Managing Nanotechnology

Earlier this month, the Woodrow Wilson International Center for Scholars hosted a standing-room-only briefing on its latest nanotechnology report. At issue was whether the current federal regulatory framework could effectively oversee the development of nanotechnology and manage any potential negative effects that may arise.

The report, "Managing the Effects of Nanotechnology," comes at a time when hundreds of nanotech products are already in the marketplace and more are on the way. Authored by J. Clarence (Terry) Davies, a senior adviser for the Project on Emerging Nanotechnologies at the Wilson Center and senior fellow at Resources for the Future, the report says that regulating nanotechnology will be difficult under the current regulations and, therefore, proposes new legislation to target the unique characteristics of the emerging technology.

"This is a critical time for nanotechnology," Davies said at the briefing. "It is the right time to come up with the right regulatory framework for nanotechnology. The ideas presented in this report challenge business and government to work together to nurture and encourage nanotechnology and to anticipate and address its adverse effects," he explained.

"If nanotechnology is to succeed, there needs to be a dialogue around the proactive approach Davies suggests," said David Rejeski about the report. Rejeski is director of the Project on Emerging Nanotechnologies. "Government, business, and citizen groups need to exchange views and discuss options to ensure the American public that, as nanotechnology matures, any adverse health and environmental effects will be identified and prevented or controlled," he said.

Davies notes that to manage nanotechnology, regulations must be flexible and interactive because the health and safety implications of engineered nanomaterials are still being uncovered. It's this lack of effects data that complicates trying to fit nanotechnology into existing regulations.

Davies reports that the most promising existing laws to protect the public and the environment from adverse effects of nanotechnology are the Toxic Substances Control Act (TSCA), the Occupational Safety & Health Act (OSHAct), and the Food, Drug & Cosmetics Act (FDCA). All three can affect some regulation of nanotechnology, but each has limitations.

For example, the broad coverage and range of measures that TSCA provides to deal with chemical risk make it the strongest existing law to protect against adverse nanotech impacts. However, as Davies states in the report, one of the weaknesses of TSCA is that it has an implicit assumption that having no knowledge about a chemical signifies that there is no risk.

The OSHAct has broad authority to cover workplace safety and would include nanotechnology manufacturing, but its effectiveness is limited by both lack of resources and the costly and sophisticated equipment needed to monitor environmental levels of nanomaterials, Davies points out. As for FDCA, he notes, it would provide adequate protection of nanotech use in drugs, biologics, medical devices, and food additives and packaging, but it would do nothing to regulate nanotech use in cosmetics, a market where many nanotech products are already commercially available.

Other environmental laws such as the Clean Air Act or the Clean Water Act have major weaknesses in that they are based on a direct relationship between concentration or volume and risk, or they require expensive and sophisticated equipment for monitoring, Davies states. Consumer protection laws such as the Consumer Product Safety Act also have major weaknesses in that they lack the necessary enforcement power.

Existing regulations can be amended or strengthened to provide better management of nanotechnology, but the associated weaknesses will be difficult to overcome, Davies states. He asserts that it would be easier to draft new legislation, which he describes in the report, specifically for nanotechnology.

Davies' proposed legislation focuses on regulation of consumer products, an area for which little oversight exists. It also places the burden on the manufacturer for showing that a product doesn't present "unacceptable risks."

The proposed legislation designates the Environmental Protection Agency to establish and oversee nanotech testing and reporting requirements, which the Davies report notes should be harmonized with the corresponding requirements of the rest of the world. Because the legislation would be tailored to the unique nature of nanotechnology, it would recognize that exposure and toxicity are dependent on the final product, as opposed to the starting nanomaterials.

Davies' report was welcomed by some policymakers, who have been waiting for answers on whether the existing regulatory framework is sufficient to provide public and environmental protection against potential adverse nanotech effects.

"This report tells us that it is difficult to address nanotechnology with existing regulations and that a new law may be required to manage potential risks of nanotechnology," Rep. Michael M. Honda (D-Calif.) says. He adds that the proposed elements of the new law are consistent with the findings in the December report of the Blue Ribbon Task Force on Nanotechnology that he established. "I'm looking closely at the recommendations made in both reports as I develop legislation to ensure that nanotechnology is developed in a safe and responsible manner," he states.

Not everyone agrees that new legislation is needed. "Until we have good, solid, scientifically validated information that would indicate significant inadequacies in existing regulatory authorities, additional regulations would just be unnecessarily burdensome," says E. Clayton Teague, director of the government's National Nanotechnology Coordination Office (NNCO).

Teague points out that current scientific data on the health or environmental impacts of nanomaterials are conflicting, and the inconsistencies make it impossible to draw any general conclusions about the safety of nanomaterials. For instance, he notes, one day he may receive a paper on buckyballs saying they are toxic and will damage the brain, but the next day he may receive a paper finding that this material is not toxic and may even be beneficial to human health and the environment. This example shows that "we don't have enough information currently to make wise and informed decisions about putting into place new regulations," he explains.

"The high priority today is to continue research on environmental, health, and safety [EHS] impacts of nanomaterials to give us a better understanding of the interaction between nanoengineered materials and biosystems," Teague says. He adds that the agencies involved in the National Nanotechnology Initiative (NNI) have laid out a strategy to do just that.

With a budget of around $1 billion this year, NNI represents the government's investment in nanotechnology. Of that total 2006 requested budget, $38.5 million, or 3.7%, was designated for research on EHS implications. Twenty-three federal agencies currently participate in NNI, with 11 of them having nanotech research and development budgets. Although each agency manages its own programs in this area, NNCO helps coordinate federal efforts.

"NNI is fully committed to making sure that this technology is developed responsibly," Teague says. He points out that one of NNI's four goals is to give appropriate and due attention to the safety, ethical, and societal aspects of nanotech development.

Teague also notes that although the overall NNI budget, like most science budgets, will do well to maintain a flat level of funding over the next few years, research in the areas of EHS implications may increase as a proportion of the total NNI budget. "I'm not sure how large the increase will be, but the proportion going into that area will go up slightly in the 2007 budget," he says.

Another group that does not support the call for new legislation is the federal agencies themselves. "All of the regulatory agencies that are part of the NNI report that their current regulatory authorities should be adequate," Teague says. This group of agencies includes EPA, which administers TSCA as well as other environmental laws that may be used to regulate nanotech, and the Food & Drug Administration, which administers FDCA.

"The agencies, both regulatory and research, have been and will continue to look at those authorities that they have available to them," Teague explains, adding that the flexibility and options the agencies have within these regulations make it possible for them to adapt with the evolving science. "As new scientific data are validated and accepted by the scientific community, the agencies will reevaluate their authorities to see if there are changes that should be made," he says.

Teague also points out that the agencies have been proactive in trying to communicate their interpretation of their regulatory authority as it applies to nanotechnology. To do this, most agencies have websites focusing on nanotechnology targeted at their stakeholders as well as the public. In addition, the regulatory agencies communicate regularly with one another as well as with the research agencies on this topic, he says.

"The agencies are really very effectively and efficiently trying to move into this area and determine the degree to which their authorities are or are not adequate," Teague says. For example, EPA is currently working with its stakeholders to develop voluntary standards for nanotechnology (C&EN, July 18, 2005, page 25).

Although the Davies report discusses the benefits of a voluntary program, the report points out that a voluntary program may leave out small companies making risky products and large companies with small consciences.

These concerns aside, some groups think that such a voluntary program is just what is needed. The American Chemistry Council Nanotechnology Panel is one of those groups.

"To date, several agencies that have reviewed their respective regulatory structures, including EPA, the Occupational Health & Safety Administration, and FDA, have concluded that the existing authority is sufficient to address nanotechnology," the panel said in a statement. "The panel believes that the initiation of a voluntary program along the lines outlined by EPA's National Pollution Prevention & Toxics Advisory Committee is the most appropriate and expedient way to foster the responsible development of nanotechnology," the statement said.

Whether existing regulations will be used or new legislation will be developed, the key is to get the discussion started now while nanotechnology is in its early stages, experts agree. "Reaching consensus on nanotechnology regulation that encourages economic innovation and environmental stewardship will not be easy, but it is a challenge that we cannot ignore," Davies says.