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Environmental connections to public health >>

New Chemicals: Sell First, Test for Safety Later?

Friday, May 31, 2013

A lot of people assume a company can’t sell a chemical until it is has been proved safe.

They’re wrong. Under current law, the Environmental Protection Agency is charged with determining that a chemical is not likely to present an unreasonable risk before it goes on the market. Yet an analysis of the EPA’s approval process has found that the agency has been making that critical decision even though it has not received health and safety data for 85 percent of the new chemicals concocted by the chemical industry.  The federal government’s regulatory framework places the burden on EPA to show that chemicals are unsafe instead of forcing chemical companies to show that their creations are safe.  

The Safe Chemicals Act, a toxic law reform bill introduced seven weeks ago by Sen. Frank Lautenberg (D-N.J.)  proposed to close this loophole, the better to protect public health and the environment. If this bill were to become law, manufacturers of new chemicals would be required to meet a health-protective safety standard demonstrating that the substances presented “reasonable certainty of no harm” before they could be used in products and sold in the U.S. Chemical manufacturers would have to submit minimum health and safety data to help EPA with its review.

But after negotiations with the chemical industry and Sen. David Vitter (R-La.), the bill’s name changed  to the “Chemical Safety Improvement Act,” and it was rewritten from top to bottom. (Just two of the 1,590 lines in Lautenberg’s original Safe Chemicals Act match lines that appear in the Lautenberg-Vitter Chemical Safety Improvement Act.)

Early news coverage indicated that for new chemicals to make it to market, EPA “would have to decide that they are likely to be reasonably safe.” However, an analysis by the Environmental Working Group has determined that the Lautenberg-Vitter bill would likely mean business as usual for the chemical industry.

For one thing, its weak safety standard mirrors current law. It is hard to see how toxic chemicals would be kept off the market, given the burden the Lautenberg-Vitter bill places on EPA to justify restricting a chemical.  The agency would be required to weigh both the costs and benefits of restrictions. It could not act solely on the basis of danger to health.

For another, the bill would give the EPA 90 days to review a company’s data and determine whether the new chemical is likely to present an unreasonable risk to human health or the environment.  In the real world, the phrase “unreasonable risk” boils down to a dollar figure. If a component of, say, a flame retardant used to treat a couch could be dangerous, but a safer chemical would raise the product’s price tenfold, some would argue that the lower cost makes the risk “reasonable.”

Suppose a company gave the EPA no health and safety information about a new chemical. If the EPA did not receive information to determine the chemical’s safety, in order to justify requesting more data from the manufacturer, regulators would have to make a detailed showing that existing information was inadequate. It is important to note that the Lautenberg-Vitter bill says the agency has the option of allowing the chemical on the market in the meantime. 

The Washington law firm of Beveridge and Diamond has interpreted the Lautenberg-Vitter bill to mean that companies could market their new chemicals in order to generate the income necessary to conduct any safety tests  requested by EPA. This is no improvement over current federal law, the Toxic Substances Control Act of 1976, which allows people to be exposed to potentially harmful chemicals before they are adequately reviewed for safety.

This situation is also similar to the federal government’s practice of permitting “conditional registration” for pesticides A groundbreaking study published last March by the Natural Resources Defense Council found that nearly two out of every three pesticides on the market were conditionally registered with the EPA, often without the necessary health and safety testing.  The process contemplated by the Lautenberg-Vitter bill would allow new chemicals to enter commerce without thorough, or indeed any, safety testing.

And what about new nanomaterials?

The original Lautenberg proposal would have allowed EPA to regulate novel nanomaterials more rigorously. It contained language that would have updated the definition of “chemical substance” to reflect the new science of nanotechnology, which exploits changes in size and shape of materials to manipulate their behavior, but also may present new health risks.

The Lautenberg-Vitter bill would maintain the status quo. It would give EPA no more power to oversee nanotechnology, despite the rapid development of these materials. That’s a serious gap.  As a chemist specializing in nanotechnology, I know that certain nanomaterials can present greater hazards to health and the environment than ordinary ones. The EPA needs to have the ability to distinguish among different material forms to ensure that both new and existing nanomaterials are safe for us all.

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