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 FDA has agreed to reconsider the issue. The agency’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.
It has been reported that the FDA’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. Although the FDA reviewed other studies, only the two multigenerational studies met its guidelines for determining safety for human consumption, according to Dr. Mitchell Cheeseman, deputy director of the agency’s Office of Food Additive Safety. Dr. Cheeseman had this to say:
I don’t want to suggest that published studies are not valuable to FDA’s safety assessment — they are. 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.
Dr. Anila Jacob, a physician and senior scientist at the EWG, observed:
This was the FDA finally acknowledging that its assertion that BPA is safe may not be correct. Still, we don’t think it’s enough. With millions of babies being exposed to this chemical on a daily basis, every day we continue to delay removing this chemical from baby products is another day millions of infants continue to be exposed.
But the FDA’s science board subcommittee on BPA, after receiving comments from an independent advisory panel, determined that the agency 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 in December. I must confess that I have more confidence in the Environmental Working Group, a Washington-based advocacy group, than I had in the leadership at the FDA on health and safety issues during the Bush Administration.
Source: New York Times
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