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Reversing itself, FDA expresses concerns over health risks from BPA

By Lyndsey Layton
Saturday, January 16, 2010; A01

The Food and Drug Administration has reversed its position on the safety of Bisphenol A, a chemical found in plastic bottles, soda cans, food containers and thousands of consumer goods, saying it now has concerns about health risks.

Growing scientific evidence has linked the chemical to a host of problems, including cancer, sexual dysfunction and heart disease. Federal officials said they are particularly concerned about BPA's effect on the development of fetuses, infants and young children.

"We have some concern, which leads us to recommend reasonable steps the public can take to reduce exposure to BPA," said Joshua Sharfstein, FDA's deputy commissioner, in a conference call to reporters Friday.

Regulators stopped short of banning the compound or even requiring manufacturers to label products containing BPA, saying that current data are not clear enough to support a legal crackdown. FDA officials also said they were hamstrung from dealing quickly with BPA by an outdated regulatory framework.

Sharfstein said the agency is conducting "targeted" studies of BPA, part of a two-year, $30 million effort by the administration to answer key questions about the chemical that will help determine what action, if any, is necessary to protect public health. The Obama administration pledged to take a "fresh look" at the chemical.

BPA, used to harden plastics, is so prevalent that more than 90 percent of the U.S. population has traces of it in its urine, according to the Centers for Disease Control and Prevention. Researchers have found that BPA leaches from containers into food and beverages, even at cold temperatures.

The FDA's announcement came after extensive talks between federal agencies and the White House about the best approach to an issue that has become a significant concern for consumers and the chemical industry.

One administration official privy to the talks said the FDA is in a quandary. "They have new evidence that makes them worried, but they don't have enough proof to justify pulling the stuff, so what do you do?" said the official, who spoke on the condition of anonymity. "You want to warn people, but you don't want to create panic."

The FDA had long maintained that BPA is safe, relying largely on two studies funded by the chemical industry. The agency was faulted by its own panel of independent science advisers in 2008, which said its position on BPA was scientifically flawed because it ignored more than 100 published studies by government scientists and university laboratories that raised health concerns about BPA. Recent data found health effects even at low doses of BPA -- lower than the levels considered safe by the FDA.

The chemical industry, which produces more than 6 billion tons of BPA annually and has been fighting restrictions on its use, said Friday's announcement was good news because the agency did not tell people to stop using products containing the chemical.

"The science continues to support the safety of BPA," said Steven Hentges of the American Chemistry Council.

In a statement, the industry group said: "Plastics made with BPA contribute safety and convenience to our daily lives because of their durability, clarity and shatter-resistance. Can liners and food-storage containers made with BPA are essential components to helping protect the safety of packaged foods. . . . ACC remains committed to consumer safety, and will continue to review new scientific studies concerning the safety of BPA."

Bisphenol A was discovered to be a synthetic estrogen in the 1930s. By the 1950s, chemists found BPA could be used to make polycarbonate plastics, giving them a "shatterproof" quality, and the uses for the chemical exploded.

But recently, consumers have placed increasing pressure on manufacturers and retailers to migrate away from BPA. In 2008, Babies R Us and other major retailers told suppliers they would no longer stock baby bottles made with BPA. Last year, the six largest manufacturers of baby bottles announced they would voluntarily stop selling bottles made with bisphenol A to consumers in the United States.

But BPA remains in the epoxy linings of most canned goods, including baby formula. Research has shown that it leaches from the linings into liquid formula, but not powered formula.

Environmental groups, public health advocates and consumer organizations applauded the FDA for recognizing concern about BPA, but some said the agency didn't go far enough.

"It's really a shame after all of the studies out there that they didn't do anything to protect the public health," said Urvashi Rangan, director of technical policy at Consumers Union. "How many pieces of evidence do we need before we have enough to act?"

Canada declared BPA a toxin and banned it from baby bottles in 2008. Similar restrictions have taken root in Chicago, Minnesota, Connecticut and Suffolk County in New York. In Congress, Sens. Dianne Feinstein (D-Calif.), Charles E. Schumer (D-N.Y.) and Rep. Edward J. Markey (D-Mass.) have filed a bill that would block BPA from all food and drink packaging.

As it awaits additional research results, the FDA plans to change the way it classifies BPA so that it can exercise tighter controls over the chemical, Sharfstein said. Currently, BPA is approved as a "food additive," which means manufacturers are not required to tell the government which products contain BPA and in what amounts. The agency wants to reclassify it as a "food contact material," which would require greater disclosure from manufacturers and would allow the FDA to take fast action if it determined that the material posed a health risk.

The Department of Health and Human Services has released recommended ways for the public to reduce exposure to BPA. It can be found at http://www.hhs.gov/safety/bpa.

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