Nanoparticles: Environmental risk and regulation

Environmental Quality Management / DOI 10.1002/tqem / Spring 2009 / 1

© 2009 Wiley Periodicals, Inc.Published online in Wiley InterScience (www.interscience.wiley.com).DOI: 10.1002/tqem.20211

Modern technol-

ogy continuously

changes, grow-

ing and evolving

rapidly. What was

once a technologi-

cal breakthrough

quickly becomes

obsolete. New scien-

tific achievements are made daily, and while we

marvel at the possibilities, we often do not stop

to fully analyze the consequences. To quote the

late Michael Crichton, “our most enlightened

past efforts have had undesirable outcomes—

either because we did not understand enough,

or our ever-changing world responded to our ac-

tions in unexpected ways.”1

Worries about the potential consequences of

modern scientific advances have led to increased

pressure for monitoring and regulation. One area

of growing concern is the field of nanotechnol-

ogy.

About This ArticleThis article offers a brief introduction to nan-

otechnology: what it is, where it is headed, the

risks and rewards it entails, and the increasing ef-

forts to regulate the environmental issues it may

create. The subject of nanotechnology is com-

plex, and an article of this length can only hope

to provide a summary of key concepts. Readers

who seek a more in-depth discussion may find

it useful to review

the sources cited in

the endnotes to this

article.

What Is Nanotechnology?

Nanotechnol-

ogy involves work-

ing with materials at very small scales. The

“nano” length scale is one thousand times smaller

than the “micro” scale. One nanometer is one-

billionth of a meter.

The National Nanotechnology Initiative

(NNI), which promotes nanoscale science activi-

ties among federal agencies in the United States,

defines nanotechnology as “the understanding

and control of matter at dimensions between

approximately 1 and 100 nanometers, where

unique phenomena enable novel applications.”2

The United States Environmental Protection

Agency (EPA), which regulates many aspects of

the field, defines nanotechnology as

research and technology development at

the atomic, molecular, or macromolecular

levels using a length scale of approxi-

mately one to one hundred nanometers

Kathleen Gibson and Daniel Pula

Nanoparticles: Environmental Risk and Regulation

TSCA rules provide new oversight

Kathleen Gibson and Daniel Pula2 / Spring 2009 / Environmental Quality Management / DOI 10.1002/tqem

Understanding the Risks of NanotechnologyMuch of modern commerce depends on mak-

ing scientific breakthroughs profitable. But re-

search into new materials rarely involves analysis

of life-cycle impacts. As a consequence, substances

are sometimes distributed in commerce before we

know how they will affect the environment.

Consider two substances that were once widely

used: asbestos and polychlorinated biphenyls

(PCBs). Nature gave us asbestos, and science helped

us understand how to exploit it for use as insula-

tion. But industry incurred enormous financial

liabilities after asbestos was found to cause serious

adverse health effects. PCBs, a group of synthetic

chemicals, were touted for their ability to remain

stable at high temperatures. But they proved ex-

tremely difficult to remove from the environment

and they accumulated in ever-greater concentra-

tions as they traveled up the food chain.6

Nanoparticles raise a number of potential en-

vironmental, health, and safety concerns. Among

them are the following:

• nanoparticles can “be much more reactive

than larger volumes of the same substance”

(because “the chemical reactivity of a material

is related to its surface area when compared to

its volume”),7

• the toxicity of nanoparticles is largely un-

known and unquantified,

• nanoparticles “can disperse easily in air or

water,”8 and

• nanoparticlesmayaggregate(clumptogether)

or agglomerate (become fused together); the

larger particles thus created could “be ab-

sorbed by plants and animals,” and then ac-

cumulate in the food chain like PCBs.9

The potential downsides of nanotechnology

have already captured the attention of popular

culture. In Prey, a novel published in 2002, Mi-

chael Crichton described a fictional company

in any dimension; the creation and use of

structures, devices and systems that have

novel properties and functions because

of their small size; and the ability to con-

trol or manipulate matter on an atomic

scale.3

More simply put, according to EPA, “nano-

technology is the manipulation of matter for use

in particular applications through certain chemi-

cal and/or physical processes to create materials

with specific properties.”4

Materials commonly used in nanotechnol-

ogy include carbon, metals and metal oxides

(including silver, gold,

and iron), and com-

posites. Typically, the

materials are utilized

in the form of small

clusters of atoms. At

the nanoscale, carbon

can be made into hol-

low balls or tubes of

atoms (fullerenes and

nanotubes). Silver can be used as an antimicro-

bial agent to keep food appliances hygienic.

Iron has been used to remediate soil contami-

nation.

Extremely small size can impart special char-

acteristics to nanoparticles that make substances

particularly useful. As the NNI notes:

Unusual physical, chemical, and biologi-

cal properties can emerge in materials at

the nanoscale. These properties may differ

in important ways from the properties of

bulk materials and single atoms or mol-

ecules: some are better at conducting elec-

tricity or heat, some are stronger, some

have different magnetic properties, and

some reflect light better or change colors

as their size is changed.5

2 / Spring 2009 / Environmental Quality Management / DOI 10.1002/tqem

Extremely small size can impart special characteristics to nanoparticles that make substances particularly useful.

Environmental Quality Management / DOI 10.1002/tqem / Spring 2009 / 3Nanoparticles: Environmental Risk and Regulation

The first phase of nanotechnology experi-

mentation focused on creating “passive” prod-

ucts such as coatings and polymers. Now, in the

second phase, researchers have broadened their

scope to more “active” nanostructures.14 As EPA

noted in its white paper, “The second generation,

which we are beginning to enter, involves tar-

geted drug delivery systems, adaptive structures

and actuators. . . .”15

The Agency goes on to note, “The third gen-

eration, anticipated within the next 10–15 years,

is predicted to bring novel robotic devices, three-

dimensional networks and guided assemblies.”16

This phase of nanotechnology could give rise

to a more sophisti-

cated range of prod-

ucts, such as implant-

able self-administering

drug devices or more

efficient medical diag-

nostic tools.

The fourth stage of

nanotechnology de-

velopment, according

to EPA, “is predicted to result in molecule-by-

molecule design and self-assembly capabilities.

Although it is not likely to happen for some

time, this integration of these fourth-generation

nanotechnologies with information, biological,

and cognitive technologies will lead to products

which can now only be imagined.”17

Funding for Nanotechnology ResearchThe actual lifespan of each research phase

ultimately depends on the results it achieves and

the types of products that can actually be made

using nanoparticles. If money is any indication,

however, nanotechnology research will continue

to develop at a rapid pace.

For example, from 1997 through 2003, fund-

ing provided for nanotechnology research and

development by governments worldwide grew

that had developed medical imaging processes

that relied on nanotechnology. In the novel, in-

telligent nanorobots escaped from human control

and became autonomous, self-replicating, and

very dangerous. Mayhem ensued, and the charac-

ters discovered that the technology they thought

would improve the world actually turned out to

be destroying it. The book offered a dark view of

the future, but one that was perhaps not entirely

fantastical.

In a 2007 white paper, EPA noted the dif-

ficulty of assessing nanotechnology risks, stat-

ing, “A challenge in evaluating risk associated

with the manufacture and use of nanomaterials

is the diversity and complexity of the types of

materials available and being developed, as well

as the seemingly limitless potential uses of these

materials.”10 The Agency also noted, “The funda-

mental properties concerning the environmental

fate of nanomaterials are not well understood . . .,

as there are few available studies on the environ-

mental fate of nanomaterials.”11

With respect to nanotechnology risk assess-

ment, EPA listed several key areas that it believed

should be the subject of research:

• chemical and physical identification and

characterization of nanomaterials,

• environmentalfate,

• environmentaldetectionandanalysis,

• potentialreleasesandhumanexposures,

• humanhealtheffects,and

• ecologicaleffects.12

Progress in Nanotechnology ResearchApplied nanotechnology research has been

going on since at least the early 1990s and has

resulted in hundreds of new products. Estimates

indicate that at least 200 consumer products

already on the market contain nanoparticles,

including sunscreens, cosmetics, toothpaste, and

food products.13


The actual lifespan of each research phase ultimately depends

on the results it achieves and the types of products that can actually

be made using nanoparticles.


in 2001. The NNI budget statement for 2008

emphasized the constructive impacts of nano-

technology research, praising the contributions

of nanotechnology in areas such as economic

competitiveness, national security, and public

health.20

The future looks good for nanoparticles,

which are likely to become an ever-bigger part of

our everyday lives. The only thing left to under-

stand, say critics, are the potentially catastrophic

aftereffects of this boom in scientific discovery.

Nanotechnology Regulatory Initiatives The rapid growth of nanotechnology has

led to calls for greater regulation of its potential

environmental, health, and safety impacts. In

the United States, current regulatory and over-

sight efforts are divided among several federal

from around $420 million to over $3 billion.18

Exhibit 1 shows the levels of funding budgeted

and anticipated by federal agencies in the United

States from 2001 through 2009.

As these figures indicate, research spending

on nanotechnology has increased very quickly.

The government agencies that make these ex-

penditures emphasize “long-term, fundamental

research aimed at discovering novel phenom-

ena, processes, and tools . . . and addressing re-

search and educational activities on the societal

implications of advances in nanoscience and

nanotechnology.”19

In the United States, the nanotechnology

research budget for 2008 was even higher than

anticipated. The National Nanotechnology Initia-

tive budget called for spending nearly $1.5 bil-

lion, or more than three times the amount spent


Exhibit 1. National Nanotechnology Initiative Budget, 2001–2009 (in Millions of Dollars)*

U.S. Federal Agency 2001 2002 2003 2004 2005 2006 20072008

(Estimated)2009

(Proposed)

Department of Defense 125 224 220 291 352 424 450 487 431

National Science Foundation 150 204 221 256 335 360 389 389 397

Department of Energy 88 89 134 202 208 231 236 251 311

National Institutes of Health 40 59 78 106 165 192 215 226 226

National Institute of Standards and Technology

33 77 64 77 79 78 88 89 110

National Aeronautics and Space Administration

22 35 36 47 45 50 20 18 19

Environmental Protection Agency

5 6 5 5 7 5 8 10 15

Cooperative State Research, Education, and Extension Service (United States Department of Agriculture)

- - 1 2 3 4 4 6 3

National Institute for Occu-pational Safety and Health

- - - - 3 4 7 6 6

Forest Service (United States Department of Agriculture)

- - - - - 2 3 5 5

Department of Justice 1 1 1 2 2 0.3 2 2 2

Department of Homeland Security

2 1 1 1 2 2 1 1

Department of Transportation - - - - - 1 1 1 1

TOTAL 464 697 760 989 1,200 1,351 1,425 1,491 1,527

* Source: National Nanotechnology Initiative Web site (totals may not add up due to rounding). Available online at http://www.nano.gov/html/about/funding.html.


materials and nanoproducts on human

health and the environment, and [EPA]

has the obligation to ensure that potential

risks are adequately understood to pro-

tect human health and the environment.

As products made from nanomaterials

become more numerous and therefore

more prevalent in the environment, EPA

is thus considering how to best leverage

advances in nanotechnology to enhance

environmental protection, as well as how

the introduction of

nanomaterials into

the environment

will impact the

Agency’s environ-

mental programs,

policies, research

needs, and ap-

proaches to deci-

sion making.23

TSCA: Regulation of New and Existing Chemicals

One key regulatory scheme affecting nano-

technology is the Toxic Substances Control Act

(TSCA).24 For purposes of nanoparticle regulation,

some of the more pertinent provisions of TSCA

are those involving new chemicals and new uses

of existing chemicals.

TSCA created a database (referred to as the

TSCA Inventory) covering all chemical substances

manufactured or processed in the United States.

Chemical substances listed on the Inventory are

considered “existing” chemicals. Any substance

not already listed on the database is classified

as “new” and is subject to specific requirements

pursuant to TSCA Section 5. Under this provi-

sion, a chemical company must submit a pre-

manufacture notification (PMN) to EPA at least

90 days prior to manufacturing or importing a

new chemical.

agencies—giving rise to both overlapping efforts

and gaps in coverage. Thus, for example, the

National Institute for Occupational Safety and

Health21 and the Department of Energy22 have

separately issued occupational health and safety

guidance covering persons who work with nano-

technology. The Food and Drug Administration

regulates certain specific types of products that

may contain nanoparticles, but not the technolo-

gies themselves.

EPA’s RoleThe federal agency most extensively involved

in regulating the environmental impacts of nano-

technology is EPA, which has regulatory author-

ity under a number of statutory programs. The

Agency has noted the many possible benefits of

nanotechnology, while also recognizing the need

to understand its risks. In its nanotechnology

white paper, EPA notes:

Nanotechnology presents potential op-

portunities to create better materials and

products. Already, nanomaterial-contain-

ing products are available in U.S. markets

including coatings, computers, clothing,

cosmetics, sports equipment and medical

devices. . . . Our economy will be increas-

ingly affected by nanotechnology as more

products containing nanomaterials move

from research and development into pro-

duction and commerce.

Nanotechnology also has the potential to

improve the environment, both through

direct applications of nanomaterials to

detect, prevent, and remove pollutants, as

well as indirectly by using nanotechnol-

ogy to design cleaner industrial processes

and create environmentally responsible

products. However, there are unanswered

questions about the impacts of nano-


The federal agency most extensively involved in regulating

the environmental impacts of nanotechnology is EPA, which has

regulatory authority under a number of statutory programs.


ticles. This should allow EPA to better predict

the human and environmental health outcomes

related to nanoparticles.

Nanotechnology ResearchersAlthough EPA has the highest regulatory

profile with respect to nanoparticles, most of the

actual research on nanotechnology is being done

by scientists outside of government—sometimes

with funding from the Agency.

In August 2008, for example, EPA “announced

the award of a $2 million grant to the University

of Kentucky . . . to investigate how the sizes and

shapes of nanoparticles affect their ability to enter

the brain.”29 While EPA gives out grants every

year for many types of research and develop-

ment, this particular grant is noteworthy because

it represents the largest single grant ever awarded

for nanotechnology research under the Agency’s

Science to Achieve Results (STAR) program. EPA

STAR is designed to fund “research grants and

graduate fellowships in numerous environmental

science and engineering disciplines.”30

Insurance Industry Interest in Nanotechnology

The insurance industry is often a bellwether

for emerging or potential risks, and it has recently

begun to take an interest in nanotechnology. In

December 2007, for example, Lloyd’s held a con-

ference on the subject, out of which a report was

published entitled “Nanotechnology: Recent De-

velopments, Risks and Opportunities.” According

to Lloyd’s, the insurance industry needs to begin

studying nanotechnology for several reasons: its

huge potential, its unknown side effects, and the

lack of regulation in the field.

The report listed a number of potential nan-

otechnology-related scenarios that, if they hap-

pened, could have significant negative effects

on the insurance industry. Among the scenarios

described were pollutant spills at facilities that

EPA states that, when determining whether

a chemical is new or existing for TSCA Section

5 purposes, it will look at whether the chemical

“has the same molecular identity as a substance

already on the Inventory.”25 The Agency “views

molecular identity as being based on such struc-

tural and compositional features as the types and

number of atoms in the molecule, the types and

number of chemical bonds, the connectivity of

the atoms in the molecule, and the spatial ar-

rangement of the atoms within the molecule.”26

Under this approach, even a chemical made

up entirely of elements that are already listed

on the Inventory can be considered new if it has

a different structure.

However, particle size

alone will not cause

a nanomaterial to be

considered a “new”

substance if it has the

same structure as an

existing chemical.27

Nanoparticle SNURsEven if a specific chemical substance is already

listed on the TSCA Inventory, EPA can require a

company to file a PMN if it plans to engage in a

“significant new use” of the chemical. In recent

years, the Agency has expanded its application of

significant new use rules (SNURs) to regulate an

array of chemical substances.

In November 2008, EPA issued SNURs for two

nanoparticles: siloxane-modified silica nanopar-

ticles and siloxane-modified alumina nanopar-

ticles. These substances raised concerns at EPA

because of their possible impact on lung function

and their dermal exposure effects.28

There is little current exposure data on nano-

particles. Tracking these two substances through

the SNUR program will offer some insight into

their effects and will also help create at least a

partial life-cycle record for each of the nanopar-


The insurance industry is often a bellwether for emerging or potential risks, and it has recently begun to take an interest in nanotechnology.


4. Ibid., at p. 7.

5. National Nanotechnology Initiative Web site. Nanotech facts, http://www.nano.gov/html/facts/whatIsNano.html.

6. The potential similarities between nanoparticles and sub-stances such as asbestos and PCBs are discussed in more detail in Lloyd’s Emerging Risks Team (2007). Nanotechnology: Re-cent developments, risks and opportunities. Available online at http://www.lloyds.com/NR/rdonlyres/B9C7371E-83D4-49-DD-8268-5D6C800FBDDF/0/ER_Nanotechnology_Report.pdf.

7. Ibid., at p. 3.

8. Ibid.

9. Ibid., at p. 18.

10. U.S. Environmental Protection Agency, Nanotechnology white paper at p. 29.

11. Ibid., at p. 33.

12. Ibid., at p. 2.

13. Seetharam, R. N., & Sridhar, K. R. (2007, September). Nanotoxicity: Threat posed by nanoparticles. Current Science, 93, 769–770. Available online at http://www.ias.ac.in/currsci/sep252007/769.pdf.

14. U.S. Environmental Protection Agency, Nanotechnology white paper at p. 13.

15. Ibid., at p. 12.

16. Ibid.

17. Ibid.

18. Roco, M. C. (2003). Government nanotechnology fund-ing: An international outlook. National Science Founda-tion. Available online at http://www.nano.gov/html/res/IntlFundingRoco.htm.

19. Ibid.

20. National Nanotechnology Initiative. (2008). National Nanotechnology Initiative FY 2008 budget and highlights. Available online at http://www.nano.gov/NNI_FY08_budget_ summary-highlights.pdf.

21. National Institute for Occupational Safety and Health. (2006, July). Approaches to safe nanotechnology: An informa-tion exchange with NIOSH. Available online at http://www.cdc.gov/niosh/topics/nanotech/safenano/pdfs/approaches_to_safe_nanotechnology_28november2006_updated.pdf.

22. Department of Energy, Nanoscale Science Research Cen-ters. (2007). Approach to nanomaterial ES&H. Available online at http://www.sc.doe.gov/bes/DOE_NSRC_Approach_to_Nanomaterial_ESH.pdf.

23. U.S. Environmental Protection Agency, Nanotechnology white paper, at p. 4.

24. 15 U.S. Code section 2601 et seq.

25. U.S. Environmental Protection Agency, Office of Pollu-tion Prevention and Toxics. (2008, January 23). TSCA Inven-tory status of nanoscale substances—General approach, at p. 2. Available online at http://www.epa.gov/opptintr/nano/ nmsp-inventorypaper2008.pdf.

26. Ibid., at p. 3.

27. Ibid., at p. 5.

produce nanoparticles, development of chronic

illness among workers who manufacture nano-

particles, leaching of nanoparticles from prod-

ucts, and recall of nanoparticle products follow-

ing research findings that indicate a hazard. The

report noted, “The likelihood of any of these

events is unknown due to lack of available re-

search and knowledge of the risks and is purely

speculative. However, they do seem plausible if

extreme.”31

If any of the scenarios were to occur, they

could create enormous financial liability for in-

surance companies. An insurer might be required

to pay out for a wide range of damages, including

“clean-up costs of land and water contamina-

tion,” medical treatment for people who are ex-

posed to injury, liability claims, costs associated

with business interruption, and costs related to

product recalls.32

ConclusionAs any innovative technology emerges, it typ-

ically gives rise to uncertainties. Nanotechnology

is no exception. We fear the unknown—and yet

science is all about exploring the unknown.

The goal for environmental protection pro-

grams—and ultimately for scientific research—is

to fully realize the benefits of innovation, while

minimizing any harmful effects to human health

and the environment. It is hoped that regula-

tory programs now being developed, especially

the TSCA regulations administered by EPA, will

provide a sufficient framework for the safe and

effective use of nanotechnology products.

Notes1. Crichton, M. (2002). Prey. New York: HarperCollins; pp. x–xi.

2. National Nanotechnology Initiative Web site. Nanotech facts, http://www.nano.gov/html/facts/whatIsNano.html.

3. U.S. Environmental Protection Agency, Science Policy Coun-cil (2007, February). Nanotechnology white paper (EPA 100/B-07/001). p. 5. Available online at http://www.epa.gov/OSA/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf.



30. U.S. Environmental Protection Agency, National Center for Environmental Research. STAR Grants and Cooperative Agreements Web site, http://es.epa.gov/ncer/grants/.

31. Lloyd’s Emerging Risks Team. (2007). Nanotechnology: Recent developments, risks and opportunities, p. 23. Available online at http://www.lloyds.com/NR/rdonlyres/B9C7371E-83D4-49DD-8268-5D6C800FBDDF/0/ER_Nanotechnology_Report.pdf.

32. Ibid.

28. U.S. Environmental Protection Agency. (2008, November 5). Significant new use rules on certain chemical substances, 73 Fed. Reg. 65743 et seq.

29. U.S. Environmental Protection Agency, National Center for Environmental Research. (2008, August 20). New $2 million grant awarded to the University of Kentucky for re-search on nanoparticles and human health. Available online at http://es.epa.gov/ncer/events/news/2008/08_20_08_press.html.


Kathleen Gibson is general manager of the WSP Environment & Energy office in Somerset, New Jersey. She can be reached at [email protected].

Daniel Pula is a staff scientist with WSP Environment & Energy. He received his BS in environmental policy, institutions, and behaviors from Cook College at Rutgers University in 2007. He can be contacted at [email protected].

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