Several recent developments concerning BPA.
The Canadian government announced earlier this month that it intends to draft new regulations to prohibit the importation, sale, and advertising of baby bottles containing bisphenol A; the proposed bans are to take effect in 2009.
Environment Canada and Health Canada have released a scientific assessment, concluding that bisphenol A poses no danger to the general public, but expressing some uncertainty about its potential impact on infants up to 18 months of age. The scientific evidence of the neuro-developmental and behavioral impact of bisphenol A on rodent test subjects, although highly uncertain and not capable of easy extrapolation to humans, is apparently providing the basis for taking action to limit exposure to the substance for newborns and infants. The government plans also to allocate almost $2 million to support additional research on bisphenol A.
The first regulatory step comes as Environment Canada and Health Canada published a notice of their intention to designate bisphenol A as toxic under the Canadian Environmental Protection Act, a first step that allows the government to take regulatory action on the chemical. The agencies also issued a draft risk management approach for the chemical that aims to reduce releases of the substance into the environment. The proposed risk management plan, which is open to a 60-day public comment period that started on Oct. 18, said that BPA should be managed using a life cycle approach that prevents or minimizes its release into the environment.
The Canadian draft plan incorporates a regulatory ban on the import, sale, and advertising of polycarbonate baby bottles made with bisphenol A. It calls for the adoption of an “as low as reasonably achievable” principle in the packaging of canned infant formula, and indicates that the government will develop migration target levels for bisphenol A from infant formula cans to the formula they contain. The government proposes exploration of imposing migration targets for bisphenol A in canned foods in general. The regulations will establish maximum bisphenol A concentrations in industrial effluents and will require the implementation of management systems for facilities where the substance is used, the draft plan said.
In addition, the plan calls for a survey on the content of bisphenol A in medical devices, further research on exposure of pregnant women to the substance, monitoring through the Canadian Total Diet Study, and additional environmental monitoring in waste water effluents and waters downstream from waste water treatment plants.
Meanwhile, back in the States…
State attorneys general from Connecticut, Delaware, and New Jersey called on manufacturers of baby bottles and baby formula to stop using BPA in their products. The AGs cite the recent studies in letters to the companies urging them to stop putting BPA into infant formula containers. “Mounting evidence suggests that BPA from the lining of these cans leaches directly into the infant formula,” claimed the AGs.
The AGs cited a February 2008 publication of the Work Group for Safe Markets, a coalition of liberal public health and environmental advocacy organizations, advocating without much support that low levels of exposure to BPA may cause damage to reproductive, neurological, and immune systems during stages of fetal and infant development. They also cite the study released by Yale School of Medicine on BPA exposure and effects on brain function and mood disorders in monkeys.
The letters were reportedly sent to: Avent, Disney First Years, Gerber, Dr. Brown, Playtex, Evenflo, Abbott, Mead Johnson, PBM Products, Nature’s One, and Wyeth.
Finally, the FDA Science Board Subcommittee on Bisphenol A has just released comments on the FDA’s draft exposure assessment of BPA. The Science Board provides advice primarily to the Commissioner of the FDA and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community. This temporary Subcommittee was established by the Science Board and consists of two members of the Science Advisory Board and five scientists drawn from academia and government agencies. The focus of this Subcommittee is the scientific peer-review of the draft assessment prepared by the FDA of bisphenol A for use in food contact applications.
While the Subcommittee agrees with the focus of the draft assessment on dietary exposures to children, they believe that the FDA assessment would be strengthened by considering cumulative exposures and differential risk in neonates. They also recommend that the FDA exposure assessment be expanded to include a larger number of infant formula samples and that it rely on mean values rather than accounting for the variability in samples. Until the qualitative and quantitative information (including application of uncertainty factors) is revised, the Subcommittee cannot yet agree that the Margins of Safety defined by FDA are adequate.