The U.S. government's voluntary program to collect data from manufacturers working with nanoscale materials has attracted a limited response so far, according to an interim report released by the U.S. Environmental Protection Agency earlier this year. But the era of voluntary reporting may be drawing to a close as calls for mandatory risk assessment of these materials grow.

California's Department of Toxic Substances Control, for example, in January sent letters to manufacturers who produce or import carbon nanotubes into the state, requiring that they provide a range of information about those materials. The manufacturers have one year to provide their responses.

In another example, Canada appears on the brink of requiring nanomaterial manufacturers to provide data. A spokesperson for Environment Canada, the Canadian government's department charged with coordinating environmental policies, says the proposed information-gathering notice will be a one-time requirement that "can include how the substance is used or managed, any existing data on physical or chemical properties, or any other information that is needed to help inform the assessment and management process." The spokesperson said the notice will target companies or institutions that made or imported more than 1 kilogram of nanomaterial during the 2008 calendar year.

Why the interest in collecting this data? Nanomaterials have been garnering a lot of attention lately for what they allegedly lack: enough government oversight in the face of many unknowns -- particularly the effects these materials have on health and the environment. The tiny size of the particles that comprise nanomaterials gives them unique characteristics not found in the same materials on a bulk scale. Yet the relative youth of the science and a lack of data have some questioning the risks they may pose. Meanwhile, some $147 billion in nano-enabled products were produced in 2007 and that figure could grow to $3.1 trillion in 2015, estimates Lux Research, an emerging technologies research and advisory firm.

BASF Corp. voluntarily submitted data on several product lines that contain nanoscale materials -- including a special zinc oxide -- to EPA's Nanoscale Materials Stewardship Program.

By the end of 2008, some 29 companies and trade associations had voluntarily provided information on 123 nanomaterials requested by the EPA under its Nanoscale Materials Stewardship Program (NMSP). An additional seven companies had committed to participate, according to an interim report on the program issued in January. The two-year program continues until January 2010.

Based on the interim results, the EPA termed the NMSP "successful." However, Lux Research points out that the program had collected data on just 5% of the more than 2,000 types of existing nanomaterials. The firm suggests that a lack of greater participation may be a result of simply not enough incentive for manufacturers to voluntarily participate. Concerns over confidentiality may also play a part. That said, "a lot of companies do work closely, very closely, with officials at the EPA," whether or not they participate in the NMSP, points out David Hwang, Lux research associate.

Cleveland area-based Nanofilm provided data to the NMSP on its commercially available nano-scale materials. "In our view, there's nothing to fear so there's no reason not to provide the data," says Nanofilm's Scott Rickert, co-founder of the 25-year-old firm. "My biggest concern is if I didn't report and then I go out and try to sell something, expand my market with my partners . . . those big companies are going to want assurance that what we provide them is safe. So I have every incentive to cooperate with regulatory bodies. Because I'll have no customers if I don't."

Lux favors a more proactive and better coordinated approach to oversight by the U.S. government to corral what Hwang described as "a lot of confusion" by manufacturers about what rules to follow and whether their material, for example, may be considered "new" under the Toxic Substances Control Act. That confusion hurts the industry, Lux says.

"People that manufacture nanomaterials are afraid to perform R&D because they don't know if they will be able to sell these materials," says Jurron Bradley, Lux senior analyst and head of the firm's nanomaterials practice. "Investors are afraid to invest in these companies because they don't know if they will invest in a material that can't be sold. Also people who are buying the materials are afraid of potentially buying materials because what happens if something happens with them? So it's best to have sensible regulations instead of having none at all."

Scott Rickert

Nanofilm's Rickert says current regulation of nanomaterials is sufficient, except possibly in specific circumstances for specific materials. He notes that some companies likely are holding back, but he expects that to change. And why is that? "Every month that goes by without a major problem is another month of confidence."

See Also