Risk Management for Bisphenol A (BPA)
What is Bisphenol A?
BPA is a high production volume (HPV) chemical widely used in manufacturing polycarbonate plastics and epoxy resins used in nearly every industry. Humans appear to be exposed primarily through food packaging manufactured using BPA, although those products account for less than 5 percent of the BPA used in this country. Food packaging is under the jurisdiction of the Food and Drug Administration (FDA), not EPA. FDA recently explained the steps it is taking to address BPA. Releases of BPA to the environment exceed 1 million pounds per year.
Why is EPA concerned?
Because BPA is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic, there are questions about its potential impact particularly on children’s health and the environment. Studies employing standardized toxicity tests used globally for regulatory decision-making indicate that the levels of BPA in humans and the environment are below levels of potential concern for adverse effects. However, results of some recent studies using novel low-dose approaches and examining different endpoints describe subtle effects in laboratory animals at very low concentrations. Some of these low-dose studies are potentially of concern for the environment because the concentration levels identified with effects are similar to some current environmental levels to which sensitive aquatic organisms may be exposed.
Regulatory authorities around the world reviewing these low-dose studies have generally concluded that they are insufficient for use in risk assessment because of a variety of flaws in some of the study designs, scientific uncertainty concerning the relevance to health of the reported effects, and the inability of other researchers to reproduce the effects in standardized studies. However, since the low-dose studies do raise questions and concerns, some authorities have taken action to protect sensitive populations, particularly infants and young children. For example, while acknowledging that science indicates exposure levels are below potential health effects levels, Canada is taking steps to ban BPA in baby bottles as a precautionary measure. On January 15, 2010, the U.S. Department of Health and Human Services (HHS) provided interim recommendations on how parents and families can reduce exposures to BPA while additional studies are underway.
What action is EPA taking?
Based on EPA’s screening-level review of hazard and exposure information, including the uncertainties surrounding the low-dose studies, EPA's action plan called for EPA to:
- Consider initiating rulemaking under section 5(b)(4) of the Toxic Substances Control Act (TSCA) to identify BPA on the Concern List as a substance that may present an unreasonable risk of injury to the environment on the basis of its potential for long-term adverse effects on growth, reproduction and development in aquatic species at concentrations similar to those found in the environment. A notice of proposed rulemaking is currently pending interagency review at the Office of Management and Budget (OMB).
- Consider initiating rulemaking under section 4(a) of TSCA to develop data with respect to environmental effects relevant to a further determination that BPA either does or does not present an unreasonable risk of injury to the environment. This may include testing or monitoring data in the vicinity of landfills, manufacturing facilities, or similar locations to determine the potential for BPA to enter the environment, including surface water, ground water, and drinking water, at levels of potential concern particularly for environmental organisms, pregnant women, and children. EPA released this advance notice of proposed rulemaking (ANPRM) on July 26, 2011.
- Initiate collaborative alternatives assessment activities under its Design for the Environment Alternatives Assessments program to encourage reductions in BPA releases and exposures. One of these activities, released in 2014, addressed alternatives to BPA in thermal paper coatings used in such applications as cash register receipts. The final report is now available on the Design for the Environment Alternatives Assessments website. Additionally, EPA intends to initiate alternatives analyses for BPA used in foundry castings since foundries are accountable for large releases of BPA as reported under the Toxic Release Inventory (TRI), and for BPA-based materials lining water and waste water pipes since this application may have a potential for human and environmental exposure.
EPA does not intend to initiate regulatory action under TSCA at this time on the basis of risks to human health. EPA remains committed to protecting human health and will continue to consult and coordinate closely with FDA, the Centers for Disease Control and Prevention (CDC), and the National Institute of Environmental Health Sciences (NIEHS) to better determine and evaluate the potential health consequences of BPA. The results of this assessment work will factor significantly in any future EPA decisions to address potential risks to human health resulting from uses within EPA’s jurisdiction.
As part of the Agency's efforts to address BPA, EPA also intends to evaluate the potential for disproportionate impact on children and other sub-populations through exposure from TSCA uses.