TOXICS INFORMATION PROJECT (TIP)
P.O. Box 40441, Providence, RI 02940
LIBERTY GOODWIN, DIRECTOR
Tel. 401-351-9193, E-Mail: TIP@toxicsinfo.org
(Lighting the Way to Less Toxic Living)
FDA PETITION ON BISPHENOL-A IN PLASTIC
BABY BOTTLES & FOOD PACKAGING
WASHINGTON, May 12, 1999 - The National Environmental Trust (NET) and eleven national consumer, health, religious, and environmental groups today called on the U.S. Food and Drug Administration (FDA) and manufacturers to make all plastic food containers, including baby bottles, safer for children. Their request comes in response to new scientific research showing higher levels of bisphenol-A leaching from clear plastic baby bottles made of polycarbonate plastic.
Recent studies on bisphenol-A (BPA) found health effects in laboratory animals, even when tiny levels of the chemical were present. Studies on the migration, or leaching, of BPA out of polycarbonate baby bottles suggest that babies could be well over safety limits based on levels at which effects were seen in animals.
"Baby bottles shouldn't release any chemical-let alone one that has been shown to function in the body like the hormone estrogen," said Philip E. Clapp, President of National Environmental Trust. "A young baby's body is rapidly developing in response to tiny, perfectly-timed hormonal signals. We have no way of knowing the subtle ways that an artificial hormone-like substance, like bisphenol-A, can interfere with that development."
A newly-identified study released at the press conference from the peer-reviewed Journal of Health Science by Dr. Koji Arizono and other researchers from the Prefectural University of Kumamoto and University of Nagasaki, Japan, used Solid-Phase Microextraction, an extremely sensitive method of detecting and measuring small concentrationsóas low as 0.1 part per billion-of BPA in water and in food.
Additional tests on polycarbonate tableware typically used in Japanese primary schools also indicated that BPA will leach into hot liquids and confirmed that worn, scratched polycarbonate shows greater leaching.
Dr. Arizono's results confirmed that polycarbonate material leaches BPA at high heat-also observed by Consumers Union in a May 1999 study reported in Consumer Reports and a in a 1997 U.S. FDA study. But the results also show leaching of BPA from polycarbonate at much lower temperatures as low as 60 degrees C.
Dr. Frederick Vom Saal, professor of
biology at the University of Missouri, has studied the health effects of
extremely low doses of bisphenol-A in laboratory mice. As he told the ABC-TV news program, 20/20,
"We've seen a wide variety of damage in the offspring when we feed this to
pregnant female mice. We have the threat of a chemical that in an adult is not
necessarily harmful, but in a developing fetus or a newborn poses a very unique
and very serious danger. We're talking about damage in organs that sometimes is
difficult to pinpoint but could have very serious health consequences,
NET also released an analysis of industry-sponsored studies that have attempted to disprove Dr. vom Saal's studies. All three industry studies-a study commissioned by the Society for the Plastics Industry; a study performed by Zeneca, Inc., a large chemical company; and a study commissioned by the Chemical Industry Institute of Toxicology-were found by independent scientists and statisticians to be either flawed in execution or to generate results that appear to corroborate rather than disprove vom Saal's findings. Chemical & Engineering News reported in their May 10, 1999, issue that a National Institute for Environmental Health Sciences statistician, Joseph K. Haseman, reanalyzed one industry study and found that, contrary to the study’s stated conclusions, he found the study actually shows a positive effect, specifically "an increase in prostate weight with bisphenol-A treatment" (p. 29).
(TIP NOTE: A researcher looking a all the current studies of Bisphenol-A found that 100% of those sponsored by industry claimed no health risk - but 100% of independent research found cause for serious concern.)
The petition calls on FDA to promptly identify all ingredients used to formulate plastic food containers that may migrate into foods to which children are routinely exposed; implement a strategy that will eliminate or greatly reduce children's exposure to all such plastic food packaging ingredients; permit the use of migrating ingredients only after manufacturers provide substantial affirmative evidence of safety; and work with other federal agencies to implement a scientific investigation into the low dose effects of migrating ingredients in plastic food packaging.
According to NET's Clapp, the FDA has not yet recognized a problem with bisphenol-A because its regulatory approach has not kept up with the emerging science on chemicals that interfere with the hormone system.