Groups Challenge FDA on Nanotechnology Risks Consumers and Environmentalists Warn of Risks from Current Uses of Unregulated Nanomaterials at First-Ever Agency Hearing
Posted Oct. 30, 2008 / Posted by: admin
FOR IMMEDIATE RELEASE: October 10, 2006
WASHINGTON, D.C. – Today, Friends of the Earth (FoE) and the International Center for Technology Assessment (CTA) challenged the FDA to protect consumers from products laced with nanoparticles. Consumer products that currently contain unregulated nanoparticles, including sunscreens and cosmetics used by children and adults could pose new dangers to human health and the environment. The challenge comes as FDA holds its first-ever hearing on nanotechnology.
“With hundreds of nano-laced products already on the market, this meeting is dangerously overdue,” said George Kimbrell, CTA staff attorney. “For any credibility, this hearing must cut through the industry’s hype and focus on the real health and environmental risks of nanotechnology.” This past May CTA and FoE led a broad coalition of consumer, health, and environmental groups in filing the first-ever legal petition challenging FDA’s failure to address the human health and environmental risks of nanomaterials in consumer products. The petition also calls on FDA to require labeling of products containing nanomaterials, as consumers currently have no way to know which products might contain the untested ingredients. The FDA has not answered the petition.
“FDA has been sleeping at the wheel, while hundreds of sunscreen and cosmetics products have been placed on store shelves without adequate regulations and safety testing,” stated Erich Pica, FoE’s Domestic Campaigns Director. “This is one of the most dramatic failures of regulation since asbestos.” In his comments, Mr. Pica highlighted FoE’s 2006 report, Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks, which lists several hundred cosmetics, sunscreens, and personal care products containing engineered nanomaterials now on market shelves.
In addition, the groups noted that FDA had so far received several thousand public comments critical of the agency’s inaction and concerned about the health and environmental risks of nanomaterials in consumer products. “The public has the right to know whether the products they buy contain nanomaterials and whether the FDA has put in place regulations to assure the safety of products containing nanoparticles,” noted Jaydee Hanson, CTA Policy Director. “To date, the FDA has failed to develop a regulatory process that assures the safety of these materials or even informs consumers by requiring labeling. The time for action is now.”
For more information, please contact:
George Kimbrell, International Center for Technology Assessment, (202) 547-9359, firstname.lastname@example.org or Charles Margulis, International Center for Technology Assessment (West Coast Office), (510) 697-0615, CMargulis@icta.org
Erich Pica, Friends of the Earth, 202-222-0739, email@example.com.
Nanotechnology 101: Nanotechnology means the design or production of structures by controlling shape and size at the nanometer (nm) scale, or one billionth of a meter. But “nano” does not mean merely tiny; it is better understood to mean fundamentally different. Engineered nanoparticles can exhibit different fundamental chemical and physical properties than their bulk material counterparts. They have unique and unpredictable human health and environmental risks. For example, nanoparticles’ exceptionally large relative surface area creates increased surface reactivity and enhanced intrinsic toxicity. Their small size allows nanoparticles unprecedented mobility. Easily taken up by the human body, they cross biological membranes, cells, tissues, and organs more efficiently than larger particles. Once in the blood stream, nanomaterials circulate throughout the body and can be taken up by the organs and tissues including the brain, liver, heart, kidneys, spleen, bone marrow, and nervous system. Once inside cells, they can interfere with cell signaling, cause structural damage, and harmful damage to DNA.
Some Red Flags:
- 2006 study shows low concentrations of manufactured nanoparticles of titanium dioxide can produce harmful free radicals in brain cells and the potential for brain cell damage.
- 2005 study concludes engineered nanoparticles of aluminum oxide bioaccumulate and stunt the growth of roots in at least five species of plants: corn, cucumber, cabbage, carrot and soybeans.
- 2004 study shows fullerenes or buckyballs-- a type of manufactured nanoparticle used in some cosmetics -- cause rapid brain damage in fish and are toxic to small crustaceans.
- 2004 study discovers that cadmium selenide nanoparticles (quantum dots) can break down in the human body potentially causing cadmium poisoning
- 2003 study finds the effects of nanotubes on the lungs of rats produced more toxic response than quartz dust.
- 1997 study finds that engineered nanoparticles of zinc oxide and titanium dioxide used in nano-sunscreens can induce free radicals in skin cells and cause DNA damage
The legal petition calls for, among other things:
- nanomaterial-specific regulation
- new paradigms of nano-specific toxicity testing
- the classification of nanomaterials as new substances
- mandatory labeling
- compliance with the National Environmental Policy Act (NEPA).
Friends of the Earth is the U.S. voice of an influential, international network of grassroots groups in 70 countries. Founded in 1969 by David Brower, Friends of the Earth has for decades been at the forefront of high-profile efforts to create a more healthy, just world. Our members were the founders of what is now the world's largest federation of democratically elected environmental groups, Friends of the Earth International.
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