American Legislative Exchange Council, November 14, 2006


[Rachel's introduction: The chemical industry wants to continue exposing children to toxic chemicals, specifically phthalates and bisphenol-A, which are used in soft plastic toys like teething rings for infants. Here is their reasoning.]


Pthalates are polycarboneate plastics are used in a wide array of products. Phthalates give nail polish and perfume desired consistency and longevity. They also give necessary flexibility to vinyl and soft plastics, and have been used in baby bottles and reusable water bottles for decades.

Environmental activists increasingly seek to ban or severely restrict the use of phthalates, and especially the phthalate known as bisphenol A, asserting that phthalate exposure poses risks to the development of male reproductive organs. Phthalate legislation often targets children's products specifically.

Scientific evidence refutes the assertion that phthalates pose a risk of harm to children or anybody else. While laboratory rats fed megadoses of the phthalate DBP have shown some reproductive development problems, the U.S. Environmental Protection Agency reports the doses correlate to a safe human intake of 300 micrograms per kilogram of body weight per day. By comparison, the U.S. Centers for Disease Control and Prevention report that the average daily human exposure is less than 1 microgram per kilogram of body weight per day.

Biomonitoring of bisphenol A shows even less real-world human exposure, with human exposure being 1 million times below the levels where no adverse health effects were observed in laboratory animals.

Moreover, a September 2006 study showed that when phthalate DEHP was fed to marmoset monkeys -- which are far more similar to humans than laboratory rats -- there were absolutely no negative health effects, even when fed to the marmosets in "astronomical" doses.

The very minimal risk of negative health effects associated with phthalates is especially remote considering the lack of human exposure. A 2005 test by the Dutch Food and Consumer Product Safety Authority measured bisphenol A migration from baby bottles to human subjects. The study found that none of the 22 new baby bottles tested allowed any migration of bisphenol A. Only 3 of the 20 old bottles allowed any bisphenol A migration, and such migration occurred at only trace levels.

As a result of these and numerous other studies showing no adverse human health effects associated with bisphenol A exposure, the U.S. Food and Drug Administration has determined as recently as November 2005 that "based on all the evidence available at this time, FDA sees no reason to change its long-held position that current uses with food are safe."

Talking Points

* The U.S. Food and Drug Administration (FDA) monitors the latest scientific research regarding phthalates such as bisphenol A. FDA has rigorously analysed numerous contemporary studies and concluded that there is no scientific justification for restrictions on phthalates such as bisphenol A.

* Even the notoriously risk-averse European Union has echoed the U.S. FDA determination that human exposure to phthalates poses no health concerns. For example, the German Federal Institute for Risk Assessment (known as the BfR) has determined that "The BfR does not recognize any health risk for babies that are fed from baby bottles made of polycarbonate."

* Phthalates have shown adverse health effects in laboratory rats only when the rats have been given megadoses of phthalates that correlate to unimaginable real-world human exposure. Moreover, marmoset monkeys -- which are far more similar to humans than laboratory rats -- showed absolutely no negative health effects even when fed "astronomical" doses of phthalates.

Additional Sources:

"Are Polycarbonate Bottles Safe for Use? New Information on an Old Scare Story," BisphenolA Website, May 5, 2006

"'Astronomical' Doses of DEHP Show No Adverse Effects on Reproductive Organs of Juvenile Marmosets," Phthalate Information Center, September 6, 2006

"Biomonitoring Studies Confirm Human Exposure to Bisphenol A is Very Low -- Low Exposure Supports Low Risk to Human Health," BisphenolA Website, May 4, 2005.

"EPA Raises Safety Profile for the Phthalate Used in Nail Polish In Review Draft," Phthalate Information Center, September 12, 2006

"EU Risk Assessments," Phthalates Information Center