The Consumer Product Safety Commission (CPSC) has proposed a new federal safety standard for phthalates in children’s toys and child care articles.
The current rule prohibits concentrations of more than 0.1 percent of three types of phthalates. The proposed rule, for which the CSPC approved a draft Dec. 17, would add five more variations to federal law.
“It shall be unlawful for any person to manufacture for sale, offer for sale, distribute in commerce, or import into the United States any children’s toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP),” section 108(a) of the Consumer Product Safety Improvement Act of 2008 states.
The proposed rule aims to expand that to include diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) as well, based on recommendations from the Chronic Hazard Advisory Panel (CHAP) on Phthalates and Phthalate Alternatives.
The CHAP, which began meeting in April 2010, studied the effects of children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles in a report of its findings July 18.
The CHAP found exposing pregnant rats to certain phthalates affected male reproductive development, which is known as “phthalate syndrome in rats,” according to the report. However, humans are often exposed to multiple kinds of phthalates, and studies have shown low doses of multiple phthalates can have a additive effect that also results in phthalate syndrome. That syndrome is believed to resemble “testicular dysgenesis syndrome” in humans, and various studies have shown associations between phthalates exposure and reproductive development in male infants. Other studies found associations between phthalates exposure and neurobehavioral effects in children.
The CHAP assessed the risks of 14 phthalates and six phthalate alternatives. Of the three currently banned phthalates, the CHAP made no further recommendations. For DINP, which currently has an interim ban, the CHAP believed it was not harmful by itself, but recommended the ban become permanent due to the additive effects of multiple phthalates. For two other phthalates with interim bans—di-n-octyl phthalate (DNOP) and diisodecyl phthalate (DIDP)—the CHAP did not find data to justify maintaining the bans. As for DIBP, DPENP, DHEXP and DCHP, which it found to be very similar to DBP and DEHP—two forms of phthalates that are banned permanently—the CHAP has recommended banning them at levels greater than 0.1 percent in children’s toys and child care articles.
The CHAP also recommended an interim ban on diisooctyl phthalate (DIOP) until sufficient data on the potential risks was available, but the CPSC did not include that in its proposed rule.
Other phthalates and alternatives were found to be not harmful, not requiring action at this time or not having enough research available on them at this time. The CHAP suggested continued risk management for many of the elements studied, especially those found in food and other products.
Submit comments for this proposed rule, CPSC-2014-0033, by March 16 via www.regulations.gov or Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814.
For more information, visit www.regulations.gov.
