A scientific advisory panel looking at bisphenol A safety issued a blistering criticism Oct. 28 of the Food and Drug Administration, saying the FDA's position that BPA is not harmful ignores critical studies and that the margins of safety the agency defines as adequate ``are, in fact, inadequate.''
The highly critical report details a number of limitations of FDA's draft assessment:
* An inadequately sized sample — 14 cans of infant formula — and the use of mean values to determine potential risk, without taking into account variability of samples.
* Failure to provide ``reasonable and appropriate scientific support'' for excluding a large number of studies from consideration.
* Failure to consider the potential cumulative and interactive effects of nonfood-contact exposures to BPA.
* No attempt to quantify uncertainties surrounding the potential effects of BPA on neurodevelopment and prostate and mammary glands, and the acceleration of puberty.
* Not addressing whether microwave heating of infant formula could alter BPA exposure.
* Leaving out biomonitoring studies that could have shed light on cumulative exposures and internal exposure variability among individuals.
``The studies excluded from the quantitative analysis raise additional and unsettling concerns about potential effects from exposure to BPA,'' the report said.
The findings did not prompt the American Chemistry Council, which has staunchly defended the safety of BPA, to back away from that stance. But in a statement, Arlington, Va.-based ACC said: ``Once the FDA assessment is complete, the public can be assured that ACC and its member companies will comply with FDA's direction.
``If the agency determines that existing margins of safety are insufficient in infant applications, our member companies that manufacture BPA will put processes in place to promptly phase out the use of materials containing BPA in baby bottles and infant formula packaging.''
The panel that issued the report is a subcommittee of the Science Board, a committee of advisers to the commissioner of the FDA.
The report was released three days before a BPA review meeting of the full Science Board in Gaithersburg, Md., and 10 days after Canadian government officials said they would draft regulations to ban the import, sale and advertising of polycarbonate baby bottles.
The report offered the FDA some very sharply pointed advice, as well as a number of admonishments, seemingly negating charges by some critics that the panel would be influenced by industry because of its chairman, Martin Philbert. Philbert is co-director of the Risk Science Center at the University of Michigan, which has received a $15 million grant from BPA manufacturer Dow Chemical Co.
For example, the panel took the FDA to task for dismissing many studies the National Toxicology Program considered in its report on BPA, released Sept. 3, that suggested parents might want to reduce infants' exposure to products containing BPA.
``The exclusion of studies … diminishes the weight of evidence judgments on hazards, dose-response and safety of food contact applications,'' said the FDA subcommittee's report.
``The subcommittee disagrees with the decision by FDA to dismiss many other studies on BPA … that were otherwise scientifically sound,'' the report said, ``and that were often indicative of BPA impacts that could potentially portend significant risks to health at lower levels of exposure'' than in the studies that were used.
Responding to the panel's report, the FDA issued a statement reiterating that ``based on all available evidence, the present consensus among regulatory agencies in the U.S., 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.''
The agency pointed out that even Canada concluded that exposure levels are ``below the levels that could cause health effects, [but] out of an abundance of caution, the government of Canada has taken steps to restrict the use of BPA,'' the FDA statement said.
The FDA said it agreed with the panel that additional research ``would be valuable.'' The agency also stated that it will ``carefully evaluate'' the findings of the studies.