Published online 25 July 2008 | Nature | doi:10.1038/news.2008.983

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EPA's voluntary safety scheme undersubscribed as deadline approaches.

Chemical trade bodies are hoping that an eleventh-hour plea for companies to volunteer information about their nanotechnology products will avert the imposition of potentially restrictive regulation.

But time is running out. The Environmental Protection Agency (EPA) has set a deadline of Monday 28 July for US companies to voluntarily hand over details about the nanoparticles they work with. Yet very few companies have participated, leaving the EPA more likely to move towards mandatory regulation, something the industry fears will be bad for business.

Carbon nanotubes: definitely different from diamond. Simone Brandt / Alamy

Scientists have long called for distinct nanotechnology regulation that takes full account of the various physical and chemical properties that arise in materials measured at scales of a billionth of a metre. In 2004, for example, Britain’s Royal Society and Royal Academy of Engineering issued a report that said: “The lack of evidence about the risk posed by manufactured nanoparticles and nanotubes is resulting in considerable uncertainty,” and urged that nanoscale versions of known chemicals be treated as entirely new products.

The EPA’s response to such calls was the Nanoscale Materials Stewardship Program (NMSP), which was launched in January to gather data about the nanomaterials being made and used in the United States, to guide future health and safety guidelines. The two-tier system first collects data on the physical and chemical characteristics of the materials, as well as information about hazards, risk management, and who comes into contact with the material. The second, in-depth part of the process asks companies to run extended tests on the materials to obtain extra details, such as toxicology assessments.

But so far only nine companies have submitted to the basic programme, with a further eleven promising to do so. Just two companies have signed up to the in-depth programme (see "Better nanosafe than sorry")

“It’s a very poor turn out,” says Andrew Maynard, chief science adviser at the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington DC, who estimates that more than 800 companies are involved with nanotech in the United States.

Big hitters of the nano-world

The list of participants does include some big-hitters in the chemicals industry, including BASF, Bayer and Dow Chemical, probably because they are used to handling this kind of regulatory requirement, notes John DiLoreto of the Synthetic Organic Chemical Manufacturers Association (SOCMA). But SOCMA, the American Chemistry Council (ACC) and the NanoBusiness Alliance are concerned that the lack of participation may push the EPA into enforcing stricter regulation. Earlier this month, they issued a joint plea to their industrial members to get their submissions in on time. “A mandatory scheme will put an additional burden on industry,” and involve much greater bureaucracy, says Maynard.

Bill Gulledge, leader of the ACC’s nanotechnology panel, thinks the plea will work. “There will be more submissions,” he says. “Like everything else, people wait until the very last minute.”

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The slow response to the EPA’s scheme could be because smaller companies do not know about the scheme, suggests Gulledge; or they simply don’t have the time and resources to get involved, thinks Maynard.

Canada already requires companies to register nanomaterials under the country’s New Substances Program, just as they must register any other new chemical. And in June this year, the European Commission announced a review into European Union legislation on nanomaterials, which are currently covered by existing chemicals legislation.

The United Kingdom has had its own voluntary reporting scheme in place since September 2006, but has received only ten submissions. “We’ve never been altogether sure what would come of the scheme,” admits Stephen Morgan, spokesman for the UK government’s Department for Environment, Food and Rural Affairs, which runs the programme.

If the EPA programme continues to see similar results, the agency has the power to demand the information. "EPA could use its information gathering authority under section 8(a) of TSCA [Toxic Substances Control Act] to gather information on the identity of the nanoscale substance, material characterization, uses, production volume, exposures and releases, and available hazard data," the agency said in a statement to Nature. “EPA will assess all submissions received under the NMSP and determine next steps as appropriate.”