Smart discussion about toxics policy reform

FDA Under Pressure for BPA Food Safety Rules

As a key deadline approaches, scientists and environmental health advocates are ramping up pressure on the federal Food and Drug Administration (FDA) to rein in food contamination from bisphenol A (BPA), a plastic component and synthetic estrogen  detected in the bodies of 93 percent of Americans tested.

During the Bush administration, the FDA contended that traces of BPA leached into food and drink from packaging were safe, even for pregnant women, infants and young children.   Despite contradictory findings from the National Toxicology Program (NTP), which last year said that BPA might damage the brains, reproductive systems and behavior of fetuses, infants and children, the FDA has refused to restrict BPA use in food packaging, provoking protests from scientists and environmental and health advocates.

Since President Obama took office, the agency’s leadership has given mixed signals, on one hand promising a “fresh look” at BPA safety but suggesting, on the other, that further studies could delay decisive regulatory action.

FDA officials have indicated they would detail their plans for the BPA issue later this month.   Meanwhile, several developments are intensifying the spotlight on BPA — and putting FDA on the spot:

BPA leaching in canned goods

The Consumers Union project augments and amplifies 2007 tests by Environmental Working Group that found BPA in more than half of 97 cans of common canned goods, including  infant formula.  BPA, made from feedstock tracing back to the petrochemical benzene, is an integral ingredient in epoxy resin, used in industrial paints and coatings, including food and beverage can linings. The chemical is also essential to the manufacture of polycarbonate plastic, found in thousands of products, from computer and cell phone casings and hard hats to water jugs and, until recently, baby bottles and sports bottles.

BPA-based synthetics are notoriously unstable.  Studies documenting widespread BPA migration into the food supply have moved an increasing number of scientists and environmentalists to press for enforceable regulatory curbs.

“If you can demonstrate that a chemical is endocrine-active,” said R. Thomas Zoeller, Ph.D. an endocrine system specialist at the University of Massachusetts-Amherst and lead author of the 33-scientists’ letter to FDA chief Hamburg, “then I think you need to look very serious at allowing every man, woman and child in this country to come in contact with it, period.”

More funds for basic research

On a second track,  NIEHS director Linda Birnbaum, Ph.D., who also heads the National Toxicology Program,  using stimulus money to  fund basic research into how BPA and other chemicals that act like hormones in the body may be causing subtle changes in vital systems and gene expression, including behavioral changes, obesity, diabetes, reproductive system cancers adn other disorders, asthma, cardiovascular diseases and gene-level changes that transcend generations.

“The kind of sophisticated research that is being sponsored by NIEHS is required for us to understand endocrine disruptors in a broader way, “ Zoeller said,  “not just BPA and not just estrogen.  There are tentacles of endocrine disruptors in the environment that are acting like weak drugs,  that are being exposed to everybody on a daily basis.”

Significantly, the NIEHS stimulus awards are going to a number of researchers who have been highly critical of the FDA. Among them: Frederick vom Saal, Ph.D., a biologist at the University of Missouri at Columbia whose research team is credited with producing the first hard evidence that low doses of BPA caused irreversible damage to the male reproductive system.

“Even if BPA were banned in all products immediately,” said Vom Saal, “there would still be billions of pounds of this product out in the environment. There is a need for research to identify in more detail what the hazards are, what the molecular mechanisms are, particularly looking at infants. We have very little information about how much BPA is actually present in infants.”

Lynn Goldman on board at FDA

To date, the FDA has not moved aggressively, as its critics had hoped.   Last August, EWG  asked Hamburg to replace Mitchell Cheeseman, Ph.D., the agency’s lead scientist for the BPA review, on grounds that he was reported to have consulted closely with chemical industry officials and that his team continued to rely heavily on just two chemical industry studies that found BPA exposure to be relatively benign.

A course correction may be in the works.  EWG has learned that Jesse Goodman, M.D., M.P.H., the FDA’s Science Advisor, has engaged Lynn Goldman, M.D., M.P.H., of the Johns Hopkins Bloomberg School of Public Health, a pioneer in research on endocrine-disrupting chemicals and a leading voice for strong environmental health policy, to act as a part-time consultant on BPA and related issues.

Industry opposition expected

Any effort by FDA to restrict BPA exposure is sure to be fought by chemical makers, who reap an estimated $6 billion yearly in global sales of BPA, and food processors hoping to avoid the expenses of developing alternative packaging and retooling assembly lines.

Advocates for a ban on BPA in food packaging argue that it constitutes a small percentage of the BPA market – and in any case, public health should take priority over corporate bottom lines, as the federal Pure Food Act intended.

Vom Saal:  FDA legal threshold met

“If you have a thousand papers and they’re showing that this estrogenic chemical impacts every system you look at adversely,” says Vom Saal, “ how can you possibly say, we’re going to tell you it’s safe?  We cannot tell the American public this chemical is safe.”


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3 Responses to “FDA Under Pressure for BPA Food Safety Rules”

  1. Charli says:

    Thanks Ms. Shannon, for posting something about chemical safety. I think making industrial chemicals safe for everyone is something we can all get behind. Problem is: mandating more chemical testing, the kind being advocated by the Safer Chemicals coalition, will kill millions of animals, cost lots of money, and give use questionable results.

    Recently the New York Times gave the example: “The chemical industry cites one recent study in which BPA did not cause harm to the reproductive health of Long-Evans rats. But that strain of rats has been found to be less susceptible to endocrine disruptors, while CD-1 mice (also used in many experiments) are more vulnerable. Are humans more like Long-Evans rats or like CD-1 mice?” This is precisely the problem.

    Many people and scientists agree that current legislation which regulates chemicals must be reformed. However, we should also be sure to reform the science that underlies these regulations—namely, the way in which toxicity testing is conducted.

    Currently, toxicity testing is largely based on experiments in animals and uses methods that were developed as long ago as the 1930’s and 40’s; they and are slow, inaccurate, open to uncertainty and manipulation, and do not adequately protect human health. These tests take anywhere from months to years, and tens of thousands to millions of dollars to perform. More importantly, the current testing paradigm has a poor record in predicting effects in humans and an even poorer record in leading to actual regulation of dangerous chemicals.

    Fortunately, many scientists have worked, and are working, on addressing these problems — and alternatives to animal testing exist in a powerful way. Chemical reform should not only modernize policy, but modernize the science that supports that policy. Let’s ensure that our new legislation uses all the necessary tools to truly make our children, our environment, and animals safe.

  2. Dami�o says:

    Thanks Ms. Shannon, for posting something about chemical safety. I think making industrial chemicals safe for everyone is something we can all get behind. Problem is: mandating more chemical testing, the kind being advocated by the Safer Chemicals coalition, will kill millions of animals, cost lots of money, and give use questionable results.

    Recently the New York Times gave the example: “The chemical industry cites one recent study in which BPA did not cause harm to the reproductive health of Long-Evans rats. But that strain of rats has been found to be less susceptible to endocrine disruptors, while CD-1 mice (also used in many experiments) are more vulnerable. Are humans more like Long-Evans rats or like CD-1 mice?” This is precisely the problem.

    Many people and scientists agree that current legislation which regulates chemicals must be reformed. However, we should also be sure to reform the science that underlies these regulations—namely, the way in which toxicity testing is conducted.

    Currently, toxicity testing is largely based on experiments in animals and uses methods that were developed as long ago as the 1930’s and 40’s; they and are slow, inaccurate, open to uncertainty and manipulation, and do not adequately protect human health. These tests take anywhere from months to years, and tens of thousands to millions of dollars to perform. More importantly, the current testing paradigm has a poor record in predicting effects in humans and an even poorer record in leading to actual regulation of dangerous chemicals.

    Fortunately, many scientists have worked, and are working, on addressing these problems — and alternatives to animal testing exist in a powerful way. Chemical reform should not only modernize policy, but modernize the science that supports that policy. Let’s ensure that our new legislation uses all the necessary tools to truly make our children, our environment, and animals safe.