The world’s smallest materials are going under the government’s microscope.
Under agency chief Lisa Jackson (pictured), the Obama Administration’s Environmental Protection Agency has promised to tighten regulations on nanomaterials, particles as small as molecules which are used by companies working in fields as varied as cosmetics and advanced materials.
At atomic levels many materials take on unique characteristics. Surface areas relative to mass can increase and often a material’s conductivity or water solubility changes. These properties make nanoparticles the basis for powerful new medical and consumer products. But some nanomaterials have also raised worries from environmental and health watchdogs.
These groups fear these sub-microscopic nanomaterials could insinuate themselves into the human body or the water supply. They could potentially lodge in places they don’t belong and, because of their size, be difficult to remove.
In an email an EPA spokesperson said the agency expects to issue new rules by the end of the year about what companies have to reveal and test about products which incorporate nanotechnology. It has also indicated that for certain types of nanoparticles it plans to implement rules which would require companies to alert the agency of new uses of the material several months before products reach the market.
A New Approach
This marks a change in how government regards nanotech. The Bush administration injected billions into the National Nanotech Initiative, a federal research and development program which disperses funds to federal agencies like the National Institutes of Health and the Department of Defense for pioneering new uses for nanotechnology.
The Bush administration was seen as being less concerned about the dangers of nanotech enhanced or enabled products to consumers or the environment.
In January 2008, EPA issued a statement saying that under the Toxic Substances Control Act (TSCA), substances which at nanosize have the same “molecular identity” as their larger counterparts —meaning roughly that its atoms connect in the same shape— would not be considered different chemicals. This meant they wouldn’t be subject to the regulatory churn that a new chemical would.
The ruling galled critics. They argued that since size altered their physical characteristics, nanoparticles should be considered new substances.
TSCA grandfathered in the use of chemicals before the law was implemented. “When TSCA was passed in 1976 there was an assumption that anything on the market is fine,” said Dr. Richard Denison, a senior scientist with the Environmental Defense Fund.
In addition to TSCA, some nanomaterials are regulated under the more robust Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
FIFRA regulates chemicals designed to kill undesirable organisms. It requires companies to report all uses of the relevant chemicals. For example nano-sized silver—frequently used an an antibacterial in products ranging from odor-eater socks to washing machines—is regulated under FIFRA.
Speaking in London in September, Steve Owens, EPA’s assistant Administrator for the Office of Prevention, Pesticides, and Toxic Substances, signaled the agency’s new assertiveness. He said TSCA “makes it difficult for EPA to take action to limit or ban chemicals even when they are found to cause unreasonable risks to human health or the environment.”
“We are working for [TSCA] reform. We at EPA also intend to use our current authority to the fullest extent under the law to address chemical risks … including potential risks presented by nanotechnology,” he said.
Owens’s comments ignited speculation, which continues to flare up, that EPA would reverse the molecular identity decision. So far the agency has not.
“It looks like they’re not going to reverse it. They’re going to refresh or clarify it,” said John Monica Jr., a Washington attorney with Porter Wright Morris & Arthur who represents companies working in nanotech.
EPA’s screw tightening also follows the lackluster showing of a voluntary EPA initiative called the Nanomaterials Stewardship Program (NMSP). EPA invited companies to share information about their use of nanomaterials as part of that effort.
According to an interim report released last year by the agency, companies reported using far fewer nanomaterials than were already included in databases maintained by two separate organizations: an outfit called Nanowerk and the Project on Emerging Nanotechnologies maintained by the Woodrow Wilson International Center for Scholars.
In an email EPA stated that “not enough companies participated or reported all available data resulting in significant data gaps. Based on the [stewardship program] response EPA has determined that a regulatory approach to gather and develop additional data ... to allow EPA to review new uses of existing nanoscale materials would be needed.”
“It did not generate the response they had hoped for,” Monica said. Among companies “there was an underlying feeling that this is all leading to more regulation no matter how you frame it.”
Monica, who expects the reporting rule to emerge in June, said companies would probably have to provide information similar to what the stewardship program requested.
On the other hand, he speculated that the product testing requirements for the most part would be less rigorous than what the EPA has already required of some companies manufacturing or importing carbon nanotubes. Prized for their strength and flexibility, these nanosized structures are consistently dogged by concerns that if they’re inhaled they could cause rare lung cancers like asbestos, another substance once hailed for its miraculous properties.
While scientists continue to study the issue, the risk is usually seen as far greater to people working in the manufacturing process than consumers.
The EPA had asked a few companies to do 90-day carbon nanotube inhalation studies in rats. Such studies, which can top $350,000, can be daunting to small companies, Monica said.
While trade groups don’t generally push government for more regulation, William Gulledge of the American Chemistry Council said the lobby has not bristled at the EPA. “In general if the agency feels like they need this information in order to make regulatory decisions and risk management decisions we’ve been supportive of that,” he said.
Most of the companies ACC represents tend to sell chemicals to other businesses rather than consumers. Gulledge said their customers are becoming more curious about the use of nanotech in industrial chemicals. That said, he wasn’t convinced that consumers really care.
“I happen to be a golfer. So if I’m buying and looking at golf clubs I know that in certain composites of golf club shafts there are carbon nanotubes,” he said.
“Does it really matter to me whether they’re there?” he asked. “I’m just interested in the performance of the product.”