Scrutiny of the emerging nanotechnology industry is ramping up. Nanotechnology involves the creation of materials, devices, and systems through the manipulation of individual atoms and molecules. It is a term used to define materials whose size is measured in billionths of a meter. (A nanometer is one billionth of a meter, or about 1/80,000 of the width of a human hair.)
Along with continued growth of the industry has come heightened interest in the potential health and safety issues posed by nanotechnology. Responding to those concerns, the U.S. Environmental Protection Agency (EPA) produced an External Review Draft of a Nanotechnology White Paper for public comment. This January, the comment period closed, and the agency now plans to revise the white paper.
Emerging Technology at Risk
Not everyone is satisfied with the first draft, and it remains to be seen whether the revision will be considered an improvement. According to numerous industry observers, the white paper fails to adequately identify many key issues that must be given careful consideration.
The U.S. Chamber of Commerce, along with other business and industry stakeholders, advised EPA that failure to develop correct regulatory policy could result in the loss of billions of dollars in profits and wasted research and development resources. Should that happen, it would undercut the nation’s ability to remain a leader in the nanotechnology marketplace.
EPA intends to use the white paper to drive follow-up activities that will inform policymakers of appropriate regulatory safeguards for nanotechnology. The document has the potential to profoundly impact regulatory policy affecting the soon-to-be multi-trillion-dollar industry.
Key Issues Unaddressed
In its comments on the draft white paper, the U.S. Chamber advised EPA the paper does not provide clarity about the agency’s current view of its own statutory authority; it fails to accommodate the instructions anticipated in the Office of Management and Budget’s forthcoming Risk Assessment Bulletin; and it does not adequately describe interagency coordination and programmatic planning.
In addition, the U.S. Chamber expressed concern that the white paper neglects to provide a satisfactory sense of the timeframes in which tasks and objectives are to be accomplished and goals achieved, and fails to describe the necessary coordination between research goals and other tasks that must be undertaken in support of decision making. Moreover, the U.S. Chamber believes the white paper does not adequately explain how the information developed by the manifold federal agencies engaged in decision making will be harmonized. Simply stated, the white paper does not lay out clear, informative roadmaps of planned and ongoing activities.
Alan J. Gotcher, CEO of Altair Nanotechnologies Inc., in his comments to EPA, said, “This draft falls short of our expectations in one area: Providing a compendium of federal funding programs that could support private-sector and public/private-sector collaborations aimed at filling identified research gaps.” According to Gotcher, “It is critical to have industry representing many of the nanomaterials innovators and most nano-commercializers involved in these R&D programs in collaboration with government and academic research groups.”
Among other comments offered, Lynne R. Harris, vice president of science and technology for the Society of the Plastics Industry, encouraged EPA to “expand its collaborations regarding nanomaterial applications and potential human health and environmental implications.” Harris advised the agency to “foster information-sharing on nanotechnology science and policy issues, and expand nanotechnology training activities for scientists and managers.”
Representing the Institute of Scrap Recycling Industries, Inc., David L. Wagger, director of environmental management, advised EPA, “the paper does not generally consider, at least explicitly, the potential human-health and environmental issues associated with nanomaterials from the perspective of recyclers.” Wagger’s concern is that “during recycling, nanomaterials composing or contained in scrap materials may behave differently than traditional scrap materials,” and he advises EPA to include a specific consideration of such potential risks in the paper.
William P. Gulledge, manager of the Nanotechnology Panel at the American Chemistry Council, said, “EPA should reprioritize its recommendations.” Specifically, he urged the following order for consideration: chemical identification and characterization; metrology; exposure, fate, and effects; risk assessment; workplace practices/best manufacturing practices; and green manufacturing/end use applications.
It remains to be seen how EPA will address the issues raised by Gulledge and other commenters. According to the agency, the final white paper is due to be issued in early 2006.
Investments, Debate Growing
Investment in research and development–a bellwether of growth in the nanotechnology sector– has been increasing by leaps and bounds. Global nanotechnology R&D expenditures are expanding at a rate of 40 percent annually, and in 2003 they passed the $3.5 billion mark.
At the same time, government officials, corporate lawyers, trial lawyers, insurance firms, and other influential policymakers, as well as many public stakeholders, are now increasingly entering the debate about the safety of nanomaterials.
William L. Kovacs ([email protected]) is vice president of the U.S. Chamber of Commerce’s Environment, Technology & Regulatory Affairs Division.
For more information …
More information about EPA’s nanotechnology white paper is available online at http://www.epa.gov/osa/nanotech.htm.