Nanotechnologies: The Promise and the Peril

2006-09-20

Richard Moore

A very good article.

Nuclear power messes with atoms.
Biotech messes with cells.
Nanotech messes in between.

All of them are dangerous at best.
None of them are properly regulated.

And all of them are being exploited by the Pentagon et al for diabolical 
purposes.

None of them are needed.

rkm

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Original source URL:
http://www.organicconsumers.org/2006/article_2145.cfm

Nanotechnologies: The Promise and the Peril
€  By Jennifer Sass, Patrice Simms, and Elliott Negin
Sustainable Development Law & Policy Vol VI Issue 3, Spring 2006
Straight to the Source

NANOTECHNOLOGIES: THE PROMISE AND THE PERIL by Jennifer Sass, Patrice Simms, and
Elliott Negin*

INTRODUCTION Despite the incredible potential of engineered nanomaterials to 
advance cleaner, safer technology, emerging data continue to indicate serious 
potential for harm to human health and ecological systems. Nanoscale materials, 
engineered to be one to one hundred nanometers (³nm²), currently have a number 
of commercial applications, from high-capacity computer drives to food 
packaging, shampoos, sunscreens, and cosmetics. The word ³nanos,² from the Greek
word for ³dwarf,² indicates 10-9, or one-billionth. Nanometer-sized materials 
are one-billionth of a meter in size; larger than atoms, but much smaller than a
cell. As a comparison, there are as many nanometers in an inch as there are 
inches in four hundred miles (25,344,000). The width of a human hair is 80,000 
nm. Scientists predict that these submicroscopic nanoparticles, or ultra-fine 
particles, will give rise to new cancer therapies, pollution-neutralizing 
compounds, more durable consumer products, advanced detectors for such 
biohazards as anthrax, and higher-efficiency fuel cells, among other things. 
These predictions are due to the unique properties of nanoscale materials 
compared with their normal-size counterparts.1 However, laboratory studies 
already warn that nanoparticles can cause inflammation, damage brain cells, and 
cause pre-cancerous lesions. Early research also has found that nanoparticles 
easily pass through body tissues from one area of the body to another. 
Responsible regulation and oversight will be needed to prevent harmful 
exposures. Beyond some basic experimental data on cells and in animals, there is
very little known about the toxicity of nanomaterials. For example, we know 
nothing about whether nanomaterials in products such as cosmetics and shampoos 
penetrate the skin, or vaporize or off-gas from consumer products. When 
considering the potential for harmful effects from nanomaterials, there are two 
lines of evidence that are helpful: first, what is known from well-conducted 
scientific tests published in the peer-reviewed journals; and second, what can 
be extrapolated from the substantial data on the harmful effects of ultrafine 
particulate air pollution.

SMALL SIZE, BIG RISKS

Carbon-based nanomaterials, such as miniscule carbon cylinders called nanotubes 
and tiny carbon spheres called buckyballs, have desirable electrical, 
mechanical, and thermal properties, useful for such applications as developing 
strong, lightweight building and packing materials, computers, and aerospace 
engineering. However, the data thus far indicate that exposure to various carbon
nanomaterials may be harmful to the brain, lung, cardiovascular, and immune 
systems. Carbon nanotubes tend to cluster into ³ropes,² acting more like fibers 
than particles when inhaled, giving rise to lung inflammation and granulomas 
(clusters of cells with injury or inflammation) that may form scar tissue 
(fibrosis). Nanotubes are also insoluble and cannot be broken down by the body¹s
natural processes.

Single-walled carbon nanotubes (³SWCNTs²) have been reported by five different 
research groups to be associated with lung toxicity.2 Government researchers 
from the National Institute of Occupational Safety and Health (³NIOSH²) reported
rapid lung inflammation, rapid progressive fibrosis, and granulomas within seven
days after a single dose of SWCNTs into the lungs of mice.3 Cell damage 
increased in a dose-dependent manner by one day after exposure. One year 
earlier, DuPont researchers had reported acute lung toxicity and transient 
inflammation in rats associated with a single dose of SWCNTs of either 1 or 5 
mg/kg administered into the upper lung.4 That same year, a collaboration between
the National Air and Space Administration (³NASA²) and the University of Texas 
reported dose-dependent granulomas and inflammation in mice that were 
administered a single dose of either 0.1 or 0.5 mg of singlewalled carbon 
nanotubes into the lungs, roughly equivalent to a mouse inhaling nanotubes for 
about three and a half workdays (low dose) or seventeen workdays (high dose) at 
the workplace standard for graphite dust. 5

Despite these data, and the lack of complete safety testing, a major supplier of
carbon nanotubes, Carbon Nanotechnologies, Inc., has registered its product 
under the Toxic Substances Control Act (³TSCA²) as a synthetic graphite. 
Workplace haz-ard labels or material safety data sheets reference the workplace 
permissible exposure limits for graphite (15 mg/m3 of total dust, and 5 mg/m3 
for the breathable fraction).6 Scientists have warned that workers breathing 
nanotube dust at a fraction of the workplace allowable level ³would likely 
develop serious lung lesions.²7

Nanomaterials can also be composed of metal atoms. Examples include nanogold, 
nanosilver, silicon nanowires, reactive metal oxides such as nanotitanium 
dioxide, and quantum dots ­ a closely packed semiconductor crystal with unique 
optical and light-emitting properties. Evidence suggests that metalbased 
nanomaterials can cause damage to humans and the environment. In 2005, 
researchers from the New Jersey Institute of Technology reported that the root 
growth of corn, cucumbers, cabbage, carrots, and soybeans was stunted after a 
24-hour exposure to high doses (2 mg/mL) of alumina nanoparticles in water.8 
Alumina nanoparticles currently are used in scratch- and abrasion-resistant 
coatings on commercial products such as safety glasses, car finishes, and 
flooring. Researchers from the University of California at San Diego reported 
that cadmiumselenium core semiconductor (quantum) dots used in biological 
imaging were acutely toxic to liver cells in a Petri dish at doses typically 
used for imaging.9 The dots are replacing traditional imaging with fluorescent 
dyes, due to their enhanced and longer-lasting brightness.

University of Rochester investigators reported in 2000 that nano-teflon fumes 
(about 16 nm) were much more acutely toxic than Teflon, the popular brand name 
for polytetrafluoroethylene, when inhaled for only fifteen minutes by rodents, 
and rapidly passed through epithelial tissues to other parts of the body, 
inducing severe inflammation, edema, and hemorrhage of lungs within hours after 
exposure.10 In 1992, University of Rochester investigators examined the effects 
of exposure to nano titanium dioxide (TiO2; 20 nm), a material in sunscreen. The
study showed that rodents that inhaled ultra-fine TiO2 for three months, under 
conditions simulating occupational exposures (six hours/day, five days/week), 
had significantly more lung inflammation and scar tissue compared with those 
that inhaled larger TiO2 particles (250 nm).11

HEEDING THE RED FLAGS

Although there is a paucity of toxicity data on nanomaterials per se, the 
hazards of nano-sized (ultra-fine) air pollution are well-documented. 
Particulate matter less than 10 micrometers (PM10; 10,000 nm) is linked to 
increased disease and death from lung cancer and cardiopulmonary disease.12 
These diseases are more closely linked with exposure to smaller particles than 
to larger-sized ones.13 The risks are especially high among sensitive 
individuals, such as those with pre-existing conditions of the heart and lungs, 
including asthma and chronic obstructive pulmonary disease.14

Some of the acute toxicity of ultra-fine particles is likely due to their larger
surface-area­to-mass ratio, ability to penetrate biological tissues, and their 
increased biopersistance compared with larger particles of the same 
composition.15 Given these characteristics and the results of targeted studies 
such as those mentioned above, the potential for harmful effects from widespread
use of nanomaterials must be taken seriously.

MISALLOCATION OF FEDERAL SPENDING

Despite these early warnings, government response thus far to the potential 
risks has been woefully inadequate. In spring 2005, the President¹s Council of 
Advisors on Science and Technology issued its five year review of the 
interagency National Nanotechnology Initiative, established in 1991 to direct 
federal research activities on nanotechnology.16 Although the text of the report
is 46 pages long, the section addressing ³Environmental, Health and Safety² does
not appear until page 35 and is less than one page long. According to the 
Project on Emerging Nanotechnologies at the Woodrow Wilson International Center 
for Scholars, only four percent of the fiscal year (³FY²) 2006 federal 
nanotechnology funding was earmarked for research on health and environmental 
effects, and another four percent on social implications and education.17 
Meanwhile, federal funding for nanotechnology research and development has 
soared from $464 million in 2001 to $1.2 billion in FY 2007.18 Of this 
investment, the National Science Foundation will get $373 million. More than 
$600 million is earmarked for the U.S. Departments of Defense ($345 million) and
Energy ($258 million). By comparison, only $142 million is slated for the human 
health and environment protection branches of the federal government, the U.S. 
Environmental Protection Agency (³EPA²) ($9 million), and the U.S. Department of
Health and Human Services ($133 million), which includes the National Institutes
of Health. With this disparity in funding priorities, it is hard to imagine how 
safety testing could ever catch up with research and development.

Some federal agencies are addressing the potential downside of nanotechnology. 
The Department of Health and Human Services¹ National Toxicology Program is 
researching potential health risks. In addition, NIOSH is developing a ³best 
practices² document on handling nanoparticles in the workplace to reduce risks. 
In FY 2005 the EPA awarded $4 million for research on nanotechnology impacts on 
human health and the environment. However, much more needs to be done to better 
understand the potential risks of nanotechnologies.

RESPONSE BY INDUSTRY AND ITS FINANCIERS

The private sector response to potential health and environment threats has been
mixed. Some corporations seem concerned only about public perception and hope to
disavow actual risk by avoiding safety testing, keeping safety data 
confidential, and providing empty reassurances to the public. Fearing actual or 
perceived risks, insurance companies such as Swiss Re,19 and financial 
investment advisers such as Innovest20 and Allianz,21 have called for safety 
testing and regulatory oversight of nanomaterials. Other large corporations and 
many small startup companies also would welcome safety testing and regulations 
if they were not overly costly or burdensome, because they would contribute to 
market stability by reducing future risks of liabilities and consumer rejection.

REGULATORY BLIND SPOT

Unfortunately, existing environmental laws render federal agencies ill-equipped 
to regulate the nanotech industry.22 TSCA, enacted by Congress in 1976 to gather
information about chemical substances and control those deemed dangerous to the 
public or the environment, is the most obvious candidate for regulating 
nanomaterials. But TSCA lacks an effective means of requiring companies to 
provide risk data, and it places the burden on the government to demonstrate 
unacceptable risk before it can adopt regulatory restrictions of any kind.

In response to a proposal by the EPA for a voluntary program to ³regulate² 
nanomaterials,23 in June 2005, Natural Resources Defense Council (³NRDC²) and 
other public interest groups urged the EPA to identify all engineered 
nanomaterials as ³new chemical substances² under TSCA because they meet the 
standard of ³organic or inorganic substance[s] of a particular molecular 
identity.²24 This would trigger TSCA section 5 pre-manufacture notice (³PMN²) 
reporting requirements prior to the commercial manufacture or import of 
nanomaterials.25 The U.S. Patent and Trademark Office issued more than 8,600 
nanotechnology-related patents in 2003,26 suggesting that at least one arm of 
the government already considers these materials to be new.

In addition to PMN reporting, the 2005 NRDC comments urged the EPAto issue test 
rules under TSCA¹s section 4 by waiving the regulatory production volume 
thresholds that otherwise would not be triggered by the miniscule product volume
of nanomaterials.27 The groups also called for regulations under TSCA¹s section 
6, requiring the EPA to prohibit or limit anyone manufacturing, importing, 
processing, distributing in commerce, using, or disposing of a chemical if there
is a reasonable basis to conclude the chemical presents, or will present, an 
³unreasonable risk of injury to health or the environment.² Tragically, the EPA 
has failed to regulate any new chemical using the TSCA¹s section 6 authority 
since that provision was gutted by the U.S. Court of Appeals for the Fifth 
Circuit in the 1991 case Corrosion Proof Fittings v. EPA (rejecting the EPA¹s 
application of the TSCA¹s section six to asbestos).28 The court¹s decision and 
subsequent problematic EPA interpretations of that decision make it 
extraordinarily difficult for the agency to adopt regulations under section 6 of
TSCA. Thus, NRDC stated that ³while requiring [premanufacture notice], issuing 
test rules, and promulgating regulations under TSCA are necessary steps for 
nanomaterials, such actions will be insufficient to protect public health and 
the environment. Ultimately, additional legislative action by Congress, the 
states, and potentially the courts will be necessary to ensure that 
nanomaterials are adequately addressed.²29

Other laws also are inadequate. For example, the Food, Drug, and Cosmetic Act 
(³FDCA²) leaves all cosmetics essentially unregulated, and the chronically 
under-enforced Occupational Safety and Health Act (³OSHA²) does not adequately 
protect worker health. Thus, neither the FDCA nor the OSHA is viable as a 
vehicle for protecting the public. Other environmental statutes are similarly 
ill-equipped to address nanomaterials ­ for example, these materials would be 
effectively unregulated under the Clean Air Act due to very small production 
quantities.

VOLUNTARY SAFETY TESTING IS NOT ENOUGH

In response to the lack of a regulatory framework for nanotechnology, the EPAis 
developing a voluntary program that will ask nanomaterial producers to submit 
basic information on material characterization, toxicity, exposure potential, 
and risk management practices. Acompany would then be able to advertise its 
participation as a means of dispelling public fears about its product. A more 
in-depth level of participation would generate more detailed risk information. 
NRDC participated in an ad-hoc working group with industry, academic, and public
interest groups to advise the EPA on a general framework for such a program. 
While this program potentially would fill a gap in the absence of real 
regulations, it is severely limited in several important ways. Participation is 
not mandatory, and would only include those products that participating 
companies choose to disclose. Those companies with the riskiest products, as 
well as those with poor business ethics, are unlikely to participate. The 
program also lacks punitive measures; it will do little more than gather data ­ 
primarily industry-generated data, which experience has shown are less likely 
than data from the government or independent studies to report products¹ harmful
effects.30 In the past, industries have gone to great lengths to downplay the 
health risks of asbestos, lead, vinyl chloride, and other toxic materials, only 
to have them lead to devastating occupational and public health consequences.

EPA¹S WHITE PAPER RECOMMENDATIONS In December 2005 the EPA issued the ³External 
Draft Nanotechnology White Paper²31 which made the following reasonable 
suggestions as first steps forward:

€ Support approaches to promote pollution prevention, sustainable resource use, 
and good product stewardship in the production and use of nanomaterials;

€ Support and undertake research on human health and ecological impacts of 
nanomaterials;

€ Conduct case studies on the risks and information gaps of specific 
nanomaterials;

€ Expand collaborations on the potential human and environmental health 
implications;

€ Convene a standing cross-agency group to share risk information and regulatory
activities; and

€ Expand efforts to train agency scientists and managers about the potential 
environmental applications and implications of nanotechnologies.


PUBLIC INTEREST GROUP RESPONSES An array of good stewardship approaches to 
nanotechnology development would increase public confidence and market 
stability. In NRDC comments to the EPA, signed by twenty other public interest 
groups, including Greenpeace International, the Sierra Club, Friends of the 
Earth, Environmental Working Group, ETC group, and Silicon Valley Toxics 
Coalition, the organizations insisted that the federal government take action on
the following initiatives:32

€ Prevent uses of nanomaterials that may result in human exposures or 
environmental releases unless reasonable assurances of safety are demonstrated 
beforehand;

€ Label products that contain nanomaterials or are made with processes that use 
nanomaterials;

€ Publicly disclose information on potential risks; € Include toxicity 
information about nanomaterials on workplace hazard labels;

€ Increase safety testing conducted by independent or government laboratories 
subject to ³sunshine laws² that allow public access to information; and

€ Conduct comprehensive assessment of the environmental and human health 
concerns that may arise across the life-cycle ­ including production, use, and 
disposal ­ of nanotech products.

CONCLUSION

While we know enough to want to avoid exposure to nanomaterials and releases 
into the environment, many issues need to be further studied. For example, we do
not know much about how these materials harm our health over a lifetime of 
exposure; long-term effects have not been studied in experimental animal tests. 
While ingestion and skin penetration are potential routes of exposure, most 
studies have only tried to mimic inhalation. The majority of toxicological 
studies with nanomaterials have been in vitro (such as skin cell toxicity), or 
short-term animal studies. We do not know whether these materials penetrate 
through our skin, even though consumers use shampoos, cosmetics, and other 
household products with nanomaterial ingredients. We do not know if 
nanomaterials are aerosolized and then inhaled when we use shampoos with 
nano-ingredients. We do not know whether ingestion results in toxicity, although
we have nanomaterials in food packaging and even in chocolate chewing gum. We 
know that toxicity of inhaled particles seems to increase as the particle size 
becomes smaller, but we lack efficient and cost-effective ways to measure the 
size distribution of airborne particles.

Many other questions remain unanswered. For example, we do not know the extent 
to which nanomaterials can penetrate the placenta and transfer from mother to 
baby. In addition, we are unaware whether nanomaterials are released from 
products when they are incinerated, buried, or degraded over time. These 
uncertainties indicate that a necessary first step to effective nanotechnology 
regulation will require investing in studies to evaluate the risks, as well as 
the benefits, of nanomaterials on human health and the environment.

ENDNOTES: Nanotechnologies: The Promise and the Peril

1 At nano-size, opaque materials may become transparent, chemically stable 
materials may become reactive, and electrical insulators may become conductors, 
or vice-versa.

2 See Anna A. Shvedova et al., Unusual Inflammatory and Fibrogenic Pulmonary 
Responses to Single-walled Carbon Nanotubes in Mice, 289(5) AM. J. PHYSIOL. LUNG
CELL MOL. PHYSIOL. 698-708 (Nov. 2005) (Epub June 10, 2005); see also David B. 
Warheit et al., Comparative Pulmonary Toxicity Assessment of Single-wall Carbon 
Nanotubes in Rats, 77(1) TOXICOL. SCI. 117-25 (Jan 2004) (Epub Sept. 26, 2003) 
[hereinafter Warheit]; see also Ann C.W. Lam et al., Pulmonary Toxicity of 
Singlewall Carbon Nanotubes in Mice 7 and 90 Days After Intratracheal 
Instillation 77(1) TOXICOL. SCI. 126-34 (Jan. 2004) (Epub Sept. 26, 2003) 
[hereinafter Lam]; see also Huckzko et al., Physiological Testing of Carbon 
Nanotubes: Are They Asbestos-like? 9(2) FULLERENE SCI. TECHNOL. 251-254 (2001); 
see also ADELMAN ET AL., EFFECT OF FULLERENES ON ALVEOLAR MACROPHAGES IN VITRO 
405­407 (ILSI Press 1994).

3 Shvedova, supra note 2. (This study tested occupationally relevant exposure 
levels: 0-40 mg per mouse administered deep into the throat, based on the 
workplace limit for graphite (carbon) particles (a twenty mg dose in a mouse is 
roughly equivalent to twenty workdays of human exposure at the workplace 
permissible exposure limit for graphite)).

4 Warheit, supra note 2.

5 Lam, supra, note 2.

6 The National Institute for Occupational Safety and Health (³NIOSH²), 1988 OSHA
PEL Project Documentation: List by Chemical Name - Graphite, Synthetic: card 
number 0406 (1988), available at http://www. cdc.gov/niosh/pel88/npelname.html 
(last visited Mar. 12, 2006).

7 Lam, supra note 2.

8 Lei Yang & Watts DJ, Particle Surface Characteristics May Play an Important 
Role in Phytoxicity of Alumina Nanoparticles, 158(2) TOXICOL. LETT. 122-132 
(2005) (The same experiment also found that nanoparticles of silicon dioxide 
(used in anti-fogging coatings) promoted plant root growth, while titanium 
dioxide (used in sunscreen) seemed to have no effect).

9 Austin M. Derfus et al., Probing the Cytotoxicity of Semiconductor Quantum 
Dots, 4(1) NANO. LETT. 11-18 (2004).

10 Chris Johnston et al., Pulmonary Effects Induced by Ultrafine PTFE Particles,
168 TOXICOL. APPL. PHARMACOL. 208-215 (2000).

11 See Gunter Oberdorster et al., Role of the Alveolar Macrophage in Lung 
Injury: Studies With Ultrafine Particles, 97 ENV¹T HEALTH PERSPECT. 193-99 (Jul.
1997); see also Raymond B. Baggs et al.,

Regression of Pulmonary Lesions Produced by Inhaled Titanium Dioxide
in Rats, 34(6) VET. PATHOL. 592-97 (Nov. 1997).

12 See Douglas W. Dockery et al., An Association Between Air Pollution

and Mortality in Six U.S. Cities, 9:329(4) N ENG. J. MED. 1753-59 (Dec.

1993); see also Bart D. Ostro, The Association of Air Pollution and

Mortality: Examining the Case for Inference, 48(5) ARCH. ENV¹T HEALTH.

336-42 (Sep-Oct. 1993); see also Douglas W. Dockery et al., Acute

Respiratory Effects of Particulate Air Pollution, 15 ANN. REVISION PUB.

HEALTH. 107­132 (1994); see also Douglas W. Dockery, Epidemiologic
Evidence of Cardiovascular Effects of Particulate Air Pollution, 109
(supp. 4) ENV¹T HEALTH PERSPECT. 483­486 (2001).
13 C.A. Pope 3rd et al.,15 ANNU. REVISION PUB. HEALTH. 107­132D
(1994); K. Ito & George D. Thurston, Lung Cancer, Cardiopulmonary
Mortality, and Long-term Exposure to Fine Particulate Air Pollution,
287(9) JAMA, Mar. 6, 2002, at 1132-41.
14 See Annette Peters et al., Air Pollution and Incidence of Cardiac
Arrhythmia, 11(1) EPIDEMIOLOGY 11-7 (Jan. 2000); see also Annette
Peters et al., Short-term Effects of Particulate Air Pollution on

Respiratory Morbidity in Asthmatic Children, 10(4) EUR. RESPIR. J. 872-

79 (Apr. 1997).

15 See Annette Peters et al., Respiratory Effects Are Associated with the

Number of Ultrafine Particles, 155(4) AM. J. RESPIR. CRIT. CARE MED.

1376-83 (Apr. 1997); see also Gunter Oberdorster et al., Nanotoxicology:

An Emerging Discipline Evolving from Studies of Ultrafine Particles,
113(7) ENV¹T HEALTH PERSP. 823-39 (Jul. 2005); see also A.M. Maynard
& E.D. Kuempel, Airborne Nanostructured Particles and Occupational
Health, J. NANOPARTICLE RES. 2005 (in press).
16 President¹s Council of Advisors on Science and Technology
(³PCAST²), The National Nanotechnology Initiative at Five Years:
Assessment and Recommendations of the National Nanotechnology
Advisory Panel, May 2005, available at http://www.ostp.gov/PCAST/
pcast.html (last visited Mar. 12, 2006).
17 Project on Emerging Technologies, First Inventory of Government
Supported Research on Environmental, Health, and Safety Impacts of
Nanotechnology, available at http://www.nanotechproject.org/
index.php?id=30 (last visited Mar. 12, 2006).

18 National Nanotechnology Initiative: Research and development funding

in the President¹s 2007 budget, available at http://www.nano.gov/
pdf/NNI_fy07.pdf (last visited Mar. 12, 2006).
19 Swiss Re, Nanotechnology: Small Matter, Many Unknowns, 2004,
available at http://www.swissre.com/INTERNET/pwsfilpr.nsf/
vwFilebyIDKEYLu/ULUR-5YNGET/$FILE/Publ04_Nanotech_en.pdf
(last visited Mar. 12, 2006).
20 Innovest Strategic Value Advisors, Nanotechnology: Non-traditional
Methods for Valuation of Nanotechnology Producers; Introducing the
Innovest Nanotechnology Index for the Value Investor, Aug. 29, 2005,
available at http://www.innovestgroup.com/pdfs/Nanotechnology_
Report.pdf (last visited Mar. 12, 2006).
21 Allianz Group and the OECD, New report on Risks and Rewards of
Nanotechnology, June 3, 2005, available at http://www.allianz.com/
azcom/dp/cda/0,,796454-44,00.html (last visited Mar. 12, 2006).
22 Project on Emerging Nanotechnologies, Getting Nanotech Right: A
New Report on Government Oversight of Nanotechnology, Jan. 9, 2006,

available at http://www.nanotechproject.org/index.php?id=39 (last visited

Mar. 12, 2006).
23 U.S. ENV¹T PROT. AGENCY (³EPA²), NANOSCALE MATERIALS; NOTICE
OF PUBLIC MEETING -DOCKET ID NO. OPPT­2004­0122, FED. REGISTER
Vol. 70, No. 89 (May 10, 2005), available at
http://www.epa.gov/fedrgstr/EPA-TOX/2005/May/Day-10/t9324.htm (last
visited Mar. 18, 2005).
24 Toxic Substances Control Act (³TSCA²) § 3(2)(A); 42 U.S.C. §
2602(2)(A).

25 See TSCA, id., at § 5 (authorizing the EPA to review activities associated

with the manufacture, processing, use, distribution in commerce, and
disposal of any new chemical substance before it enters commerce, and

requiring pre-manufacture notice (³PMN²) reporting prior to commercial

manufacture or import under § 5 and 42 U.S.C. §2604).
26 PCAST, supra note 16.

27 See TSCA, supra note 24, at § 4(a) (stating that where there are insufficient

data to assess the effects of the manufacture, distribution, processing,

use or disposal of a chemical substance, and testing is necessary to
develop such data, the TSCA provides that the EPA shall promulgate

regulations requiring manufacturers and/or processors of such substances

to develop new data that are needed to assess potential risks to human

health and the environmental if the administrator finds: (1) that manufacture,

distribution, use, and disposal practices may present an unreasonable

risk of injury (§ 4(a)(1)(A)(i)); or (2) that the chemical will be produced

in substantial quantities and that it enters or may be reasonably

anticipated to enter the environment in substantial quantities or that there

is or may be significant or substantial human exposure to the substance, §

4(a)(1)(B)(i)).
28 Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991).
29 NATURAL RESOURCES DEFENSE COUNCIL (NRDC) ET AL., NRDC AND
OTHERS COMMENT ON EPA PROPOSAL TO REGULATE NANOMATERIALS
THROUGH A VOLUNTARY PROGRAM, OPPT-2004-0122 (Jun. 2005), available
at http://www.icta.org/doc/OPPT-2004-0122-0037.pdf (last visited
Mar. 12, 2006).

30 Jennifer Sass, Credibility of Scientists: Conflict and Bias, 114(3)

ENV¹T HEALTH PERSPECT. A147 (2006); 11(4) Int. J. Occup. Env. Health,
Special Issue, (Oct/Dec 2005), available at http://www.ijoeh.com/
archive_01.html#1104 (last visited Mar. 5, 2006); F.S. vom Saal & C.
Hughes, An Extensive New Literature Concerning Low-Dose Effects of
Bisphenol A Shows the Need for a New Risk Assessment, 113(8) ENV¹T
HEALTH PERSPECT. 926-933 (2005); E.K. Ong & S.A. Glantz,
Constructing ³Sound Science² and ³Good Epidemiology²: Tobacco,
Lawyers, and Public Relations Firms, 91(11) AM. J. PUB. HEALTH 1749-
1757 (2001).
31 U.S. Env¹t Prot. Agency¹s Sci. Policy Council, Nanotechnology
Workgroup, External Review Draft Nanotechnology White Paper, 73-81

(Dec. 2, 2005), available at http://www.epa.gov/osa/pdfs/EPA_nanotechnology_

white_paper_external_review_draft_12-02-2005.pdf (last visited
Mar. 12, 2006).
32 NATURAL RESOURCES DEFENSE COUNCIL, COMMENTS ON U.S. EPA
EXTERNAL REVIEW DRAFT NANOTECHNOLOGYWHITE PAPER, Docket ID:
EPA-HQ-ORD-2005-0504 (Jan. 31, 2006), available at
http://www.icta.org/doc/Comments%20on%20EPA%20Nanotech%20Whi
te%20Paper%20Jan%2006.pdf (last visited Mar. 12, 2006).


Ms. Jennifer Sass, •••@••.•••, is a senior scientist in Natural Resource 
Defense Council¹s (³NRDC²) health and environment programs. Mr. Patrice Simms is
a senior project attorney in NRDC's air and energy, and health programs, where 
he specializes in coal-fired power plant issues. Mr. Elliott Negin is NRDC¹s 
Washington communications director. Portions of this article are reprinted with 
permission from J. Sass, ATOMIC BULL. SCI., Mar/Apr 2006, Vol. 62(2).
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