Cal-EPA to pass rule on chemical used in plastics
Agent found in hospitals, toys, may cause birth defects

Jane Kay, Chronicle Environment Writer

Tuesday, October 21, 2003

The California EPA will become this week the first regulatory agency in the country to rule that a chemical compound used to soften the plastic in hospital IV bags, medical tubing and many other products can cause birth defects, The Chronicle has learned.

The chemical DEHP, one of a family of compounds known as phthalates, will be placed Friday on the state's list of more than 750 chemicals known to cause cancer or reproductive harm. Companies that use DEHP in their products will have one year to warn consumers of potential exposure or reformulate their products.

DEHP - di (2-ethylhexyl) phthalate - is used to add flexibility and durability to blood storage bags, hospital tubing and gloves. It is also used in vinyl flooring and coated fabrics and paper.

The listing by Cal-EPA's Office of Environmental Health Hazard Assessment is based on studies by the federal Food and Drug Administration and the National Institute of Occupational Safety and Health. Both agencies found that DEHP caused birth defects in laboratory rodents, and could potentially cause the defects in humans.

The FDA concluded that exposure during gestation of a male fetus could harm the fetus' testicles and that it could also damage male infants if they were exposed in their early months.

In the case of medical devices that use DEHP, health researchers worry that the chemical will leach out of plastic IV bags and tubing into the solution that goes into a patient.

The state's listing under Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, applies not only to medical devices but also to other products that contain DEHP, said Allan Hirsch, a spokesman for Cal-EPA.

Officials of the American Chemistry Council, which represents major phthalate manufacturers, could not be reached for comment Monday. According to its Web site, phthalates have been extensively tested for health effects and have been shown to break down quickly once inside the human body.

The council said that "there have been 6 to 9 billion patient days of exposure to DEHP-plasticized medical devices with no scientifically validated reports of serious adverse health effects in children or humans.''

Last year, the FDA put out a public health notice on DEHP, offering precautions on how to limit exposure to male fetuses, newborns and young boys. Transfusions, multiple procedures on sick male babies, nutritional feedings to babies and adults were some of the activities posing the highest risks, it said.

There are substitutes for vinyl devices on the market. For example, the neonatal intensive care unit at Stanford University's Lucile Packard Children's Hospital in Palo Alto is phasing out DEHP in medical devices.

In 1986, toy manufacturers voluntarily agreed not to exceed certain levels of DEHP in vinyl teething rings, pacifiers and squishy infant toys. Some replaced it with other phthalates, which have been tested even less.

On Monday, representatives for environmental groups hailed California's decision. "The step that California is taking is critical because it would require the products to be labeled,'' said Stacy Malkan, a spokeswoman for Health Care Without Harm, an advocacy group that has tested products for phthalates.

"Health care providers need to know which products contain DEHP in medical devices so they can limit exposure,'' Malkan said.

In the past six years, environmental groups have found DEHP at elevated levels in kids' vinyl backpacks, baby bibs, baseball mitts, hats, purses, stroller covers and flexible straws.

Andy Igrejas, environmental health program director at National Environmental Trust, an advocacy group, has been examining a 2000 toxics-use reporting database kept by New Jersey and Massachusetts. DEHP was used in vinyl flooring, rubber, laminated paper, coated fabrics, printing ink and other plastic products, Igrejas said.

The European Union banned DEHP in cosmetics last year and is now considering limiting its use in medical devices and other products. In August, the EU renewed its emergency ban on six phthalates, including DEHP, in chew toys for children under three.

E-mail the writer at jkay@sfchronicle.com