Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 24, 2009
Thank you for the opportunity to testify on behalf 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 were very pleased with the Science Board’s criticisms of the FDA Draft report on BPA and were disappointed that the FDA has not acknowledged the bottom line criticism: that the FDA drew conclusions about the safety of BPA that were not based on sound science, and that no conclusions can be made about safety until the FDA pays attention to the best studies conducted by federally funded scientists and designs appropriate follow-up research.
The FDA’s response to the Science Board criticisms also ignored several issues that were raised at your meeting in October:
1. Prenatal Exposures
The FDA says they agree with the Science Board that they should focus on the health effects of BPA on infants and young children. However, in our testimony in October and in the Science Board’s response, it was pointed out that prenatal exposures are probably even more important.
Unfortunately, pregnant women don’t have a special diet of canned foods and beverages-they eat the same food as everyone else. That means the FDA needs to be concerned about BPA exposure from all containers for foods and beverages commonly consumed by adults.
2. Chemotherapy Patients
A study published online in Environmental Health Perspectives in October and in the print edition this month found that the effectiveness of chemotherapy could be undermined by exposure to BPA among women with breast cancer. At the Science Board meeting in October, the need to study the impact of BPA on chemotherapy was also mentioned. Again, this means that BPA levels in all foods and beverages consumed by adults will need to be examined.
3. Sprague-Dawley Rats
The FDA is proposing new research using Sprague-Dawley rats. The use of Sprague-Dawley rats was criticized at the Science Board subcommittee meeting because those rats are inappropriate for use in BPA research: they are less sensitive to estrogens than other types of rats. If the FDA’s goal is to do objective research, these are not the right rats to use.
What Else is Needed?
We are pleased that the FDA plans to do a new study of BPA levels in cans of infant formula. This decision responds to criticisms we made in September, echoed by the Science Board subcommittee on BPA, that the safety levels for infant formula were based on an inadequate sample-a sample of infant formula that was outdated, too small, and not generalizable to a national sample.
The next question is: Will the FDA move quickly to answer these crucial safety questions, or will they follow the time-honored Washington tradition of study and stall.
New studies will be enlightening, but the FDA has thus far ignored many very well-designed studies which indicate that there are real risks to BPA exposure. While the FDA studies and stalls, new research is emerging almost every month. These studies need to be scientifically summarized by the FDA to determine BPA’s likely risks to human health.
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 suggests that current BPA levels are likely to be harmful for at least some of our children, and perhaps many adults and children.
The FDA has continued to reassure consumers that BPA is safe at current levels when the FDA does not even know what current levels are and doesn’t have well-designed research to conclude that they are safe.
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. It is still unclear how unsafe they are, and for whom.
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 Canada has designated BPA as the highest priority chemical in need of regulation and has banned its use in infant products. A number of cities and states across the U.S. have weighed the scientific evidence and are seeking to implement bans.
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.2 Bottle manufacturers such as Playtex and Nalgene are using non-BPA materials for their products.
Keeping Consumers Safe
It is the FDA’s job 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.
We urge the Science Board to carefully monitor the FDA’s efforts on BPA and to make sure that well-designed studies-free of industry bias-are conducted immediately. Well-designed, independently conducted studies in the scientific literature should be reviewed and summarized within the next few months. The Science Board should also ensure that FDA’s reports and regulatory actions on BPA are completed as quickly as possible and 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.