FDA Petitioned to Assess Nanotech Risk

Posted: May 22, 2006

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The preeminent UK 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 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 the 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. It is uncertain how easily the particles can penetrate and circulate throughout the body.

Specifically, the legal petition requests:
-a formal FDA opinion clarifying the agencys 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 the 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 reportedly 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).

- International Center for Technology Assessment (CTA)