Wednesday, August 03, 2005

GAO, NY Times & Wall St Journal: US Chemical Policy Needs Fixing

It was 1976, just a few optimistic years after the first Earth Day that Congress passed the Toxic Substances Control Act to provide EPA with the authority to obtain more information on chemicals and regulate those chemicals that pose an unreasonable risk to human health or the environment. Now, almost thirty years later, a Government Accountability Office report reveals how far we have -- or have not -- come.
  • EPA has used its authority to require testing for fewer than 200 of the 62,000 chemicals in commerce when EPA began reviewing chemicals under TSCA in 1979.

  • EPA does not routinely assess the human health and environmental risks of existing chemicals and faces challenges in obtaining the information necessary to do so.

  • TSCA does not require chemical companies to test new chemicals for toxicity and to gauge exposure levels before they are submitted for EPA’s review, and chemical companies typically do not voluntarily perform such testing.

  • In the absence of industry data, EPA must predict potential exposure levels and toxicity of new chemicals by using scientific models and by comparing them with chemicals with similar molecular structures (analogues) for which toxicity information is available.

  • TSCA authorizes EPA to require chemical companies to develop test data only when the agency finds that a chemical (1) may present an unreasonable risk of injury to health or the environment or (2) is or will be produced in substantial quantities and (a) there is or may be significant or substantial human exposure to the chemical or (b) it enters or may reasonably be anticipated to enter the environment in substantial quantities.

  • Estimates of a chemicals’ production volume and anticipated uses provided in the premanufacture notice, which EPA uses to assess exposure, can change substantially after EPA completes its review and manufacturing begins. These estimates do not have to be amended by companies unless EPA promulgates a rule determining that a use of a chemical constitutes a significant new use.

  • EPA has limited ability to publicly share the information it receives from chemical companies under TSCA because TSCA prohibits the disclosure of confidential business information, and chemical companies claim much of the data submitted as confidential.

Shortly after the GAO report was issued, the NY Times made use of its conclusions to describe the continuing saga of DuPont's contamination of the water near its factory in Parkersburg, W.V. with PFOA or C8, an important ingredient used in processing Teflon. I've already written a couple of times (here and here) about the EPA proposing millions of dollars of fines against DuPont for failing for two decades to report possible health and environmental problems related to PFOA. DuPont has denied that PFOA causes harm to human health, although it paid $100 million to settle a lawsuit due to its contamination of the water supplies near Parkersburg.
But that was before a group of scientists advising the Environmental Protection Agency determined earlier this month that the ingredient, perfluorooctanoic acid, also known as PFOA or C8, was a "likely carcinogen," or cancer-causing agent. That finding could compel the E.P.A. to formally regulate the chemical.

***

Increased regulation or a successful class-action suit would be a heavy blow to one of DuPont's most successful and profitable businesses. According to the suit, which was filed in several states by two Florida law firms, DuPont nets an estimated $200 million in profit a year from sales of Teflon. The scientific panel's finding could also be bad news for the chemical industry in general if it fuels debate over the use of chemicals in industrial and consumer products, and their potential link to diseases like cancer and to reproductive disorders.

It could also complicate DuPont's position in two matters: a criminal investigation into whether it hid tests showing a public health threat, and a class-action suit filed last week on behalf of people who bought Teflon-coated cookware.
Finally, the Times uses the example of asbestos to point out how difficult it would be for EPA to ban PFOA. In the late 1980's, EPA banned the use of asbestos in this country. Some manufacturers of asbestos products filed suit against EPA, arguing, in part, that the rule was not promulgated on the basis of "substantial evidence" regarding "unreasonable risk." In October 1991, the U.S. Court of Appeals for the Fifth Circuit agreed with the chemical companies, concluding that EPA had failed to muster substantial evidence to justify its asbestos ban and returning parts of the rule to EPA for reconsideration.

David M. Ozonoff, a professor of environmental health at Boston University's School of Public Health sums up where are thirty years after the passage of TSCA: "The system does not work, and our blood and bodies and tissues are proof."

Meanwhile, that radical tree-hugging enviro paper called the Wall St. Journal raises alarming evidence of how “even minute traces of some chemicals, always assumed to be biologically insignificant, can affect such processes as gene activation and brain development in newborns.”

Much of this effect comes from a group of chemicals called “endocrine disrupters.” These are chemicals that mimic or interfere with the effects of hormones in the human body.

Some of the most common chemicals that may have effects at extremely low levels are bisphenol A (used in polycarbonate platic baby bootes and resins in food cans), phthalates (used in toys, building material, drug capsules, cosmetics and perfumes), perchlorate (used in munitions) and the weed killer atrazine. Japan and the European union have already moved to ban some of these substances.

Meanwhile, at home here in the U.S., chemical industry groups “have attacked low-dose research as alarmist,” and the White House “plays down the issue.” While regulators at EPA and the Department of Health and Human Services forge ahead with research, “the administration has proposed funding cuts for EPA research on suspected endocrine disrupters, but Congress has kept the funding roughly level at about $10 million a year.”

At the same time, legislatures in California and New York are considering bills that would ban phthalates in toys, child-care products and cosmetics, and a bill in California would restrict bisphenol

Just to make matters worse, while EPA has trouble regulating high use chemicals with good toxicological evidence, and scientists struggle to identify the health effects of tiny amounts of chemicals, there is more and more evidence that combinations of chemicals can cause problems over and above the effects of single chemicals alone.
Environmental chemicals don't exist in isolation. People are exposed to many different ones in trace amounts. So scientists at the University of London checked a mixture. They tested the hormonal strength of a blend of 11 common chemicals that can mimic estrogen.

Alone, each was very weak. But when scientists mixed low doses of all 11 in a solution with natural estrogen -- thus simulating the chemical cocktail that's inside the human body today -- they found the hormonal strength of natural estrogen was doubled. Such an effect inside the body could disrupt hormonal action.
"In isolation, the contribution of individual [estrogen-like chemicals] at the concentrations found in wildlife and human tissues will always be small," wrote the scientists, led by Andreas Kortenkamp, who directs research on endocrine disruptors for the EU. But because such compounds are so widespread in the environment, the researchers concluded, the cumulative effect on the human endocrine system is "likely to be very large."
The GAO recommended that Congress grant EPA explicit legal authority to force companies to test chemicals for toxicity. The report also recommended that EPA be authorized to share information about potentially toxic chemicals with states and other countries which is difficult now because more than 60% of the information submitted for new chemicals is declared confidential business information.

The GAO also recommended that EPA require companies to provide information to EPA that it is required to provide to foreign governments.

The American Chemistry Council argues that TSCA is just fine as it is and that voluntary programs have been working to protect Americans from chemical hazards.

Although the US chemical industry and their wholly owned subsidiary in the White House and Capitol Hill fight the emerging science and resist regulations, they may be dragged, kicking and screaming, into a sensible chemical policy by their chief trading partners. I've written quite a bit about the European Community's REACH proposal which would require chemical manufacturers who produce or sell chemicals in Europe to required to gather and report the quantity, uses and potential health effects of approximately 30,000 chemicals. Essentially, REACH would end the U.S. practice of assuming chemical to be innocent until proven guilty.

Some think the the PFOA controversy points out how the proposed European system makes a bit more sense than the current American system which considers chemicals to be innocent until proven guilty:
"It's been produced for 50 years," said Jane Houlihan, vice president of the Environmental Working Group, an environmental organization based in Washington that has been a leading critic of DuPont. "Why only now are we studying it? That is a system that's completely backwards."


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