The U.S. Consumer Product Safety Commission issued a final rule in October prohibiting companies from manufacturing for sale, offering for sale, distributing in commerce or importing toys and child care products that contain more than 0.1 percent of five phthalate chemicals. The final vote was three to two and split down party lines, reflecting the ongoing controversy about the “science” behind the rule and its scope.
The rule — like so many others — pitted industry against consumer advocate groups, with consumer advocates coming out narrowly ahead in this round. While the rule may resolve current questions about using phthalates in toys, it raises the future question as to whether the federal government may attempt to regulate phthalate use in other industries.
How Did We Get Here?
The CPSC’s new phthalates regulation is nearly a decade in the making and follows hard-fought litigation between the CPSC and advocacy groups including the Natural Resources Defense Council, the Environmental Justice Health Alliance for Chemical Policy Reform and the Breast Cancer Fund.
Though phthalates are useful for softening plastic and making plastics more pliable for use in toys and other products, they have been shown to affect hormone levels and reproductive system development.
Phthalates come in many forms and have been regulated in stages. Congress originally prohibited toys and child care items containing three phthalates in the Consumer Product Safety Improvement Act of 2008 (CPSIA). The CPSIA also imposed an interim ban on three additional phthalates until an expert panel known as the Chronic Hazard Advisory Panel (CHAP) completed its investigation into the health impact of those phthalates.
The permanent ban applied to any toys containing DEHP, DBP or BBP, while the interim ban was limited to toys that contained DINP, DNOP or DIDP and could be placed in a child’s mouth. In July 2014, the CHAP published a report recommending that the CPSC ban five additional phthalates, making permanent the interim ban on DINP and including four more phthalates that hadn’t been subject to the interim ban (DIBP, DPENP, DHEXP and DCHP).
The permanent rule took a long time to finalize. The CPSC proposed the rule banning the five additional phthalates in December 2014, but then the rule stalled. The CPSC did not vote on the final rule until three years later, after it had been sued to pass a final rule.
In a statement emailed to CNN in October, the Toy Association, the trade association representing the toy industry, confirmed that “safety is the toy industry’s top priority” and noted that the rule’s passage will only minimally impact manufacturers in the toy industry because “[t]he industry largely moved away from using phthalates in the late 1990s.” But at the same time, in a statement about the rule that was reaffirmed in October, the Toy Association said that it does not believe the rule is fully supported by scientific evidence. The rule will take effect on April 25, 2018.
What is the Controversy About the Rule?
In addition to stirring up the classic controversy over whether and how the government should regulate widely used chemicals, the rule is hotly debated for several other reasons.
Opponents are quick to point out that the data supporting it is old — from studies conducted in 2005 and 2006 that use now-outdated methodologies. Former CPSC commissioner Joseph P. Mohorovic, who stepped down after the rule passed, characterized the vote as “a missed opportunity to pass a reasoned, evidence-based rule prohibiting the phthalates that pose actual risk to consumers,” specifically disagreeing with the decision to make the DINP ban permanent.
Mohrovic suggested that, since the ban on the potent phthalate DEHP took effect in 2008, overall phthalate exposure has decreased to the point that it is now “statistically insignificant” and argued that it is therefore impossible to say with reasonable certainty that the less-potent DINP causes harm to children, pregnant women or susceptible individuals — which is the standard the CPSC must meet in order to regulate. He also argued that the “Commission cannot say with confidence that any of the general population is exposed to an unacceptable risk.”
Other critics of the rule also contend that the outdated studies do not clearly support the rule’s permanent ban on DINP, which is considered a less potent phthalate than the other banned substances. Acting CPSC chairman Anne Marie Buerkle published a statement in which she, like Mohorovic, argued that the data do not support the commission’s decision to make the DINP ban permanent.
She argued that the increase of DINP, which has been used in place of DEHP, is a net positive for health outcomes. And both former commissioner Mohorovic and acting chairman Buerkle took issue with the final rule because it expanded the category of products covered by the prohibition to include all toys, even though Congress’ interim ban on DINP covered only toys that could be placed in a child’s mouth.
Finally, those opposed to the rule challenge the process by which it was passed. Both Mohorovic and Buerkle argued that the difference between the proposed rule and the final rule is so significant that industry effectively had no notice or opportunity to comment on the rule before it was finalized.
Mohorovic stated that he opposed the final rule “because it [wa]s in no way a logical outgrowth of the proposed rule” and nobody could have seen the ultimate regulation coming. Buerkle also noted that the proposed rulemaking did not give industry players adequate notice of methodologies the commission would use to determine the final rule.
Neither commissioner explicitly invited litigation, but their statements highlight one argument industry leaders could make to challenge the rule: without notice and comment, the final rule would violate the Administrative Procedure Act, which requires a notice and comment period before rules binding the public — like this one does — can be finalized.
What Might Come Next?
Even the rule’s supporters have recognized that it will likely be challenged. In his statement defending the final rule, CPSC commissioner Elliot F. Kaye stated that future litigation and judicial review are “very likely,” and urged “the judges and law clerks who may look over the record and make a final determination” to “observe how carefully the Commission and its staff reviewed the scientific report, as well as the public comments at each stage of the rulemaking” if the final rule becomes the subject of future litigation.
Kaye argued that the CHAP followed congressional directives in its thorough review, and stated that the rulemaking process “included the latest and most credible and relevant scientific information available.”
For consumer advocate groups, the CPSC’s rule may be the first step towards a regulatory scheme banning the use of phthalates in a wide variety of other products and industries, from cosmetics to food packaging. There is considerable debate among industries concerning what products are the source of phthalate exposure. Some experts argue that regulating cosmetics is the logical next step towards limiting phthalate exposure.
Meanwhile, former commissioner Mohorovic’s statement indicated that dietary sources are the biggest contributor to phthalate exposure. While Mohorovic didn’t call for regulation to curb phthalate use in dietary sources, his statement and that of acting chair Buerkle indicate that regulators may have their sight set on other industries that are open to potential regulation as advocates push to reduce phthalate exposure in the general population even further.