Regulating Nanotech Barely at the Starting Gate

The European Union (EU) is leading the way on regulation of nanotechnology with two recent initiatives, while the U.S.—which is putting nano ingredients in an increasing number of products—has done very little. Even the European regulations will take some time to go into effect, but they’re a significant start.

The EU will require increased safety testing for nano-containing cosmetics, and require labeling of nanoparticles on the ingredient lists for such products. These products go directly on the body and can be absorbed by the skin—and sunscreens are a particular worry.

Nanomaterials in food are not yet regulated, though rules are pending in the EU’s Novel Foods Directive that would keep them out of foods until subjected to non-animal standardized safety testing. Earlier this year, Canada became one of the first countries to require companies to disclose information about nano ingredients in products.

According to the Project on Emerging Nanotechnologies (PEN), there are more than 800 manufacturer-identified consumer products on the market with nano ingredients. Nick Berning, a spokesperson for Friends of the Earth (FOE), which has been leading the campaign to regulate nanomaterials internationally, says, “There’s scant regulation if any in the U.S.; Europe—which has generally been more cautious about adopting new technologies and more open to regulation—is leading the way. In the U.S., we’ve had two decades of ideological push to limit regulations and safety precautions for consumers. Although nanotech is widely used in clothes, household appliances, sunscreens—all sorts of products—we don’t regulate it.”

FOE has called for a moratorium on the commercial release of new nano food products until a legislative framework to regulate them is developed. FOE has identified more than 100 food and agricultural products that contain untested and potentially dangerous nanomaterials or were made with nanomanufacturing. But it thinks the actual number of such products is much higher.

In a doctoral thesis for the Technical University of Denmark, Steffen Foss Hansen points out that nanomaterials could be covered by existing EU regulations, but “it is often unclear if current regulation is actually applicable when it comes to specific nanomaterials and their diverse applications.” He says, for example, that safety testing is triggered by specific production weight thresholds—in tons—that are hardly likely to be met by products on the nanoscale.

Some governments have adopted voluntary environmental programs (VEPs) for nanotech, Hansen says, but these have not had much effect. Further regulation is needed, he says, becuause “we do not know enough to say that nanomaterials are safe, but there is evidence that some nanomaterials are hazardous depending on their particle characteristics, how they are applied and how humans and the environment are exposed to them.”

In the U.S., which earmarked $1.5 billion for nanotech research in 2009 (with only $256 million going to risk-assessment work), federal officials have been slow to recognize the need for regulation—though that could change under President Obama. Clayton Teague, director of the National Nanotechnology Coordination Office, downplays it. “Until we have information that there are truly inadequacies in existing regulations, any additional regulations beyond what we already have would be burdensome to industry and the advancement of the field,” he says.

It’s not clear what “existing regulations’ Teague is talking about. According to Ian Illuminato, FOE’s ranking nanotech expert, in the U.S. “nano product manufacturers are still not required to identify nanoparticle ingredients on product labels or conduct nano-specific safety tests on these ingredients, or submit their products for approval prior to commercialization. No U.S. law or regulation is specifically designed or has been amended to regulate nanotechnology and nanomaterials.”

In what might be a parallel to state action on climate in the face of eight years of federal inaction, California may be ready to regulate nanotech on its own. Assembly member Mike Feuer said in March that he intends to introduce nanotech regulations into the state legislature this year. According to Feuer, the legislation could include a notification provision and standards for worker exposure and environmental releases.

It could be that California is already empowered to take action on nanotech. A state law signed last year gives the California Department of Toxic Substance Control broad authority to regulate “chemicals of concern” in consumer products. Regulations will be in place by 2011.