WASHINGTON — Phthalates used in plastics destined for children's toys and child care items will likely get a new, more stringent federal safety regulation even though scientists say the report used to make the decision is flawed.
The proposed rule from the U.S. Consumer Products Safety Commission also would expand existing law to include Di-n-pentyl phthalate (DnPP), diisobutyl phthalate (DIBP), di-n-hexyl phthalate (DnHP) and dicyclohexyl phthalate (DCHP) as chemicals permanently banned from use in children's toys and childcare items at concentrations greater than 0.1 percent.
The change, which could come as soon as mid-March, is based on the recommendations in a July 2014 report from the Chronic Hazard Advisory Panel (CHAP), which includes years of studies and research on phthalates. But the CHAP report is deeply flawed, said scientists in a Wednesday conference call coordinated by the American Chemistry Council.
The four experts who independently and individually reviewed the science behind the CHAP report said they came to the same conclusions, with concerns ranging from the inclusion of highly uncertain phthalate exposure estimates, potential problems with the small sampling of chemicals evaluated, a lack of information on tissue exposure to contaminants and the inaccurate extrapolation of phthalate sensitivity in laboratory rats to humans.
The problem isn't the rat studies themselves or how they were conducted, but how the data on phthalates' effects on rats is extrapolated to other species and eventually to humans that is errant, said Warren Foster, a reproductive and developmental toxicity researcher in the Obstetrics and Gynocology Department at McMaster University in Hamilton, Ontario. In mouse and non-human primate studies, subjects have shown significantly lower sensitivity to phthalate exposure at any level and “we don't see the same effects — and that is good news,” Foster said. “I don't think that there's anything wrong with the science that's being considered [in the CHAP study]. It's how we interpret the science and the data we're getting. The species' differences in metabolism are very important here.”
“It's a matter of a good interpretation of the data,” said Christopher Borgert, president and principal scientist at Applied Pharmacology and Toxicology Inc. in Gainseville, Fla., “Regulations weren't our charge. We're scientists and we focused on the science. But speaking for myself, personally, I'm not weighing in on regulation or policy, but I find very weak scientific basis for doing anything based on this report.”
Three other phthalates, di (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP), have been banned from use in children's items in concentrations greater than 0.1 percent since February 2009; DINP, DIDP and DPHP are no longer used in personal care products and DnPP has already been phased out most U.S. and European PVC production.
CPSC is accepting public comment on the proposed rule until March 16.