[ 14 November 2003 ]

California Action on DEHP "Not Justified by the Scientific Evidence"

The State of California's action in listing DEHP as a reproductive toxicant under the provisions of Proposition 65 is not justified by the scientific evidence, according to the American Chemistry Council's Phthalate Esters Panel.

"This action is unnecessary and inappropriate on three counts," said Marian Stanley, manager of the Phthalate Esters Panel of the American Chemistry Council. "First, the premise for the ruling is flawed. The regulatory reports from the Food and Drug Administration and the National Institute for Occupational Safety and Health on which the action is said to be based did not set out to determine if DEHP causes reproductive toxicity in humans, nor did either conclude that it does. Second, in over 50 years of its use, there has been no reliable evidence that DEHP has caused reproductive toxicity in humans. Third, there is recent research suggesting that there are indeed no adverse reproductive effects in humans, even from relatively high exposures.

Recent data collected by the Centers for Disease Control and Prevention, when converted to actual exposure levels, show the average DEHP exposure in humans to be more than 30 times lower than safety levels set by the Environmental Protection Agency. Federal regulators have expressed concern that critically ill newborn males who undergo intensive, life-saving medical procedures may be exposed to levels of DEHP that exceed the conservative federal safety levels based on rodent studies. But a recent follow-up study of a few such children found normal reproductive development, which is what would be expected based on results from earlier studies in monkeys (which are closer to humans than rodents).

For further information please contact:

Marian K Stanley
Senior Director, CHEMSTAR
Manager, Phthalate Esters Panel

Telephone +1 703-741-5623
Fax +1 703-741-6091