American Legislative Exchange Council  [Printer-friendly version]
November 14, 2006

PHTHALATES AND BISPHENOL-A

[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.]

Summary

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