Congressional Panel Investigating Bisphenol A in Infant Formula Investigates the Sale of Science

There have been some very interesting developments in connection with the Congressional investigation into the use of bisphenol A (“BPA”) in infant and baby products.  I’ve been paying attention to the investigation to see what information is developed.  But the investigation seems to have morphed since its initial launch.  I don’t know if anything will come of it, but it seems like that at least somebody is interested in determining whether science has been for sale in connection with assessing the safety of chemicals.  The panel started its inquiry into the use of BPA-containing epoxy resin in infant formula containers.  But the most recent letters issued by the Congressional panel are broader in scope.  The Committee on Energy and Commerce issued letters to the U.S. Environmental Protection Agency (“EPA”), a law firm and a scientific consulting firm inquiriing into whether, basically, science has been for sale.

The letter to the consulting firm, the Weinberg Group, is most entertaining.  It uses the publicity on the Weinberg Group’s website and asks for the information to support the assertions.  The very first question asks for the information associated with the Weinberg Group’s assertion that it worked to delay the cancellation of a new drug allowing for “10 additional years of sales prior to the ultimate cancellation of the drug.”

The letter to the EPA is also entertaining.  It questions the EPA’s recent dismissal of Dr. Deborah Rice from the external peer review panel reviewing the draft health risk assessment for decabromobipheny ether (deca PBDE) for an apparent conflict of interest and an “appearance of a lack of impartiality.”  It notes that the American Chemistry Council objected to Dr. Rice after she testified to th Main legislature on the human health risks associated with deca PBDE as a scientist employed by the Maine Department of Health and Human Services.  It points out that the ACC’s objection to Dr. Rice seems to suggest that scientific expertise with regard to a particular chemical and its human health effects is the basis for the disqualification, a conclusion that the Congressional committee says “does not seem sensible on its face.”  The letter then goes on to ask about nine different individuals who are sitting or sat on various panels while being in more compromising positions. 

The responses of the Weinberg Group and the EPA should be quite entertaining. 

But I think what is most frightening is the U.S. Food and Drug Administration’s response to the Congressional inquiry.  The panel had asked the FDA about certain information regarind the use of BPA in epoxy-based enamels used to line infant formula metal cans.   Why are metal cans lined?  Metal cans require a lining to prevent interaction between the food and the metal can, especially those metal cans that undergo heat treatment to ensure commercial sterility. 

For some background, the Environmental Working Group (“EWG”) investigated the potential leaching of BPA into infant formula, and found BPA present in formula.  Liquid formulas in metal cans had higher concentrations of BPA present than powdered formula.  In fact, the EWG concluded that liquid formulas have the potential to leach at a rate 8 to 20 times higher than powdered formula in metal cans.

The EWG’s study tested 6 liquid formulas.  The FDA has also tested liquid formulas.  Both studies found an average of 5 parts per billion BPA, with four samples above 10 ppb.  The FDA has approved the use of epoxy resins containing BPA in food contact items such as formula.  The FDA maintains that the use of BPA-containing enamels for infant formula containers is safe.  In its response, the FDA stated “FDA has compared the ‘no observed effect’ levels of the data reviewed to the estimated daily intake values and considers that an adequate margin of exposure exists for the conclusion of reasonable certainty of no harm under the intended conditions of use.”  But, the response to the Congressional inquiry stated that FDA’s determination is based on two studies, both of which were reportedly funded by the American Plastics Council, and both of which have been criticized.  The studies have been criticized because one was never published in a peer reviewed journal and the other study used Charles River Sprague-Dawley rats, which some studies have shown only respond to estrogen at high doses.  This study did not use any positive control, which means that it cannot be determined whether the study was capable of finding any health effects from BPA.  The FDA’s letter relies on the conclusion that 7 ug/infant/day is safe.  But, according to the EWG “a baby of average size would exceed FDA’s worst-case dose if he or she drank more than 2.5 bottles (20 ounces) contaminated with BPA at the maximum levels measured in the 20 total samples tested to date in FDA and EWG testing programs.”  The EWG also criticized the BPA migration study cited by the FDA.  The BPA migration study used a level of detection of 100 ppb, a level of detection too high to detect the low levels of BPA leaching, and also well above the level of detection used by the FDA in other migration studies.

It is clear that infant formula containers can leach BPA into infant formula, with liquid formulas having a higher rate of leaching than powdered formulas.  Whether the rate of leaching of BPA results in a risk of harm is subject to debate.  Over a 100 published animal studies indicate adverse health effects at low levels, especially in infants.  Many BPA experts believe that the adverse health effects in animals at low doses of BPA, and that there is no reason to think that such effects would not also occur in humans. 

So what’s a concerned parent to do?  Choose glass over metal contains for infant formula and, if using formula (breast milk is best) powdered infant formula over liquid infant formula.

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