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FDA Petitioned to Assess Nanotech Risk
Posted: May 22, 2006
The International Center for Technology Assessment (CTA) and a coalition of consumer, health, and environmental groups filed a formal legal petition this week with the U.S. 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. According to a report from the group, this petition is the first U.S. legal action filed to address the potential human health and environmental risks of nanotechnology.
Nanotechnology, according to the press announcement, 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 are said to exhibit different fundamental chemical and physical properties than their bulk material counterparts. Several hundred self-identified consumer products composed of nanoparticles currently are widely available, including many sunscreen products 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 reportedly have been developed and no U.S. government regulations are currently in place to protect the public or the environment from these unassessed risks. According to the report, the 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 calls on the 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, in a press announcement. "Scientists say that these nanomaterials may pose new health threats, but the FDA has failed to take sound scientific precautionary steps. The FDA needs to develop comprehensive regulations that account for the unique hazards that may be posed by nanomaterials in commerce."
The 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 are said to 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.