F.D.A. to Reconsider Plastic Bottle Risk

From The New York Times:

WEEKS after its own advisory board accused the Food and Drug Administration of failing to adequately consider research about the dangers of bisphenol-A, found in many plastic baby bottles, plastic food containers and metal can linings, the agency has agreed to reconsider the issue.

The F.D.A.’s draft risk assessment in August, finding the chemical safe as it is now used, stood out against a tide of recent scientific opinion. The National Toxicology Program, part of the Department of Health and Human Services, has said there was reason to be concerned that BPA, as the chemical is called, could harm the brain, behavior and the prostate gland in fetuses, infants and children. Canada added the chemical to its list of toxic substances this year and has said it will ban BPA from polycarbonate baby bottles.

In September, a study published in the Journal of the American Medical Association found that adults with high levels of BPA in their urine were more prone to heart and liver disease and diabetes.

More than 200 animal studies have linked ingesting minute amounts of the substance to a range of reproductive problems, brain damage, immune deficiencies, metabolic abnormalities, and behavioral oddities like hyperactivity, learning deficits and reduced maternal willingness to nurse offspring.

The F.D.A.’s position that current human exposure to BPA in food-packaging materials provides an adequate margin of safety appeared to be based on two large multigenerational studies by research groups that received funding from the American Plastics Council, according to a letter sent to the F.D.A. by Representatives John D. Dingell and Bart Stupak, Democrats of Michigan.

Although the F.D.A. had reviewed other studies, only the two multigenerational ones met its guidelines for determining safety for human consumption, said Dr. Mitchell Cheeseman, deputy director of the agency’s Office of Food Additive Safety.

“I don’t want to suggest that published studies are not valuable to F.D.A.’s safety assessment — they are,” Dr. Cheeseman said. “But they lacked details about how the study was done, they don’t include all the raw data, so independent auditing can’t be done by agency scientists, and they have a variety of protocol limitations.”

The F.D.A.’s science board subcommittee on BPA, however, after receiving comments from an independent advisory panel, determined that the F.D.A. was wrong to disregard the large body of research showing health effects even at extremely low doses. The agency’s decision to reconsider was made public earlier this month.

Makers of BPA say that the chemical poses no known risk to human health.

Exposure to BPA is widespread. A study by the Centers for Disease Control and Prevention found it in the urine of nearly 93 percent of a sample population.

Posted: 12/31/2008 9:31:00 AM

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