by Marion Nestle
Apr 20 2012

Where are we on BPA?

BPA has become a classic example of how point of view influences decisions about low-dose chemicals in the food supply for which the science is uncertain.

If you are a believer in the “precautionary principle,” any suggestion of harm is enough to support banning BPA until it is proven safe.

European countries tend to subscribe to the precautionary principle.  Sweden, for example, has just banned BPA.

If, on the other hand, you believe that nothing should be banned until incontrovertibly demonstrated by science to cause harm, you won’t act against BPA until the evidence for harm is overwhelming.

That’s the FDA’s position.  Even though the FDA is troubled by the lack of better information about the safety of BPA, it recently denied a petition from the National Resources Defense Council to ban it (see FDA Law Blog for details).

Although FDA is not persuaded by the data and information in your petition to initiate rulemaking to revoke the food additive approvals for BPA, FDA will continue in its broader and more comprehensive review of emerging data and information on BPA.

This tells me that the FDA is plenty worried about BPA but will not (or cannot) act without more evidence.

The FDA’s main page on BPA says:

At this interim stage, FDA shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.

Its page on the chemical nature of BPA explains that because it is used to make a hard, clear plastic used for reusable water bottles (including baby bottles) and epoxy resins that line the inside of metal-based food and beverage cans, BPA is extremely widespread in the food supply.

The FDA first approved BPA in the early 1960s. In 2008, the agency released a draft report judging BPA safe in food contact materials. In 2010 and again on March 30, 2012, the FDA issued an interim update on BPA.

These reports say that the FDA considers BPA safe at current levels of exposure, but also suggest that reducing exposure is a good idea.

Thus, the FDA’s consumer page on BPA says

The Food and Drug Administration’s assessment is 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 [note obfuscating double negative].

The agency has performed extensive research on BPA, has reviewed hundreds of other studies, and is continuing to address questions and potential concerns raised by certain studies [it must be desperate for answers].

FDA scientists have also recently determined that exposure to BPA through foods for infants is much less than had been previously believed and that the trace amounts of the chemical that enter the body, whether it’s an adult or a child, are rapidly metabolized and eliminated [if true, this should come as a huge relief].

FDA’s parent agency, the Department of Health and Human Services, offers advice for parents about BPA, reiterating its safety, but asking:

Q: Should I throw away baby bottles that contain BPA?

A: Parents should examine bottles and discard them if worn or scratched because scratches can both harbor germs and, in BPA-containing bottles, lead to greater release of BPA.  For those who want to use baby bottles and feeding cups not made with BPA, consumers should know that such products are now widely available in the U.S. market.

What all this means is that the FDA is sticking to—or has to stick to—a science-based position on BPA, but it is hedging bets by urging parents and the public to apply the precautionary principle and avoid BPA whenever possible.

This shifts the burden of protection against harm from the government to you.

Does this make sense?  I don’t think so.  You?

  • Almost nobody agrees with me on this issue, but BPA is a difficult case and I think the FDA got it right here. The fact is that when it comes to can linings, there is no affordable substitute yet that works properly with acidic foods or as the FDA said:

    “Because reliable can lining materials are a critical factor in ensuring the quality of heat processed liquid infant formula, safe replacement of such materials requires not only that they both be safe for food contact but also allow for processing that is fully functional in protecting the safety and quality of the infant formula itself.”

    The fact of the matter is, before BPA based epoxies were added, can corrosion was a major cause of deadly food poisoning. If just one baby got sick from tainted formula caused by a rusty can, you can imagine the result. Even the greenest of companies that bottles in glass to eliminate BPA, has it in the metal lids. They told me:

    “Currently, we are told, there is no known viable alternative to BPA based epoxy coatings that provides the same level of corrosion resistance and is as safe.”

    Also the huge elephant in the room is the fact that BPA is used in the linings of soft drink and beer cans. Try taking on Coke and Bud on the basis of the precautionary principle in the current political environment. The American Chemistry Council and its Republican congressional stooges would put the FDA out of business.

    The real answer is: stop buying canned food and pop.

  • Harry MacKay

    If the U shaped dose-response curve for early-life BPA exposure holds, then the cynic’s answer might be to actually increase the levels of environmental BPA until the average dose is within the middle ‘safe’ range. I’m sure that would go over well.

  • David Resseguie

    In Japan, in the 1998-2003 time frame, after research showed deleterious effects of small quantities of bisphenol compounds in the aquatic environment and elsewhere, canners in Japan found alternatives to bisphenol based linings and moved on. The government did not regulate, because the food processors were not recalcitrant and reactionary, and just did the right thing. Now, most of the BPA-free can linings, in things like canned fish, come from SE Asia, as that’s where they figured out how to get along without it.

    Anyone following the science, rather than the spin, knows that the jig is up. If the FDA were really following the science, and were not beholden to chemical companies and food processors, bisphenol compounds would have been long gone from contact with food and people.

  • FG_2009

    Wow I am impressed with the reader’s opinions on this page! Really interesting

  • Janet Camp

    @David R

    Do you have any links to the science you reference? Was the Japanese response based on science or on politics?

    @Lloyd A
    I am also with the FDA on this, but maybe for a bit different reason. Unless someone shows me the science that says there is a real danger, I’m not going to worry too much. I’ve never used much plastic or tin cans I don’t drink soda. My beer is in bottles, and my kids were breastfed. That’s ok for me but I would be concerned for the general public IF I could see that there is good science showing harm.

    I’ve looked for the data but only find second hand opinion and in vitro studies. Not to say my search is exhaustive and not to say the FDA is not bowing to political pressure–just that I’d like to see the evidence.

  • brad

    It’s true that BPA is metabolized and eliminated quickly in the body, but the fact that it’s found in detectable levels in 93% of all tested urine samples in U.S. biomonitoring studies suggests that exposure is not only widespread but frequent (see ref. 1 below). Humans and rats are not the same thing, but laboratory animal studies show that BPA is metabolized more slowly by young rats compared with older ones, which if it applies to human children could be cause for concern. Children also would generally receive higher “doses” of BPA because they eat and drink more, pound for pound, than adults do. See references 2-4 below. Reference 2, published in 2008, also summarizes and evaluates the health risks identified for BPA based on the literature available at that time.

    1. Calafat, A.M., X. Ye, L.Y. Wong, J.A. Reidy, and L.L. Needham. 2008. Exposure of the U.S. population to bisphenol A and 4-tertiary-octylphenol: 2003-2004. Environmental Health Perspectives 116 (1):39-44.

    2. National Toxicology Program. 2008. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NTP CERHR MON (22):i-III1.

    3. vom Saal, F.S., and C. Hughes. 2005. An extensive new literature concerning low-dose effects of bisphenol A shows the need for a new risk assessment. Environmental Health Perspectives 113 (8):926-33.

    4. Domoradzki, J.Y., C.M. Thornton, L.H. Pottenger, S.C. Hansen, T.L. Card, D.A. Markham, M.D. Dryzga, R.N. Shiotsuka, and J.M. Waechter, Jr. 2004. Age and dose dependency of the pharmacokinetics and metabolism of bisphenol A in neonatal sprague-dawley rats following oral administration. Toxicological Sciences 77 (2):230-42.

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  • Tanya

    The impact of not regulating BPA is that those who are educated about such issues will take preventative measures to avoid it, and (as usual) the least educated will not take action and be exposed to it. The burden should not be on individuals to take individual action.

  • Tara

    I want to avoid BPA, but am concerned about what they are replacing it with. If something is listed as “bpa free” what is in it instead? Is that safer than BPA?

  • Anthro

    Thank you Brad for the citations, but as you note, the studies are rat studies and rats are not people. While there may be room for concern, I don’t see any definitive cause for alarm. I think the FDA may have it right, but unfortunately they are so often politicized, that it becomes difficult to tell when they are actually following the science.

    This leaves thinking people with only avoidance to be on the safe side, but as Tanya points out, that is hardly a broad public health measure.

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  • Michael

    Janet, Anthro: I’m genuinely surprised to hear that you are only aware of cell culture and rodent studies suggesting harm from BPA, as there have been several human studies finding associations between BPA exposure and adverse health effects, in adults and especially in developing children; many of these have received a lot of media coverage and/or have appeared in very high-impact journals, and are widely cited in the subsequent scientific literature, including some of those same rodent and in vitro studies. Eg:

    Melzer D, Rice NE, Lewis C, Henley WE, Galloway TS. Association of urinary bisphenol a concentration with heart disease: evidence from NHANES 2003/06. PLoS One. 2010 Jan 13;5(1):e8673. PubMed PMID: 20084273; PubMed Central PMCID: PMC2800195.

    Braun JM, Yolton K, Dietrich KN, Hornung R, Ye X, Calafat AM, Lanphear BP. Prenatal bisphenol A exposure and early childhood behavior. Environ Health Perspect. 2009 Dec;117(12):1945-52. Epub 2009 Oct 6. PubMed PMID: 20049216; PubMed Central PMCID: PMC2799471.

    Yang YJ, Hong YC, Oh SY, Park MS, Kim H, Leem JH, Ha EH. Bisphenol A exposure is associated with oxidative stress and inflammation in postmenopausal women. Environ Res. 2009 Aug;109(6):797-801. Epub 2009 May 22. PubMed PMID: 19464675.

    Lang IA, Galloway TS, Scarlett A, Henley WE, Depledge M, Wallace RB, Melzer D. Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults. JAMA. 2008 Sep 17;300(11):1303-10. Epub 2008 Sep 16. PubMed PMID: 18799442.

    Sugiura-Ogasawara M, Ozaki Y, Sonta S, Makino T, Suzumori K. Exposure to bisphenol A is associated with recurrent miscarriage. Hum Reprod. 2005 Aug;20(8):2325-9. Epub 2005 Jun 9. PubMed PMID: 15947000.

    Li DK, Zhou Z, Miao M, He Y, Qing D, Wu T, Wang J, Weng X, Ferber J, Herrinton LJ, Zhu Q, Gao E, Yuan W. Relationship between urine bisphenol-A level and declining male sexual function. J Androl. 2010 Sep-Oct;31(5):500-6. Epub 2010 May 13. PubMed PMID: 20467048.

    Meeker JD, Calafat AM, Hauser R. Urinary bisphenol A concentrations in relation to serum thyroid and reproductive hormone levels in men from an infertility clinic. Environ Sci Technol. 2010 Feb 15;44(4):1458-63. PubMed PMID: 20030380; PubMed Central PMCID: PMC2823133.

    Kandaraki E, Chatzigeorgiou A, Livadas S, Palioura E, Economou F, Koutsilieris M, Palimeri S, Panidis D, Diamanti-Kandarakis E. Endocrine disruptors and polycystic ovary syndrome (PCOS): elevated serum levels of bisphenol A in women with PCOS. J Clin Endocrinol Metab. 2011 Mar;96(3):E480-4. Epub 2010 Dec 30. PubMed PMID: 21193545.

    Li D, Zhou Z, Qing D, He Y, Wu T, Miao M, Wang J, Weng X, Ferber JR, Herrinton LJ, Zhu Q, Gao E, Checkoway H, Yuan W. Occupational exposure to bisphenol-A (BPA) and the risk of self-reported male sexual dysfunction. Hum Reprod. 2010 Feb;25(2):519-27. Epub 2009 Nov 10. PubMed PMID: 19906654.

    These studies are of course observational and can’t conclusively prove harm — but no one is going to do a controlled multidecade multidose study involving developmental, early childhood, adolescent, and adult exposure. I agree that caution is needed, but not enough caution to refuse to put some restrictions on the stuff (especially products aimed at or heavily used by children and pregnant and lactating women), and to warn consumers about the possible dangers