Statement of Diana Zuckerman at the FDA Science Board Meeting on the FDA Draft Assessment of Bisphenol A for Use in Food Contact Applications

At the FDA Science Board Meeting on the FDA Draft Assessment of Bisphenol A for Use in Food Contact Applications

 

October 31, 2008

Updated July 12, 2013

Thank you for the opportunity to testify as president of the National Research Center for Women & Families. 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 health and safety issues.

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; was on the faculty at Yale and Vassar; and directed a longitudinal research project at Harvard. I have worked on health policy issues in Congress, the White House, and for nonprofit organizations for 25 years.

Science Board Subcommittee Report on Bisphenol A (BPA)

We generally agree with the Science Board Subcommittee criticisms of the FDA Draft report.

I was especially pleased that the report included criticisms I made in September that the safety levels for infant formula were based on an inadequately small sample. I want to emphasize that it isn’t just the small sample size that is a problem – the sample of infant formula cans were from about 15 years ago, and the sample was only from Washington, D.C. area stores. The FDA needs to conduct new studies of a much larger and more representative sample of infant formula containers. And, we agree that the FDA should not focus on the average BPA level but rather the range of BPA levels, in determining safety.

We also agree that the 5 mg/kg level is too high and that for these and other reasons, the margins of safety are inadequate.

We applaud the Science Board report for taking on the more complicated issue of whether the FDA should be analyzing safety as if food containers are the only source of BPA exposure. We agree that the FDA is not doing its job if they are ignoring the fact that all of us are exposed to BPA from many sources, and that BPA from food containers is adding to our levels, it is not the only source of exposure. That raises broader issues of how to safeguard the health of the American people, especially our children.

And of course, exposure of pregnant women to BPA is crucially important and needs to be considered. For that reason, the FDA needs to analyze the implication of BPA levels from products other than infant formula, baby bottles, and other products used by infants and children.

Why was the FDA Draft Report so Flawed?

It’s great that the Science Board subcommittee did a good job, but here’s a crucial question: why did the FDA do such a bad job in their draft report? Why did they make the fundamentally flawed decision to base their conclusions on two industry-funded studies, ignoring so many other excellent peer-reviewed studies? Why did the FDA rush to judgment, concluding that there was evidence of safety when it was so obvious that there were many unanswered questions about BPA? And why, after the Science Board subcommittee criticized the FDA’s draft report on BPA, did the FDA come out with a misleading statement that was obviously intended to reiterate their claim that there was every reason to think that BPA levels in food containers are safe. A closer look shows how disingenuous that statement is. The FDA carefully parsed their words so that they could justify their report as being consistent with other countries’ regulatory inaction. They did not want to point out that Canada had just taken action to eliminate BPA from baby bottles, for example.

Risks vs. Benefits

We’d like to believe that BPA in food containers is safe, but wishing doesn’t make it so. There is a growing body of research evidence that suggest that current BPA levels are likely to be harmful for at least some of our children, and perhaps many of our children.

The most disturbing aspect of the FDA report is the conclusion that BPA is safe at current levels when the FDA does not know what current levels are and doesn’t have well-designed research to conclude that they are safe.

For example, the FDA’s 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 Are 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 and Companies Are Reducing BPA Exposure-But Not The FDA
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.1

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 2008.2 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 the amount of 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. The FDA’s job is to protect consumers. For that reason, the FDA should ban BPA in baby bottles, as Canada has done. And the FDA should go further, by eliminating BPA in food and beverage containers used by pregnant women, infants, and children.

I urge the Science Board to endorse the subcommittee’s report, and to carefully monitor the FDA’s efforts on BPA and to make sure that well-designed studies – free of industry bias — are conducted as soon as possible. The Science Board should also ensure that any resulting reports and regulatory actions on BPA are consistent with the scientific evidence and the public health needs of all our families. We depend on the FDA to protect our families, but the agency has let us down in their failure to acknowledge the need for caution regarding BPA.

*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.

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1. Advanced Industrial Science and Technology. 2007. Risk Assessment Document: Bisphenol A.
2. Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.