Natural Resources Defense Council
March 20, 2006


[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 (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

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