First nanotechnology lawsuit filed

Feb 3, 2012
by WLJ

Consumer safety and environmental groups sued the Food and Drug Administration (FDA) last month citing scientific reports cautioning against the unregulated use of nanotechnology in consumer products. The case is the first lawsuit over the health and environmental risks of nanotechnology and nanomaterials.

While nanotechnology in agriculture is still relatively new, researchers see a number of uses for nanoparticles, including improving fertilizers and pesticides, allowing for more uniform applications. In addition, some scientists say nanotechnology may improve food safety, with nanoparticle sensors that are able to detect the smallest amounts of contamination in water, feeds, and even on meats.

Scientists say these nanoparticles have the potential to transform agriculture and make current “precision ag” devices obsolete.

But, as with any scientific transformation, the topic is full of controversy.

According to the Institute of Nanotechnology, nanotechnology is the manipulation or self-assembly of individual atoms, molecules, or molecular clusters into structures to create materials and devices with new or vastly different properties. Nanotechnology can work from the top down (which means reducing the size of the smallest structures to the nanoscale e.g. photonics applications in nanoelectronics and nanoengineering) or the bottom up (which involves manipulating individual atoms and molecules into nanostructures and more closely resembles chemistry or biology).

The groups that filed the lawsuit want FDA to respond to a petition the public interest organizations filed with the agency in 2006. The coalition is led by the International Center for Technology Assessment on behalf of fellow plaintiffs Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group and the Institute for Agricultural and Trade Policy (ICTA).

“Nano means more than tiny; it means materials that have the capacity to be fundamentally different. Yet more and more novel nanomaterials are being sold infused into new consumer products every day, while FDA sits idly by,” said George Kimbrell, ICTA attorney. “The agency’s unlawful delay unnecessarily places consumers and the environment at risk.”

The 80-page petition documents the scientific evidence of nanomaterial risks stemming from their unpredictable toxicity and seemingly unlimited mobility, according to a press release put out by the groups. The 2006 petition requested that FDA take several regulatory actions, including requiring nanospecific product labeling and health and safety testing, and undertaking an analysis of the environmental and health impacts of nanomaterials in products approved by the agency.

Nanomaterials in sunscreens, one of the largest sectors of the nano-consumer product market, were also a focus of the action. The petitioners called on the agency to regulate nano-sunscreens to account for their novel ingredients rather than assume their safety, and to pull such sunscreens from the market until and unless the agency approves them as new drug products.

“Year after year goes by but we have yet to see the FDA do the bare minimum and require nanosunscreens to be labeled as such. This is a basic consumer right,” said Ian Illuminato of Friends of the Earth. “We’re well past the 1800s—nobody likes or should be forced to use mystery chemicals anymore.”

According to the groups, since 2006, numerous studies and reports, including agency publications by the Environmental Protection Agency, the Office of the Inspector General, and the U.S. Government Accountability Office, acknowledge significant data gaps concerning nanomaterials’ potential effects on human health and the environment. The report cites a study with mice showing that nano-titanium dioxide when inhaled and when eaten can cause changes in DNA that affect the brain function and may cause tumors and developmental problems in offspring. According to the release, in one study, titanium dioxide nanoparticles were found in the placenta, fetal liver and fetal brain. — Traci Eatherton, WLJ Editor