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Nano World: Regulations in prospect

By CHARLES Q. CHOI   |   Nov. 5, 2004 at 1:00 PM
NEW YORK, Nov. 5 (UPI) -- Nanotechnology remains under the radar of many regulatory agencies, who have yet to craft major rules specifically to deal with the rapidly expanding field.

As the results of science and engineering on the scale of molecules begin to affect more and more lives over the coming decade, however, so will laws surface for the field, experts told UPI's Nano World.

"The planning phase for nanotechnology regulations needs to start now," said J.D. Shipman, a research associate with the University of South Carolina currently at the University of North Carolina School of Law. "We don't want to be caught up in the possibilities of a life-altering technology and not think about the long-term implications of what it will mean."

There is a "deep divide" in approaches toward nanotechnology regulation, Shipman explained, depending largely on where one stands on the ideas of scientist Eric Drexler.

Drexler coined the word "nanotechnology" in his 1986 book, "Engines of Creation." The landmark and influential work popularized the concept of molecular nanotechnology, which encompasses ideas such as self-replicating nano-robots that could have the power to grow entire cities from scratch or, conversely, turn civilizations into puddles of gray goo.

Drexler and others think molecular nanotech "has very broad ramifications, and needs strong regulations before it gets into the wrong hands," Shipman said.

On the other hand, physicist Richard Smalley at Rice University -- who won a Nobel Prize for discovering the soccer ball-shaped, carbon-based nanostructures called Buckminsterfullerenes, or buckyballs for short -- and others doubt molecular assemblers are scientifically possible.

U.S. Senators Ron Wyden, D-Ore., and George Allen, R-Va., both major legislative proponents of nanotech, "do not back the Drexlerian view," Shipman said. "They don't see the sweeping, broad, change-every-aspect-of-life view of nanotechnology and don't see the need for regulation."

Drexlerians also contend that the 21st Century Nanotechnology Research and Development Act, which authorizes $3.4 billion for nanotech over the fiscal-year 2004-to-2008 period, moves away from the doctrine of molecular nanotechnology.

Whether or not the momentous issues posed by molecular nanotechnology arise, regulatory agencies inevitably will have to deal with nanotech issues. For example, nanomaterials often are merely smaller versions of existing materials, but their reduced size can grant them significantly different physical properties and potential health and environmental risks, said John Miller, a managing editor at the journal Nanotechnology Law & Business and vice president of intellectual property for Arrowhead Research Corp., a nanotech research firm in Pasadena, Calif.

"The export control laws (administered by the Department of Commerce and other agencies) were not drafted with nanoscale materials and devices in mind," Miller said. "For example, there are references to 'carbon fibers.' Does that include carbon nanotubes? There are also specific regulations on microprocessors. Does that include nanoscale circuits?"

The President's Export Council's Subcommittee on Export Administration, or PECSEA, is launching a study on the need for nanotech export controls. The study will go to the full council for review, then be forwarded to President George W. Bush. It will examine, among other things, the state of nanotech in foreign countries, potential export-control parameters and the effect of imposing such controls on nanotech items.

The study also will review international standards and how other countries are assisting their nanotech industries, market access, environmental concerns and energy.

PECSEA Chairman Brian Ferguson, chief executive officer of Eastman Chemical, suggested social and political concerns about the application of nanotechnology might be comparable to the debate over genetically modified organisms.

"You've seen what's happened in the (GM) regulatory environment," Ferguson said at an Oct. 20 PECSEA meeting. "There has been a great emotional debate. That is an issue that people did not see coming. We judge that nanotechnology has the same potential. That is why we want to get a head-start on this before it overtakes us."

Other agencies that will have to review nanotech include the Environmental Protection Agency, where "there are real concerns about the toxicity of nanomaterials," Miller said. "The Toxic Substance Control Act regulates new chemicals. Because nano-scale materials are just smaller sized versions of existing chemicals, under the current regulatory regime, they can be manufactured with minimal regulatory scrutiny."

The Food and Drug Administration is another potential regulator, Miller added. The primary issue the FDA must grapple with is "when a nanoparticle-based drug-delivery system is used in combination with an already-approved drug, does the new product have to go through full-blown clinical trials all over again?" Moreover, though the FDA classifies any product it examines as either a drug, a device or a biologic, nanotechnology-based healthcare products can blur such distinctions.

The Patent & Trademark Office already has proven a challenge for nanotech companies, because the patents the office issues lie at the core of many startups. The problem is nanotechnology is multidisciplinary, which confounds the PTO system of operating centers specializing in fields such as chemistry.

"Similar patents on nanomaterials and devices are being sent to different centers for review," Miller explained. "Different examiners are reviewing different prior art when evaluating similar nanotech patents." He added that the PTO recently announced a new registration category just for nanotechnology inventions -- Class 977.

Nanotech also poses ethical concerns that are rooted in the way it can enhance present technologies, he added, "for example, the privacy implications of having microscopic sensors or, in the more distant future, molecular diagnostics that provide comprehensive information about health and genetic predisposition. Do we really want to know if we are predisposed to certain illness?"

Then there are the political problems, "in particular with elected officials," Shipman said. "Nanotechnology was spearheaded by people like Sen. Allen, who is said in political circles to seek the presidency in 2008, and those people could come under serious fire for one of two things -- either nanotechnology doesn't make changes in society, which brings up the question of why all the money was spent, or you pushed nanotechnology but failed to also push regulation of nanotechnology and you find out that was a bad idea."

Miller noted that some agencies are moving proactively to incorporate nanotechnology into their regulatory frameworks. Along with PECSEA and the PTO, "FDA has definitely recognized nanotechnology on its radar screen, and is preparing for regulatory issues on nanoparticle drug-based delivery. EPA in the same way is really focused, in putting together grants for studying ethical implications and regulatory scenarios."

Shipman thinks as soon as a federal agency such as the EPA or the Department of Labor's Occupational Safety and Health Administration enacts a nanotech regulation, "it would probably have a domino effect -- you would see other agencies start to pass similar regulations. In biotech, once some regulations started coming out, other agencies (would follow)."

If federal agencies do not establish a pre-existing regulatory framework, "the result is a lot of uncertainty about which regulations apply," Miller said. "The impact it will create is enhanced risk on the business side. On the other hand, regulatory agencies could be too restrictive and the result will definitely be stifled development in the field. It's a difficult road."

Miller said he thinks the single biggest event with the most potential to effect nanotech regulation is evidence of toxicity of nanomaterials.

"It would have a devastating impact on stock prices and create some public consternation and eventually cause additional regulations," he said. "That's the thing to look for. There are a lot of studies into nanomaterial toxicity right now at Rice University. Alternatively, there could be a high-profile case of a failed clinical trial for a nanotech product. Or, if somebody dies because a nanoparticle product is toxic, it could trigger a lot of regulatory scrutiny," he added.

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Nano World is a weekly series by UPI examining issues surrounding the explosive growth of nanotechnology. E-mail sciencemail@upi.com

© 2004 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.
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