Natural Resources Defense Council  [Printer-friendly version]
March 20, 2006

TINY PARTICLES PROMISE MUCH, BUT COULD POSE BIG RISK.

[Rachel's introduction: During the past 40 years, we have learned an
important lesson from the chemical, nuclear, and genetic-engineering
industries: all governments are now too puny to regulate the behavior
of giant corporations that offer us new technologies whenever it
suits their business plans. Now they are giving us nanotech. Here we
go again.]

You may have seen the TV commercials, or you may have read about it in
the clothing catalogs that clog your mailbox. You now can buy wrinkle-
free clothes.

How do they make it wrinkle-free? With nanotechnology: the science of
manipulating tiny particles that are one-billionth of a meter in size
-- larger than an atom but smaller than a cell -- which in this case
are impregnated into cotton.

But nanotechnology isn't only for pants. It already has a number of
other commercial applications, from high-capacity computer drives to
food packaging, shampoos, sunscreens and cosmetics. And it is being
hailed as the next industrial revolution, likely to change everything
from the cars we drive to the clothes we wear to the medical
treatments doctors can offer. Scientists expect these invisible
nanoparticles, or ultra-fine particles, will enable them to create new
cancer therapies, pollution-eating compounds, more durable consumer
products, advanced detectors for biohazards like anthrax, and higher-
efficiency fuel cells, among other things.

While nanotechnologies promises much, very little is known about the
risks it may pose to people, wildlife or the environment. The limited
research on nanotechnologies indicates that there is a very real
potential for harm. Likewise, there are no adequate federal or state
regulations governing its use, so there is nothing holding back the
nanotechnology industry from continuing to market products containing
nanoparticles, which are likely to wind up in our bodies or the
environment.

Nanomaterials Are Not Benign

Nano, which comes from the Greek word for "dwarf," is used by
scientists to indicate 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 400 miles -- 25,344,000.
Molecules in the range of 1 to 100 nm are considered nano-sized. The
width of a human hair, for example, is 80,000 nm.

Nanotechnology describes the engineering of nano-size materials from
such elements as carbon, iron or titanium. While nano-sized materials
are not new, scientists' ability to construct geometric arrays of
elements on a nano-scale has become increasingly sophisticated over
the last decade.

Nanomaterials come in a number of shapes and sizes, such as
buckeyballs (60 carbon atoms in the shape of a soccer ball named after
R. Buckminster Fuller, the designer of the geodesic dome), fibers and
dots, and have different properties than their normal-size
counterparts. At nano-size, opaque materials may become transparent,
chemically stable materials may become reactive, and electrical
insulators may become conductors, or vice-versa.

Laboratory animal studies suggest that nanoparticles can cause
inflammation, damage brain cells, and cause pre-cancer lesions. Early
research also has found that nanoparticles easily move from one area
of the body to another. A nanoparticle may easily penetrate a cell,
while the normal-size form of the same chemical may not be able to
enter.

There are three main ways people can be exposed to nanomaterials:
inhaling them, ingesting them, or absorbing them through their skin. A
June 2005 study by researchers at Rice University found that carbon
buckeyballs will clump together and become soluble in water. This is
disconcerting given that buckeyballs can damage the brain cells of
fish, according to a 2004 Duke University study. Meanwhile, scientists
at the New Jersey Institute of Technology found that high levels of
nano-alumina oxide stunts the growth of five plant species, which
include corn, cucumbers, cabbage, carrots and soybeans. Nano-alumina
already is used to make scratch-resistant coatings and sunscreen
lotions, and to neutralize water pollution, where it could be released
directly into waterways.

Industry response to these early warnings has been mixed. Some large
manufacturers and many small start-ups welcome safety testing and
adequate regulation if they are not overly costly or burdensome. But
other manufacturers are either avoiding conducting safety tests or are
keeping their test data confidential. At the same time they are
reassuring the public that the technology is safe.

The insurance industry, meanwhile, is worried about nanotechnology's
potential health and environmental hazards; it does not want to face
another asbestos liability debacle. Reinsurance companies such as
Swiss Re, and financial investment advisers such as Innovest and
Allianz, have called for strict safety testing and regulatory
oversight.

Federal Safeguards and Research Inadequate

Federal laws have not kept up with advances in nanotechnology, and the
regulations that may apply to the field cross numerous agencies,
including the Environmental Protection Agency, Occupational Safety and
Health Administration, National Institute for Occupational Safety and
Health, Food and Drug Administration, Consumer Product Safety
Commission, and Department of Agriculture.

The Toxic Substances Control Act is the most obvious law for
regulating nanomaterials. But the law does not require manufacturers
to provide safety data before registering a chemical, instead placing
the burden on the government to demonstrate that a substance is
harmful. If the government does not follow up on potential risks with
a new product application within several months, the company can
proceed to sell its product. Other laws on the books also are
inadequate. The Food, Drug and Cosmetic Act includes only feeble
safeguards for cosmetics, which already promise to be a major use of
nanomaterials. Likewise, the poorly enforced Occupational Safety and
Health Act fails to address nano-specific worker protections.

In response to the dearth of sufficient regulations, the EPA is
developing a voluntary program with the input of industry, academic
health and environmental groups, including the Natural Resources
Defense Council (NRDC). The agency will ask manufacturers to
voluntarily submit basic information on their nanomaterials and their
risk management practices. The EPA also plans to establish another
voluntary "in depth" program to gather more specific information to
help the agency conduct risk assessments of nanomaterials and develop
regulations. Manufacturers have at least one incentive to participate:
they would be able to advertise that they are acting responsibly.

The EPA's volunteer approach may help to fill an immediate need for
data, but it is severely limited. Companies do not have to
participate, and those producing the riskiest products are unlikely to
do so. In addition, the program is designed to do little more than
gather data, and does not define what protective actions the
government should require, if any, in response.

The federal government established the National Nanotechnology
Initiative (NNI) in 1998 to coordinate multi-agency research and
development on nanotechnologies. Federal funding for nanotechnology
research and development through the NNI has tripled since it was
established in 2001, from $464 million in 2001 to $1.2 billion in
2007. The budget for fiscal year 2005 earmarked $38.3 million -- less
than 4 percent of federal nanotech research dollars -- for
investigating the potential risks nanotechnology poses to health and
the environment. That amount should be at least tripled if safety
testing is going to keep up with research and development.
Unfortunately, it is unlikely that federal priorities will change
soon, given that in the FY2007 nanotechnology research budget the
president has proposed $603 million for the Defense Department and
Energy Department, and only $182 million for the agencies charged with
protecting health -- the EPA and Health and Human Services.

Some federal agencies are addressing the potential downside of
nanotechnology. Health and Human Services' National Toxicology
Program, for example, is researching potential health risks. The EPA
awarded $4 million in research grants last year to study the potential
impact of nanotechnologies on human health and the environment. And
the National Institute for Occupational Safety and Health is
developing a "best practices" document on handling nanoparticles in
the workplace to reduce risks. But much more needs to be done to
better understand potential risks.

What Needs to Be Done

In December 2005, the EPA released a nanotechnology "white paper" that
provides an overview of the field, its benefits and applications, a
toxicological review of available data, and research needs. Most
important, it recommends that the EPA:

** 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 its collaborations on the potential human and environmental
health implications;

** convene a standing cross-agency group to share risk information and
regulatory activities; and

** expand its activities to train agency scientists and managers about
the potential environmental applications and implications of
nanotechnologies.

While the white paper's recommendations are a good start, they do not
go far enough to prevent harmful exposures. To ensure the safety of
nanoscale materials, NRDC recommends that the federal government also:

** take immediate action to prevent uses of nanomaterials that may
result in human exposures or environmental releases, unless reasonable
assurances of safety are demonstrated beforehand;

** require labels for products that contain nanomaterials, and for
products made with processes that use nanomaterials;

** publicly disclose information on potential risks;

** include toxicity information on nanomaterials for worker protection
on material safety data sheets;

** increase safety testing conducted by independent or government
laboratories subject to "sunshine laws" that allow public access;

** 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.

In addition to these policy recommendations, NRDC has asked the EPA to
expand its outreach to include the advice of public health experts,
worker protection advocates, community groups, state regulatory
agencies, ethicists, and public interest groups. NRDC also has
encouraged the EPA to reach out to small businesses, companies that
use nanomaterials in their products, and retailers selling products
that contain nanomaterials or use nanomaterials in their production.
Each of these stakeholders represents a unique and important
perspective in determining appropriate ways to go forward with
nanotechnology development safely and sustainably.

The genie is out of the bottle, but we still can demand assurance that
our families, wildlife and the environment are safe before more
nanomaterials are used in consumer products or released into the
environment.

We are at the same crossroads we were a few years ago with genetically
modified food, and that showed that empty assurances of safety will
not win over a wary public. The federal government, state regulators,
and industry have an opportunity to develop this exciting new
technology openly, with public participation and government oversight.
Otherwise we will be allowing the nanotechnology industry to conduct
an uncontrolled experiment on the American people.

More Information on the Web

For ongoing technical information about the research and development
of nanomaterials, see the Small Times site.

The Woodrow Wilson International Center for Scholars Project on
Emerging Nanotechnologies provides information about responsible
approaches to nanotechnology development, including a searchable
nanotechnology consumer products inventory.

The 2005 EPA Draft Nanotechnology White Paper provides a summary of
the hazards of nanotechnologies, as well as research recommendations.

Innovest, an investment advisor group, published a report on risks in
2005 titled "Nanotechnology: non-traditional methods for valuation of
nanotechnology producers: Introducing the Innovest Nanotechnology
Index for the Value Investor." It is available at
www.innovestgroup.com (see "specialized reports" section).

The Swiss Re insurance site features a 2004 report, "Nanotechnology
-- small matter, many unknowns" about the risks of nanotechnologies.

A 2004 report by the Royal Society of Engineers in the United Kingdom,
"Nanoscience and Nanotechnologies: opportunities and uncertainties,"
provides an overview of scientific concerns and makes recommendations
for strict regulation. last revised 3.20.05

Copyright Natural Resources Defense Council