Regulatory system called into question - intra-body toxins - !!!

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Regulatory system called into question

By SCOTT STREATER

STAR-TELEGRAM STAFF WRITER

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

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 , 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 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

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 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 , 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. 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 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 , 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 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

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