By Colleen Kave, J.D.
The Consumer Product Safety Commission (CPSC) issued a final rule banning children’s toys and child care articles containing more than 0.1 percent of diisononyl phthalate (DINP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), dicyclohexyl phthalate (DCHP), and diisobutyl phthalate (DIBP). The rule will become effective on April 25, 2018. Additionally, CPSC issued a notice of proposed rulemaking (NPR) that would update the existing notice of requirements (NOR) for prohibitions of children’s toys and child care articles containing specified phthalates that provide the criteria and process for CPSC acceptance of accreditation pursuant to the Consumer Product Safety Act (CPSA). The proposed NOR would revise the current NOR to be consistent with the final phthalates rule. Comments on the NPR are due by January 10, 2018 (CPSC Final Rule, 82 FR 49938, October 27, 2017; CPSC Proposed Rule, 82 FR 49767, October 27, 2017).
Phthalates, chemicals that are used to make vinyl and other plastics soft and pliable, can have harmful health effects on children when ingested. Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) established permanent and interim prohibitions on the sale of certain consumer products containing specific phthalates. That provision also directed the CPSC to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives used in children’s toys and child care articles and to provide recommendations to CPSC regarding whether any phthalates or phthalate alternatives, other than those already permanently proscribed, should be prohibited. The CPSIA requires the agency to promulgate a final rule after receiving the final CHAP report, and this rule fulfills that requirement.
Final rule. The final rule bans children’s toys and child care articles containing more than 0.1 percent of five specific phthalate chemicals. The CPSC majority determined, based on the CHAP’s report, that DINP, DPENP, DHEXP, DCHP, and DIBP cause harmful effects on male reproductive development. Therefore, the final rule brings to eight the total number of phthalates that are restricted from use in children’s toys and child care articles at concentrations of more than 0.1 percent. The rule also makes the interim prohibition regarding DINP permanent and expands it to cover "all children’s toys and child care articles" containing concentrations of more than 0.1 percent of DINP. Finally, the final rule removes the interim prohibition regarding DNOP and DIDP, as the agency has determined that these phthalates do not cause adverse effects on male reproductive development, and other risks attendant to their use are low.
Commissioner statements. Three CPSC commissioners issued statements reacting to the final rule, illuminating the panel’s divergent opinions on the measure. Commissioner Elliot F. Kaye praised the final rule as a victory in the fight for reasonable chemical management. According to Commissioner Kaye, the rule serves the public health well and is entirely consistent with the directive given to CPSC by Congress to study phthalates. Commissioner Robert Adler applauded the CPSIA’s comprehensive approach to addressing phthalate hazards and expressed relief that, by ordering the CHAP, Congress avoided a "piecemeal one-by-one ‘whack-a-mole’ plan that merely sets the stage for what has come to be known as regrettable substitution of one hazardous chemical for another." Commissioner Adler further intimated that he hopes comprehensive study of potentially hazardous substances continues, stating, "…it is my profound hope that once the budget-cutting, regulation-bashing madness that I see in Washington these days passes, we will be able to give our most vulnerable citizens the protection from chronic hazards that they deserve." In contrast, Commissioner Joseph P. Mohorovic described the final rule as "contrary to the most recent and best available scientific data" and criticized the rule as lacking any rational connection to the CHAP’s factual findings.
Proposed rule. Products covered by the phthalates rule are subject to the testing and certification requirements of section 14 of the CPSA. Because children’s toys and child care articles constitute children’s products, samples of these products must be tested by a third party conformity assessment body whose accreditation has been accepted by CPSC. In accordance with section 14(a)(3)(B)(vi) of the CPSIA, the agency has previously published two NORs for accreditation of third party conformity assessment bodies for testing children’s toys and child care articles under section 108 of the CPSIA (76 FR 49286, August 10, 2011, and 78 FR 15836, March 12, 2013). If CPSC finalizes the NOR as proposed, there would be an interim process during the transition period from the current test method to a revised version of the method. Laboratories that wish to conduct testing to support product certifications to the new phthalates prohibitions would have to apply to transition their accreditation scope to the revised test method. CPSC would open the laboratory application process for the revised test method on the date the final NOR rule is published in the Federal Register.
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