FDA Panel Offers Corrections to BPA Draft

Subcommittee to FDA: Room For Improvement

The FDA subcommittee reviewing the FDA's August 2008 draft report has released its first recommendations(PDF) on the draft BPA report. The subcommittee brought lots of suggestions for improvement.

They wrote that the draft did not adequately provide scientific support for their method of choosing which studies to include: "Specifically, the Subcommittee does not agree that the large number of non-GLP studies should be excluded from use in the safety assessment."

The subcommittee also questioned the use of "no observed adverse effect level" (NOAEL) standard the FDA employed to determine the safety of exposure. The panel pointed out that so many studies show effects in neurobehavioral development, prostate gland, mammary gland and puberty in females, that it seems BPA must bind to gonadal hormone receptors during development. The panel said this suggests safe exposures "at least an order of magnitude below the 5 mg/kg/bw/day NOAEL identified in the draft assessment." The panel authors suggest several alternative ways to measure dose response that would model findings across the many studies that the FDA excluded in its draft.

The subcommittee offered additional point by point criticism and noted that the studies cleared by the NTP's Center for the Evaluation of Risks to Human Reproduction (CERHR) indicate that the FDA standard should be "substantially below (i.e., at least one or more orders of magnitude lower than) the 5 mg/kg bw/day level selected in the draft FDA assessment."

Living Through Chemistry -- U. Michigan and Dow

The FDA panel released their draft at an opportune time. Philbert was under increasing pressure about his role on the panel given appearances of conflict of interest. Acronym Required wrote a couple of weeks ago on Philbert's directorship of the University of Michigan SPH Risk Science and Analysis program, founded and heavily contributed to by Charles Gelman, a retired manufacturer and tireless critic of chemical regulation. Had the subcommittee's report dared reach the opposite conclusion than the pressure would have increased.

Following our post Martin Philbert wrote a letter to the editor of the Milwaukee Journal Sentinel protesting the paper's allegations that his work would be influenced by the donations he accepted from Gelman: "This simply is not true", he said.

To illustrate his point he described in his letter the $15 million dollar grant the Risk Science Center took from Dow Chemical for a dioxin study. Philbert told how, given the grant, his colleagues "still found that people living near the Dow plant had higher levels of dioxins in their bodies."

Nobody found Philbert's assurance about his work for Dow Chemical comforting since Dow manufactures bisphenol A and takes political action to protect its market when necessary. For instance at (http://dowaction.com/grassroots/notice-description.tcl?newsletter_id=30665022), you can read Dow's letter thanking their employees for their "Best in Class", 31.5% "grassroots" effort in defeating California SB 1713 Bisphenol-A Ban.

The University of Michigan task in the Dow study was to measure blood dioxin levels of home-owners in different geographic areas -- not to investigate health affects. In that sense the dioxin study is not an analogous situation to the BPA panel. But even if were comparable, the University of Michigan results got Dow off the hook in a way, by finding that the variation in dioxin levels was due to things like age and body mass index (BMI), not levels of dioxins in the air or soil.

Media, politicians, citizens and scientists criticized the study because Dow had long been under pressure from the EPA to clean up dioxin contamination ¹ and the study was seen as a stalling technique. The EPA had this to say in one memo: "the study was initiated at the request of Dow in order to downplay the risks of exposure to dioxin contaminated soils." The EPA went on to say:

"public presentations of the preliminary results have emphasized how little effect living on contaminated soils has one an individual's dioxin blood level. This emphasis has resulted in numerous media stories, an understanding by some members of the public, that remediation of dioxin contamination is unnecessary."

The BPA memo on the FDA draft will no doubt assure the doubters in the public that Philbert's panel has their best interests in mind. ² If not, Philbert warns that he will "think long and hard" before taking time to "perform this kind of public service".

Stay on your toes...

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¹ Burnham, D. "1965. Memo Show Dow's Anxiety on Dioxin.", NYT 1983)

² Perhaps Dow's BPA economy is not at stake in Michigan? John Dingell (D-MI), bulldog for the auto-industry, has also taken on BPA.