Does nanotechnology offers threats
Or promises? The jury is still out

Does nanotechnology promise a series of innovations in healthcare, consumer products and industry or does it offer the threat of unknown potential for environmental and individual risks?

That was the underlying question at a session – “Nanotechnology: Will Big Legal Problems Come in Very Small Packages?” – presented at the recent Annual Meeting in San Francisco.

On one hand, representatives of the FDA and the chemical industry point out existing safeguards under consumer protection laws. They also note that because nanotechnology deals with a different form of existing chemicals these chemicals are covered by current laws. The suggestion from the FDA is to wait and see how nanotechnology is used to determine what types of legislation or regulation might be needed.

Not good enough, said George Kimbrell, staff attorney for the International Center for Technical Assessment. Today firms are spending $9 billion a year on research and development in adapting nanotechnology to new and existing products, he said. By 2015, Kimbrell estimated that that amount will grow to $1 trillion.

"Paints and coatings, packaging, personal care products, cosmetics and sunscreens are all areas where nanotechnology is being used today," he said.

Because of their extremely small size nano-particles can go places other chemicals cannot. For example, nano-materials from sunscreens can enter the body through the skin and move from blood into tissues. No one knows the long-term implications, said Kimbrell.

His organization has filed a petition against the FDA for failing to regulate the health and environmental hazards of nanotechnology. The ICTA would like a recall of all sunscreens containing nano-particles until the safety is assured.

Paul Howard of the FDA pointed out that the FDA is actively studying nanotechnology for health and safety. The FDA regulates 25 percent of the nation's commerce, and Howard noted that the agency not only looks at products on a case-by-case basis, but just completed a report on nanotechnology that was released in July 2007.

From a company perspective, Mark Duvall, management counsel for Dow Chemical, said the question is how to balance risks versus benefits. “Good tests are years away. We don't want to hold up products.” At the same time, Duvall said his company does not want to endanger employees or the public.

“We actively comply with all FDA regulations and work with government review of new products.” He explained that knowing when something is new can be a challenge because often nano-particles are extremely small versions of existing chemicals. “The FDA regulates the molecular or chemical structure, not the physical properties, of a product. We are left to wonder if we are working with a new product.”

John Pendergrass of the Environmental Law Institute looked at another facet of nanotechnology: the impact of nano-particles on plants, animals and natural resources. Co-author of a report – Where Does the Nano Go? End-of Life Regulation of Nanotechnologies, published by The Pew Charitable Trust – Pendergrass said that although nano-particles are extremely small, they have extensive surfaces that can interact with the environment.

He raised the question of whether wastes from nanotechnology processes should be considered solid wastes under RCRA (Resource Conservation and Recovery Act) and CERCLA (Comprehensive Environmental Response, Compensation and Liability Act), or Superfund.

Pendergrass's group is working in a joint partnership with E.I. du Pont de Nemours and Company to evaluate risks.

All panelists agreed that products incorporating nanotechnology are already on the market making the need to know more about possible effects on humans and other parts of the natural world critical.

They emphasized the positive implications of nanotechnology. For example, a scaffold of carbon nanotubes can help restore severed spinal cords so that people with certain injuries can walk again.

Further information is available at www.NanoRiskFramework.com, www.nanotechproject.org, and www.fda.gov/nanotechnology/taskforce/report2007.html.

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