Published October 31, 2008
GAITHERSBURG, Md. — A Food and Drug Administration advisory board voted today to say that the agency ignored critical evidence suggesting that a controversial plastic chemical bisphenol A, or BPA, could harm children.
The FDA's science board, a group of outside experts, voted unanimously to endorse a report that found major flaws in the agency's decision to declare BPA safe. The agency oversees the safety of food containers and is in charge of deciding the level of BPA to which people may be exposed without harm. The critique was written by a board subcommittee and released Wednesday.
Children are commonly exposed to BPA from plastic baby bottles, the linings of metal liquid formula cans and other consumer products. Tests have found the chemical in 93% of Americans.
The science board agreed with the finding that that the FDA was wrong to base its August decision that BPA is safe only on studies funded by the chemical industry. Excluded studies suggest that BPA, which acts like the hormone estrogen, could pose harm to children at levels at least 10 times lower than what the agency allows.
Excluding this evidence of harm "creates a false sense of security" about BPA, the report says, and "overlooks a wide range of potentially serious findings."
Many consumers and environmentalists at the meeting urged the FDA to act now to protect infants from BPA, even as it continues to evaluate research. "We only have one chance to get it right for a child born today and for the 4 million children who will be born this year," says Olga Naidenko with the Environmental Working Group, an advocacy group.
One board member at the meeting agreed, saying the public appears hungry for advice from the government.
Larry Sasich, an associate professor of pharmacy at the Lake Erie College of Osteopathic Medicine and the consumer representative on the advisory board, urged the board to tell the FDA to immediately inform the public about the risks of BPA. Instead, the board agreed to allow its members to express their wishes to the FDA commissioner individually.
"The point of the whole process is: Do we have a chemical out there that is potentially harmful to infants and small children?" Sasich asked. "There becomes a point in time when the science has to become policy. The system is running the risk of losing credibility with the public unless we take some definitive action that the public can understand."
A work in progress
In statement Wednesday, the FDA affirmed the safety of BPA: "Current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies."
On Friday, FDA Commissioner Andrew von Eschenbach denied that the agency had done an inadequate job in setting a safety standard. He said that the FDA's August decision was a work in progress, and that the science board's input is a vital part of that ongoing process.
"We would not have asked them (the science board) to do this if we weren't open to listening and learning from this input and incorporating it into our decision-making," von Eschenbach says.
In a presentation to the science board, he said, "There's no shame in having one's hypothesis or previous tenants questioned or disproved. That's the purpose of science: to test hypotheses and theses appropriately and have a healthy debate about where the data do and do not lead us."
Von Eschenbach said the agency tries to include the latest research. But the agency is leery of changing regulations with every new study, a practice that could "rather harm than help the American public."
"Cutting-edge, discovery science is, by its very nature, in flux and requires critical evaluation," von Eschenbach said. "Science is always filled with controversy and evaluation, and we want it to be. But the doctrine of today may be refuted tomorrow.. .. We are a regulatory agency that must make public health decisions that are enforceable. .. that must endure."
Other regulatory bodies have taken more aggressive positions on BPA. Earlier this month, Canada declared BPA to be toxic and announced plans to ban it in baby bottles.
The National Toxicology Program, part of the Department of Health and Human Services, concluded last month that there is "some concern" that BPA alters development of the brain, prostate and behavior in children and fetuses.
A flawed report
In the report endorsed Friday, the FDA's science board said the agency erred in discounting research upon which the toxicology program based its conclusions. The FDA made other significant mistakes that lead it to underestimate BPA's potential dangers, the report says:
•When measuring the amount of BPA to which babies are exposed from liquid infant formula, for example, the FDA used data from more than a decade ago and sampled only 14 liquid formula cans, all from the Washington, D.C. area. It also based its exposure estimate on the average BPA level. That could allow children fed from cans with above-average BPA levels to receive far more of the chemical.
• The FDA also failed to consider the cumulative effect of being exposed to BPA from dozens of products, from sippy cups to medical devices. That fundamental error "severely limits the usefulness" of the agency's safety estimate.
At the advisory group's September meeting, experts testified that children with certain health problems are given only liquid formula, as are children in the federal government's Women, Infants and Children program for the poor.
• The FDA didn't consider that many parents heat baby bottles in the microwave and sterilize them with boiling water, which could cause the bottles to release far more BPA.
• The FDA report doesn't include recent studies, such as a "landmark" September report from the Journal of the American Medical Association linking BPA, for the first time, with diabetes and heart disease, says Martin Philbert, a University of Michigan professor who led the science board's BPA subcommittee. Another study published this month suggests BPA could make breast cancer patients less likely to benefit from chemotherapy.
• The industry-funded studies used by the FDA weren't designed to study newborns, whose bodies may process BPA very differently than adults, Philbert says. At the meeting, other science board members noted that the FDA draft doesn't consider others who might be especially vulnerable to BPA, such as pregnant women and breast cancer patients being treated with estrogen-suppressing drugs.
Consumers aren't waiting for FDA action
Critics have long contended that BPA can cause harm at extremely low doses. The Environmental Working Group, for example, says BPA could cause brain, behavior and prostate damage at levels 500 times lower than the FDA's proposed exposure limit.
"You cannot tell parents with a straight face that BPA is safe," said Sonya Lunder, a scientist with the group, in an interview before the meeting. "As a parent, it's outrageous to think that another generation is going to be born and subjected to these toxic exposures while this process works itself out."
An advocacy group, the Natural Resources Defense Council, believes BPA is too toxic to use in baby products at all. The group has formally asked the FDA to remove BPA from food and beverage containers.
Many businesses, consumers and lawmakers, however, aren't waiting for the FDA to act.
CVS, Safeway, Wal-Mart, Toys 'R'Us and others are phasing out BPA. Attorneys general from New Jersey, Connecticut and Delaware have asked 11 companies to remove BPA from their bottles and formula cans. Most baby bottle makers now offer BPA-free alternates. And many formula makers are in the process of finding substitutes for BPA. Lawmakers in Congress have introduced legislation to ban the chemical in children's products.
Industry groups — including the American Chemistry Council, the North American Metal Packaging Alliance and the International Formula Council — noted at Friday's meeting that other regulatory agencies, including ones in Europe and Japan, have found BPA to be safe.
The formula council's Mardi Mountford said that manufacturers hope to introduce BPA alternatives as soon as chemical and container manufacturers can make them available.
Lunder notes that alternatives already exist, however, and that some companies now sell liquid formula in BPA-free plastic bottles. Powdered formula is also sold in packaging that has virtually no BPA, she says.
The subcommittee has attracted controversy itself.
Philbert refrained from voting because of concerns that his research center has accepted funding from the chemical industry.
More on BPA from Environmental Working Group:
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