Nano World  [Printer-friendly version]
January 17, 2006


[Rachel's introduction: In a new report on nanotech, Terry Davies
advocates a law that places the burden on nanotech manufacturers to
show that their products are reasonably safe, as opposed to a law
like TSCA [Toxic Substances Control Act], where the burden of proof
lies on the government to show that a product is dangerous. Shifting
the burden of proof in this way is basic to the precautionary

By Charles Q. Choi

NEW YORK, Jan. 17 (UPI) -- A new law specifically targeting
nanotechnology could prove necessary to regulate its potential risks
[3.3 Mbyte PDF] and promoting its continued development, experts told
UPI's Nano World.

"If one takes a 10 or 20 or 30 year perspective, the idea of a new law
is not a radical proposition. In fact, it could be the best way to
deal with what are going to be significant uncertainties and
increasing complexities around this technology," said David Rejeski,
director of the Project on Emerging Nanotechnologies in Washington, at
the announcement of a new report [1 Mbyte PDF] from the group
regarding the existing regulatory framework for nanotechnology.

Now was the time to think about how best to regulate nanotechnology,
"before there are thousands or hundreds of thousands of potential
products in the marketplace, before industry has invested millions,
tens of millions or hundreds of millions into ramping up production,
and before there have been any problems, accidents or mishaps that can
undercut public confidence or optimism about this technology," Rejeski

Nanotechnology "is being commercialized at an accelerating pace.
Roughly 60 or so consumer products are out there now and several
hundred other kinds of applications," said Terry Davies, a senior
advisor at the Project on Emerging Nanotechnologies. "The extent to
which it promises to either ameliorate or solve most of the major
problems that we face, going from cancer to cleaning up Superfund
sites to dealing with an oil shortage, and everything in between."

Davies coauthored the plan that created the Environmental Protection
Agency. He analyzed the existing regulatory framework of laws and
agencies that might impinge on nanotechnology and found most of it
demonstrated three significant kinds of weaknesses.

First, most statutes or programs failed to address the fact that
nanomaterials "behave differently from materials of ordinary size,"
Davies said. "The assumption built into most environmental statutes
and the health ones as well is that there is a pretty direct
correlation between volume or weight on the one hand and toxicity and
exposure on the other hand. That isn't true for nano."

Next, many programs lacked resources. For instance, the Consumer
Product Safety Commission, which administers the Consumer Product
Safety Act, "had a staff of about 900 or so in 1980, and it's now down
to 446 to deal with all consumer products in the United States,"
Davies said. "Four hundred or so is not enough to answer the mail."

Finally, statutes often had major shortcomings in legal authority when
it came to monitoring nanotechnology adequately, Davies contended. For
instance, the Toxic Substances Control Act [TSCA] has quite broad
coverage and is often considered the primary vehicle for regulating
nanotechnology. Davies, who wrote the original version of what became
TSCA, said it was "very flawed" because an "implicit assumption of the
act is that no information means no risk. In fact, TSCA provides a
disincentive for manufacturers to generate health and safety and
environmental information, and if there's anything we need in dealing
with nanotechnology, it's a regulatory system that encourages the
generation of information."

Instead of making do with existing laws to address the potential
risks nanotechnology poses [3.3 Mbyte PDF], Davies argued that a new
law specific to nanotechnology was necessary. Such a law should focus
away from products already well covered by existing regulation, such
as with drugs, food, medical devices and the like, and on consumer
products such as cosmetics.

For instance, "the cosmetics part of the Food, Drug and Cosmetics Act
is totally toothless. For all practical purposes, cosmetics are not
regulated in this country," Davies said. At the same time,
nanomaterials are increasingly finding their way into cosmetics, "and
we have no idea of what adverse effects, if any, they are having."
Nanomaterials are also finding their way into consumer products such
as clothing, golf clubs and tennis racquets, he noted.

Davies advocates a law that places the burden on nanotech
manufacturers to show their products are safe, as opposed to a law
like TSCA, where the burden of proof lies on the agency to show a
product is risky. For instance, all products containing nanomaterials
would have to go through testing and reporting requirements most
likely established via international coordination. The government
could take steps to ease the burden such requirements would have on
smaller companies, he added.

A new law would also require manufacturers to submit sustainability
plans that would show a product would not present an unacceptable
risk. Moreover, such a law should deal with product issues such as
imports, exports, national defense and citizen lawsuits, Davies said.

Not all nanotechnology analysts agree new legislation is necessary.
"New regulations would be a disaster at this point," said Sonia
Arrison, director of technology studies at the Pacific Research
Institute, a San Francisco-based public-policy think tank.
"Nanotechnology, the manipulation of matter at the level of individual
atoms and molecules, offers the greatest benefits for society if left
to grow through modest regulation, civilian research, and an emphasis
on self-regulation and responsible professional culture."

While Davies applauded voluntary programs for nanotechnology oversight
that the EPA has established for manufacturers, he does not feel
voluntary programs offer a long-term solution. While such programs can
be put in place quickly, "the question is, do they include the people
you really want to include, the really bad actors who don't care very
much about being responsible corporate citizens," Davies said.

New York-based nanotechnology analyst firm Lux Research's Vice
President of Research Matthew Nordan said a concern regarding new
regulation was that "the net effect would be to slow things down." A
new law could be "very onerous and perhaps premature, given the
limited knowledge of the impact of nanomaterials. What we know about
the safety of fullerenes, for example, is all over the map, from
highly dangerous to probably benign. A lot of existing regulations can
be tweaked or interim measures can be imposed for responsible

Davies argued that waiting for a slowdown in nanotechnology before
instituting regulation would lead to years of delay, opening the
public and industry to years of risk.

"You've got a technology or set of technologies in a field that's
evolving very rapidly and will continue to evolve very rapidly for the
foreseeable future. So even if we're talking about putting something
in place 20 years from now, whatever you put in there is going to be
obsolete pretty fast also," Davies said. "One of the characteristics
which hopefully you can incorporate in anything that you do in the way
of legislation is an ability to adapt fast, to change fast, to keep up
with the changes in the technology itself."

Davies cautioned that a nanotech law was unlikely unless there was a
pretty strong consensus that it was needed. Even if dialogue
concerning a nanotech law does not lead to legislation, it could help
"identify ways in which we can get an oversight system that is
adequate to deal with the technology," he said. In the meantime,
programs could coordinate, amend and strengthen existing laws to help
manage nanotechnology.

Copyright 2006 by United Press International.