December 12, 2011
The U.S. Food and Drug Administration (FDA) announced intentions recently to enhance the agency’s and industry’s ability to trace the supply chain of all food related products. Part of the suppy chain attention is shining on BPA in packaging. FDA says it will announce in March 2012 whether it will ban BPA in food packaging.
BPA is a chemical used to harden plastics -- it's in everything from labels to paint to cardboard to liner paper. The chemical was banned this year for certain uses in China and Malaysia (in theory at least) -- who were following the lead of Canada and the entire European Union.
FDA & BPA today In the immediate, FDA seems keenly interested in data from the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children. FDA also recognizes substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure.*
FDA is pursuing additional studies to address the uncertainties in the findings, seeking public input and input from other expert agencies, and supporting a shift to a more robust regulatory framework for oversight of BPA. The goal, and this is fair, is to be able to respond quickly, if necessary, to protect the public.
In addition, FDA is supporting reasonable steps to reduce human exposure to BPA, including actions by industry and recommendations to consumers on food preparation.
BPA studies FDA is supporting studies by both governmental and non-governmental entities, to acquire additional information and address uncertainties about the safety of BPA.
For instance, FDA’s National Center for Toxicological Research is pursuing a set of studies on the safety of low doses of BPA, including assessment of the novel endpoints where concerns have been raised. These include studies pursued in collaboration with the National Toxicology Program and with support and input from the National Institute for Environmental Health Sciences. Depending on the results, each could influence regulatory decisions about BPA.
Typically we don't as granular as the following on these matters but the reasoning behind these hot-button topics such as BPA should not be overlooked. Note the 2012 deadlines cited in FDA's list of key studies:
- Physiologically based pharmacokinetic modeling studies in both rodents and nonhuman primates are under way to predict internal exposure of BPA in both the free and conjugated forms, and to provide data on the magnitude of inter-individual differences. These data will facilitate comparisons of exposure across all stages of development and development of relationships between the results of rodent and nonhuman primate feeding studies, and will allow comparisons of internal doses of BPA when given by oral and intravenous routes. This approach has been identified as critical in order to fully evaluate the potential human health implications of studies that have used novel endpoints or non-oral dosing, particularly in rodents, which may metabolize BPA differently than humans. These data will also allow the agency to assess the magnitude of the potential differential exposure (and risk) to neonates. Results from this study are expected to be available to FDA to inform the agency’s decisionmaking starting in spring 2010.
- Rodent subchronic studies are in progress to characterize potential effects, and, where observed, the dose-response relationship in the prostate and mammary glands for orally administered BPA. In addition, these studies will explore other issues including potential effects of BPA on metabolic changes and cardiovascular endpoints. These studies will include an in utero phase, mimic bottle feeding in neonates, and employ a dose range that will cover the low doses where effects have been previously reported in some animal studies, as well as higher doses where estrogenic effects have been measured in guideline oral studies. Results from this study are expected to be available to FDA to inform the agency’s decisionmaking starting in 2012.
- Rodent behavioral/neuroanatomical pilot studies are also already in progress as part of the sub-chronic study to characterize dose levels at which behavioral, neuroanatomical, neurochemical and hormonal endpoints may be affected by developmental exposure to BPA. These data are intended to evaluate possible effects of exposure to BPA during development that have been reported in some published studies on sexually dimorphic behavioral endpoints such as anxiety, as well as on standard developmental neurotoxicity tests. Results from this study are expected to be available to FDA to inform the agency’s decisionmaking starting in 2012.
Other studies on the safety of BPA are underway, for example, the National Institute of Environmental Health Sciences has recently announced that it is providing $30 million in funding to study BPA, which includes support both for FDA studies and external grants.
*Uncertainties aknowledged by FDA relate to:
- the routes of exposure employed
- the lack of consistency among some of the measured endpoints or results between studies
- the relevance of some animal models to human health
- differences in the metabolism (and detoxification) of and responses to BPA both at different ages and in different species
- limited or absent dose response information for some studies