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New Chemical Legislation Could Help Protect Future Generations

By Samuel L. Jacobs, M.D.
This opinion piece was printed on May 11, 2010, in the North Jersey Record.

As if new parents didn’t have enough to worry about, now they have to ponder the safety of their baby’s bottle.

As an obstetrician and gynecologist, I have patients who are losing sleep over whether their infant’s bottle contains Bisphenol A—known as BPA—or whether they were exposed to this estrogen-mimicking chemical during pregnancy.

BPA has also been on the minds of federal lawmakers—and legislation just introduced shows they are seriously concerned about protecting humans from potentially harmful chemicals.

Sen. Frank Lautenberg introduced a bill in the U.S. Senate with the goal of fixing shortcomings in our chemical regulation system. The Safe Chemicals Act of 2010, along with the bill’s House version, would be the first major revision to the Toxic Substances Control Act in its 34-year history.

The two bills would require the Environmental Protection Agency to make important changes to better protect consumers and the environment from dangerous chemicals, including use of new scientific methods. It would compel the EPA to develop more computer models, human cell and tissue tests, and other nonanimal methods to more quickly and accurately assess chemicals.

Unfortunately, the legislation does not go far enough in addressing limitations of animal-based methods. For truly modern chemical regulation, use of nonanimal methods should be required, rather than just encouraged, when these methods are available. Writing this into law could spur innovation and development of new and better methods.

It is now widely acknowledged that animal-based toxicity tests have questionable value for predicting human health effects. A comprehensive 2005 study examined decades of developmental toxicity results for nearly 1,400 substances in 12 animal species and found that the data was poorly predictive of outcomes in humans. The scientific community has experienced similar failures in testing other types of toxicity in animals.

Nonanimal methods are anchored in human biology and biological pathways, so they more accurately assess how chemicals may affect our bodies. There are even methods that assess sensitive populations such as infants and developing children.

Testing chemicals on human cells and tissues allows scientists to detect harmful changes long before toxic effects would appear in an animal test. For example, using cell-based methods, researchers can detect subtle changes indicating the development of cancer within cells. In an animal test, they’d have to wait years for a tumor to form.

Tests on animals are expensive and time-consuming. From a practical standpoint, it is not possible to test all the chemicals people are exposed to every day using animal-based methods.

A traditional series of animal tests on one chemical costs about $6 million and can take three to five years to conduct. It has been estimated that to get a better handle on the chemicals we may be exposed to, we need data on at least 30,000 substances in our environment and the products we use. Testing these chemicals for reproductive toxicity in animals would take more than a century.

The BPA fiasco offers a key example of what is wrong with our current system. Food and Drug Administration officials have expressed concern about the effects of BPA on the development of fetuses, infants, and children. But the agency called for five years and $10 million worth of testing in rats and primates, just to be sure. There are already more than 900 peer-reviewed animal-based studies on BPA, but the effects of BPA on humans remain controversial.

A testing approach emphasizing nonanimal methods would allow us to accurately determine the toxicity of many more chemicals before they reach the market. Ideally, a system of nonanimal methods could assess many chemicals in a few weeks for around $25,000. These tests can assess far more chemicals and far more doses of each chemical than any animal test can. If we had been more open to adopting cell- and computer-based testing approaches, it is possible that the BPA controversy could have been avoided.

The National Research Council has already outlined a detailed plan for moving toward modern, nonanimal methods, and Sen. Lautenberg’s bill encourages this shift. But the legislation also should provide the resources and support needed to move this plan forward. A move toward nonanimal methods would make chemical testing quicker and more cost-effective. But most important, it is the best way to protect future generations.

Samuel L. Jacobs, M.D., is a clinical associate professor of obstetrics and gynecology in the Division of Reproductive Endocrinology at the UMDNJ-Robert Wood Johnson Medical School.


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