What's Next For Nanotechnology

NO MATTER who wins the presidential election in November, the next Administration will have to decide how best to protect the American public, workers, and environment from the potential adverse effects of nanotechnology. The challenge will be to do so without stifling innovation.

A recent report released by the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars, in Washington, D.C., looks at actions the next Administration should take to foster nanotechnology. Meanwhile, as the country waits to see who will win the presidential race and what policies will follow, Congress is moving forward with legislation to amend the National Nanotechnology Initiative (NNI), which coordinates federal nanotech research.

The pace of nanotech development is extraordinary. Consumers can expect about $3.1 trillion worth of nanotech-enabled goods by 2015, according to the latest estimates from Lux Research, a consulting firm that monitors emerging technologies. In comparison, $147 billion worth of nanotech-based goods were produced in 2007.

The Wilson Center's PEN tracks consumer products based on nanotechnology. More than 600 products from 20 different countries are currently listed in its database, and three to five new products are added each week, according to PEN. "We've seen a doubling in the number of products in the past 14 to 16 months, and I don't think that upward trend will change much in the future," says David Rejeski, director of PEN. The growing number of products will add to the pressure the next Administration faces in setting up policies to regulate nanomaterials.

Rejeski also points out that nanomaterials are becoming increasingly complex. "We are shifting from first-generation to second-generation and potentially third-generation nanotechnology, so these products or substances that might be in the workplace or market will become significantly more complex in terms of their structure and properties," he says.

As nanotechnology becomes more pervasive, many people worry that the government is not doing enough to understand the potential risks the technology poses to human health and the environment. Legislation working its way through Congress aims to quell those fears by strengthening the federal government's commitment to environmental, health, and safety (EHS) research on nanomaterials.

In an attempt to prioritize what needs to be done by the next Administration in terms of nanotechnology oversight, PEN asked J. Clarence (Terry) Davies, a senior adviser to PEN and a senior fellow at the nonprofit Resources for the Future, to sift through a series of reports released by PEN over the past few years and summarize the major recommendations. Davies' findings were released in a report published by PEN in late July.

In his report, "Nanotechnology Oversight: An Agenda for the New Administration," Davies recommends that each major agency involved in NNI develop a strategy for dealing with nanotechnology that spells out how the different legal authorities and resources in the agency will be focused. "We have a group under NNI now—the National Nanotechnology Coordination Office—that looks at the regulatory agencies, but it's oriented entirely toward research. What we need is a coordinating group that is oriented toward regulation," he says.

Davies prioritized more than 35 recommendations into short-term and long-term agenda items, and he provided a few thoughts on what could be done today. Items that are high on his list include increasing resources at federal agencies, increasing funding for EHS research on nanomaterials, and creating a better way to guide how that research money is spent. He also stresses that some legislation needs to be strengthened to deal with nanomaterials.

IN PARTICULAR, nanomaterials should be defined as "new" substances under the Toxic Substances Control Act (TSCA), Davies says. The Environmental Protection Agency, which oversees TSCA, considers a nanomaterial an existing chemical if its structure is the same as a chemical already in EPA's inventory. The agency has decided that size should not be a factor in determining what constitutes a new chemical. This is important because new chemicals are subject to more testing and scrutiny than existing chemicals. Critics argue that many nanomaterials are not being properly tested because EPA considers them existing chemicals under TSCA.

In many cases the properties of nanomaterials are significantly different from those of their bulk counterparts. "We need to consistently recognize the unique character of nanomaterials and that the biological effects and potential hazards are not the same in most cases as the bulk material," Davies emphasizes.

The Federal Food, Drug & Cosmetics Act also needs reform, Davies notes. "FFDCA has at least two glaring gaps in coverage, both of which are very relevant to nanotechnology," he says. One pertains to cosmetics and the other to dietary supplements. Nanotechnology is increasingly being used in cosmetics, which are essentially not regulated, and in encapsulation of vitamins and other kinds of supplements.

Richard Denison, a senior scientist with the nonprofit Environmental Defense Fund, says that agencies like EPA could serve the public better if they would be more transparent about what they are doing with regard to nanomaterials. "EPA has received and reviewed numerous new chemical notices under TSCA for nanoscale materials," but the agency has provided no information about the number of submissions or the outcomes of those submissions, he says.

Looking ahead to the future, "both the agencies and Congress need some place they can turn to for an analysis of what technologies and what scientific breakthroughs are coming down the pike," Davies notes. "The pace of innovation is going to get faster and faster." And unless it can get some kind of technology-forecasting capability, "the government is going to become more and more irrelevant," he warns.

As PEN addresses what the next Administration can do to foster nanotech development, Congress is moving forward to amend the 21st-Century Nanotechnology Research & Development Act, which President George W. Bush signed into law in 2003. Specifically, Congress is calling for a federal strategy to strengthen EHS research on nanomaterials.

Just weeks before Congress left for its August recess, Sen. John F. Kerry (D-Mass.) introduced the National Nanotechnology Initiative Amendments Act of 2008 (S. 3274). The bill, sponsored by Kerry and six other senators, sets the stage for developing commercially successful, safe nanotechnologies.

"Nanotechnology is a huge part of America's future, but it'll never take off if people don't trust that it's safe," Kerry said in a statement introducing S. 3274. "As we begin to further understand the immense capacity of this technology to improve our quality of life, public health and environmental safety must be top priorities."

The Senate Committee on Commerce, Science & Transportation, which has jurisdiction over nanotech R&D, was scheduled to vote on the bill before the August recess, but that vote was delayed for reasons unrelated to the bill. The committee is expected to clear the bill when it returns in September, and the full Senate is expected to follow.

S. 3274 is similar to the House of Representatives' nanotechnology bill (H.R. 5940), with only small differences. The House passed its version by an overwhelming majority in June (C&EN, June 23, page 26).

BOTH THE House and Senate bills call for the creation of a senior-level position within the White House Office of Science & Technology Policy to oversee the societal dimensions of nanotechnology. That person would be responsible for coordinating EHS research among the various federal agencies that participate in NNI???currently 25 agencies are involved???and address other ethical and societal concerns.

That is a huge portfolio for a single person to manage, says Denison, who, like others, fears that it will be difficult to find someone with the right expertise and breadth of experience needed to handle all of those issues. "Our recommendation was to break out the EHS component from the ethical and societal concerns component and have a coordinator for each one," Denison tells C&EN.

Among the differences in the bills is that the Senate version is much more explicit in terms of support for standards for EHS testing of nanomaterials, says Kristen M. Kulinowski, director of the International Council on Nanotechnology (ICON) at Rice University. Specifically, the Senate bill calls for the development of nomenclature standards associated with engineered nanomaterials, standard reference materials for EHS testing, standardization of instrumentation, and standard methods for measuring EHS impacts of nanomaterials.

Kulinowski is pleased to see the emphasis on standardization, noting that in a recent ICON report an international community of researchers perceived standards "as one of the key missing elements required to develop a comprehensive research program for addressing potential risks of nanomaterials."

Another difference between the bills is that the Senate version calls for the Government Accountability Office (GAO) to review the regulatory authority of all of the federal agencies that oversee nanotechnology to identify any gaps in current codes, standards, and regulations and to recommend changes to close those gaps. The primary agencies that regulate nanotechnology are EPA, the Food & Drug Administration, the Department of Agriculture, the Consumer Product Safety Commission, and the Occupational Safety & Health Administration.

Jaydee Hanson, policy director at the International Center for Technology Assessment, a nonprofit organization that analyzes how technologies impact society, says that a study such as the one assigned to GAO in the Senate bill is sorely needed. "If the government is going to be funding the development of nanotechnology, it ought to make sure that it is done safely," he notes. "We like the emphasis in the bills on developing the technology to measure nanomaterials and characterize them, but we think you need to actually apply these new measurement technologies to help you understand what nanotechnologies are doing in the environment, in someone's body, and inside cells."

Critics applaud the increased focus on EHS research in both bills, but they say that neither of them goes far enough in terms of regulatory oversight. "The Senate bill is focused exclusively on research," Denison says. "It is not an oversight bill at all. The NNI itself is not regulatory in any way, shape, or form."

"If you are going to have adequate markets you have to have adequate oversight," Davies emphasizes. "We can't just rely on markets to protect the public or to protect the environment. I think oversight is important for the future of nanotechnology as well as for the public."

What's really needed is an interagency nanotechnology regulatory group, Davies says. "The existing legislative authorities are weak. There are very large gaps in the laws that we have on the books, and in fact, a lot of the existing legislation is now an impediment to protecting the public," he notes.