FDA Fighting Mounting Evidence on BPA

The U.S. Food and Drug Administration (FDA) continues to claim there is insufficient evidence about the health effects of a chemical widely used in consumer products to justify regulating the substance. Evidence is mounting from a variety of other sources, however, that bisphenol-A (BPA) may affect human development and mental health. FDA continues to advise consumers that there is no reason to "discontinue using products that contain BPA."

BPA is a common chemical found in certain hard plastics and the linings of food cans. The most common plastic products that contain BPA are shatterproof water bottles, baby bottles, and food cans with plastic linings used to reduce the amount of metal leaching into food.

The latest evidence to conclude that BPA is harmful was reported in a Sept. 4 Washington Post article describing a Yale School of Medicine study that links the chemical to brain functions and mood disorders. The study was published Sept. 3 in the Proceedings of the National Academy of Sciences. According to the abstract of the article, "This study is the first to demonstrate an adverse effect of BPA on the brain in a nonhuman primate model and further amplifies concerns about the widespread use of BPA in medical equipment, and in food preparation and storage."

The scientists who conducted the study used monkeys as subjects to better approximate the likely response in humans exposed to BPA. The scientists exposed the primates to levels the U.S. Environmental Protection Agency (EPA) considers a safe daily limit. Other studies used rodents as subjects "which may not be representative of the effects of human BPA exposure," according to the scientists. The authors conclude that because exposure to the chemical causes the loss of connections between brain cells, there may be memory loss, brain impairment, and depression at the exposure level the EPA has established as safe. EPA has the responsibility for setting safe chemical exposure limits, while FDA can limit or ban the use of BPA in food-related items.

On Sept. 3, another study was released indicating potential harm from BPA. The National Toxicology Program (NTP), part of the Department of Health and Human Services, released its final report on the health effects of BPA. According to the report, "The NTP has some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A." A spokesperson for NTP said the study indicates that concern about exposure cannot be dismissed.

These latest studies come on the heels of earlier analyses of BPA that led to warnings and product withdrawals. The Canadian government reviewed more than 150 studies on BPA exposure and announced in April that it would move to ban the use of BPA in baby bottles. At the time, the Health Canada minister concluded that it was "pretty clear" that the highest risk was to infants and young children, according to an April 19 Washington Post article. As a result of the announcement, Wal-Mart Canada pulled BPA products from the shelves and a manufacturer of plastic water bottles containing BPA, Nalgene, switched to producing non-BPA plastic bottles. Other retailers and manufacturers in Canada and the U.S. also began withdrawing products and changing their manufacturing processes.

FDA, meanwhile, continues to claim the science regarding BPA is too uncertain to warrant regulation of the chemical in food products. An Aug. 14 Draft Assessment of Bisphenol A for Use in Food Contact Applications being circulated for FDA's scientific peer review program concludes that there is no adverse effect from BPA. The draft assessment continues to rely heavily on two industry-funded studies that formed the basis of FDA's earlier assessment of BPA. FDA is holding a public hearing on the issue Sept. 16.

According to FDA's website, the agency is not recommending consumers change their habits regarding BPA-based products:

At this time, FDA is not recommending that anyone discontinue using products that contain BPA while we continue our risk assessment process. However, concerned consumers should know that several alternatives to polycarbonate baby bottles exist, including glass baby bottles.

 

The Center for Science in the Public Interest's (CSPI) Integrity in Science Watch newsletter from Aug. 18 notes that eleven states and Canada are all considering tougher stances on BPA in light of accumulating evidence. California, for example, is considering banning the use of BPA in any products designed for use by children three years old or younger. It also reports the chemical industry has launched a campaign to counter California's proposal, insisting the scientific evidence is too uncertain and has not established a connection between exposure to the chemical and adverse health effects. The industry group is also challenging the conclusions drawn by the Health Canada scientific review.

In addition to the state activity, Congress is investigating the FDA's approach to BPA, reviewing the science, and considering several proposed bills to limit or ban the use of BPA in some products. It is unlikely that legislation will be passed in the short September session Congress is planning before the recess for the November elections. Meanwhile, consumers are advised by public health experts like CSPI and Consumers Union to avoid using most plastic containers marked with the recycling number 7, the most likely plastics to contain BPA.

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