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CPSC to Finalise Rule that Could Ban Five Phthalates by 18 October

The Consumer Product Safety Commission has announced its intention to finalise by 18 October a rule that could ban five phthalates in toys and child care articles. Section 108 of the Consumer Product Safety Improvement Act of 2008 prohibits children’s toys and child care articles that contain six specified phthalates (DEHP, DBP, BBP, DINP, DIDP and DnOP) in concentrations above 0.1 percent in accessible plasticised component parts and other component parts made of materials that may contain phthalates. The CPSC has since proposed to make the interim prohibition on DINP permanent, lift the interim prohibitions on DIDP and DnOP, and add four other phthalates to the prohibited list (DIBP, DPENP, DHEXP and DCHP), but those actions have not yet been finalised. However, the Commission has agreed to vote on a final rule by 18 October as part of a consent agreement settling a lawsuit filed in December 2016 by the National Resources Defense Council, Environmental Justice Health Alliance for Chemical Policy Reform and the Breast Cancer Fund.

As required by the CPSIA, a Chronic Hazard Advisory Panel (CHAP) was convened to study the effect on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles and to provide recommendations regarding whether any such substances other than those already permanently prohibited should be banned. The CHAP assessed the risks of 14 phthalates and six phthalate alternatives and made a number of recommendations, all but one of which have been accepted by CPSC staff.

While the CPSC commissioners have not yet made a final decision on whether to proceed with a ban on the five phthalates in question, a draft final rule issued by agency staff on 13 September would adopt the prohibition effective 180 days from the date of issuance of such rule in the Federal Register. The draft final rule is substantially the same as the December 2014 proposed rule and includes the following provisions.

  • The interim ban on the use of DNOP and DIDP in toys that can be placed in a child’s mouth or child care articles would be lifted because these substances do not appear to possess anti-androgenic potential. While the CHAP is aware that both are potential development and system toxicants, it did not find compelling data to justify the interim ban because margins of exposure in humans are likely to be very high for these compounds individually.
  • The interim ban on the use of DINP in toys that can be placed in a child’s mouth or child care articles would be made permanent and extended to all children’s toys. The CHAP found that this substance induces anti-androgenic effects in animals, although with lesser potency than other active phthalates, and can therefore contribute to the cumulative risk from other anti-androgenic phthalates. CPSC staff indicates that expanding the scope of this prohibition is expected to have a minimal effect on manufacturers because few products would need to be reformulated to comply with the broader scope.
  • No further action on DBP, BBP or DEHP would be taken at this time, which means that the permanent bans on these three phthalates would remain in place.
  • Diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP) and dicyclohexyl phthalate (DCHP) would be permanently banned from use in children’s toys and child care articles at levels greater than 0.1 percent because their toxicological profiles are very similar to those of DBP and DEHP. The CPSC has detected DIBP in a small portion of toys and child care articles during routine compliance testing but has not detected DPENP, DHEXP or DCHP.
  • Diisooctyl phthalate (DIOP) would not be subject to an interim ban because the CPSIA did not provide for an interim prohibition as an option under section 108.
  • No action would be taken on two phthalates that are not currently banned: dimethyl phthalate (DMP) and diethyl phthalate (DEP).
  • Although the CPSC has detected di(2-propylheptyl) phthalate (DPHP) in some children’s toys, given the general lack of publicly available information on this substance no action would be taken on it.

The draft final rule would also add a paragraph, which was not in the proposed rule, that repeats the statutory provision stating that the phthalates prohibitions apply to plasticised component parts of children’s toys and child care articles, or other component parts of those products that are made of materials that may contain phthalates. This addition does not make any substantive change but provides clarity by placing this statutory language in the regulation.

CPSC staff has issued a parallel draft notice of proposed rulemaking that would revise the existing notice of requirements for phthalates to make that notice consistent with the staff’s recommendation for a final phthalates rule. Should this proposal be approved, interested parties would have 75 days from the date of publication of the notice in the Federal Register to submit any comments.

Not surprisingly, the American Chemistry Council described the proposal to ban DINP as “arbitrary and capricious.” The industry association contends that this ban is not based on the current science but instead relies on a scientifically unjustified report that was finalised without public input. ACC further argues that the most recent exposure data demonstrates that the cumulative exposure to the phthalates targeted by the draft final rule is actually well below any level of concern, even for sensitive populations. ACC reiterates that phthalates have been used for more than 50 years to enhance the durability, flexibility and performance of a range of products and are some of the most tested substances in commerce.

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