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Great Lakes Article:

Thousands of chemicals approved without testing
By Tom Avril
Philadelphia Inquirer

PHILADELPHIA - Without requiring lab tests to determine their safety, the U.S. government has approved thousands of chemicals for use in such products as sofa cushions, soaps, paints and baby bottles.

On average, two more chemicals are approved every day.

The result: consumers are unwittingly part of a kind of vast, uncontrolled lab experiment.

"We're treating (people) worse than lab rats," said Karen Florini, an attorney with the non-profit group Environmental Defense. "At least with lab rats, somebody bothers to collect the data."

The U.S. system of regulating chemicals is under renewed scrutiny as European officials voted last week to adopt much tougher rules, which would require substantial testing of many substances before they can be sold there.

With growing amounts of synthetic substances detected in human blood and breast milk, U.S. critics have stepped up calls for similar rules here.

Chemical makers counter that the European proposal would cost billions, stifling research in an industry whose products are overwhelmingly safe and perform valuable functions in society. With strong support from the Bush administration, the companies favor a more voluntary approach toward testing.

Aside from saving time and money, conducting fewer tests on lab animals means less criticism from animal-rights groups.

As the debate continues, new concerns emerge regularly:

Polybrominated diphenyl ethers, used as flame retardants, have been linked to brain damage and lower fertility in lab animals. The amounts in human breast milk in the United States are doubling every two to five years, in some cases nearing levels linked to health problems in animals.

In a rare move Monday, the chief U.S. maker of two such chemicals agreed to stop making them by the end of 2004.

Bisphenol-A, used in baby bottles, dental sealants and linings of food cans, has been tied to lower fertility in rats and defective chromosomes in mice eggs.

Perfluorinated compounds, used to make Teflon pans and, formerly, Scotchgard, have been turning up in human blood and breast milk. Some members of this chemical family have been linked to cancer in lab animals; human risks are unclear.

Methyl tertiary-butyl ether (MTBE), a gasoline additive that reduces air pollution, readily infiltrates groundwater because of its high solubility. It is linked to cancer in mice and is labeled a potential human carcinogen.

With most chemicals, there is no proven risk to humans; manufacturers often sponsor research that contradicts the findings of possible risk.

And in most cases, that's the end of the story.

Even if health concerns are raised after a chemical is on the U.S. market, the government often does not require that it be tested in any systematic way.

And manufacturers can continue making it for years.

When companies do come across possible risks, they must submit data to the U.S. Environmental Protection Agency. But companies can - and for most new chemicals, do - claim that the information is confidential.

As a result, the information is never available to the public.

This system for screening chemicals, enacted 27 years ago, allowed continued production of the 62,000 chemicals then in use and required little, if any, lab testing for the 18,000 approved since then. (Other laws govern chemicals in pesticides, food and drugs, which do require tests.)

Though criticized now, the Toxic Substances Control Act was seen in 1976 as a big improvement, said a lab technician at DuPont's Chambers Works plant in Deepwater, Salem County, N.J.

"They used to put `XYZ' on the drums," said Corliss Sheppard, former head of Local 2-943 of the Paper, Allied-Industrial, Chemical & Energy Workers union. "You couldn't even say what it was. We were tickled to death to at least make them have to tell us what it was."

Difficulties in implementing the law soon became apparent.

EPA has the power to require testing of any chemical, old or new, which it believes may pose a "reasonable risk" to human health or the environment.

Yet the burden of demonstrating risk lies with the agency, a lengthy process that involves estimating exposures for each way a substance might be used. The agency rarely requires tests through this process; more often it negotiates with companies to conduct tests.

A 1997 EPA study found that of the 3,000 chemicals imported or produced in the United States in amounts above 1 million pounds, 43 percent had no publicly available data on toxicity.

Just 7 percent had a full set of basic data, which includes information on how long a chemical persists in the environment and its short- and long-term impacts on the health of lab animals.

Soon after, manufacturers volunteered to test these high-volume chemicals, an effort that is ongoing. Industry officials say they already had some data for most of the high-volume chemicals, though they concede it was not publicly available.

"This allegation that these chemicals haven't been evaluated isn't necessarily accurate," said Steve Russell, an attorney for the American Chemistry Council, an industry group.

Moreover, Russell said, most of the 80,000 approved chemicals are not made in significant amounts. Council officials estimate 15,000 chemicals are actively made, but could not provide an exact figure, nor could they say how many have been tested.

If requiring tests is hard, restricting a chemical's use is even harder.

To take such action, the EPA must determine that any risks are not outweighed by a substance's economic and societal benefits, again for each way in which it might be used. In practice, this provision is so difficult and expensive to implement that it is rarely used.

Even with asbestos, a substance known to cause a rare lung cancer, the EPA spent a decade documenting the risks but ultimately could not make a proposed ban stand up in court.

Restricting new chemicals is easier, through a 90-day screening process. Using computer models, the EPA predicts which new chemicals may be harmful by comparing their structures to those of existing substances - yet again, safety data on the old chemicals can be limited.

In a handful of cases, manufacturers have volunteered to stop making chemicals. In 2000, 3M agreed to phase out a chemical used in Scotchgard. Yesterday, Indianapolis-based Great Lakes Chemical Corp. agreed to phase out two flame retardants by the end of next year.

California had previously banned the two flame retardants as of 2008; a European ban takes effect next year. Great Lakes also announced a replacement product for use in furniture, dubbed "Firemaster 550," which it had voluntarily submitted for an unusual EPA review.

Officials declined to reveal the exact chemical name or structure but said it was not in the same family as the original products. EPA officials said the new substance did not appear to be toxic but said they would monitor future tests.

A representative of flame-retardant makers maintained there is no risk from the old varieties.

"Just detecting something in the environment doesn't mean it's going to have any effect on human health, or on animal health," said Peter O'Toole, U.S. program director for the Bromine Science and Environmental Forum.

Critics counter that evidence of harm will be elusive without required testing.

"How do you know?" said Joel Tickner, an occupational health professor at the University of Massachusetts in Lowell. "Unfortunately, the lack of proof of harm is very often misinterpreted as proof of safety."

That may change in Europe. Wednesday, the European Commission voted to require various tests on more than 10,000 chemicals, depending on the amounts produced. Other data are required on 20,000 more.

Final approval of the proposal could take two years.

The commission estimates the direct cost to chemical makers at $2.7 billion; other companies that use chemicals in their products would spend billions more. Industry officials say the costs would be higher.

Upon evidence of potential risk, Europe could restrict or ban chemicals without waiting years for proof, a concept known as "the precautionary principle."

Proof of risk is a high hurdle, one cleared by only a handful of substances to which humans are exposed at significant levels. Some scientists think the evidence against polybrominated flame retardants, for example, is headed in that direction.

How the chemicals enter the body is unclear. What is not in dispute is that the chemicals are "persistent," meaning they don't break down in the environment for years, even decades.

All the more reason to play it safe, Tickner said.

"If we wait until we have perfect data on the chemicals," he said, "and we're wrong (about their safety) - then you deal with them for a long time."

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