At the FDA Public Meeting on its Draft Assessment of
Bisphenol A for Use in Food Contact Applications
September 16, 2008
Updated July 12, 2013
I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families. Our nonprofit research and education center does not accept contributions from companies that make medical products that we evaluate, or competing companies, and so I have no conflicts of interest.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies, and to compare their safety and effectiveness.
In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation.
I was trained in epidemiology at Yale Medical School; I have worked on federal health policy issues in Congress, the White House, the Institute of Medicine, and for nonprofit organizations for 25 years; and I have reviewed FDA safety issues for almost 20 years.
Bisphenol A (BPA)
BPA is used in a variety of products including reusable water bottles, baby bottles, and plastic tableware. Epoxy resins made with BPA are used to coat the insides of canned foods and beverages.
There is no debate that BPA leaches out of plastic into liquids and foods. The Centers for Disease Control and Prevention (CDC) found measurable amounts of BPA in the bodies of more than 90 percent of the U.S. population studied.1
FDA Draft Assessment Conclusion
The FDA Draft Assessment concluded “that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.”
The FDA’s conclusions are primarily drawn from two-industry funded studies, one of which was sponsored by the American Plastics Council and the other by the Society of Plastics Industry.2
In contrast to the industry-funded studies, more than 150 government-funded BPA experiments on lab animals and tissues reported adverse effects, while only 14 did not. These statistics were compiled by the journal published by the American Chemical Society, the professional association for chemists.
However, 13 out of 13 industry-funded studies found no adverse effects.3 It seems that “He who pays the piper calls the tune.”
In addition, the FDA’s estimates of exposure are based on questionable data. On page 7, the FDA draft report explains that the studies by FDA laboratories were done in the early 1990’s-more than 12 years ago. The study was based on only 14 samples of infant formula representing 5 brands purchased in Washington, DC supermarkets. Is that representative of all infant formula cans in the early 1990s or today? No. In an update from this past June, an FDA official pointed out that studies of more recent samples of infant formula have found a more dramatic range of BPA levels. The FDA has stuck with their old estimate of 6.6 ppb as the maximum level, but it is not the maximum level, as the FDA well knows. In fact, 6.6 ppb is lower than the level found in several other studies.4
What does “some concern” mean?
The FDA Draft Assessment focuses on cancer and reproductive and developmental toxicity of BPA. They quote the National Toxicology Program’s report, which concluded that “some concern” exists for developmental toxicity, and less concern for other risks.
Unfortunately, the terminology used is misleading. The National Toxicology Program is judging their “concerns” on the basis of how conclusive the research evidence is. The research on rats and mice and tissue can’t be considered conclusive regarding human health. But, this does not mean there is conclusive evidence that there is no need for concern. The lack of conclusive evidence is not the same thing as the evidence of safety.
On the contrary, the weight of the evidence, especially the unbiased evidence of government-funded research, is that we should be concerned.
The FDA relies on industry for research everyday, but in this case there is an abundance of well-designed studies that are being discounted for inappropriate reasons, such as the lack of good laboratory practices (GLP). GLP are industry standards – they have nothing to do with whether the study is well designed or not. A poorly designed study using GLP will not provide accurate safety information, and that is exactly the problem we have with the industry studies FDA relied on. In academia, science is built on replication by different scientists in different labs.
Most Independent Studies Show Risks of BPA
Well-respected scientists from across the country have found that BPA is potentially dangerous for humans. Many of these scientists worked together on the Chapel Hill Consensus Statement on BPA, which expressed strong concerns about the impact of BPA on human health.
The Statement also noted increases in neurobehavioral problems, such as attention deficit hyperactivity disorder and autism, increases in childhood and adult obesity and Type II diabetes, decrease in sperm count, and increases in hormonally mediated cancers, such as prostate cancer.5
Several newly published studies support the concerns of the Chapel Hill Consensus Statement. Several of these studies were not published in time to be considered by the National Toxiciology Program or the FDA.
Researchers at Yale just published the first study of the effect of BPA on primates, which demonstrated “an adverse effect of BPA on the brain…and further amplifies concerns about the widespread use of BPA…in food preparation and storage.”6
A study that is published online in Environmental Health Perspectives and will soon be in print concluded that low doses of BPA could inhibit the release of a key hormone (adiponectin) that protects humans from the metabolic syndrome, thereby linking BPA to an increase in heart attacks and Type II diabetes.
In addition, a study in this month’s issue of Endocrinology found that young female mice exposed to BPA showed brain and behavior traits more typical of male mice.
A study in the June issue of Cancer Research showed a correlation between rats that had early BPA exposure and those that developed prostate cancer in later life. The study was done by Shuk-mei Ho, head of environmental health at the University of Cincinnati, and Gail Prins, physiology professor at the University of Illinois in Chicago.
Risks vs. Benefits
Companies that make plastics and plastic food and beverage containers have said that BPA has been used for years and therefore it is safe. We’d like to believe it, but wishing doesn’t make it so. There are several disturbing disease trends that coincide with the increased use of BPA, such as Type II diabetes, learning disabilities, and breast cancer. And, of course, the lag time between exposure to a carcinogen and developing cancer is usually 15-20 years or more. If it weren’t so long, we’d have a lot of Americans dying of lung cancer in their 20’s and 30s.
What Should The FDA Do?
The most disturbing aspect of the FDA report is the conclusion that BPA at current levels is safe when the FDA does not know what current levels are and doesn’t have well-designed research to conclude that they are safe.
The FDA estimates of BPA are based on studies of 14 samples sold more than 12 years ago, in supermarkets in Washington, D.C. We need more recent measurements in a larger number of products sampled from stores across the country.
The draft assessment states: “FDA does not have a specific list of BPA-containing end products as provided to consumers.” Why not? Without it, we don’t really know what the exposure is, and consumers can’t avoid BPA-tainted products.
The FDA should not draw conclusions that are biased and premature.
While the FDA is deciding what to do about BPA in food containers, they should at the very least empower consumers by requiring that food and beverage containers list whether or not they contain BPA.
But ultimately, it is not fair to consumers to give them information (this container has BPA!) without explaining the implications. For that reason, the FDA should ban the use of BPA or at the very least require reduced levels of BPA until more conclusive studies can be performed to assure the American public that the chemical is safe. I think we can all agree that there is no clear evidence that the products are safe, the only question is whether they are unsafe.
Alternatives to BPA Available
Alternatives include oleoresinous, vinyl, or PET film lamination to line cans, and glass bottles, polypropylene bottles and bottles with polymeric liners for baby bottles.
Other Countries Are Reducing BPA Exposure-But Not The U.S.
Japan has taken measures to reduce BPA in consumer products, such as canned beverages and plastic tableware. They are using different linings for beverage cans, which either contain no BPA or leach only a small amount of BPA, and plastic tableware that had BPA has been replaced with tableware that does not.7
In the United States, the NTP points out that “exposure to bisphenol A may be increasing” and the median levels of BPA in human urine doubled from 1988 to 2004.8
Responsible retailers are not waiting for the FDA to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves at the end of 2008.9 Bottle manufacturers such as Playtex and Nalgene are using non-BPA materials for their products.
Keeping Consumers Safe?
It is your job and the job of the FDA to make sure that food and beverage containers don’t increase the risks of food and beverages. The bottom line is we just don’t know if BPA in infant formula cans and other food containers is safe.
More than 100 studies have raised doubts about the safety of BPA, and alternatives to BPA are available. If the FDA is to err, it should be on the side of consumer safety, not corporate profits, by banning BPA in baby bottles, plastic tableware, foods and beverages, and other products.
*On July 12, 2013 the FDA banned the use of BPA in packaging for infant formula (a copy of the ruling can be found here). This final rule came five years after Dr. Zuckerman first spoke to the FDA’s Science Board about the safety risks of BPA in food containers. Efforts continue to remove BPA from other products.
1 Hileman, B., (2007, April). Bisphenol A on Trial, Chemical & Engineering News Government & Policy, Vol. 85, Number 16. http://pubs.acs.org/cen/government/85/8516gov2.html
3 Hileman B., (2007, April). Ibid.
4 Bailey, A, June 2, 2008 Update on Cumulative Exposure to BPA, Memorandum to the File, Division of Food Contacts Notification, http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-0038b1_01_07_FDA%20Reference%20Material-FDA%20Memo%20Cumulative.pdf
5 vom Saal, F., (2007). Chapel Hill Bisphenol A Expert Panel Consensus Statement: Integration of Mechanism, Effects in Animals and Potential to Impact Human Health at Current Levels of Exposure, Reproductive Toxicology.
6 Leranth, C., et.al., (2008). Bisphenol A prevents the synaptogenic response to estradiol in hippocampus and prefrontal cortex of ovariectomized nonhuman primates, Yale University School of Medicine, The National Academy of Sciences. http://www.pnas.org/content/early/2008/09/02/0806139105.abstract?sid=a6820950-175f-4d84-86b1-035e4b42213b
7 Advanced Industrial Science and Technology. 2007. Risk Assessment Document: Bisphenol A.
8 National Toxicology Program, U.S. Department of Health and Human Services, Center for the Evaluation of Risks to Human Reproduction, (September 2008). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08-5994.
9 Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.