On March 29, 2010, the U.S. Environmental Protection Agency (EPA) announced its action plan on bisphenol A (BPA). In its press release, EPA states that the BPA action plan “focuses on the environmental impacts of BPA and will look to add BPA to EPA’s list of chemicals of concern and require testing related to environmental effects.” EPA notes that, in January 2010, the Food and Drug Administration (FDA) announced that it had some concerns about the potential human health impacts of BPA, and would study the potential effects and ways to reduce exposure to BPA in food packaging. According to EPA, it “share[s] FDA’s concern about the potential health impacts from BPA,” and “EPA and FDA, and many other agencies are moving forward to fully assess the environmental and health impacts to ensure that the full range of BPA’s possible impacts are examined.” EPA states in its press release that “[f]ood packaging represents the most obvious source of BPA exposure to people and is regulated by FDA” and that EPA’s efforts would focus on the “potential environmental impacts of BPA,” noting that releases of BPA to the environment exceed 1 million pounds per year. According to EPA, BPA has caused reproductive and developmental effects in animal studies and may also affect the endocrine system. The BPA action plan is available online.
The action plan on the environmental impacts of BPA includes considering the following steps:
- Adding BPA to the Toxic Substances Control Act (TSCA) Section 5(b)(4) Concern List on the basis of potential environmental effects;
- Requiring information on concentrations of BPA in surface water, ground water, and drinking water to determine if BPA may be present at levels of potential concern;
- Requiring manufacturers to provide test data under Section 4 to assist EPA in evaluating its possible environmental impacts, including long-term effects on growth, reproduction, and development in aquatic organisms and wildlife and “testing or monitoring data in the vicinity of landfills, manufacturing facilities, or similar locations to determine the potential for BPA to enter the environment”;
- Using EPA’s Design for the Environment (DfE) Program to look for ways to reduce unnecessary exposures, including assessing substitutes for BPA’s use in thermal and carbonless paper coatings, in foundry castings, and in linings for water and wastewater pipes, while additional studies continue; and
- Continuing to evaluate the potential disproportionate impact on children and other sub-populations through exposure from non-food packaging uses.
According to EPA, it is working closely with FDA, the Centers for Disease Control and Prevention, and the National Institute of Environmental Health Sciences on research to assess and evaluate better the potential health consequences of BPA exposures, including health concerns from non-food packaging exposures that fall outside of FDA’s reach but within EPA’s regulatory authority. EPA states that, based on what this new research shows, EPA will consider possible regulatory actions to address health impacts from these other exposures.
Commentary
It is interesting that EPA has decided to consider adding BPA to the TSCA Section 5(b)(4) Concern List on the basis of possible risks to the environment, and concedes in the action plan that “EPA considers that FDA has the lead in making human health judgments on BPA. EPA does not consider that action under TSCA would be warranted at this time on the basis of potential human health concerns from exposures through TSCA uses of BPA.”
EPA also notes that “limited information is available for BPA concentrations in U.S. water, and most available environmental monitoring results show that the concentrations of BPA in water bodies are lower than 1 µg/L” (or 1 ppb). EPA further notes that the available environmental measurements “represent only isolated snapshots in time” and that additional information would help resolve uncertainties, and thus the rationale for obtaining environmental monitoring data under Section 4 to understand better BPA’s presence in the environment.