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FDA’s assessment of BPA is inadequate

September 15, 2008

FDA’s Assessment of BPA is Inadequate Given Mounting Scientific Evidence; CU to Testify before FDA on Issue on September 16

Yonkers, NY—Consumers Union (CU) and Consumer Federation of America (CFA) today announced that the Food and Drug Administration’s (FDA) draft assessment of bisphenol A (BPA) as safe for food contact applications does not adequately account for the large body of mounting scientific evidence to the contrary. In addition, CU and CFA believe that materials made with BPA should not be used in any food or beverage containers and should be replaced with safer alternatives. On September 16, Consumers Union will testify on behalf of both organizations at a public hearing on this issue before a key FDA panel.
The FDA said in a report last month that BPA is safe at current levels found in food products and containers. The FDA report contradicts a report released in early September from the National Toxicology Program (NTP), which is part of the National Institutes of Health, and which held that there is some concern that low-doses of BPA may affect brain, behavioral and prostate development.
“The safety of BPA, at current exposure levels in the U.S. population, has not been demonstrated and the government is giving consumers contradictory messages about the level of concern,” said Dr. Urvashi Rangan, Senior Scientist and Policy Analyst, Consumers Union, nonprofit publisher of Consumer Reports. “BPA is metabolized quickly and yet, constant, elevated levels are circulating in most Americans. This indicates that consumers are constantly exposed to BPA.”
“While scientists continue to assess the health risks of BPA to consumers, the FDA is taking on a bigger risk by taking no action to protect the health and safety of consumers. Consumers expect to buy products that have a proven safety record, not a lack of proven harm,” said Rachel Weintraub, Director of Product Safety and Senior Counsel for Consumer Federation of America. “Too many examples of potential risks today become tomorrow’s hazardous reality. FDA should not take that gamble in the face of mounting evidence of harm.”
BPA—a chemical found in the linings of cans and in many plastic products, including sports bottles, food-storage containers and baby bottles—has potential links to a wide range of health effects. Cellular, animals and some human studies have shown BPA effects on the brain, prostate, normal hormonal systems, gene programming which can lead to several problems with reproduction, behavior, insulin resistance and even cancer. CU was one of the first organizations to test and report on consumer products with BPA, and warned consumers about the potential risks almost a decade ago. CU recently tested “BPA-free” claims on bottles and has also published advice on how consumers can reduce their exposure to BPA. For more information, please visit the food section of greenerchoices.org. Since CU’s first study, more than a hundred studies have been published showing a wide range of adverse effects in animals at low doses of BPA, doses that approximate current levels circulating in the human population.
Consumers Union and Consumer Federation of America are concerned about this extremely narrow safety margin, and believe that the FDA should use its full authority to prevent consumers from ingesting constant elevated levels of BPA by eliminating BPA from food and beverage contact applications. In addition, FDA should:

• Account for the entire body of scientific literature, not only 2-3 studies;

• Revise its safety threshold calculation;

• Convene independent expert panels with representatives from consumer and unbiased scientific groups to discuss how to include important, modern-day toxicology tests and results into future risk assessments; and

• Expand the toxicological endpoints required for safety testing.

Congress has also demonstrated concern about this chemical. Bills have been introduced, both in the House of Representatives (by Rep. Edward Markey) and in the Senate (by Senators Schumer and Feinstein) to ban BPA in various products.
“The FDA depiction of BPA safety is like a picture taken at very low resolution where the finer—and perhaps most important features—are muted,” said Rangan. “FDA has the opportunity, and the responsibility, to consider hundreds of finer studies and to improve their ability to analyze the problem. In the meantime, FDA should prevent consumers from ingesting current questionable levels by eliminating the use of BPA materials used for food and beverage containers.”

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Dr. Urvashi Rangan, 646.594.0212
Rachel Weintraub, 202.387.6121
Naomi Starkman, 917.539.3924