Regulators not Prepared for Developments in Nanotechnology

J. Clarence (Terry) Davies

The text below is derived from an article in the Spring 2006 issue of Resources.



In an appearance before the United States Senate Committee on Commerce, Science, and Transportation February 15, RFF Senior Fellow J. Clarence (Terry) Davies cautioned that current regulatory structures are not adequate to manage advances in the science of nanotechnology. A video of this hearing can be seen at the Committee's web page for the hearing.

This rapidly developing field processes materials at sub-microscopic levels - materials that often exhibit very different physical, chemical, and biological properties than their normal-sized counterparts. However, because the public's views of nanotechnology remain largely unformed, he said, legislators are afforded a rare opportunity to "get it right."

Inadequacy of Current Regulations

Davies' testimony was largely based on "Managing the Effects of Nanotechnology", a report he authored for the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies. He began the study in 2005 to assess the strengths and weaknesses of the U.S. regulatory system in relation to nanotechnology. At the outset, he did not believe that new legislation would be necessary, but he quickly realized that the existing regulatory structure suffers from three types of problems. Davies addressed these shortcomings before the Senate committee.

Managing the Effects of Nanotechnology
J. Clarence (Terry) Davies
Woodrow Wilson International Center for Scholars
2006

First, he said, gaps exist in statutory authority, most obviously with respect to two common uses of nanomaterials - cosmetics and consumer products. "A wide variety of nano-based consumer products have already begun to enter the market as sporting goods, clothing, cleaning materials, and kitchen appliances. Similarly, nano-based cosmetic products already range from skin creams to spray-on foot deodorizers, all with significant exposure potential (dermal, inhalation, and ingestion) and little publicly available risk data," Davies said.

He also reported that all federal regulatory programs governing nanotechnology suffer from a shortage of funding and expertise. As an example, he pointed out the Occupational Safety and Health Administration (OSHA) has approximately 25 percent fewer employees than in 1980, when already its numbers were inadequate for its responsibilities.

Finally, "none of our health and environmental laws were drafted with nanotechnology in mind," said Davies. This can be problematic because certain guiding assumptions - for instance, about the relationship between quantity or volume of a toxin and degree of risk - do not hold true for nanotechnology.

These problems, Davies said, have rendered existing laws inadequate, and no amount of coordination or patching is likely to fix them.

Developments in Nanotechnology
J. Clarence (Terry) Davies
United States Senate Committee on Commerce, Science, and Transportation
February 15, 2006

Beginning a Dialog

"We should now begin a dialog among major interested parties that acknowledges the shortcoming of the existing regulatory framework and identifies what needs to be done," Davies said. As a starting point, he addressed three questions that he has frequently been asked since the release of his January 2006 project report:

Is there any reason to believe that there are any adverse effects from nanotechnology?
Can't industry be trusted to test new products since it is in its best interest to do so?
Don't we need to wait for more information before we can regulate nanotechnology?

Regarding the first question, Davies pointed out that every technology of the scope of nanotechnology has had adverse effects and that decades of study have shown that fine particulates can be harmful. While the current state of knowledge cannot answer how harmful nanotechnologies are, he said, "it raises red flags concerning some materials and products" and "enables us to ask the right questions," he said.

The topic of testing leaves Davies less to be optimistic about. There are currently no laws requiring manufacturers to test the health and environmental effects of nanomaterials, and because long-term testing in particular is so costly, companies are often tempted to skip it.

Finally, Davies addressed the question of developing an oversight system in the face of knowledge gaps. Although more information is needed before adequate regulations can be put in place, Davies stressed that it is not too early to start discussing the outlines of such a system. He pointed out that early data suggests that there are at least 80 nanotechnology consumer products on the market and more than 600 nanomaterials being used by manufacturers already - creating some urgency to the issue. In addition, the process of discussion can itself "help foster international harmonization, research, and public participation."

Getting It Right

In his concluding remarks, Davies said that the future of nanotechnology hinges on sustaining public confidence, which in turn depends on adequate government oversight. "Based on polling and focus groups, I believe that the public will hold both government and industry to a higher standard of safety for nanotechnology than it has for any previous technology," he said. Failure to meet this standard will generate intense public pressure, eliminating the opportunity Davies says the legislative community now has to carefully deliberate with stakeholders.

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