[Pharmwaste] Regulatory system called into question

[DeBiasi,Deborah]

http://www.dfw.com/mld/dfw/news/local/16155354.htm


 Posted on Sun, Dec. 03, 2006  
 


Regulatory system called into question

By SCOTT STREATER
STAR-TELEGRAM STAFF WRITER

Picture this scenario: You own the Wonderful Chemical Co., and you have
developed a new compound that when added to dishwasher detergent
promises to help make plates remarkably clean every time.

You want to put it on the market as quickly as possible.

Lucky for you, the federal approval process for new chemicals is suited
to companies like yours.

All you have to do is apply to the Environmental Protection Agency's
new-chemicals program, an overworked corner of the agency that handles
an average of about 142 applications a month. Staff members have 90 days
to review your application and determine whether the chemical poses a
risk to human health or the environment.

You're not required to test your chemical for health effects unless
evidence already exists of potential harm. You do not have to develop
computer models that demonstrate what happens to your chemical once it
enters the environment, how long it stays in the air or soil or whether
it could get into people.

And if problems are discovered after it is in widespread use, it's up to
the EPA to prove that your chemical is to blame. If you find a problem,
you're required to tell the government.

To industry, the beauty of the U.S. chemical-regulatory system is that
it gives manufacturers the upper hand in a competitive global economy.

"We have new chemical introductions at a rate four times greater than
Europe because our system creates a climate where new chemicals can be
introduced and markets developed," said Steve Russell, a senior director
at the American Chemistry Council, the chemical industry's national
trade group.

But to many medical researchers and health experts, the system is a
growing cause for concern. They are asking whether the United States
regulates toxic chemicals in a way that adequately protects people.

Even the government's own watchdog agency questioned why the burden is
on the public, not industry, to ensure that chemicals in production are
safe.

Critics point out that very little information exists on the potential
health effects of many of the nearly 82,000 chemicals in commercial use.

"We have lots of products that are still being sold every day that we
really don't know enough about to be confident that they're safe," said
Dan Esty, a senior EPA administrator for former President George H.W.
Bush who now directs the Yale Center for Environmental Law and Policy at
Yale Law School.

Others disagree.

Many regulations control how industry uses chemicals on the market and
limit the amounts that can be emitted into the air and water, said Paul
Rubin, a professor of economics and law at Emory University in Atlanta.

What's more, many of those regulations were implemented "in the absence
of a lot of good scientific evidence," said Roger Meiners, a professor
of economics and law at the University of Texas at Arlington.

"It's not because the people doing the work are not competent or intend
to have any negative consequences as a result," Meiners said. "But a lot
of regulation, when it is imposed, is a reflection of the knowledge that
exists at that point in time, which is limited."

And Congress, he said, has little interest in funding research.

The Toxic Substances Control Act, implemented in 1976, dictates how new
chemicals are approved and regulated. It also says chemicals must not
pose an "unreasonable risk to health or the environment."

But the definition of "unreasonable risk" is vague, and it's up to the
EPA to do the costly research to show that a chemical poses a risk.

People have to be dropping like flies, critics say, before federal
regulators can limit or ban the use of a chemical.

That's the opposite of what most scientists would consider a
comprehensive chemicals policy, said Michael Wilson, a research
scientist with the Center for Occupational and Environmental Health at
the University of California, Berkeley. "You sort of wait for the
airplanes to fall out of the air before you design an air traffic
system."

In July, the Government Accountability Office criticized the
toxic-substances act for placing the burden of testing new chemicals for
human risks on the EPA instead of on industry. In August, the Senate
Environment & Public Works Committee held hearings to determine whether
the act needs to be amended to better protect human health and the
environment.

The committee declined to act. But some lawmakers have proposed changes.

One is the Kids Safe Chemical Act, which among other things would
require chemical manufacturers to provide health and safety information
on chemicals used in a wide array of products. The bill, introduced last
year by Sens. Frank Lautenberg, D-N.J., and Jim Jeffords, I-Vt., is
stalled in committee, and observers say its prospects for approval do
not look good.

The European Union adopted legislation that starting July 1 banned the
use of two kinds of flame retardants in electrical equipment and
components sold in Europe.

But that's minor compared with the EU's Registration, Evaluation &
Authorization of Chemicals initiative. It will require chemical
manufacturers who want to do business in Europe to submit health hazard
data, most of which is not available today, for thousands of chemicals.
The U.S. government has joined a number of other governments and
industry leaders in lobbying against the proposal, saying it would
restrict chemicals that could be harmful no matter how remote the risk.
.

The initiative could receive final approval soon.

If data submitted by U.S. manufacturers show potential health hazards no
one knew of before, that would put tremendous pressure on chemical
companies to develop cleaner alternatives, said Esty, the Yale Center
director.

"I suspect that chemicals that are found to be unacceptably toxic based
on European testing will be withdrawn from the U.S. market as well," he
said. "I suspect that the presence of tort lawyers looking for
opportunities to bring cases would make it untenable to continue to sell
any chemicals that had, in effect, flunked European testing."

Industry leaders say the EPA already has an effective system, the High
Production Volume Challenge. It's a voluntary program in which companies
have agreed to gather and submit hazard data for chemicals of which more
than 1 million pounds a year are manufactured in or imported into the
U.S. The program will ultimately yield information about some 2,200
chemicals, said Charles Auer, director of the EPA's Office of Pollution
Prevention & Toxics.

That information, some of it already available on the EPA's Web site, is
more than enough, said Russell, the American Chemistry Council official.

"It's just simply not accurate to say that information doesn't exist on
these chemicals," he said.

But Auer concedes that the information is limited to basic screening
data, not in-depth research on long-term health effects.

Jane Houlihan, vice president of research at the Environmental Working
Group, a national advocacy organization, said, "It's better than
nothing. But is it what we need in order to know whether these chemicals
are safe? Absolutely not."

Berkeley researcher Wilson says a good chemical-regulation policy would
consist of improving the flow of information about chemical toxicity,
strengthening the government's ability to protect public health and
devoting more public money to develop cleaner chemical alternatives.

"We can create a market that moves steadily toward the design and
production of safer chemicals," he said. "We can do that if that's what
we decide to do."

Good intentions

Many man-made chemicals are sources of concern today. But most have or
had beneficial uses:

Polychlorinated biphenyls (PCBs): They were used extensively as coolants
and lubricants in transformers and other electrical equipment because
they don't burn easily and are good insulators. Their manufacture
stopped in the U.S. in 1977.

Polybrominated diphenyl ethers (PBDEs): Compounds designed to prevent
the chemical reaction that ignites a fire. They are used in seat cushion
foam and computer wiring insulation and are added to plastics. Two of
the three most widely used PBDEs were voluntarily withdrawn in the U.S.
in 2004.

Perfluorooctanoic acid (PFOA): Designed to help make nonstick cookware,
it is also used on fast-food wrappers and in microwave popcorn bags to
keep food from sticking. DuPont and eight other companies worldwide have
agreed to phase out its use by 2015.

Perfluorooctane sulfonate (PFOS): It was widely used on carpets and on
sofas and other furniture to protect against staining. It was also in
aerosol spray that repelled water when applied to items like camping
gear and shoes. 3M voluntarily stopped making it in 2000.

DDT: A pesticide used extensively against mosquitoes, it helped control
the spread of malaria and other illnesses. It was banned in the U.S. in
1972.

SOURCES: Environmental Protection Agency, federal Agency for Toxic
Substances and Disease Registry
 



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
Mail:          P.O. Box 1105, Richmond, VA  23218 (NEW!)
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028
FAX:      804-698-4032