FDA: Chemical found in plastic bottles is safe

August 15, 2008 1:07:47 PM PDT
Despite ongoing safety concerns from parents, consumer groups and politicians, a chemical used in baby bottles, canned food and other items is not dangerous, federal regulators said Friday. Food and Drug Administration scientists said the trace amounts of bisphenol A that leach out of food containers are not a threat to infants or adults. The agency acknowledged that more research is needed to fully understand the chemical's effects on humans, and noted "there are always uncertainties associated with safety decisions."

The FDA previously declared the chemical safe, but agreed to revisit that opinion after a report by the federal National Toxicology Program said there was "some concern" about its risks to infants.

The plastic-hardening chemical, similar to the hormone estrogen, is used to seal canned food and make shatterproof bottles. It also used in hundreds of household items, ranging from sunglasses to CDs.

The FDA's draft report was greeted with enthusiasm by the American Chemistry Council, which has defended the chemical's safety.

"FDA is the government agency we rely upon to assess food-contact products. They've assessed this issue in great detail and their conclusion is very reassuring," said Steve Hentges, an executive director with the council.

But environmental groups were quick to criticize the agency's conclusions, which they said relied on industry-funded studies.

"It's ironic FDA would choose to ignore dozens of studies funded by (the National Institutes of Health) -- this country's best scientists -- and instead rely on flawed studies from industry," said Pete Myers, chief scientist for Environmental Health Sciences.

Myers said the agency disregarded recent studies of bisphenol's effects included in the National Toxicology Program's April draft report.

That group's review of animal studies suggested low doses of bisphenol can cause changes in behavior and the brain, and that it may reduce survival and birth weight in fetuses. A final version of the group's findings is expected next month.

Commenting on those studies in its 105-page assessment, the FDA said they had "inconsistencies and inadequacies which limit the interpretations of the findings."

About 93 percent of Americans have traces of bisphenol in their urine, according to the Centers for Disease Control and Prevention. And while the chemical is known to disrupt hormones at high levels, the FDA concluded that the levels people are actually exposed to are thousands of times below what are dangerous.

The FDA released its preliminary re-evaluation ahead of a September meeting where outside advisers will debate the chemical's safety.

Many lawmakers at home and abroad aren't waiting for the agency to complete its review.

Canada has announced its intention to ban the use of the chemical in baby bottles, and state and federal lawmakers have introduced legislation to ban bisphenol in children's products.

Some environmental groups questioned the timing of the FDA's report, noting California lawmakers are expected to soon vote on removing bisphenol from children's products. If signed into law, it would be the first state ban of the chemical.

"For this to come out on a Friday afternoon, just before California takes action, it definitely raises some eyebrows," said Renee Sharp, a senior analyst with the Environmental Working Group.

At least 10 states besides California are also considering bills to restrict use of the chemical.

More than 6 billion pounds of bisphenol are produced in the U.S. each year by Dow Chemical, BASF, Bayer AG and other manufacturers.


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