WASHINGTON, DC - The International Center for Technology Assessment (CTA) and a coalition of consumer, health, and environmental groups today filed a formal legal petition with the Food and Drug Administration (FDA), calling on the agency to address the human health and environmental risks of untested and unlabeled nanomaterials in consumer products. The petition is the first U.S. legal action filed to address the potential human health and environmental risks of nanotechnology.

Nanotechnology means the design or production of structures by controlling shape and size at the nanometer (nm) scale, or one billionth of a meter. Engineered nanoparticles exhibit different fundamental chemical and physical properties than their bulk material counterparts. Several hundred self-identified consumer products composed of nanoparticles are currently widely available, including many sunscreens and cosmetics, although estimates vary because no labeling is required.

Despite studies suggesting that the new properties of nanoparticles create unique human health and environmental risks and the public's growing exposure, no health and safety testing protocols for products with nanomaterials have been developed and no U.S. government regulations protect the public or the environment from these unassessed risks. FDA relies on safety testing guidelines that were developed for assessing risks of bulk scale materials; however, scientists universally agree that the properties and adverse effects of nanoparticles cannot be reliably predicted from the properties of the material in bulk form. The petition filed today calls on FDA to amend its regulations to require new nano-specific toxicity testing and mandatory product labeling.

"FDA's current regulatory stance is at loggerheads with the view of the scientific community about nanoparticles," said George Kimbrell, the lead CTA staff attorney on the legal petition. "Scientists say that these nanomaterials may pose new health threats, but FDA has failed to take sound scientific precautionary steps. FDA needs to develop comprehensive regulations that account for the unique hazards that may be posed by nanomaterials in commerce. "

The eighty-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility. For example, a 2004 study showed rapid brain damage in fish exposed to a type of manufactured nanoparticle (fullerenes or buckyballs) used in some cosmetics. Other studies suggest that nanoparticles can trigger unpredictable inflammatory and immune responses, and have found that nanoparticles can penetrate cells and move within the body freely, even crossing the blood-brain barrier. The preeminent U.K. Royal Society and the Royal Academy of Engineering concluded in 2004 that nanoparticles unique hazards warranted a moratorium on their release into the environment. Most recently, last month an aerosol spray bathroom cleaner marketed as a nano-product was recalled by German authorities after eighty people reported severe respiratory problems and six were admitted to the hospital with fluid in their lungs. While German authorities are still uncertain about what caused the recent health problems, the incidents alarm many scientists and regulators concerned about the urgent need for regulatory standards and labeling for nano-products.

The CTA legal petition also focuses on FDA's regulation of nano-sunscreens, sunscreens composed of engineered nanoparticles that, due to the nanoparticles fundamentally different properties, appear transparent or "cosmetically clear." But the engineered nanoparticles of zinc oxide and titanium dioxide used in nano-sunscreens raise red flags for scientists who have found that they can induce free radicals and cause DNA damage, and are uncertain how easily the tiny particles can penetrate and circulate throughout the body.

"Nano-sunscreens are the poster child of FDA's gross failure to adequately protect the publics health and safety with regard to nano-products," continued Kimbrell. "These unlabeled products are marketed without adequate safety testing, yet they are placed directly on human skin, including on children, repeatedly and in large amounts."

Specifically, the legal petition requests:

a formal FDA opinion clarifying the agency's stance regarding nano-products;

the amendment of FDA regulations to include nanotechnology terminology and comprehensive nano-product regulations, including nano-specific toxicity testing and mandatory nano-product labeling;

the amendment of sunscreen regulations to address nanoparticle sunscreen ingredients, including the requirement that all nano-sunscreens be considered new drug products;

the declaration that nano-sunscreens are an imminent hazard to public health and must be recalled until FDA's nano-products regulations are implemented and nano-sunscreen manufacturers submit new drug applications; and

agency consideration of human health and environmental impacts related to nano-product regulation, in accordance with the National Environmental Policy Act (NEPA).

The legal petition was filed in conjunction with the release of a comprehensive report on the dangers of nano-sunscreens and nano-cosmetics by Friends of the Earth (FOE). The petitioning organizations are CTA, FOE, Greenpeace International, The Action Group on Erosion, Technology, and Concentration (ETC Group), Clean Production Action, The Center for Environmental Health (CEH), Our Bodies Ourselves, and The Silicon Valley Toxics Coalition (SVTC).

The full petition and an executive summary are available at  www.icta.org/nanotech/index.cfm