[Pharmwaste] E.U.'s New Rules Forcing Changes By U.S. Firms

[DeBiasi,Deborah]

http://www.washingtonpost.com/wp-dyn/content/article/2008/06/11/AR200806
1103569.html?wpisrc=newsletter

Chemical Law Has Global Impact
E.U.'s New Rules Forcing Changes By U.S. Firms

By Lyndsey Layton
Washington Post Staff Writer
Thursday, June 12, 2008; A01



Europe this month rolled out new restrictions on makers of chemicals
linked to cancer and other health problems, changes that are forcing
U.S. industries to find new ways to produce a wide range of everyday
products.

The new laws in the European Union require companies to demonstrate that
a chemical is safe before it enters commerce -- the opposite of policies
in the United States, where regulators must prove that a chemical is
harmful before it can be restricted or removed from the market.
Manufacturers say that complying with the European laws will add
billions to their costs, possibly driving up prices of some products.

The changes come at a time when consumers are increasingly worried about
the long-term consequences of chemical exposure and are agitating for
more aggressive regulation. In the United States, these pressures have
spurred efforts in Congress and some state legislatures to pass laws
that would circumvent the laborious federal regulatory process.

Adamantly opposed by the U.S. chemical industry and the Bush
administration, the E.U. laws will be phased in over the next decade. It
is difficult to know exactly how the changes will affect products sold
in the United States. But American manufacturers are already searching
for safer alternatives to chemicals used to make thousands of consumer
goods, from bike helmets to shower curtains.

The European Union's tough stance on chemical regulation is the latest
area in which the Europeans are reshaping business practices with
demands that American companies either comply or lose access to a market
of 27 countries and nearly 500 million people.

>From its crackdown on antitrust practices in the computer industry to
its rigorous protection of consumer privacy, the European Union has
adopted a regulatory philosophy that emphasizes the consumer. Its
approach to managing chemical risks, which started with a trickle of
individual bans and has swelled into a wave, is part of a European focus
on caution when it comes to health and the environment.

"There's a strong sense in Europe and the world at large that America is
letting the market have a free ride," said Sheila Jasanoff, professor of
science and technology studies at Harvard University's John F. Kennedy
School of Government. "The Europeans believe . . . that being a good
global citizen in an era of sustainability means you don't just charge
ahead and destroy the planet without concern for what you're doing."

Under the E.U. laws, manufacturers must study and report the risks posed
by specific chemicals. Through the Internet, the data will be available
for the first time to consumers, regulators and potential litigants
around the world. Until now, much of that information either did not
exist or was closely held by companies.

"This is going to compel companies to be more responsible for their
products than they have ever been," said Daryl Ditz, senior policy
adviser at the Center for International Environmental Law. "They'll have
to know more about the chemicals they make, what their products are and
where they go."

The laws also call for the European Union to create a list of
"substances of very high concern" -- those suspected of causing cancer
or other health problems. Any manufacturer wishing to produce or sell a
chemical on that list must receive authorization.

In the United States, laws in place for three decades have made banning
or restricting chemicals extremely difficult. The nation's chemical
policy, the Toxic Substances Control Act of 1976, grandfathered in about
62,000 chemicals then in commercial use. Chemicals developed after the
law's passage did not have to be tested for safety. Instead, companies
were asked to report toxicity information to the government, which would
decide if additional tests were needed.

In more than 30 years, the Environmental Protection Agency has required
additional studies for about 200 chemicals, a fraction of the 80,000
chemicals that are part of the U.S. market. The government has had
little or no information about the health hazards or risks of most of
those chemicals.

The EPA has banned only five chemicals since 1976. The hurdles are so
high for the agency that it has been unable to ban asbestos, which is
widely acknowledged as a likely carcinogen and is barred in more than 30
countries. Instead, the EPA relies on industry to voluntarily cease
production of suspect chemicals.

"If you ask people whether they think the drain cleaner they use in
their homes has been tested for safety, they think, 'Of course, the
government would have never allowed a product on the market without
knowing it's safe,' " said Richard Denison, senior scientist at the
Environmental Defense Fund. "When you tell them that's not the case,
they can't believe it."

The changes in Europe follow eight years of vigorous opposition from the
U.S. chemical industry and the Bush administration. Four U.S. agencies
-- the EPA, the Commerce Department, the State Department and the Office
of the Trade Representative -- argued that the system would burden
manufacturers and offer little public benefit.

In 2002, then-Secretary of State Colin L. Powell directed the staffs of
American Embassies in Europe to oppose the measure. He cited talking
points developed in consultation with the American Chemistry Council, a
manufacturers trade group.

Mike Walls, the chemistry council's managing director of government and
regulatory affairs, said that 90 percent of its members are affected by
the E.U. laws and that some cannot afford the cost of compliance. "We're
talking about over 850 pages of regulation," he said.

The E.U. standards will force many manufacturers to reformulate their
products for sale there as well as in the United States. "We're not
looking at this as a European program -- we're buying and selling all
over the globe," said Linda Fisher, vice president and chief
sustainability officer for DuPont and a former EPA deputy administrator.

DuPont expects to spend "tens of millions" of dollars to register about
500 chemicals with the European Union, Fisher said. About 20 to 30 are
expected to make the list of "substances of very high concern."

One such chemical is likely to be perfluorooctanoic acid (PFOA), used to
make Teflon and other substances used in food packaging, carpet,
clothing and electrical equipment. A suspected carcinogen, it
accumulates in the environment and in human tissue.

DuPont reached a $16.5 million settlement with the EPA in 2005 on
charges that it illegally withheld information about health risks posed
by PFOA and about water pollution near a West Virginia plant. Dupont and
other companies have agreed to cease production by 2015.

Once a chemical is included on the E.U. list, manufacturers are likely
to feel pressure to abandon production, observers say. "It will be a
market signal that says, 'These are best to avoid,' " said Joel Tickner,
director of the Lowell Center for Sustainable Production at the
University of Massachusetts.

Linking the word "concern" to a chemical is enough to trigger a market
reaction. Earlier this year, when government officials in Canada and the
United States said they worried about health effects possibly caused by
bisphenol A (BPA), a chemical used in plastics, major retailers pulled
from their shelves baby bottles containing the chemical.

"When we see lead in toys and BPA in baby bottles, all of these things
arouse a kind of parental anxiety that overrides any counter-arguments
based on science that industry might make," Jasanoff said.

In the absence of strong federal regulations in the United States, a
patchwork system is emerging. Individual states are banning specific
chemicals, and half a dozen lawmakers on Capitol Hill have introduced
bills aimed at shutting down production of various chemicals.

Sen. Frank Lautenberg (D-N.J.) introduced a measure last month that
would overhaul U.S. chemical regulation along the lines of the new
European approach. It would require the Centers for Disease Control and
Prevention to use biomonitoring studies to identify industrial chemicals
present in umbilical cord blood and decide whether those chemicals
should be restricted or banned. A study by the nonprofit Environmental
Working Group found an average of 200 industrial chemicals in the cord
blood of newborns.

Said Denison: "We still have quite a ways to go in convincing the U.S.
Congress this is a problem that needs fixing." But new policies in
Europe and in Canada push the United States closer to change, he said.
"They show it's feasible, it's being done elsewhere, and we're behind."


Deborah L. DeBiasi
Email:   dldebiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
PPCPs, EDCs, and Microconstituents
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
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