FDA Subcommitee Harshly Critical of Draft Safety Report on Bisphenol A (BPA)

babyI recently expressed concern about whether the Food and Drug Administration’s (FDA) Subcommitee reviewing the FDA’s draft safety assessment of the use of bisphenol A (BPA) could provide a fair review.  I expressed concern because it had been revealed that Subcommittee Chairman Prof. Philbert had failed to disclose a significant donation from pro-plastics contributor Charles Gelman to the chairman’s research center at the Univ. of Michigan.  To resolve that question, the FDA Chair has issued a letter stating that he agrees with the findings of the review conducted by William McConagh a of FDA’s Office of Accountability and Integrity.  That review found that the $5,000,000 donation made by Charles Gelman and the unrestricted grant to the University of Michigan from Dow Chemical for a risk study of dioxin do not require Prof. Philbert to recuse himself but he nevertheless recommends that Prof. Philbert refrain from voting on the questions before the Board relating to BPA.


In any event, imagine my surprise to learn that the Subcommittee’s scientific peer-review report roundly criticizes the FDA’s draft BPA safety assessment.  So perhaps science isn’t for sale after all, at least with respect to the Subcommitee.


Okay, to catch you up, low level exposure to BPA has been linked to hormone disrupting effects in laboratory animals.  BPA is the key monomer of polycarbonate plastic, used for baby bottles.  BPA is also found in the epoxy resins used to line virtually all canned foods and beverages.  BPA can leach out of polycarbonate plastic and the epoxy resins and into your food.  Whether the effects seen in laboratory animals are likely to occur in humans based upon current levels of exposure is subject to much intense debate in the scientific community.  The National Toxicology Program (NTP) issued a report finding the risk a 3 on the NTP’s 5 point scale for 3 health endpoints.  The FDA has maintained that BPA is safe.


In August of this year, the FDA issued a draft report finding BPA safe.  Then, the FDA convenened a Subcommitee to review the draft report.  I thought that the Subcommitee would be, in essence a rubber stamp.


But surprise, surprise, the FDA’s Subcommitee does not agree with the draft safety assessment on BPA.  In fact, it is pretty critical of it.  It finds that the “draft FDA report does not articulate reasonable and appropriate scientific support for the criteria applied to select data for use in the assessment.  Specifically, the Subcommittee does not agree that the large number of non-GLP [good laboratory practice] studies should be excluded from use in the safety assessment.”  The report goes on to state “[c]oupling together the available qualitative and quantitative information (including the application of uncertainty factors) provides a sufficient scientific basis to conclude that the Margins of Sfatey defined by the FDA as ‘adequate’ are, in fact, inadequate.”


Okay, so what does that mean?


Well, what it means is that the peer reviewed assessment of the FDA’s draft report on BPA is telling the FDA that the draft report is inadequate.  The Subcommitee has particular criticisms – it finds that the FDA didn’t use enough infant formula samples and didn’t adequately account of variations among the samples.  It also finds that the FDA didn’t take into account multiple sources of BPA exposure.  But it also is particularly critical of the FDA’s wholesale discounting of studies found adequate by the NTP.  And, I think that this is most important.  The Subcommittee harshly criticizes the FDA for discounting or failing to consider scores of studies that have linked BPA to adverse health effects in animals.


Is the debate over?  No.  The Subcommitee’s report will be considered as part of a briefing on October 31, 2008.  What is likely is that more research will be approved.  And, in the interim, the FDA has issued a Statement on the release of the Subcommitee’s report, pointing out that “the present consensus among regulatory agenices in the United Sates, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.”


In light of the animal studies and the conclusion from the NTP finding “some” concern for effects on the prostate, brain and behavior, you may not want to take that risk.  So, if you want to try to avoid BPA, skip polycarbonate plastic.  Lots of alternatives exist – and don’t cost any more than polycarbonate plastic.  So you can play it safe.  Also, instead of canned foods and beverages, go for jarred, fresh, frozen or dried.

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