Nanoparticles Fall Through Policy Cracks

Nanomaterials end up in a wide range of consumer products such as cosmetics, clothing, and medications. And just like any other chemical or material used in such products, engineered nanomaterials fall under the jurisdiction of U.S. federal environmental, health, and safety guidelines. However, existing rules may be inadequate to regulate the new technologies, concludes a new study (Environ. Sci. Technol. 2013, DOI: 10.1021/es303591x). By slipping through these gaps in regulations, some nanomaterials may not receive appropriate risk assessments, the researchers say.

“The same properties that make nanomaterials so promising, namely that they behave differently than their bulk chemical counterparts, also make them very difficult to assess and regulate,” says Christian E. H. Beaudrie of the University of British Columbia, in Canada. Scientists can’t fully predict a nanomaterial’s physical and chemical properties before it’s created, so they can’t always determine how it might interact with humans or the environment, he says. This uncertainty contributes to how some kinds of new materials might escape federal oversight and rigorous risk review.

In their study, Beaudrie and his coworkers looked at how nanomaterials would be handled by several U.S. government agencies, including the Environmental Protection Agency and Consumer Product Safety Commission (CPSC). They examined how these agencies would deal with a nanomaterial over its life cycle—from production, commercial use, to disposal.

For example, a new material meant to be a pesticide would receive scrutiny from the EPA, which assesses the risks of pesticides before they enter the market. Meanwhile, CPSC can review products like children’s toys already on the market if the agency receives information suggesting the products’ materials are unsafe.

In examining this complicated web of regulations, the researchers found several gaps that many nanomaterials would fall through. For example, a new nanomaterial associated with a consumer product could avoid a risk assessment by the EPA if its related bulk material has already been approved for that use. For instance, regulations might not kick in for a gold nanoparticle, even though it has vastly different properties than bulk gold.

A nanomaterial could also escape a risk review by the EPA under the Toxic Substances Control Act (TSCA) if it’s manufactured or imported in amounts less than 10,000 kg annually. Due to their high surface areas, many nanomaterials have high levels of reactivity, so small volumes could still pose significant health or environmental risks, the researchers say.

Overall, the researchers found that the biggest gaps occur after a nanomaterial enters the market and when it gets released into the environment. Most notably, no guidelines for air and water emissions exist for nanomaterials.

Whether the U.S. needs new regulations that cover nanoparticles is a matter of debate, says André E. Nel, director of the University of California’s Center for Environmental Implications of Nanotechnology. “You want to prevent unnecessary regulation that could stymie materials getting to the marketplace,” he says.

The use of nanoparticles has been growing over the past decade, and to others, the lack of significant reported safety concerns suggests no need for changes to existing regulations. However, Nel points out that the technology is still new, and scientists are rapidly acquiring knowledge about the effects of engineered nanomaterials. Beaudrie conducted the policy analysis as a student researcher within the center.

A bill introduced in the Senate May 22 would rework TSCA and could fill some of these regulatory gaps. The bill would give the EPA more power to evaluate the risks of chemicals and even ban substances that they deem unsafe. However, Beaudrie says that the lack of provisions specific to nanoparticles in the bill would severely limit the EPA’s ability to regulate nanoscale versions of existing chemicals.

Beaudrie believes regulation reform may be needed to assess nanomaterials’ risks “in a way that we can reap those benefits without making mistakes that were made with other technologies or chemicals past.”