F.D.A. Criticized for Assurances on Chemical in Plastic

Tag : plastic
By TARA PARKER-POPE The New York Times Published: Oct 30, 2008
A scientific panel has issued a blistering report against the Foodand Drug Administration, saying the agency ignored importantevidence in reassuring consumers about the safety of thecontroversial chemical bisphenol-A.
The panel, in a report issued this week, did not draw anyconclusions about the safety of the chemical, known as BPA. But itcriticized the F.D.A. for ignoring crucial studies and using whatit said were flawed methods in reaching its conclusions.
The drug agency’s evaluation of BPA “creates a falsesense of security” and “overlooks a wide range ofpotentially-serious findings,” the panel’s report said.
In a statement, the F.D.A. said that the report “raisedimportant questions” and that more study was needed, but itdid not back away from its claim that the chemical is safe. Theagency will review the report of the scientific advisory board onFriday.
BPA is widely used to make hard, clear plastic water and babybottles, and it is found in the lining of nearly every soft drinkand canned food product. The chemical appears to have estrogen-likeeffects, and in animal studies it appears to accelerate puberty andpose a cancer risk.
While most worries about BPA focus on children, some recent reportssuggest BPA may interfere with chemotherapy, and in adults thechemical has been associated with higher risk for heart disease anddiabetes. The F.D.A. has maintained that the levels of BPA to whichchildren and adults are exposed do not pose a meaningful risk.
This fall, the agency asked an independent panel of scientificadvisers to review its conclusions. The seven-member panel includesenvironmental health, toxicology and statistics experts from threemajor universities, the Environmental Protection Agency and theCenters for Disease Control and Prevention.
These are among the concerns raised by the panel:
¶The F.D.A. assessment does not have an adequate number ofinfant formula samples and relies too heavily on averages, ratherthan accounting for variability in the samples.
¶The agency excluded several important animal studies thatraised questions about the safety of BPA.
¶New research on BPA in adult humans and animals was publishedafter the F.D.A.’s draft report and should be included in itsfindings.
¶The margins of safety for BPA exposure used by the agency are“inadequate.”
¶The agency focused only on food-source exposures to BPArather than the “totality of exposures” from othersources, which “severely limits the usefulness of the safetyassessment.”
In its statement, the F.D.A. said consumers should know that“based on all available evidence, the present consensus amongregulatory agencies in the United States, Canada, Europe and Japanis that current levels of exposure to BPA through food packaging donot pose an immediate health risk to the general population,including infants and babies.” © The New York Times. All rights reserved. This articleoriginally appeared in The New York Times .