Staff recommends denial of greenpeace petition to ban phthalates.

CPSC will take up the issue of possible hazards to children from the use of phthalates in plastic toys at a Commission briefing scheduled for Oct. 24. This will likely be the first Commission briefing to be held with Hal Stratton as the new chairman. At that time, Commissioner Mary Gall will also have returned to the agency following her recuperation from surgery.

In 1998, CPSC was petitioned by Greenpeace, the U.S. Public Interest Research Group (PIRG), and ten other groups to ban phthalates in toys. (1)

Commissioners and their staffs will be working hard to absorb information contained in a 440-page staff briefing package. Commissioners Gall and Moore have both been on the job long enough to have some grasp of the issue, but Chairman Stratton will be confronting the issue for the first time.

After years of study, and two Chronic Hazard Advisory Panels (CHAPs), the staff is recommending that the Commission deny the Greenpeace-PIRG petition. Extensive research shows, they say, that children, in using poly-vinyl chloride (PVC) toys, are not exposed to any dangerous amounts of phthalates.

CPSC Monitor has frequently reported on the issue of phthalates in children's vinyl toys. The issue has been around for some time at CPSC, dating back to the 1980's when CPSC dealt with possible hazards to children from using teethers and rattles containing DEHP (2), one form of the chemical. Phthalates have been used for more than 50 years to soften plastic products, making them more pliable and moldable. When considering the issue, the agency convened a chronic hazards advisory panel of scientific experts as called for in its statute. Their report found no evidence that DEHP as used in plastics was toxic to children. Frightened by the negative publicity, however, major toy manufacturers in the U.S. voluntarily discontinued using DEHP, and switched to DINP, (3) another form of the chemical.

CPSC's consideration of phthalates is still focused on children's toys, this time as a result of a campaign by the extremist environmental group, Greenpeace, which really wants to eliminate the use of PVC worldwide. The group claims phthalates can cause harm to reproductive organs, kidneys and livers, despite overwhelming evidence that human exposure to the chemical has caused no discernible harm.

The toxicity of DEHP, as one example, is so low that test animals must ingest huge amounts to reach the maximum tolerated dose (MTD), which would equal 500 g/day for an adult. DEHP, if given in very large amounts to rats produced liver tumors. However, the specific biology of rats, (peroxisome proliferation) was the contributing factor. Similar amounts fed to primates (marmosets and monkeys) did not produce tumors.

CPSC's staff studied the issue at length and ultimately released a report in December 1998. It concluded, "few, if any children are at risk of liver or other organ toxicity from PVC toys that contain DINP."

In order to address "uncertainties" about the issue, however, CPSC staff did not let go of the matter. It initiated an observational "mouthing" study to get an estimate of the amount of time children typically spend mouthing products containing phthalates. The study was designed to provide "exposure data" on 200 children, aged three months through 35 months, to determine what these children put in their mouths and for how long. The survey also included a telephone survey of parents of 400 children between 36- and 72-months old.

The American Chemistry Council's Phthalate Esters Panel and its members have sponsored extensive research into the allegations made by Greenpeace and others about the alleged toxicity of phthalates. Phthalates, in fact, have been studied exhaustively from a health and safety perspective over a period of many years.

Another CHAP convened by CPSC issued its report in June 2001. The scientific panel concluded that children are not exposed to high enough levels of phthalates through PVC toys to pose any health risk. The panel suggested that a child would have to mouth a PVC toy for 75 minutes a day every day to approach that level of risk.

"That child does not exist," stated Marilyn Wind of CPSC's Health Sciences Directorate.

She pointed out that the agency's mouthing study revealed that children were typically mouthing PVC items much less than had originally been thought. Results of the mouthing study are included in the staff briefing package. (4)

After the Commissioners are briefed on the phthalates issue, they will vote Nov. 1st on the staff recommendation. Will this end the issue at CPSC? Don't bet on it.

(1) See CPSC Monitor, Vol. 3, Issue, 10, November, 1998, "Greenpeace, et al., Petition CPSC to Ban Soft Vinyl Toys."

(2) DEHP is di (2-ethylhexyl) phthalate.

(3) DINP is di-isononyl phthalate.

(4) Conversation with Dr. Marilyn Wind of CPSC, Sept. 25, 2002.