Federal agencies lagging in efforts to ensure safety of nanotechnology

Despite the growing use of nanoengineered materials in consumer products, recent indications from the Food and Drug Administration and the Consumer Product Safety Commission suggest that neither agency is prepared to act any time soon to regulate nanoscale ingredients. Increasingly, manufacturers are developing products with substances like carbon nanotubes, engineered at the nanometer scale to have dramatic new chemical and physical properties. These tiny new substances, some 100,000 times smaller than the width of a human hair, can be more reactive, more toxic, and more accessible to critical organs like the brain than their larger counterparts. 

Last month, nearly two years after its first public meeting on the subject, the FDA hosted another meeting, requesting more feedback about whether and how it should develop guidance for manufacturers on testing to assess unique risks posed by materials manipulated at the molecular level. Such guidance was recommended by the FDA Task Force on Nanotechnology in its 2007 report. The FDA focused its request on nanoscale applications within its jurisdiction to regulate foods, drugs, personal care products and medical devices.

Consumers Union staff scientists Carolyn Cairns and Michael Hansen called for mandatory safety testing and product labeling for drugs, cosmetics, foods, and dietary supplements. Speaking in the session on nanomaterials in foods, Hansen told the audience "we want the FDA to recognize that [engineered nanoscale materials] have the potential for structure-dependent health effects that are uniquely different than their larger counterparts and raise toxicity questions."

So far, the agency has been reluctant to require any mandatory safety testing specifically for nanoscale risks. The FDA currently considers nanoscale ingredients like carbon nanotubes and mineral oxides, found in products like face creams, sunscreens, toothpaste, and dietary supplements, equivalent to much larger, conventional forms of these materials. This despite a growing body of research that suggests many nanomaterials can exhibit very different properties that can increase or change toxicity and the amount of material absorbed by the body. Most of these products do not require any pre-market safety testing. Even for drugs, which the FDA does evaluate before they go on the market, it's not clear whether or not any new data have been required when nanoscale features are introduced. "FDA needs to mandate disclosure of new nanoscale ingredients, and regulate them as new," said Carolyn Cairns, in her statement for the session on nanoscale ingredients in prescription and over-the-counter drugs, and sunscreens. 

Meanwhile, a new report "The Consumer Product Safety Commission and Nanotechnology," finds that the CPSC is further behind the FDA and has yet to take any steps to consult the public or propose actions to address nanoscale hazards in the more than 800 products identified by manufacturers whose products contain nanoscale ingredients. The CPSC oversees such consumer products as toys, furniture, appliances, clothing, and baby products, some of which are formulated with nanoscale ingredients such as silver nanoparticles, according to manufacturer's claims.  The report, from a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts, concludes that the CPSC lacks the staff and financial resources, and in some cases the legal authority, to prevent nanoengineered products from reaching store shelves.