Summary EPA Action Plan on BPA

EPA released its bisphenol A (BPA) Action Plan on March 29, 2010. Importantly, the agency clearly indicated that it “does not intend to initiate regulatory action under TSCA at this time on the basis of human health.”

EPA did indicate that it intends to consider initiating two actions to address questions about potential environmental effects. In particular, the agency stated it will consider a requirement to develop further data with respect to environmental effects, and consider creating a list of chemicals for potential further review. The agency also will begin to evaluate how to encourage reductions in BPA releases and exposures from several specific products.

Quotes below are directly from the U.S. Environmental Protection Agency (EPA) Bisphenol A Action Plan.

Human Health

EPA’s review of BPA included both the potential for environmental exposure and human exposures.

“In conducting this review, EPA focused on the two areas with the most potential for environmental releases and exposures: manufacturing and processing. EPA also considered potential human exposures to workers during the manufacturing process and to the general population from the presence of BPA in drinking water sources and systems….EPA considered exposures to children from drinking water and from the use of BPA in consumer products.”

EPA concluded that exposure to BPA from non-food contact applications is below levels of potential concern and noted that it is in FDA’s purview to determine the safety of BPA for human health.

“Given that human exposures from TSCA uses of BPA are minor compared with human exposures from uses under FDA jurisdiction, 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 reports that numerous regulatory bodies around the world agree that BPA does not present a risk to human health.

“Numerous foreign governmental bodies and review panels have conducted human health risk assessments for BPA in the recent past... these regulatory bodies concluded that expected exposures even from food contact uses, the largest expected source of exposure, did not present concern for risk to human health.”

Studies conducted using globally-accepted testing methods conclude that BPA does not cause harm to humans or 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.”

Studies conducted using “novel low-dose” testing methods show subtle effects in laboratory animals.

“….results of some recent studies using novel low-dose approaches and examining different endpoints describe subtle effects in laboratory animals at very low concentrations.”

Global regulatory authorities have examined the full body of low-dose studies and have generally found them insufficient to determine human health risk from BPA. Many of these studies were not able to be replicated or had flaws in the study design.

“Japan (AIST, 2007), the European Union (EC, 2008), and the European Food Safety Administration (EFSA, 2008) all concluded within the past three years that the novel studies indicating low dose, endocrine-related effects were insufficient for the purposes of hazard evaluation/risk assessment.”

“Regulatory authorities around the world reviewing these low-dose studies (FDA, 2008; California, 2009a; AIST, 2007; EC, 2003, 2008; EFSA, 2006, 2008a-b) 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.”

Animal studies may be more sensitive to and therefore over-predicting BPA effects on human health.

“Given the laboratory animal data, it is important to note that metabolism studies have been performed in multiple species (rats, mice, monkeys, and humans) and show that humans and rodents metabolize BPA differently... These differences in metabolism suggest that rodents may be more sensitive to effects from BPA than humans.”

Although Canada recently took regulatory action addressing BPA in baby bottles, it should be noted that the agency itself admitted that BPA levels were too low to present a risk to infants.

“In announcing this decision, Canada noted ‘The Government has concluded that exposure levels for newborns and infants up to 18 months of age are below those that could cause health effects. However, due to the uncertainty raised in some studies relating to the potential effects of low levels of BPA, the Government wants to further limit exposure. (Canada, 2009)... Canada acknowledged high uncertainty in the data, but took precautionary action to restrict BPA exposures to infants and young children.’”

While paper coatings found on tickets, labels and receipts are not a major use of BPA, EPA plans to investigate possible alternatives.

“One of these activities, intended to be initiated in April 2010, will address thermal and carbonless paper coatings, a use where preferable alternatives to BPA may be readily available….Paper coatings are not a major use of BPA, but thermal paper has been reported to contain free BPA, which would be expected to be more available for exposure than BPA bound into resin or plastic... While there is little concern for dermal absorption of BPA, free BPA can readily be transferred to skin and residues on hands can be ingested.”

Environmental Effects

Most information shows that concentrations of BPA in water bodies are too low to cause harm to aquatic organisms. However, EPA suggested more information would be helpful to determine the actual risks to the environment from BPA.

“… 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 (median concentration of 0.14 μg/L, below any calculated PNEC). These environmental measurements represent only isolated snapshots in time and do not provide an indication of how many areas may exceed PNEC values or concentrations of concern, how often or how long such concentrations may be exceeded, or the pathways leading to BPA presence in the environment from manufacturing, processing, distribution in commerce, use, or disposal. Additional information would help to resolve these uncertainties.”

Accordingly, EPA plans to “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…”

EPA concluded that BPA is not a Persistent, Bioaccumulative, and Toxic substance (PBT), and that other than leaching of unreacted BPA, polycarbonate and epoxy resins are a source of environmental BPA.

“Based on the criteria set forth in EPA’s policy statement … for Persistent, Bioaccumulative, and Toxic … Substances …, BPA is expected to have low persistence (P1) and low bioaccumulation potential (B1). ….Any residual, unreacted BPA remaining in polycarbonate products and epoxy resins can leach out into food or the environment. Polycarbonate is generally stable, but some BPA can be released from polycarbonate when it is exposed to strongly basic conditions, UV light, or high heat. Epoxy resins made with BPA are stable; only residual BPA is expected to be released from epoxy resins.”

Several government agencies around the world believe current levels of BPA are not posing an environmental risk. The EU believes more information is needed.

“Ecological risk for BPA has been evaluated by the European Union (EC, 2008), Canada (Canada, 2008), and Japan (AIST, 2007). Japan concluded that ‘the urrent exposure levels of BPA will not pose unacceptable risks to the local populations of aquatic life, particularly fish.’ The EU concluded that although the predicted exposure concentrations were significantly below its hazard values, there was a need for further information and/or testing on such organisms as freshwater snails.”

In Canada, a new, “novel low-dose study” indicates “potential” for adverse effects but there is a “low risk of direct adverse effects” to some environmental organisms.

“Based on a novel low-dose study (Lahnsteiner et al., 2005), Canada concluded that BPA concentrations in water have the potential to cause adverse effects on populations of pelagic organisms in Canada and concentrations in biota have the potential to cause adverse effects in populations of wildlife in Canada, but that there is a low risk of direct adverse effects to sediment organisms and to avian wildlife species in Canada.”

EPA’s Next Steps

Although “EPA does not intend to initiate regulatory action under TSCA at this time on the basis of human health,” due to uncertainty about environmental exposure and risks, EPA plans to take several steps, including collaborating with industry.

“EPA intends to: Consider initiating rulemaking under section 5(b)(4) of the Toxic Substances Control Act (TSCA) to identify BPA on the Concern List....”