BPA – Questions & Answers

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: Does FDA’s announcement mean that BPA is not safe in polycarbonate baby bottles or sippy cups?
A: The Los Angeles Times reported that the FDA Principal Deputy Commissioner stated that for the present “FDA does support the use of baby bottles with BPA.” He also stated, “If we thought it was unsafe, we would be taking strong regulatory action,” as reported by The New York Times.

FDA has not said that BPA is unsafe and has not advised parents to stop using polycarbonate baby bottles or sippy cups. HHS provided consumers with precautionary steps they can take to reduce exposure to BPA, if they so wish. However, consumers should be reassured that 10 regulatory agencies from around the world continue to reaffirm the safety of BPA based on current science.

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.

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: Has HHS advised against using baby bottles made with BPA?
A: No. HHS has provided guidance for how consumers can reduce exposures if they so wish, but has not advised that consumers need to discontinue use of baby bottles made with BPA:

Bear in mind, HHS indicated that most major manufacturers no longer use BPA in baby bottles. HHS advises parents to throw away plastic baby bottles and infant feeding cups that are scratched, primarily to reduce the risk of bacterial growth. Similarly, HHS recommends that parents avoid putting boiling or very hot liquids into bottles made with BPA in order to minimize exposures.

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