seek a
multi-year roadmap with specific milestones, metrics, and funding levels. Such a roadmap, they
assert, would contribute to a more coordinated approach among agencies and between the
executive branch and Congress on the magnitude, timing, prioritization, and management of
federal EHS research.
NNI officials argue that the NSET
Subcommittee, the coordinating body for the
NNI, has developed an EHS research strategy
and articulated it in three reports (see text box,
“NNI EHS-focused Reports”), though they
acknowledge that these documents do not
constitute a roadmap. Some Members of
Congress have expressed concerns about the
time required by the National Nanotechnology
Coordination Office to produce a prioritized,
detailed implementation plan for NNI EHS
research.54 While acknowledging the
challenges faced by the NNCO in developing
consensus among the 25 NNI agencies, some
Members suggested that these challenges were
emblematic of the need for a more top-down
approach to EHS research.
NNI EHS-focused Reports
Environmental Health and Safety Research Needs for
Engineered Nanoscale Materials, published in September
2006, identified the research and information needed to
enable sound risk assessment and risk management
decision making with respect to nanoscale materials and
products that incorporate them.
Prioritization of Environmental, Health, and Safety Research
Needs for Engineered Nanoscale Materials, published in
August 2007, identified five broad categories of EHS
research and information needs, and five specific
research areas in each category.
The National Nanotechnology Initiative: Strategy for
Nanotechnology-related Environmental, Health, and Safety
Research, published in February 2008, defined the NNI’s
strategy for addressing priority research on EHS aspects
of nanomaterials. The document reviewed current
agency research using the taxonomy developed in the
second report; identified research gaps; and articulated a
framework for prioritizing research, implementing the
strategy, and coordinating agency efforts.
Opposition to an EHS roadmap stems
primarily from doubts of the practicality and
efficacy of such an approach. Some argue that it is unlikely that OMB would commit to a multiyear, multi-agency roadmap accompanied by specific funding levels. Such an approach would
depart from the current executive branch annual budget development process and reduce OMB’s
flexibility in future years. In addition, agencies often have to respond to new requirements based
on emergent circumstances, Congressional direction, or other factors. Agency funding is often
redirected from planned efforts to new, often imminent, priorities. The need for such redirection
of funding could impede the achievement of roadmap milestones and metrics or, conversely,
impede the movement of funding to new priorities.
52
Ibid.
Rejeski, David, director, Project on Emerging Nanotechnologies. Public comments on the Nanoscale Science,
Engineering, and Technology Subcommittee’s report, Prioritization of Environmental, Health, and Safety Research
Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment, September 12, 2007.
http://www.nanotechproject.org/process/files/5891/nehi_comments_070912_final.pdf
54
Hearing on “Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and
Implementation under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October 31, 2007.
53
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
To overcome the obstacles associated with the development of a roadmap by the agencies, some
have suggested the National Academies produce such a roadmap. Some experts assert that this
approach worked well with respect to the development of a federal research roadmap to reduce
EHS uncertainties associated with airborne particulate matter. Others argue that the particulate
matter effort focused only a narrow field and covered research conducted by only a single agency
(EPA); in contrast, nanotechnology spans a broad range of materials and applications across many
fields, and requires EHS research efforts by several agencies.
In February 2007, 19 environmental and business organizations, large and small companies, and
research organizations signed a letter to the Senate Appropriations Subcommittee on Interior,
Environment, and Related Agencies requesting $1 million be appropriated for the development of
a federal roadmap and research strategy. The letter recommended that this work be done by the
National Institute of Environmental Health Sciences (NIEHS).55
The Senate Appropriations Committee report (S.Rept. 110-91) accompanying the Department of
the Interior, Environment, and Related Agencies Appropriations Act, 200856 urged the
Environmental Protection Agency (EPA) to
contract or enter into a cooperative agreement with the National Academy of Sciences’
Board on Environmental Studies and Toxicology within 90 days of enactment to develop and
monitor implementation of a comprehensive, prioritized research roadmap for all Federal
agencies on environmental, health and safety issues for nanotechnology.57
In July 2009, the National Academies’ Board on Environmental Science and Toxicology began an
EPA-sponsored project, titled “A Research Strategy for Environmental, Health, and Safety
Aspects of Engineered Nanomaterials.” According to the National Academies, the project is to
produce two reports over four years. The first report, due 18 months from project inception, is to
present a conceptual framework and priorities for the research program, identify the most
important short-term and longer-term research priorities, develop a strategy for monitoring
and evaluating research progress, and estimate the resources needed to implement this
strategy.58
The second report, due at the end of the study period (approximately July 2013), is to
evaluate research progress and update the research priorities and resource estimates based on
results of studies and emerging trends in the nanotechnology industry.59
55
An electronic copy of this letter, dated February 22, 2007, was provided to the Congressional Research Service
(CRS) by the American Chemistry Council.
56
Incorporated as division F of the Consolidated Appropriations Act, 2008 (P.L. 110-161).
57
S.Rept. 110-91, p. 54.
58
Study in Progress: A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials,
National Academies website. http://dels.nas.edu/Study-In-Progress/Research-Strategy-Environmental-Health/BEST-K08-01-A
59
Ibid.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Budget Development, and Coordination and Integration of Efforts
The process used to develop research priorities and the federal EHS budget has also raised
management concerns. As discussed earlier, the federal nanotechnology EHS research portfolio
results from research funding requests made by individual agencies pursuing their missions and
by decisions made in the congressional appropriations process. Informal research coordination
among EHS funding agencies occurs through the NEHI working group and more formally
through the OMB budget development process.
In its third review of the NNI, PCAST recommended that
the NSET Subcommittee implement organizational changes that support consequential crossagency action on addressing nanotechnology EHS issues. In particular, the NNCO should
create a senior-level position to lead interagency coordination of efforts in the area of EHS.60
In 2010, the NNCO established and filled a new position with the dual titles of Deputy Director
and EHS Coordinator. A primary duty of this position is the coordination of EHS research among
NNI agencies.
Some proponents for an integrated federal EHS research effort have called for a more top-down
approach. The Woodrow Wilson Center’s Project on Emerging Nanotechnologies (PEN) has been
a leading advocate on this issue. PEN’s chief science advisor, Andrew Maynard, asserted that
to realize nanotechnology’s benefits ... the federal government needs a master plan for
identifying and reducing potential risks. This plan should include a top-down risk research
strategy, dedicated and sufficient funding to do the job, and the mechanisms to ensure that
resources are used effectively.61
PEN has recommended increasing the authorities of the NEHI working group to empower it to
develop and implement the top-down research plan, increasing EHS funding, and appointing a
full-time director to support the NEHI working group.
Responding to the PEN recommendation, E. Clayton Teague, director of the NNCO, testified
before Congress that there was a consensus among NNI agencies that a centralized office with
budgetary authority to oversee the NNI’s EHS research program would have significant
detrimental effects. According to Dr. Teague,
No one agency or centralized organization would have the breadth of scientific expertise and
knowledge of regulatory authorities and needs currently represented by the 20 agencies
participating in the NEHI working group.
Creation of a new central authority would undermine the existing successful interagency
coordination.
60
The National Nanotechnology Initiative: Third Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, The White House, March 12, 2010. p.
xiii.
61
Maynard, Andrew, chief science advisor, Project on Emerging Nanotechnologies. “Public Meeting on Research
Needs and Priorities Related to Environmental, Health, and Safety Aspects of Engineered Nanoscale Materials,”
comments, January 4, 2007. http://www.nano.gov/html/meetings/ehs/uploads/
20070103_1505_Nanotechnology_Maynard_NNCO_Comments.pdf
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Moving the management of all nanotechnology EHS research into a single office would
likely decouple such research from related efforts within NNI agencies and from the
knowledge base in the agencies that is currently networked into the NNI’s EHS research
effort.
Creating a separate office would, on the one hand, give mission agencies a disincentive for
doing nanotechnology-related EHS research. They would reasonably assume that another
agency is responsible, and they therefore could redirect their limited resources to address
other priorities. A likely result could be that the level of research would actually decrease.
Conversely, creating a separate office could lead to duplicative work being funded, thereby
wasting tax dollars and not optimizing progress.62
Andrew Maynard counters that “it should be possible to develop a functional structure that
enables agencies to work within a broader plan.” According to Maynard, while a centralized
office is not necessary,
top-down leadership with authority and the ability to ensure resources get to where they are
needed is necessary.... [Such] leadership does not take away from agencies’ expertise and
missions, but rather empowers agencies to do the best they can, while coordinating and
partnering as effectively as possible with each other.63
62
Teague, E. Clayton, director, National Nanotechnology Coordination Office. Testimony before the Subcommittee on
Research and Science Education, Committee on Science and Technology, U.S. House of Representatives. Hearing on
“Research on Environmental and Safety Impacts of Nanotechnology: Current Status of Planning and Implementation
under the National Nanotechnology Initiative.” 110th Cong., 1st Sess., October 31, 2007.
63
E-mail communication, November 21, 2007.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
A Cooperative Approach to Addressing EHS Concerns
Some organizations have taken a cooperative approach to promote EHS research. For example, the Environmental
Defense Fund, an environmental advocacy group, partnered with the American Chemistry Council, a trade group, to
issue a Joint Statement of Principles in June 2005 that recognizes the “significant societal and sustainable development
benefits” expected from nanotechnology, while calling for a multi-stakeholder dialogue to achieve the timely
development of nanomaterials “in a way that minimizes potential risks to human health and the environment.” The
statement also called for increased federal investments in EHS research and
development of an international effort to standardize testing protocols, hazard and exposure
assessment approaches, and nomenclature and terminology ... to maximize resources and minimize
inconsistent regulation of nanomaterials.a
There is general agreement among stakeholders that these activities can contribute to creating an environment where
research results can be reliably shared and compared, to protecting human health and safety, and to creating a
common language about nanotechnology that increases clarity in the sharing of ideas and information. However
international standardization efforts are often time- and resource-consuming, and can divert resources from more
pressing needs. In addition, such efforts can be used by nations and other organizations for competitive advantage
(e.g., by securing the adoption of a favorable standard, slowing others’ progress).
In June 2007, the Environmental Defense Fund and DuPont issued a Nano Risk Framework “to assist with the
responsible development and use of nanotechnology and to help inform global dialogue on its potential risks.”b The
framework is a six-step process to identify, address, and manage potential risks: (1) describe the material and the
intended application; (2) profile the material’s lifecycle in the application; (3) evaluate associated risks; (4) assess risk
management options; (5) decide on and document actions; and, (6) regularly review new information and adapt
actions accordingly.c
a Environmental Defense and American Chemistry Council Nanotechnology Panel: Joint Statement of Principles, Comments on
EPA’s Notice of a Public Meeting on Nanoscale Materials, June 23, 2005.
b “DuPont and Environmental Defense Launch Comprehensive Tool for Evaluating and Addressing Potential Risks of
Nanoscale Materials,” press release, E. I. du Pont de Nemours and Company, June 21, 2007.
http://vocuspr.vocus.com/VocusPR30/Newsroom/Query.aspx?SiteName=DupontNew&Entity=PRAsset&
SF_PRAsset_PRAssetID_EQ=106677&XSL=PressRelease&Cache=False
c Nanorisk Framework, Environmental Defense-DuPont Nano Partnership, June 2007.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Project on Emerging Nanotechnologies Recommendations
The Project on Emerging Nanotechnologies (PEN), a joint venture of the congressionally-chartered Woodrow
Wilson Center for International Scholars and the Pew Charitable Trusts, has produced inventories of both
nanotechnology-based products and government-funded EHS research. PEN has asserted the need for more EHS
research, more aggressive oversight, and a more centralized federal government approach to funding EHS research.
In addition, PEN contends that the increasing complexity of systems incorporating nanoparticles with multiple
functions will make the behaviors more complex and difficult to predict. To minimize the likelihood of a
nanotechnology accident, PEN made the following recommendations:
•
Creating a Nano Safety Reporting System where people working with nanotechnology can anonymously report
safety issues and concerns. PEN states that the information gleaned from this system could be used to inform the
design of educational materials, better structure technical assistance programs, and provide an early indicator of
emerging safety issues.
•
Creating technologies that provide an early-warning system to allow for risk to be assessed early in research
efforts. Such a technology might enable low-cost, fast-screening for novel properties that would allow for risk
assessment integrated and concurrent with the R&D process.
•
Pushing information out to small businesses, start-ups, and laboratories that, due to their size and resources, are
unlikely to be able to devote significant resources to EHS issues. PEN states that existing assistance programs
could be used to deliver this information, as well as the development of peer-to-peer mentoring programs within
industrial supply chains.
•
Application of lessons learned in other technology areas to make nanotechnology more inherently safe, using
strategies such as multiple levels of protection, learning from failures, not oversimplifying the complex, awareness
of operations, and building in resilience to prevent cascading of errors.
Source: Rejeski, David, director, Project on Emerging Nanotechnologies. “Nanotech Safety 101 or How to Avoid
the Next Little Accident,” paper, Workshop on Disaster Prevention, Harvard University, April 27, 2006.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Federal Regulation
Some have raised concerns about whether current laws, regulations, and authorities are adequate
to protect human health, safety, and the environment from potential adverse implications of
nanotechnology. Several factors may affect the ability of the regulatory system to keep pace with
advances in technology, both broadly and specifically with respect to nanotechnology.
Unique Properties Emerge
Broadly, market forces have increased the
pace of global innovation, challenging
at the Nanoscale
institutions’ ability to identify and cope with
Scientists have discovered that elements and materials
with the same chemistry can exhibit fundamentally
the societal implications of rapid change.
different properties at the nanoscale. For example,
Speed-to-market has become a driving factor
platinum, which exhibits no magnetism in its bulk form,
in competition for many industries as a result
shows significant magnetic properties in nanoscale
of the entry of new and nimble competitors in
clusters of 13 atoms. The optical properties of gold also
the global marketplace, increased public and
can change with particle size. At 10 nanometers, gold
particles absorb green light and appear red, not gold.
private investments in R&D, global models of
innovation, increased flows of scientific and
Not only can nanoscale particles differ in properties from
technical knowledge, and greater numbers of
bulk material with the same chemical composition, they
may also differ from other nanoscale materials with the
scientists and engineers around the world. In
same chemical composition. For example, the melting
addition, growing global markets enable
point of an element—which was believed to be constant
companies to recoup their investments faster
regardless of the element’s particle size—can change
and enable earlier investments in subsequent
with particle size. Nanotechnology research has
demonstrated that the melting temperature of gold
generations of technology, further accelerating
decreases when the particle’s radius drops below 10
the pace of innovation. The increased pace,
nanometers (from a melting temperature of
scope, and complexity of technological
approximately 1,000oC at 10 nanometers to
innovation may pose challenges to the existing approximately 500oC at 2 nanometers).
regulatory system. While these factors may
Source: Roduner, Emil. “Nanoscopic Materials: Sizeaffect a broad range of technologies,
Dependent Phenomena,” University of Stuttgart,
nanotechnology may be especially affected
Germany, August 2006.
due to the rapid growth in public and private
R&D investments in the field since the year
2000 and the potential for nanomaterials to be used in a wide array of products.
Nanotechnology also may pose unique challenges to the regulatory system. For example,
historically, regulatory agencies have defined a chemical by its chemical composition, usually
without regard to its particle size. In contrast, the essence of nanotechnology is that a material
may exhibit different properties at the nanoscale than it does at a bulk, molecular, or atomic scale.
(See text box, “Unique Properties Emerge at the Nanoscale.”) Accordingly, questions are being
raised by representatives of the scientific, advocacy, and regulatory communities about how an
EHS research portfolio might be structured when particle size may affect a material’s properties,
whether it may be necessary to incorporate particle size into regulatory regimes, and how this
might be accomplished given the vast spectrum of particle sizes that might affect the
characteristics of a particular material.
Some experts argue that EHS concerns about nanotechnology products can be handled under
existing laws and regulations, while others see legal obstacles to adequate EHS regulation. In
both of its assessments of the NNI, PCAST concluded that existing regulatory authorities were
adequate for the current activities; that appropriate regulatory mechanisms should be used to
address instances of harmful human or environmental effects of nanotechnology; and that new
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
regulatory policies related to nanotechnology should be rational, science-based, and consistent
across the federal government. Similarly, Sean Murdock, then-executive director of the
NanoBusiness Alliance, asserted that
The apparatus for effective nanotechnology regulation is largely in place through various
statutes and agencies, but it lacks data and resources. To enable these agencies and for the
nanotech regulation effort to succeed we must increase the level of funding available to them
for nanotech environmental, health and safety research; coordinate efforts between agencies;
establish metrics and standards that can be used to characterize nanomaterials; conduct
ongoing research; and more.64
Others believe that new laws and regulations, or modifications to existing ones, may be required.
J. Clarence Davies, senior advisor to the Project on Emerging Nanotechnologies and former EPA
Assistant Administrator for Policy, Planning, and Evaluation argued that
Nanotechnology is difficult to address using existing regulations. There are a number of
existing laws—notably the Toxic Substances Control Act; the Occupational Safety and
Health Act; the Food, Drug and Cosmetic Act; and the major environmental laws (Clean Air
Act, Clean Water Act, and Resource Conservation and Recovery Act)—that provide some
legal basis for reviewing and regulating [nanotechnology] materials. However, all of these
laws either suffer from major shortcomings of legal authority, or from a gross lack of
resources, or both. They provide a very weak basis for identifying and protecting the public
from potential risk, especially as nanotechnologies become more complex in structure and
function and the applications become more diverse.
A new law may be required to manage potential risks of nanotechnology. The law would
require manufacturers to submit a sustainability plan which would show that the product will
not present an unacceptable risk.65
In a 2008 PEN report, Oversight of Next Generation Nanotechnology, Davies asserted that
nanotechnology, along with other advanced technologies, have characteristics that challenge
conventional methods of risk assessment, standard setting, and oversight implementation,
severely hampering the effectiveness of the existing regulatory structure.
Since 1980, the capability of the federal agencies responsible for environmental health and
safety has steadily eroded. The agencies cannot perform their basic functions now, and they
are completely unable to cope with the new challenges they face in the 21st century.66
As an alternative, Davies put forward a concept for a Department of Environmental and
Consumer Protection, “a scientific agency with a strong oversight component, in contrast to the
current regulatory agencies, which are primarily oversight bodies.” The agency would incorporate
six existing regulatory and science agencies and establish new units for risk assessment,
64
“Nanotechnology Leaders to Converge in Washington, D.C., This Week for NanoBusiness Alliance Public Policy
Tour,” article, nanotechwire.com, February 16, 2006. http://nanotechwire.com/news.asp?nid=2929
65
Davies, J. Clarence. Managing the Effects of Nanotechnology, Project on Emerging Nanotechnologies, Woodrow
Wilson International Center for Scholars, Washington, DC, January 2006. p. 3. http://www.nanotechproject.org/
process/assets/files/2708/30_pen2_mngeffects.pdf
66
Davies, J. Clarence. Oversight of Next Generation Nanotechnologies, Project on Emerging Nanotechnologies,
Woodrow Wilson International Center for Scholars, Washington, DC, April 2009. http://www.nanotechproject.org/
process/assets/files/7316/pen-18.pdf
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
forecasting, technology assessment, health monitoring, and collection of environmental
statistics.67
Davies also stated that new mechanisms and institutional capabilities—including research
programs, tax breaks, acquisition programs, and regulatory incentives—are needed to encourage
beneficial applications of nanotechnology.
In developing the regulatory structure, some in the business and financial communities argue that
stability and predictability are key characteristics for attracting investment and spurring
commercial applications. According to Matthew Nordan, then-vice president of Lux Research, the
ambiguity surrounding environmental, health, and safety regulation of nanoparticles is
hampering commercialization. Firms do not want to play a game whose rules may change at
any time.... That doesn’t mean they want more regulations or more onerous regulations.
They’re just looking for a roadmap on how federal agencies such as the EPA or OSHA
[Occupational Safety and Health Administration] plan to approach nanoparticles.68
Some tension exists between the goals of promoting the development of nanotechnology,
ensuring the global competitive position of the United States, addressing potential EHS
implications of nanotechnology, and coping with the unique challenges nanotechnology poses to
the current regulatory regime. To prevent health and safety concerns from becoming an
impediment to innovation, some suggest that health and safety research and regulation must be
done near-concurrently with product development, keeping pace with the speed of innovation.
Alternatively, others argue that the potential health, safety, and environmental implications are
either unknown or of such significance that EHS research and regulation must precede
nanotechnology development and commercialization. “By the time monitoring catches up to
commerce the damage will already have been done,” asserted Ian Illuminato, health and
environment campaigner for Friends of the Earth.69 AFL-CIO industrial hygienist Bill Kojola
warned that
Even though potential health hazards stemming from exposure have been clearly identified,
there are no mandatory workplace measures that require exposures to be assessed, workers to
be trained, or control measures to be implemented. [Nanotechnology] should not be rushed
to market until these failings are corrected and workers assured of their safety.70
The National Research Council assessment of the NNI acknowledged the need for additional
reproducible, well-characterized EHS data to inform risk-based guidelines and best practices and
warned that until such information is available precautionary measures should be taken to protect
the health and safety of workers, the public, and the environment.71
In its 2008 assessment of the NNI, PCAST asserted that risk research must not be considered in
isolation, but rather in the context of the overall risks and benefits of a particular material or
67
Ibid.
“U.S. Risks Losing Nano Lead,” article, physorg.com, July 6, 2005. http://www.physorg.com/news4963.html
69
“International Coalition Calls for Oversight of Nanotechnology,” press release, Friends of the Earth, July 31, 2007.
http://action.foe.org/dia/organizationsORG/foe/pressRelease.jsp?press_release_KEY=248
70
Ibid.
71
A Matter of Size: Triennial Review of the National Nanotechnology Initiative, National Research Council, 2006.
p.11.
68
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
technology. This perspective is shared by many industry advocates who argue that regulatory
decisions must balance the potential risks associated with a nanotechnology product against the
benefits it delivers and the risk it displaces. Further, they maintain that nanotechnology products
should not be held to a higher standard than non-nanotechnology products. PCAST also noted
that manufacturers and sellers of nanotechnology products had responsibilities for ensuring
workplace and product safety, and asserted that the NNI has a vital role in supporting federal
regulatory agencies by providing them with EHS research results.
International Engagement
International engagement on EHS issues is believed by many to be important to the responsible
development and successful commercialization of nanotechnology. NNI officials assert that the
United States has played a central role in convening international efforts to address EHS
concerns. In its 2008 assessment, PCAST encouraged the NNI to coordinate its efforts with other
nations to avoid duplication and to leverage investments, characterizing such work as “noncompetitive.”72 In its 2010 assessment, PCAST acknowledged the wide range of international
engagement by the NNI and its member agencies and recommended that these efforts be
“continued and expanded.”73
Federal agencies have engaged internationally (e.g., with agencies of other nations, international
organizations, standards organizations) across a wide range of nanotechnology-related areas,
including standards, nomenclature, and EHS research. The NSET established the Global Issues in
Nanotechnology (GIN) working group in 2005 to monitor foreign nanotechnology programs,
promote U.S. commercial and trade interests in nanotechnology, and broaden international
collaboration on nanotechnology R&D, including research on safeguarding the environment and
human health.
Advocates for international engagement assert a variety of potential benefits. For example,
transparency and/or harmonization of standards and regulations may contribute to assurance of
global supply chains and market confidence in nanotechnology products. Increased globalization
of production and markets means that companies and consumers around the world are
increasingly part of a common network. Manufacturers of final products generally rely on inputs
from multiple suppliers in their global supply chains. The reliability of a final product often
depends on the reliability of inputs, such as materials or components. Transparent and common
standards and regulations may help to ensure the integrity of supply chains and final products.
While this is an issue for a variety of non-nanotechnology products (e.g., the recent discovery of
lead-tainted toys and other products imported from China), nanotechnology may present a unique
challenge in that at least some nanoscale particles can be incorporated into materials and products
in ways that cannot be easily detected or detected at all. Thus, producers and the consumers they
serve must rely, in large measure, on standards and regulatory systems to ensure that nanoscale
materials are properly produced and represented throughout the supply chain. In the absence of
such standards and regulatory systems, producers may not be able to rely on inputs or may incur
additional costs for testing and verification; substandard inputs may be incorporated in final
products making them underperform or unsafe, and possibly resulting in loss of market
72
The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology
Advisory Panel, President’s Council of Advisors on Science and Technology, April 2008. p. 33.
73
Report to the President and Congress on the Third Assessment of the National Nanotechnology Initiative, President’s
Council of Advisors on Science and Technology, The White House, March 12, 2010, p. 42.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
confidence and/or potential litigation; or nanotechnology materials may be incorporated without
disclosure.
Internationally agreed upon standards could also contribute to greater comparability of research
results, improving understanding of EHS-related aspects of nanotechnology, and promoting
regulations that help protect human health and the environment. Common standards and
nomenclature also may contribute to more effective global R&D collaboration, accelerating the
realization of nanotechnology’s economic and societal potential.
Global engagement may help to establish a common environment for the development and
production of nanotechnology products and to promote access to global markets. In the absence
of such an environment, some nations may seek to attract investments in their markets by
adopting lower environmental, health, and safety standards and regulations.
Finally, while much remains unknown about the transport and fate of nanoscale materials released
into the environment, it is possible that countries and populations other than those where research
and production activities take place may be affected. Efforts to promote the adoption of best
practices in nanotechnology research, production, use, disposal, and recycling may protect human
health and the environment worldwide.
International engagement on EHS research may pose problems, including the time, cost,
difficulty, and alleged ineffectiveness of such collaborations. For example, while some advocates
assert the need for swift action in advancing EHS research, international engagements often entail
slow processes. Also, given the strong U.S. position in nanotechnology, broadly, and in
nanotechnology EHS research, specifically, some may argue that other countries have little to
contribute, that such efforts tax limited federal EHS financial and human resources, and that such
diffusion of resources may slow overall EHS progress. Others might assert that international
engagement efforts focused explicitly on nanotechnology are unnecessary given the wide variety
of existing mechanisms and pathways for sharing academic research and environmental, health,
and safety information across national borders.
Some may oppose international engagement efforts because they lack faith in the goodwill of
participating parties due to the potentially strong national interests at stake (e.g., military
applications, economic growth, job creation). In 2003, then-Under Secretary of Commerce for
Technology Phillip J. Bond questioned whether global calls for a slowdown in nanotechnology
R&D to address EHS concerns were intended to allow other nations to close the nanotechnology
leadership gap with the United States:
I wonder very often if there are really calls for a slow-down so that other governments and
countries might catch up.74
Others assert that the research required to understand and address EHS implications may be
closely linked to applications-related R&D to create nanotechnology materials, products, or
processes. In such cases, companies and countries may be reluctant to reveal EHS concerns and
efforts, to cooperate in EHS research, or to share results as such actions may reveal competitive
strategies, provide information others might use to compete against them (e.g., insights into
promising materials or manufacturing processes), or result in unwanted scrutiny by regulators.
74
Regional, State, and Local Initiatives in Nanotechnology, Nanoscale Science, Engineering, and Technology
Subcommittee, National Science and Technology Council, The White House, 2005. p. 33.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Concluding Observations
Advocates and critics agree that potential environmental, health, and safety implications of
nanotechnology must be addressed if the full economic and societal benefits of nanotechnology
are to be achieved. There is also general agreement that the current body of knowledge of how
nanoscale materials might affect humans and the environment is insufficient to assess, address,
and manage the potential risks. While there is agreement on the need for more EHS research,
there are differing views on the level of funding required, how it should be managed, and related
issues.
In the 111th Congress a variety of legislation was considered seeking to address, in some manner,
EHS-related issues, including: H.R. 5116 (111th Congress) (Title I, Subtitle A); H.R. 554 (111th
Congress) and S. 1482 (111th Congress), both titled “National Nanotechnology Initiative
Amendments Act of 2009,” which would reauthorize and amend the 21st Century
Nanotechnology Research and Development Act; S. 2942 (111th Congress), the Nanotechnology
Safety Act of 2010; H.R. 820 (111th Congress), the Nanotechnology Advancement and New
Opportunities Act; and the appropriations bills that fund the NNI agencies’ nanotechnology EHS
research.
None of these bills were enacted. The 112th Congress may again seek to address nanotechnology
EHS implications issues, including:
•
Is there a need for a national EHS research strategy to identify and address
knowledge gaps? If so, which institutions should be a part of such a strategy?
Which institution(s) should develop such a strategy?
•
Should the federal approach to EHS research be bottom-up, driven by individual
agency decisions and coordinated by the NNCO? Should it be top-down with a
central controlling authority? Or should the federal government take a hybrid
approach, using a central office with its own funding to address research needs
not addressed by other agencies?
•
How much should the federal government appropriate for EHS research? Should
the amount of EHS funding be proportionate to the overall NNI budget? How
should the research be prioritized? How can the federal EHS research investment
be better accounted for? How can EHS research results and best practices be
shared more broadly?
•
Can voluntary programs effectively provide needed information about industrial
nanotechnology production activities? Are existing laws, regulations, guidelines,
and regulatory structures adequate? Should agencies be more aggressive in their
use of regulatory authority to collect more information from companies about the
nanotechnology and nanotechnology-enabled products they manufacture? Is
there sufficient coordination among federal regulatory agencies?
•
How can efforts to develop common nomenclature and standards be improved?
What types of international engagement on nanotechnology research and
regulatory issues could best foster responsible development of nanotechnology
and ensure confidence in supply chains?
Congress’ approach to each of these issues may have a substantial effect on U.S. leadership in
nanotechnology R&D and commercialization, the realization of the potential societal benefits of
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
nanotechnology, public health and safety, the environment, and the public policy decisions and
investments made by other nations.
Nanotechnology EHS-Related Legislation in the
111th Congress
Five bills introduced in the 111th Congress contained provisions that sought to address
nanotechnology EHS concerns. The following section summarizes selected EHS-related
provisions of these bills.
Title I, Subtitle A, H.R. 5116 (111th Congress)—National
Nanotechnology Initiative Amendments Act of 2010
The provisions of Title I, Subtitle A of H.R. 5116 (111th Congress), the National Nanotechnology
Initiative Amendments Act of 2010, are nearly identical to H.R. 554 (see “H.R. 554—National
Nanotechnology Initiative Amendments Act of 2009” below). H.R. 5116 changes the name of
the act from the “National Nanotechnology Initiative Amendments Act of 2009,” to “National
Nanotechnology Initiative Amendments Act of 2010,” and removes the term “interdisciplinary”
from a provision establishing “green nanotechnology” research centers.
H.R. 554 (111th Congress)—National Nanotechnology Initiative
Amendments Act of 2009
H.R. 554 (111th Congress), the National Nanotechnology Initiative Amendments Act of 2009, was
introduced on January 15, 2009, and referred to the House Committee on Science and
Technology. On February 11, 2009, the bill was brought to the floor on a motion to suspend the
rules and passed by voice vote. The bill was received in the Senate and referred to the Committee
on Commerce, Science, and Transportation. This act would revise the 21st Century
Nanotechnology Research and Development Act in a variety of ways, several of which
specifically address nanotechnology EHS concerns. The legislation:
•
directs the National Nanotechnology Coordination Office to develop and
maintain a public database of NNI EHS projects, including the agency funding
source and funding history;
•
requires the National Nanotechnology Advisory Panel (NNAP) to be established
as a “distinct entity” (the NNAP’s functions are currently performed by the
President’s Council of Advisors on Science and Technology), and requires the
establishment of a subpanel to assess whether societal, ethical, legal,
environmental, and workforce concerns are adequately addressed by the NNI;
•
directs that the National Research Council, as part of its triennial review of the
NNI, evaluate the adequacy of the NNI’s efforts to address ethical, legal,
environmental, human health, and other appropriate societal concerns;
•
requires the designation of an associate director of the White House Office of
Science and Technology Policy to serve as Coordinator for Societal Dimensions
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
of Nanotechnology with responsibility for developing an annual research plan for
federal nanotechnology EHS activities, monitoring and encouraging agency EHS
efforts, and for encouraging agencies to engage in public-private partnerships to
support EHS research;
•
requires certain interdisciplinary research centers supported under the NNI to
include EHS research to develop methods for developing environmentally benign
nanoscale products and processes, to foster the transfer of research results to
industry, and to provide interdisciplinary study programs to educate scientists and
engineers in these methods;
•
directs NNI agencies to support the activities of standards setting bodies involved
in the development of standards for nanotechnology, including authorizing
agency reimbursement of travel costs of scientists and engineers participating in
these activities; and
•
requires activities supported under the NNI’s Education and Societal Dimensions
program component area to include environmental, health, and safety education
in its informal, pre-college, and undergraduate nanotechnology education efforts.
S. 1482 (111th Congress)—National Nanotechnology Amendments
Act of 2009
S. 1482 (111th Congress), the National Nanotechnology Amendments Act of 2009, was
introduced on July 21, 2009, and referred to the Senate Commerce, Science, and Transportation
Committee. The purpose of the bill is to reauthorize the 21st Century Nanotechnology Research
and Development Act and to expand the scope of the National Nanotechnology Program (NNP).
Among its provisions, the bill:
•
requires the NNP to solicit and draw upon the perspectives of the industrial
community to promote the rapid commercial development of nanoscale-enabled
devices, systems, and technologies and to coordinate research in determining the
key physical and chemical characteristics of nanoparticles and nanomaterials that
may pose environmental, health, and safety risks;
•
requires the NNCO and other appropriate agencies and councils to issue guidance
to agencies that describes a strategy for transitioning research into commercial
products and technologies and how the program will coordinate or conduct
research on the environmental, health, and safety issues related to
nanotechnology;
•
requires each participating agency to provide funds to support the work of the
NNCO. Authorizes appropriations to: (1) NIST for the development of
nanotechnology standards; and (2) NSF, for use by the NNCO, to develop and
maintain a public information database of NNP projects in EHS; education;
public outreach; ethical, legal, and other societal issues; and of nanotechnology
facilities accessible for use by individuals from academia and industry;
•
makes the National Nanotechnology Advisory Panel (NNAP) a distinct entity,
and requires the NNAP to establish a subpanel to enable it to assess whether
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
societal, ethical, legal, environmental, and workforce concerns are adequately
addressed by the NNP;
•
requires the designation of a “coordinator for societal dimensions of
nanotechnology,” within OSTP, to convene a panel to develop a research plan,
and requires the coordinator to enter into an arrangement with the National
Science Board to create a report that identifies the broad goals and needs of EHS
researchers;
•
directs the NSTC to establish an interagency Education Working Group to
coordinate, prioritize, and plan formal and informal educational activities
supported under the NNP, including activities to help participants understand the
EHS implications of nanotechnology; and
•
requires the NNP to support nanotechnology R&D in areas of national
importance (e.g., economic competitiveness, energy production, water
purification, agriculture, and health care; in environmental, health, and safety
research on the risks of nanoparticles) and in ethical, legal, and societal issues
related to nanotechnology.
S. 2942 (111th Congress)—Nanotechnology Safety Act of 2010
S. 2942 (111th Congress), the Nanotechnology Safety Act of 2010, was introduced on January 21,
2010, and referred to the Senate Committee on Health, Education, Labor, and Pensions. The bill
would require the Secretary of Health and Human Services to establish within 180 days a
program for the scientific investigation of nanoscale materials included or intended for inclusion
in FDA-regulated products, to address the potential toxicology of such materials, the effects of
such materials on biological systems, and interaction of such materials with biological systems.
The bill would authorize $25 million per year for fiscal years 2011 to 2015.
H.R. 820 (111th Congress)—Nanotechnology Advancement and New
Opportunities Act
H.R. 820 (111th Congress), the Nanotechnology Advancement and New Opportunities Act, was
introduced on February 3, 2009, and referred to the House Science and Technology Committee;
the House Ways and Means Committee; the House Energy and Commerce Committee; and the
House Homeland Security Committee. Among its provisions, the bill would require the NNCO to
produce an annual research strategy that establishes priorities for the development and
responsible stewardship of nanotechnology, as well as providing recommendations regarding the
funding required to implement the strategy.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Appendix. Overview of Selected Federal Agencies’
Roles in the Regulation of Nanotechnology
Several federal regulatory agencies have begun to grapple with the EHS issues raised by
nanotechnology in their spheres of responsibility. Some critics argue that there is a potential
conflict of interest among some regulatory agencies that are, on the one hand, conducting and
promoting nanotechnology research and that are, on the other hand, responsible for regulating
nanotechnology applications. The following section provides an overview of selected federal
agencies’ roles in the regulation of nanotechnology.
Environmental Protection Agency
The Environmental Protection Agency (EPA) has both a research function and a regulatory
function. The agency has asserted a need for more information to assess the potential EHS
impacts of most engineered nanoscale materials. According to EPA, this information is needed
... to establish a sound scientific basis for assessing and managing unreasonable risks that
may result from the introduction of nanoscale materials into the environment.75
In this regard, EPA is supporting research on the toxicology, fate, transport, transformation,
bioavailability, and exposure of humans and other species to nanomaterials to obtain information
for use in risk assessment, a central aspect of EPA’s mission.76
EPA plays a central role in coordinating the federal governments research efforts to address
nanotechnology EHS issues, serving as co-chair of the NSET Nanotechnology Environmental
Health Implications (NEHI) working group. The National Institute for Occupational Safety and
Health (NIOSH), a research institute within the Department of Health and Human Services, is
EPA’s co-chair of the NEHI working group.
EPA also works with international organizations engaged in nanotechnology-related regulatory
issues, such as the International Organization for Standardization and the Organization for
Economic Cooperation and Development.
With respect to its regulatory function, multiple statutes govern EPA’s authority to regulate
nanotechnology materials and devices, including the Clean Air Act (CAA, 42 U.S.C. 7401 et
seq); Clean Water Act (CWA, codified generally as 33 U.S.C. §§1251-1387); Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C.136-136y); and Toxic Substances Control Act
(15 U.S.C. 2601 et seq.).77
75
“Fact Sheet for Nanotechnology under the Toxic Substances Control Act,” Environmental Protection Agency.
http://www.epa.gov/oppt/nano/nano-facts.htm
76
“Exploratory Research: Nanotechnology Research Grants Investigating Fate, Transport, Transformation, and
Exposure of Engineered Nanomaterials: A Joint Research Solicitation - EPA, NSF, & DOE,” Environmental Protection
Agency. http://es.epa.gov/ncer/rfa/2007/2007_star_nanotech.html
77
For additional information, see CRS Report RL30798, Environmental Laws: Summaries of Major Statutes
Administered by the Environmental Protection Agency, coordinated by (name redacted).
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
Important issues have been raised about the application of EPA’s authorities to regulate
nanotechnology. Several issues revolve around TSCA, which authorizes regulation of chemical
commerce.78 Under the provisions of TSCA, producers of a “new” material must provide EPA
with a premanufacture notification (PMN). EPA then has 90 days to approve manufacture, to
require information from manufacturers, or to restrict chemical use. Other TSCA provisions
permit EPA regulation of existing chemicals already in commerce, but these rely on EPA factfinding and rulemaking before EPA can require testing or restrict uses. Several NGOs have urged
EPA to consider all nanoscale materials “new” regardless of whether the material is on the EPA
inventory list in its bulk form.79 However, some nanotechnology materials have the same
chemical composition as materials that are already in commerce, raising the question of whether
the nanotechnology materials are “new” and thus subject to PMN requirements.
When nanomaterials are intended to control pests, including microbes, FIFRA may offer EPA
more authority to regulate nanotechnology than TSCA, according to Lynn Bergeson, chair of the
American Bar Association’s Section on Environment, Energy, and Resources:
Under TSCA, once a substance is on the approved inventory list, any use is legitimate, but
FIFRA is use-specific. The EPA always has the authority to assess the risk of pesticides,
regardless of the use.80
Applicability of FIFRA to nanotechnology products was one aspect of a November 2006 EPA
ruling that a device that “incorporates a substance intended to prevent, destroy or mitigate pests”
is considered a pesticide and is required to be registered under FIFRA. While the ruling is not
unique to nanomaterials, it came in the context of advertising claims for a washing machine
containing nanoscale silver ions that kill microbes. EPA’s ruling made this appliance the first
nanotechnology product to be regulated under FIFRA. However, claims for the pesticidal
effectiveness of the washing machine have been removed from advertisements, possibly limiting
EPA’s ability to regulate the device as a pesticide under FIFRA.
In a May 2010 review of EPA’s role in regulating nanotechnology, the U.S. Government
Accountability Office concluded that EPA was missing opportunities to collect additional
information under TSCA, FIFRA, the Clean Water Act and other environmental statutes.81
Food and Drug Administration
A variety of current and future products that incorporate nanotechnology fall, or may fall, under
the regulatory auspices of the FDA, including cosmetics, medical devices, foods, drugs,
biological products, and combination products.82 FDA anticipates that many of the
nanotechnology products that the agency is likely to regulate will be combination products, such
as drug-device, drug-biological, or device-biological products. According to FDA, it regulates
products based on their statutory classification rather than the technology they employ, thus the
78
For more information about TSCA and nanotechnology, see CRS Report RL34118, The Toxic Substances Control
Act (TSCA): Implementation and New Challenges, by (name redacted).
79
“The EPA’s Toxic Substances Control Act: What you must know,” Small Times, September/October 2007.
80
“EPA Regulates Nano Product, Not Nano Industry,” Small Times, January 2007.
81
Ibid.
82
For additional information, see CRS Report RL34334, The Food and Drug Administration: Budget and Statutory
History, FY1980-FY2007, coordinated by (name redacted).
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
agency may not provide regulatory consideration to a nanotechnology product until well after its
initial development.83 Also, some critics maintain that FDA’s limited regulatory authority over
certain categories of products may limit its authority to regulate nanotechnology products.
With respect to the need for unique tests or requirements for regulating nanotechnology products,
FDA states that its existing requirements may be adequate for most nanotechnology products it
expects to regulate. FDA asserts that nanotechnology products are in the same size-range as the
cells and molecules its reviewers and scientists deal with every day. The agency says that every
degradable medical device and injectable pharmaceutical generates particulates that pass through
the nanoscale size range during the processes of their absorption and elimination by the body.
FDA says that it has no knowledge of reports of adverse reactions related to the “nano” size of
resorbable drug or medical device products. New tests or other requirements may be needed,
according to FDA, if new risks are identified arising from new materials or manufacturing
techniques. Others, in particular consumer groups, counter that FDA’s resources are insufficient
to adequately address the safety of emerging technologies in general, and that the agency’s
regulatory approach, particularly for cosmetics, dietary supplements, and other products for
which pre-market review is not required, would not detect any problems until such products had
been in use.84
FDA does not provide grants for nanotechnology research but does conduct research in several of
its centers to understand the characteristics of nanomaterials and nanotechnology processes. FDA
is collaborating with NIEHS on studies, as part of the interagency National Toxicology Program.
FDA says that there currently is no international regulation of nanoproducts or the underlying
nanotechnology. FDA participates in multinational organizations where cooperative work on
nanotechnology has been proposed, including the Organization for Economic Cooperation and
Development, ASTM International, and the International Organization for Standardization.
National Institute of Environmental Health Sciences/National Toxicology
Program
While not a regulatory agency, NIEHS, a part of the National Institutes of Health, is conducting
nanotechnology EHS research that will support the missions of regulatory agencies. In particular,
NIEHS serves as home to the interagency National Toxicology Program (NTP). The NTP’s
mission is to coordinate toxicological testing programs, develop and validate improved testing
methods, develop approaches and generate data to strengthen scientific knowledge about
potentially hazardous substances, and communicate with stakeholders.85 In 2006, the NTP
established the Nanotechnology Safety Initiative (NSI), a broad-based research program to
83
“FDA and Nanotechnology Products,” Food and Drug Administration. http://www.fda.gov/nanotechnology/faqs.html
See, for example, Michael Taylor, Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?
The Project on Emerging Nanotechnologies, October 2006, at http://www.nanotechproject.org/news/archive/
is_fda_nanotech-ready. The FDA Science Board, Subcommittee on Science and Technology, designated
nanotechnology as one of eight emerging technologies that are most challenging for FDA. See FDA Science Board,
Subcommittee on Science and Technology, FDA Science and Mission at Risk, November 2007, p. 4, at
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA Report on Science and Technology.pdf.
The FDA Science Board is the advisory board to the FDA Commissioner.
85
“Toxicology in the 21st Century: The Role of the National Toxicology Program,” Update, National Toxicology
Program, January 2004. http://ntp.niehs.nih.gov/ntp/htdocs/Liaison/2004JanLO_News.pdf
84
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
address potential human health hazards associated with the manufacture and use of nanoscale
materials. The goal of this research program is to evaluate the toxicological properties of major
nanoscale materials that represent a cross-section of composition, size, surface coatings, and
physical and chemical properties, and to use these as model systems to investigate fundamental
questions concerning whether nanoscale materials can interact with biological systems and how
they might do so.86
According to NTP, the NSI is focused on three areas of research with respect to specific types or
groups of nanoscale materials:
•
non-medical, commercially relevant and available nanoscale materials to which
humans are intentionally being exposed, such as cosmetics and sunscreens;
•
nanoscale materials representing specific classes (e.g., fullerenes and metal
oxides) so that information can be extrapolated to other members of those
classes; and
•
subsets of nanomaterials to test specific hypotheses about a key characteristic
(such as size, composition, shape, or surface chemistry) that might be related to
biological activity.87
NSI research activities are focused on metal oxides, fluorescent crystalline semiconductors (also
known as quantum dots), fullerenes, carbon nanotubes, nanoscale silver, and nanoscale gold.
Occupational Safety and Health Administration/National Institute for
Occupational Safety and Health
The mission of the Occupational Safety and Health Administration (OSHA), an agency of the
Department of Labor, is to ensure the safety and health of America’s workers by setting and
enforcing standards; providing training, outreach, and education; establishing partnerships; and
encouraging continual improvement in workplace safety and health. OSHA has not yet taken any
regulatory actions with respect to nanotechnology.
The National Institute for Occupational Safety and Health (NIOSH), a part of the Centers for
Disease Control, is the lead federal agency conducting research and providing guidance on the
occupational safety and health implications and applications of nanotechnology. NIOSH co-chairs
the NSET’s NEHI working group together with EPA. NIOSH is not a regulatory agency, but its
work directly supports OSHA and other regulatory agencies. NIOSH and OSHA are considering
new risk management approaches that seek to maximize flexibility for innovation while ensuring
the health and safety of workers.88
86
Toxicology in the 21st Century: The Role of the National Toxicology Program, Department of Health and Human
Services, February 2004. http://ntp.niehs.nih.gov/ntp/main_pages/NTPVision.pdf
87
National Toxicology Program website, available at http://ntp.niehs.nih.gov/?objectid=30302D16-F1F6-975E7B315D93D4A1246F
88
Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, Nanoscale Science,
Engineering, and Technology Subcommittee, National Science and Technology Council, The White House, September
2006.
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Nanotechnology and Environmental, Health, and Safety: Issues for Consideration
NIOSH states that its nanotechnology efforts are building on its experience in defining the
characteristics, properties, and effects of ultrafine particles—such as welding fumes and diesel
particulates—as well as its experience in conducting advanced health effects laboratory studies
and in fostering industrial hygiene policies and practices.
NIOSH has developed interim guidelines for working with nanomaterials. The agency asserts that
these guidelines are consistent with the best scientific knowledge of nanoparticle toxicity and
control. NIOSH also maintains a Nanoparticle Information Library with information on the health
and associated properties of nanomaterials as an online resource for occupational health
professionals, industrial users, worker groups, and researchers.89
Consumer Product Safety Commission
The Consumer Product Safety Commission (CPSC) is charged with protecting the public from
unreasonable risks of serious injury or death from certain types of consumer products.90 CPSC
has asserted that potential safety and health risks of nanomaterials can be assessed under existing
CPSC statutes, regulations and guidelines. Since the Consumer Product Safety Act (15 U.S.C.
2051 et seq.) and the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) do not require
pre-market registration or approval of products, CPSC does not evaluate a product’s risk to the
public until it has been distributed in commerce.
In August 2005, CPSC commissioners approved a nanotechnology statement which notes that
nanotechnology presents challenges that “may require unique exposure and risk assessment
strategies.” The CPSC statement identified regulatory challenges, including identification of the
specific nanomaterial in a product; the need to characterize the materials to which a consumer is
exposed during product use, including an assessment of the size distribution of the materials
released; and the application of toxicological data of appropriate particle sizes to assess health
risks. The CPSC takes the position that it is unable to make any general statements about
potential consumer exposure to nanomaterials or the health effects that may result from exposure
to nanomaterials during consumer use and disposal due to the wide variation in potential health
effects and the dearth of exposure and toxicity data for specific nanomaterials.91
Author Contact Information
(name redacted)
Specialist in Science and Technology Policy
[redacted]@crs.loc.gov, 7-....
89
“Nanotechnology at NIOSH,” National Institute for Occupational Safety and Health. http://www.cdc.gov/niosh/
topics/nanotech/
90
CPSC’s regulatory authorities are provided by the Consumer Product Safety Act; Federal Hazardous Substances Act
of 1960, as amended by the Toy Safety Acts of 1969 and 1984 and the Child Protection Amendments of 1966; Poison
Prevention Packaging Act of 1970; Flammable Fabrics Act of 1953; and Refrigerator Safety Act of 1956.
91
“CPSC Nanomaterial Statement,” Consumer Product Safety Commission, August 2005. http://www.cpsc.gov/library/
cpscnanostatement.pdf
Congressional Research Service
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