BPA – Questions & Answers

Q: What does a recent court settlement between the FDA and Natural Resources Defense Council (NRDC) mean for BPA?

This is a non-event. A U.S. District Court formalized a routine agreement often made by parties in cases of this type - nothing more. It does not in any way indicate that FDA agrees with the premise of NRDC's petition, nor does it mean that FDA has changed its position on the safety of BPA or that FDA is taking any action on BPA. The consensus of government regulatory bodies around the world, including the U.S. FDA and the European Food Safety Authority (EFSA), is that BPA is safe for use in food-contact materials, including products intended for infants and children. Just last week, EFSA restated that BPA is safe for use in food-contact products.

Q: What did the American Chemistry Council (ACC) announce about BPA?

A: ACC announced that it asked the U.S. Food and Drug Administration (FDA) to revise certain regulations on BPA to clarify for consumers that BPA is no longer used to manufacture baby bottles and sippy cups and it will not be used in these products in the future. ACC proposed this regulatory revision to reflect the fact that in the U.S., BPA is no longer used in baby bottles and sippy cups. This action is not based on any finding or concern that these products are unsafe. Because manufacturers who make these products for the U.S. market no longer use BPA in baby bottles and sippy cups, there is no practical need for industry or government officials to spend further time and effort on a matter that is not relevant in today’s marketplace. We hope this action also will help eliminate confusion for consumers. For additional questions and answers about this announcement, click here. To view the ACC announcement, click here. To view the additional background information about BPA, click here.

Q: Is ACC asking the FDA to revise its regulations on baby bottles and sippy cups containing BPA because BPA is unsafe?

A: No, this action is not based on any finding, conclusion or concern that baby bottles and sippy cups containing BPA are unsafe. BPA is one of the most thoroughly tested chemicals in commerce today. The consensus of government regulatory bodies around the world, including the U.S. FDA and the European Food Safety Authority, is that BPA is safe for use in food-contact materials, including products intended for infants and children. However, manufacturers of baby bottles and sippy cups announced several years ago that due to consumer preference they had stopped using BPA in these products; this action will provide certainty in the future. For more information on BPA safety, click here. To see what scientific experts have said about BPA safety, please click here.

Q: The Japanese National Institute of Advanced Industrial Science and Technology (AIST) recently conducted a comprehensive risk assessment of BPA, which was completed in 2011. What did it find?

A: The AIST concluded that "the risk of BPA with regard to human health was believed to be very small." This conclusion is consistent with AIST's previous 2005 BPA risk assessment, as well as with the many other agencies that have reviewed the science on BPA. Along with many other new studies, AIST specifically incorporated results from new research conducted by FDA to answer key questions and clarify uncertainties about BPA. Also of note, in its 2011 assessment, the data uncertainty factor was reduced to 25 as compared to 100 in the previous assessment, indicating higher confidence in the scientific data supporting the 2011 conclusion. To learn more about the AIST risk assessment, please click here.

A: Because of the way it is used, paper currency is expected to carry traces of many substances and microorganisms. Finding trace levels of BPA in currency is neither surprising nor a concern. As noted by the authors, human exposure to BPA from contact with paper currency is minor; orders of magnitude below science-based safe intake levels set by regulatory authorities worldwide.

Furthermore, available data suggests that BPA is not readily absorbed through the skin. Extensive biomonitoring data from the U.S. Centers for Disease Control and Statistics Canada shows that exposure to BPA from all sources, which would include any exposure from handling currency, is extremely low – about 1,000 times below safe intake levels.

Q: A new EPA-funded study evaluated BPA levels in adults on a diet including significant sources of BPA. What do the findings of this study mean for consumers?

A: In this EPA-funded study published in Toxicological Sciences, scientists at Pacific Northwest National Laboratory (a U.S. government national laboratory), the CDC and the FDA conducted a clinical exposure study to assess blood and urine concentrations of BPA in healthy adults who had consumed a controlled diet including high levels of canned foods likely to be significant sources of BPA. Consistent with previous human and animal studies, this new study confirms that BPA is efficiently converted to a biologically inactive metabolite and rapidly excreted in urine. Illustrating the efficiency of this metabolic process, no un-metabolized or biologically active BPA was detected in the bloodstream of any participant at any time point in the study even with the atypically high BPA exposure levels and a sensitive analytical method. Only the inactive metabolite of BPA was transiently found at low levels before it was eliminated from the body.

The results of this study indicate that, because of the way BPA is processed in the body, it is very unlikely that BPA from typical human exposures could cause health effects as estimates of peak BPA blood levels found in this study were 1 to 3 orders of magnitude below levels associated with potentially adverse health effects in the most sensitive experimental rat models. In addition, based on their results, the authors note that reported high levels of BPA in blood found in other studies are unlikely to be valid, and that sample contamination has likely been the cause of high levels of free BPA reported by smaller-scale studies. 

Q: A new study published in the Proceedings of the National Academy of Sciences examined certain reproductive and sexual behaviors in adult deer mice whose mothers were exposed to BPA during pregnancy and lactation. Is there a reason for consumers to be concerned about exposure to BPA based on these results?

A: This study tested a single extremely high dose of BPA on a type of mouse not commonly used in scientific research of this type. Given the extremely high exposure levels of BPA used in this study--a single dose level approximately 250,000 times higher than typical human intake--it is of limited relevance for human health or the environment. Extensive biomonitoring data from the Centers for Disease Control and Prevention and other credible agencies confirm that typical human exposures are miniscule compared to the dose used in this study.

This non-standard approach makes it very difficult to assess the significance of the study for human or environmental health. However, based on an inaccurate characterization of actual human exposure, the authors hypothesize that their findings may be relevant for the reproductive success of animals in the wild, such as deer mice, as well as relevant for human health. Animals in the wild are likely to be exposed to even lower levels since BPA does not persist or bioaccumulate in the environment and, if detected at all, can be found only at extremely low levels.

In addition, the results of this study are inconsistent with several more robust, guideline-compliant studies exclusively designed to support human risk assessment. These studies tested both high and low doses using validated study designs, and have been reviewed and accepted by regulatory agencies worldwide:

• In a 2010 study, "Developmental Neurotoxicity Study of Dietary Bisphenol A in Sprague-Dawley Rats" (Stump et al.), BPA had no effect on neurodevelopment or neurobehavior and did not cause developmental delays. Based on the conditions of this study, there was no evidence that BPA is a developmental neurotoxicant.
• A 2010 study funded and conducted by the Environmental Protection Agency (EPA) (Ryan et al.) found that in utero or lactational exposure to BPA, even at low doses, did not affect the brain, reproduction or developmental behavior.
• In July 2010, Germany's Federal Institute for Risk Assessment (BfR) released a detailed review of both of the aforementioned studies and concluded that "The results of the two studies do not substantiate the concerns for a specific toxic potential of bisphenol A adverse to neurological and behavioural development."

Regulatory bodies worldwide, including the U.S. FDA, have confirmed that BPA exposure levels are low, and well within safety standards. According to the CDC, typical human exposure to BPA is approximately 1,000 times below government safety limits.

Q: A new study by researchers at the University of Missouri tested dietary exposure to BPA in mice. Is there a reason to be concerned about dietary exposure to BPA based on these results?

A: In this study, the authors compared how BPA is processed in the body when mice were exposed to BPA either through their diet (i.e., the mice are exposed continuously as they eat, more like how people are exposed) or through a single dose fed orally (i.e., same dose but fed all at once). The latter is how previous studies of this type have been done. Consistent with previous studies, the authors find that BPA is efficiently metabolized into a biologically inactive form and rapidly eliminated from the body. Very little BPA enters the bloodstream in "free" unmetabolized form.

An important implication of this study is that the amount of free BPA in blood after typical human exposure – more than 100,000 times lower than the dose tested in this study – would be well under 1 part per trillion. Levels so low could not even be detected and would not raise any health concerns. Based on their findings, the authors further report that dietary exposure is the preferred testing method to better simulate how people are exposed. This recommendation would also apply to toxicity studies, which look for health effects resulting from exposure. Consistent with the low levels of free BPA found in this study, several large-scale multi-generational toxicity studies conducted with dietary dosing have confirmed that low doses of BPA do not cause health effects.

Overall, this study confirms and highlights how efficiently BPA is metabolized and cleared from the body. The results of this study are scientifically interesting, but do not raise any health concerns.

Q: A recent study by scientists at the FDA found BPA in most canned foods. Is BPA exposure from canned goods safe?

A: A recently released study by scientists at the U.S. Food and Drug Administration (FDA) measured the amount of bisphenol A (BPA) found in commonly consumed canned foods and beverages in the United States. The results are generally consistent with what has been previously reported in other studies. Regulatory bodies worldwide, including the U.S. FDA, have confirmed that BPA exposure levels are low, and well within safety standards. According to the Centers for Disease Control and Prevention, typical human exposure to BPA from all sources, including through canned products, is approximately 1,000 times below government safety limits.

The results of this new FDA study are consistent with exposure levels reported by CDC and, therefore, not a cause for concern. Epoxy resins made from bisphenol A (BPA) are approved by the U.S. Food and Drug Administration (FDA) to line food and beverage cans in order to help prevent corrosion, contamination and food spoilage, and to provide an extended shelf life—sometimes two years or more. Epoxy resins have been used for decades, and BPA is itself one of the most thoroughly tested chemicals in commerce today.

Many global regulatory bodies—including the European Food Safety Authority and Health Canada—have recently completed scientific evaluations and found BPA safe in food-contact products, including canned foods and beverages. A recent review by the Advisory Committee of the German Society for Toxicology, published in Critical Reviews in Toxicology, concludes that "BPA exposure represents no noteworthy risk to the health of the human population, including newborns and babies."

Q: A new report published in Environmental Health Perspectives (Jan. 2011) analyzed biomonitoring data from the CDC's National Health and Nutritional Examination Survey (NHANES) to show that pregnant women in the U.S. are exposed to low levels of a number of chemicals, including BPA. Do pregnant women need to be concerned about BPA exposure?

A: Today's state-of-the-art scientific technology and biomonitoring techniques can detect even the tiniest traces of chemicals in the human body, so it's not surprising that the NHANES survey detected BPA and other chemicals in over 90 percent of the general population, including in pregnant women. However, the fact that BPA and other chemicals were found in the urine of pregnant women is not indicative of actual health effects, including in prenatal infants.

According to the Centers for Disease Control and Prevention (CDC), "Finding a measurable amount of bisphenol A in the urine does not mean that the levels of bisphenol A cause an adverse health effect." Furthermore, the levels of BPA found in the NHANES survey were well within safe ranges of intake for BPA as determined by government regulatory agencies. In addition, the primary substance found in urine is not BPA itself, but rather inert metabolites of BPA that are not estrogenic.

Repeated studies have shown that BPA does not accumulate in adults or infants, as both have the ability to convert BPA into this inert metabolite form, which is then rapidly excreted in urine. This was recently demonstrated by a Harvard and CDC study that indicated that even premature infants have ample capacity and capability to metabolize and eliminate BPA.

Q: A new report by the President's Cancer Panel focuses on reducing environmental cancer risks and it states that there is a "growing link between BPA and several diseases, including various cancers." Is there an established link between BPA and cancer?

A: Regulatory agencies around the world have recently assessed the full body of science on BPA. Based on sound, robust scientific evidence, these government bodies specifically have concluded that BPA is not carcinogenic in humans. For example, in 2008 a comprehensive European Union risk assessment reviewed all relevant scientific evidence and concluded that "BPA does not possess any significant carcinogenic potential."

This panel's report claims numerous BPA-related health effects including cancer, but cites "low-dose" studies that other credible scientific bodies have dismissed. The FDA, along with 10 other regulatory agencies from around the world, have found these studies unacceptable for use in risk assessments due to methodological flaws, and continue to reaffirm that sound science supports the safety of BPA.

Q: What did the Environmental Protection Agency (EPA) recently say about BPA?

A: 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 will consider initiating two actions to address questions about potential environmental effects. In particular, the agency stated it will consider creating both a requirement to develop further data with respect to environmental effects, and 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.

Q: What is the purpose of the recently released docket of information from the FDA?

A: FDA indicated in January, 2010, that BPA is not proven to harm children or adults; it also noted that it would open a docket to assist with transparency to the public on this topic of interest. The docket will make it easier for the public to access and view key information relevant to FDA's review of BPA. To visit the docket online, please click here.

Q: Is there any new data contained in the docket?

A: The docket contains summaries and outside reviews of the FDA risk assessment. Notably, the docket also contains a memorandum prepared by FDA staff which reviews estimates of current levels of human exposure to BPA. The memorandum concludes that current human exposures to BPA are moderately lower than previously estimated.

Q: What did the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) recently say about BPA?

A: In an update announced in January 2010, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) made it clear that BPA "is not proven to harm children or adults..." This is consistent with a draft assessment issued by FDA in 2008, and the scientific conclusions of many other government regulatory agencies around the world. FDA confirmed that studies using standardized toxicity tests continue to support the safety of BPA: FDA noted some studies, using novel approaches to testing for subtle effects, had raised questions and the agency stated it would conduct additional scientific research to answer these key questions and clarify uncertainties.

Although the agency noted "some concern," it did not take regulatory action or impose restrictions on the use of BPA as a part of this review. FDA chose to proceed with additional research, indicating the results of that research will be available in about 18-24 months. FDA did not recommend avoiding the use of polycarbonate products in food contact products. HHS, which oversees FDA, provided consumers with precautionary steps they can take to reduce exposure to BPA: For example, parents should not put very hot or boiling liquid that is intended for a baby's consumption in containers that contain BPA.

Q: What does FDA mean by the comment that it has "some concern" about BPA?

A: As reported in the Los Angeles Times, the FDA Commissioner explained, "We have some concern meaning in part that we need to know more." As part of its update, FDA outlined research, some of which is already underway, that is aimed at addressing certain questions about BPA. However, it is important to note that while FDA gathers additional scientific information on BPA, it did not take regulatory action or imposed restrictions on the use of BPA as a part of this review. FDA made it clear that BPA "is not proven to harm children or adults." This recent statement is consistent with conclusions of numerous other government regulatory agencies around the world.

Q: Does BPA bioaccumulate in people?

A: No. Much is known about how BPA is metabolized (processed) by the human body. Scientific research shows that in humans BPA is quickly metabolized in the intestines and liver and is quickly eliminated from the body. It does not accumulate in blood or tissues. When it is ingested through contact with food, it is rapidly converted into a metabolite (BPA-glucuronide) that has no known biological activity. In November 2010, an international panel of experts brought together by the World Health Organization (WHO) were able "to model circulating levels of BPA in the human body, which are very low, indicating that BPA is not accumulated in the body and is rapidly eliminated through urine."

Q: Are infants particularly sensitive to BPA?

A: A recent study with premature infants by researchers at Harvard and the Centers for Disease Control and Prevention (CDC) demonstrated that premature infants have ample capacity and capability to metabolize and eliminate BPA: HHS noted that for liquid infant formula, "the benefits of good nutrition from liquid infant formula sold in cans far outweigh the potential risk of exposure to a small amount of BPA: As a result, HHS does not advise against the use of liquid infant formula in cans."

Q: Why is BPA used in food containers?

A: BPA is used to make clear, durable and shatter-resistant plastic that provides a clear view of the food or beverage in a durable and temperature-resistant container. BPA is also used to make epoxy resins, which are used as durable linings in cans that help protect the integrity and the safety of the canned food. Approved by FDA for safe use in food containers for decades, BPA is one of the most thoroughly tested chemicals in commerce today.

Q: Is polycarbonate plastic safe for use in non-food contact applications, including children's toys?

A: Regulatory agencies around the world charged with reviewing the science on BPA have consistently and repeatedly answered - yes. While not widely used in toys, polycarbonate plastic is used in sports safety equipment such as bicycle helmets for its shatter-resistant properties. HHS stated that plastic children's toys need not be thrown away and, for pacifiers, the "part of the pacifier that a child puts in his or her mouth is made from latex or silicone and does not contain BPA: In some pacifiers, the hard plastic shield designed to prevent swallowing might contain BPA; however, the only exposure would come from the child mouthing the shield, and the transfer of BPA is negligible."

Q: Why is further research being conducted?

A: Questions about how to interpret certain animal research and its implications for human health led FDA to conduct additional research to more fully evaluate and understand potential health effects of BPA exposure. According to the agency, results are expected in 18-24 months.

Q: What have other regulatory agencies said about BPA?

A: Ten regulatory bodies around the world have assessed the science on BPA and have determined that BPA is safe for use in food contact products.

• European Food Safety Authority (January 2007, July 2008, October 2008)
• European Commission Risk Assessment (June 2008)
• Swiss Federal Office of Public Health (February 2009)
• French Food Safety Authority (November 2008)
• Dutch Food and Consumer Product Safety Authority (November 2008)
• Danish Environmental Protection Agency (October 2008)
• German Federal Institute for Risk Assessment (September 2008)
• Food Standards Australia and New Zealand (March 2009, January 2010)
• Japanese National Institute of Advanced Industrial Science and Technology (November 2005)
• Health Canada (October 2008, July 2009) concluded that exposure is below levels that pose a risk, but as a precautionary measure proposed to ban polycarbonate baby bottles in Canada.

Q: Where can I get further information?

A: Consumers can get more information on BPA at the following Web sites:
www.americanchemistry.com
www.factsaboutBPA.org
www.hhs.gov/safety/bpa
www.fda.gov/NewsEvents/PublicHealthFocus