A Regulatory Sweet Spot?

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by Gwyneth K. Shaw | Jun 20, 2011 9:13 am

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Posted to: Health Care, Nanotech, Science/ Medical

(NHI Nanoblog) Super-small carbon materials are relatively new. Regulators in the United States, and internationally, want new materials and products tested for safety. That testing is expensive and time-consuming.

Is there a sweet spot somewhere that can balance the need to protect public and environmental health with innovation? John C. Monica Jr. thinks so, and hopes the U.S. Environmental Protection Agency will agree.

Gwyneth K. Shaw Photo Monica (pictured) is working with the NanoSafety Consortium for Carbon, an industry coalition that’s pushing the EPA to allow it to pool its resources to test some of its products for safety, rather than evaluating each kind of carbon nanotube or fiber separately. The consortium submitted its proposal to the agency this spring, and is waiting for a formal start to negotiations, said Monica, an attorney at Porter Wright Morris & Arthur LLP in Washington.

“The idea of being good corporate citizens and good public stewards was a driving force,” he said.

In a presentation last week at the massive TechConnect World conference, which featured a wide range of companies looking to capitalize on nanotechnology, Monica said the 15 companies involved are hoping to make the testing process more efficient and transparent while offering a model to other parts of the industry.

The tests required by the EPA for each version of a carbon nanotube, for example, is a 90-day experiment in which rats inhale the material. Companies in the consortium have gotten estimates between $350,000 and $700,000 to do that testing, Monica said. That’s a lot of money for companies in the group, which are generally small or mid-sized firms, he said.

Safety, testing and the question of setting new guidelines are a thorny issue within the nanotechnology field, which leverages the often amazing properties of ultra-tiny substances to make bike frames stronger, medical treatments better and batteries last longer. But shrinking these materials—some of them widely used in their larger form—can change their properties dramatically, raising questions about long-term safety.

Carbon materials that have been engineered to nanoscale (a nanometer is a billionth of a meter), such as carbon nanotubes, have been heavily scrutinized, and some of the evidence is disturbing. The tiny tubes behave like fibers and can be inhaled, even though you can’t see them. Certain types of the multi-walled tubes can reach the same spaces in the lungs of mice where mesothelioma, a type of cancer associated with asbestos exposure, shows up.

These concerns prompted the National Institute for Occupational Safety and Health to issue draft recommendations late last year for handling carbon nanotubes in the workplace. Those guidelines effectively suggest that manufacturers protect workers from virtually any exposure to the material.

Monica said the consortium companies understand the need for safety testing.

“People want to know before they buy and use a product: are they safe?” he said.

The consortium has recruited a number of outside experts, including Gunter Oberdorster, a University of Rochester professor who was among the first to raise serious questions about nanomaterials. Officials from NIOSH and the National Institute of Standards and Technology are also on board as consultants.

Monica said the member companies are committed to being open about their results, and have vowed to release the final results of any testing that’s done for the group.

It will take several months to negotiate if the EPA signals that it’s willing to do so, Monica said, and the testing itself could take two to three years. But if the cooperative works, he said, it could move the science-based safety evaluation of a whole host of nanomaterials forward.

“Hopefully, it’ll be a road map,” he said.

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