Nearly ten years after the first three phthalates were banned from children’s toys by Congress, the U.S. Consumer Product Safety Commission (CPSC) issued a final rule on October 27 prohibiting five more. The rule bans the manufacture for sale, offer for sale, distribution in commerce, or importation of children’s toys and products containing more than 0.1% of five phthalate chemicals. Phthalates are a group of chemicals used to soften plastics and make them pliable and easier to grip and are found in numerous household products, including children’s toys. The long-awaited final rule continues to face significant controversy regarding its scope and the data used to support it.

Years in the making

Due to concerns that phthalates can act as endocrine disruptors, Congress originally prohibited certain phthalates in the Consumer Product Safety Improvement Act of 2008 (CPSIA). The CPSIA permanently banned three phthalates (DEHP, DBP, and BBP) and imposed an interim ban on an additional three (DINP, DNOP, and DIDP). Section 108 of the CPSIA then required CPSC to convene a group of experts called the Chronic Hazard Advisory Panel (CHAP) to assess the risks of phthalates and phthalate alternatives.

Thereafter, CHAP convened and ultimately recommended banning five additional phthalates in a July 2014 final report. In addition to recommending that the interim ban on DINP be made permanent, CHAP recommended banning DIBP, DPENP, DHEXP, and DCHP. According to the CPSIA, CPSC was required to issue a final rule addressing whether to make the interim ban permanent and whether to add any more phthalates to the ban no later than 180 days after the CHAP report was issued. However, no rule was issued before the deadline and the final rule did not follow until this October—over two years and nine months later.

The rule also ends litigation against CPSC for its delay in issuing the final rule. The Natural Resources Defense Council and other groups had sued CPSC in December 2016 for failing to meet its January 14, 2015 deadline. On October 31, 2017, that suit was dismissed with prejudice in light of CPSC’s issuance of the final rule.

The final rule

Predictably, the U.S. will now permanently ban toys containing the eight phthalates identified by CPSC in the proposed rule from 2014— DEHP, DBP, BBP (the three originally prohibited in the CPSIA) and DINP, DIBP, DPENP, DHEXP, DCHP (the five recommended by CHAP for a ban). The rule takes effect on April 25, 2018.

Controversy about the rule

The final rule passed by a vote of three to two commissioners, reflecting the political divide on the Commission as well as the contentiousness surrounding a ban on phthalates. Sensing the likelihood of litigation, CPSC Commissioner Elliot F. Kaye issued a statement defending the rule and highlighting “how thorough the CHAP was and how its methods and conclusions were validated by a substantial peer review.” He implored “judges and law clerks who may look over this record” to study Congress’s directive to the CPSC in the CPSIA, the science, and how the CPSC reviewed public comments during the rulemaking.

Then-CPSC Commissioner Joseph P. Mohorovic, who voted against the rule, issued a statement that the Commission “missed [an] opportunity to pass a reasoned, evidence-based rule prohibiting the phthalates that pose actual risk to consumers.” He stated that the standard for a phthalate to survive the ban—“reasonable certainty of no harm”—was inconsistently applied by CPSC throughout the rulemaking process. Additionally, he noted that there is “scant evidence showing that the products covered by the Final Rule—toys and child care articles—contribute in any measureable way to overall phthalate exposure for the vulnerable population.” Instead, he pointed to dietary sources as contributing “the most to overall phthalate exposure.” Acting CPSC Chairman Anne Marie Buerkle also published a statement agreeing with some of the criticisms raised by Commissioner Mohorovic. Their criticisms echo those raised by phthalate manufacturers that the CHAP report, and now the final rule, relied on outdated data from 2005.

Challenges ahead

Litigation and industry challenges are certain to follow. The Toy Association issued a statement that it does not believe the rule is fully supported by scientific evidence. Other industries may be subject to scrutiny for phthalate use in the future, including cosmetics and dietary sources, as raised by Commissioner Mohorovic. Manufacturers outside of the toy and child product industries should monitor the controversy and seek counsel to determine whether their products may be at issue.