BPA – Questions & Answers
Q: What is the Food and Drug Administration (FDA)'s most recent stance on the safety of BPA?
A: On March 30, 2012, the Food and Drug Administration (FDA) announced its decision to reject a petition from the Natural Resources Defense Council (NRDC) that proposed to ban bisphenol A (BPA) in food-contact materials. FDA denied the petition in its entirety, stating in the letter: "Therefore, for the reasons set forth below, FDA is denying your citizen petition in its entirety. As a matter of science and regulatory policy, FDA has determined that its continued scientific study, including completion of studies in progress at FDA's National Center for Toxicological Research (NCTR), and supported by the National Toxicology Program (NTP), and review of all new evidence as it becomes available is the most appropriate course of action at this time."
The response to NRDC was based on a set of scientific principles that were used to evaluate the studies cited in the NRDC petition. The priniciples cover important study design and evaluation parameters including route of exposure, study size, plausibility, reproducibility, and others. Overalll, FDA commented, "For a variety of reasons, the studies cited in your petition have limitations in their utility for assessing safety of dietary exposures to BPA."
In its decision, FDA also reviewed exposure and pharmacokinetic studies on BPA. FDA estimates that humans are exposed to BPA in the range of 0.1-0.4 micrograms/kg bw/day, which is 12,500-50,000 times below the no-observed-adverse-effect-levels reported by FDA for systematic and reproductive effects. In other words, human exposure to BPA is 12,500-50,000 times less the lowest amount that FDA has determined could result in adverse effects in laboratory animals. In addition, based on studies conducted in their own laboratory, FDA reported that "people of all ages process and rid their bodies of BPA faster than the rodents used as test animals." This important observation further adds to the already large margin of safety between actual human exposure and levels that could cause effects.
Furthermore, FDA notes that it made its decision based on scientific evidence, not on claims, stating, "The regulatory agency must objectively weigh all the evidence, says [Dennis M. Keefe, Ph.D., director of FDA's Office of Food Additive Safety]. 'We make public health decisions based on a careful review of well performed studies, not based on claims or beliefs. We have to perform an unbiased evaluation of the data,' he says."
Visit the FDA website for more information on this decision.
Q: What does the FDA decision tell us about the safety of BPA?
A: In its decision to reject the NRDC's petition, the FDA reconfirmed its earlier conclusion that BPA is safe for use in food-contact applications. In an update coinciding with their response to the petition, FDA stated that "the scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe." This is consistent with both an August 2008 assessment and a January 2010 update that affirmed that BPA "is not proven to harm children or adults..." As noted by an FDA spokesperson, FDA objectively weighs all the evidence in an unbiased evaluation to reach their conclusion.
Q: Is this FDA's final word on BPA?
A: Although FDA provided a final response to the NRDC petition, it also noted that this is not FDA's final word on BPA. FDA is currently conducting additional research in their laboratory and anticipates providing a further update later in 2012 that will take into account new results.
Q: What have other regulatory agencies said about BPA?
A: The consensus of government regulatory bodies around the world, including 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. Regulatory bodies around the world have assessed the science on BPA and have determined that BPA is safe for use in food contact products, including:
- European Food Safety Authority
- European Commission Risk Assessment
- Swiss Federal Office of Public Health
- German Federal Institute for Risk Assessment
- Food Standards Australia and New Zealand
- Hong Kong Centre for Food Safety
- Japanese National Institute of Advanced Industrial Science and Technology
- Health Canada concluded that exposure is below levels that pose a risk, but as a precautionary measure proposed to ban polycarbonate baby bottles in Canada.
Q: What did the American Chemistry Council (ACC) ask of the U.S. Food and Drug Administration (FDA) on October 7, 2011?
A: ACC asked the 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.
Q: Has FDA taken action on the ACC petition?
A: FDA noted in the Federal Register on February 17, 2012 that it would begin a 60 day public comment period on the ACC petition. That process is underway.
Q: Why did ACC ask the FDA to revise its regulations on baby bottles and sippy cups containing BPA?
A: 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: What does this action mean for consumers?
A: This action will have no practical effect on consumers, as BPA has not been used by U.S. manufacturers of baby bottles and sippy cups in recent years.
Q: Did ACC take this action because BPA is unsafe?
A: No, this action was 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 such as baby bottles and sippy cups intended for infants. 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: What should consumers do if they have baby bottles or sippy cups that contain BPA in their homes? Should they still use them?
A: Yes, consumers can continue to use products containing BPA. Consumers should be reassured that the consensus of government agencies around the world is that BPA is safe for use in food-contact materials, including products such as baby bottles and sippy cups intended for infants.
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.
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: 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: Where can I get further information?
A: Consumers can get more information on BPA at the following Web sites:
www.americanchemistry.com
www.hhs.gov/safety/bpa
www.fda.gov/NewsEvents/PublicHealthFocus