FDA expresses concern for Bisphenol-A’s potential effects on children
by Brian Lewis, Ph. D
On January 15, 2010, the Food and Drug Administration (FDA) reversed its position that exposure to bisphenol-A (BPA) is not harmful, stating that they now “have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children”.1 In the same report, the FDA voiced their support for the food and beverage container industry to halt production of baby bottles and feeding cups in the U.S. that contain BPA.
The FDA’s current position on BPA follows a 2008 draft report by the agency that claimed the no observable adverse effect level (NOAEL) of 5 mg/kg body weight/day was “an adequate margin of safety … for BPA at current levels of exposure from food contact uses,” and that the 2.42 μg/kg body weight/day and 0.185 μg/kg body weight/day exposure levels found in infants and adults, respectively, was safe.2 However, when that draft report was submitted to a seven-member panel of experts for peer review, the panel refuted the FDA’s position, stating that “the available qualitative and quantitative information … provides a sufficient scientific basis to conclude that the Margins of Safety defined by FDA as ‘adequate’ are, in fact, inadequate”.3
In 2004, U.S. production of BPA exceeded 2 billion pounds.4 Since the 1960s, BPA has served as one of the monomers from which polycarbonate drink containers (including baby bottles) and epoxy resins for lining the inside of canned-food containers are made. BPA can, however, leak into the liquids inside such containers, particularly if the containers are heated.5,6
According to a 2005 report, BPA was detected in the urine of 95% of 394 study participants.7 The concentrations were highest in infants that had been fed formula. These and other results led six manufacturers, under pressure from several state attorneys general, to stop marketing polycarbonate baby bottles in the U.S.8 In April 2008, Wal-Mart announced their decision to voluntarily stop selling baby bottles containing BPA.9
For adults, dietary intake is believed to be the primary pathway for human exposure to BPA.10 The Environmental Working Group, a self-described environmental and advocacy organization, found BPA levels as high as 385 parts per billion (ppb) in canned foods such as soup.11 Consumers Union recently found BPA in 17 of 19 canned and boxed foods purchased from a supermarket, including a can of tuna labeled as “BPA-free” that did not use an epoxy-based liner, a probable source of BPA. Dr. Urvashi Rangan, Consumers Union’s director of technical policy, speculated that the source of the BPA may have been environmental, such as seawater or the fish itself.12
According to the Toxic Release Inventory database of the Environmental Protection Agency (EPA), more than 181,000 pounds of BPA was released into the environment in 2004, of which 73% was released to air, 25% to land, 19% to water, and less than 1% to underground injection.13 Researchers with the U.S. Geological Survey found traces of BPA in 41.2% of 139 sampled streams in the U.S. with a median concentration 0.14 μg/L.14 BPA was the eleventh most frequently detected compound of the 95 organic contaminants for which the researchers tested.
Animal studies suggest that BPA is an endocrine disruptor.15 According to The Endocrine Society, an endocrine-disrupting substance “alters the hormonal and homeostatic systems that enable the organism to communicate with and respond to its environment”.16 Furthermore, the number of human health problems linked to BPA exposure—even at low doses—continues to grow, and now includes17,18:
• Behavioral changes
• Brain damage
• Breast cancer
• Down Syndrome
• Early puberty
• Impaired immune function
• Prostate cancer
• Reduced sperm count
Controversy continues, however, over what exposure level actually constitutes a health risk. Critics of the FDA’s position on BPA, including the American Chemistry Council (ACC), which represents chemical manufacturers, point to pharmacokinetic studies that indicate BPA is rapidly metabolized and does not accumulate in test animals.19 Some researchers have extrapolated this data to humans and concluded that the harmful effects of human exposure should be practically nonexistent. This conclusion, however, is directly contradicted by numerous reports of BPA being detected in blood and tissue at the μg/L level.10
The ACC also points to reports from other governments that contradict the FDA’s position, stating that “Regulatory agencies around the world, which have recently reviewed the research, have reached conclusions that support the safety of BPA”.20 Indeed, health officials in Germany, The Netherlands, and Switzerland have issued public statements that BPA is safe for use in food and beverage containers.
Other governments, however, have adopted a more cautionary position. The Canadian government’s risk assessment of BPA “confirms exposure levels are below those that could cause health effects”.21 However, that same public information website goes on to state, “Health Canada [Canada's public health agency] is moving to ban the importation, sale and advertising of polycarbonate baby bottles and recommends that readily available alternatives be used.” Canada became the first country to ban BPA in baby bottles in April 2008.
Both the FDA and Health Canada call for additional research to firmly establish the risks posed by BPA. At this point, further research appears to be one of the few certainties concerning BPA. The National Institute of Environmental Health Sciences (NIEHS) has announced plans to distribute $30 million in grant funding over two years to address the gaps in BPA research.22
According to the NIEHS, the research will focus on determining the effects of BPA exposure on humans at doses significantly below the NOAEL set by the FDA (5 mg/kg body weight/day). The program announcement from the NIEHS indicates that one of the points of emphasis for the program is the development of pharmacokinetic models that allow more reliable cross-species extrapolation of results, presumably to reconcile the data that indicates BPA is metabolized quickly in animals with data indicating elevated levels of BPA found in humans.22
Instead of waiting for conclusive evidence concerning BPA’s toxicity and biological fate, some U.S. municipalities and states are taking preemptive measures. An ordinance banning the sale, manufacture, or distribution of BPA-containing children’s products was enacted in San Francisco in 2006. It was repealed less than one year later. The California State Assembly voted down a statewide BPA ban in children’s items, although the bill is scheduled to be reconsidered later this year.23
In April 2009, Suffolk County, New York banned BPA in baby bottles and children’s cups.23 Minnesota, Connecticut, and the city of Chicago followed suit; Washington, Hawaii, Massachusetts, Michigan, Missouri, New York, Oregon, and Wisconsin are considering similar measures.24,25
The U.S. House of Representatives and Senate are currently considering identical bills (H.R. 1523 and S. 593) that would ban BPA in all food and drink containers sold in the U.S.26 In addition, the Senate is considering a bill that would ban BPA only in children’s food and drink containers (S. 753). No action on the bills has been taken since March 2009, when all three were referred to committees.
The continuation of the use of BPA in products sold in the US may be decided before more information about its toxicity and biological fate becomes available.
1 U.S. Food and Drug Administration. 2010. Update on bisphenol A for use in food contact applications: January 2010. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm197739.htm.
2 U.S. Food and Drug Administration. 2008. Draft assessment of bisphenol A for use in food contact applications, 14 Aug 2008. U.S. Food and Drug Administration. http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-0038b1_01_02_FDA%20BPA%20Draft%20Assessment.pdf.
3 U.S. Food and Drug Administration Science Board Subcommittee on Bisphenol A. Scientific peer-review of the draft assessment of bisphenol A for use in food contact applications, 31 October 2008. U.S. Food and Drug Administration. http:www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4386b1-05.pdf.
4 Burridge, E. 2003. Bisphenol A: Product profile. European Chemical News (April): 14–20. http://cerhr.niehs.nih.gov/chemicals/bisphenol/BPAFinalEPVF112607.pdf
5 Duck, S.L., S.J. Kwack, K.-B. Kim, H.S. Kim, and B.M. Lee. 2009. Potential risk of bisphenol A migration from polycarbonate containers after heating, boiling, and microwaving. Journal of Toxicology and Environmental Health, Part A 72: 1285–1291.
6 Brede, C., P. Fjeldal, I. Skjevrak, and H. Herikstad. 2003. Increased migration levels of bisphenol A from polycarbonate baby bottles after dishwashing, boiling, and brushing. Food Additives & Contaminants, Part A 20: 684–689.
7 Calafat, A.M., Z. Kuklenyik, J.A. Reidy, S.P. Caudill, J. Ekong, and L.L. Needham. 2008. Urinary concentrations of bisphenol A and 4-nonylphenol in a human reference population. Environmental Health Perspectives 113(4): 391–395. http://ehpnet1.niehs.nih.gov/members/2004/7534/7534.html.
8 Kay, J. 2009. 6 firms stop sales of hard-plastic baby bottles. The San Francisco Chronicle, March 6. http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2009/03/06/MNKR16A8QS.DTL.
9 Mui, Y.Q. 2008. Wal-Mart to pull bottles made with chemical BPA. The Washington Post, April 18. http://www.washingtonpost.com/wp-dyn/content/article/2008/04/17/AR2008041704205.html.
10 Vandenberg, L.N., R. Hauer, M. Marcus, N. Olea, and W.V. Welshons. 2007. Human exposure to bisphenol A (BPA). Reproductive Toxicology 24(2): 139–177.
11 Environmental Working Group. 2007. A survey of bisphenol A in U.S. canned foods. Environmental Working Group. http://www.ewg.org/reports/bisphenola.
12 MCT News Service. 2009. Consumer advocates find BPA in food packaging. The Los Angeles Times, November 2. http://www.latimes.com/news/nationworld/nation/wire/sns-200911022152mctnewsservbc-health-bpa-tb50313no,0,7737210.story.
13 US Environmental Protection Agency (EPA). 2004. Toxic Release Inventory database. Bisphenol A.
14 Kolpin, D.W., E.T. Furlong, M.T. Meyer, E.M. Thurman, S.D. Zaugg, L.B. Barber, and H.T. Buxton. 2002. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999–2000: A national survey. Environmental Science & Technology 36: 1202–1211. http://toxics.usgs.gov/pubs/OFR-02-94/index.html
15 Matsushima, A., K. Yoshimitsu, T. Teramoto, K. Takumi, X. Liu, H. Okada, T. Tokunaga, S.-I. Kawabata, M. Kimura, and Y. Shimohigashi. 2007. Structural evidence for endocrine disruptor bisphenol A binding to human nuclear receptor ERR γ. Journal of Biochemistry 142(4): 517–524.
16 The Endocrine Society. Endocrine disruptors. The Endocrine Society. http://www.endo-society.org/media/ENDO-07/webcasts/endo-disruptors.cfm.
17 Lang, I.A., T.S. Galloway, A. Scarlett, W.E. Henley, M. Depledge, R.B. Wallace, and D. Melzer. 2008. Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults. Journal of the American Medical Association 300(11): 1303–1310.
18 Vom Saal, F.S., B.T. Akingbemi, S.M. Belcher, et al. 2007. Chapel Hill Bisphenol A Expert Panel consensus statement: Integration of mechanisms, effects in animals and potential to impact human health at current levels of exposure. Reproductive Toxicology 24(2): 178–198.
19 Pottenger, L.H. 2000. The relative bioavailability and metabolism of bisphenol A in rats is dependent upon the route of administration. Toxicological Sciences 54(1): 3–18.
20 American Chemistry Council. 2010. American Chemistry Council reacts to statement from HHS and FDA on bisphenol A. American Chemistry Council. http://www.bisphenol-a.org/whatsNew/20100115.html.
21 Government of Canada. Questions and answers for action on bisphenol A under the Chemical Management Plan. Government of Canada. http://www.chemicalsubstanceschimiques.gc.ca/fact-fait/bisphenol-a_qa-qr-eng.php.
22 National Institute of Environmental Health Sciences (NIEHS). 2009. NIEHS awards Recovery Act funds to address bisphenol A research gaps. NIEHS. http://www.niehs.nih.gov/news/releases/2009/bisphenol-research.cfm.
23 Verespej, M. 2009. California effort to ban BPA fails. Plastics News, September 14. http://plasticsnews.com/headlines2.html?id=16601.
24 Von Sternberg, B. 2009. State bans chemical in baby bottles. Minneapolis-St. Paul Star Tribune, May 8. http://www.startribune.com/lifestyle/health/44586267.html?elr=KArksUUUoDEy3LGDiO7aiU.
25 Verespej, M. 2010. Two states prepare to regulate BPA. Plastics News, January 27. http://plasticsnews.com/headlines2.html?id=17709.
26 Kissinger, M., S. Rust. 2009. U.S. lawmakers move to ban BPA from food, beverage containers. Milwaukee Journal Sentinel Online, March 13. http://www.jsonline.com/watchdog/watchdogreports/41215752.html.