October 18, 2017

Today the U.S. Consumer Product Safety Commission voted to issue a Final Rule prohibiting children’s toys and child care articles containing certain phthalates. I was unable to join in this decision because the Final Rule is contrary to the most recent and best available scientific data.

The Final Rule Does Not Follow the Data

One of my colleagues commented that the Commission’s regulation of phthalates should “follow the data.” I agree. However, it is clear from today’s decision that the Commission willfully ignored the data to justify its predetermined decision to approve the Final Rule. I regret that today’s vote was a missed opportunity to pass a reasoned, evidence-based rule prohibiting the phthalates that pose actual risk to consumers.

The Consumer Product Safety Improvement Act (“CPSIA”) banned certain phthalates known to be potentially harmful to consumers (namely, DEHP, DBP, and BBP). The Commission was charged with deciding whether to permanently ban additional phthalates based upon studies conducted by the Chronic Hazard Advisory Panel (“CHAP”). The CHAP was required to “review all relevant data, including the most recent, best-available, peer-reviewed, scientific studies” of the specified phthalates.[1] The Commission’s final determination was to be based upon the standard of “a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety.”[2]

However, the “reasonable certainty of no harm” test has been inconsistently applied by the Commission throughout this rulemaking process—from the proposed rule, to the evaluation of phthalates in isolation and in combination with other phthalates, and in the Final Rule. The Notice of Proposed Rulemaking (“NPR”) was based upon the cumulative risk assessment conducted by the CHAP, which found that up to 10% of pregnant women in the U.S. population and up to 5% of infants had a Hazard Index (“HI”) greater than one and, therefore, may be at risk for the adverse effects of phthalate exposure. Based upon the CHAP’s findings, the Commission proposed rulemaking prohibiting certain phthalates because this portion of the population at risk of adverse effects did not meet the standard of a reasonable certainty of no harm with an adequate margin of safety.[3]    

The CHAP’s findings, however, were based upon data from 2005, which predated the CPSIA’s permanent and temporary bans on certain phthalates. Since that time, exposure to DEHP, the most potent phthalate, has markedly decreased while exposure to the much less potent DINP has increased. Because of this, the most recent biomonitoring data shows that the cumulative risk of adverse effects from phthalate exposure has decreased to such a statistically insignificant amount that it cannot even be calculated with certainty.[4] Specifically, an HI greater than one only was detected in the 99th percentile of the most recent data set, which staff characterized as “statistically unstable,” and warned that “one should use caution when drawing conclusions” about these estimates. The Commission even acknowledges in the Final Rule that the agency is unable to make any reliable estimate of the precise number of women of a reproductive age with HIs greater than one in the general population. [5]  

Simply put, this Commission cannot say with confidence that any of the general population is exposed to an unacceptable level of risk. This is shaky footing for rulemaking.

Additionally, there is also scant evidence showing that the products covered by the Final Rule—toys and child care articles—contribute in any measurable way to overall phthalate exposure for the vulnerable population. It is undisputed that dietary sources contribute the most to overall phthalate exposure. The agency has been unable to rebut the point made by many commenters that toys and child care articles contribute very little to exposure. Although the Final Rule hypothesizes that 29% of infant exposure to DINP could come from toys and child care articles, it also notes that it is impossible to quantify the number of these products that would contain DINP if the ban was lifted or the effect on overall risk.[6] Moreover, the basis for banning DINP in the Final Rule is, in part, the risk to women of a reproductive age, and there simply is no evidence that children’s toys and child care articles present a significant exposure risk to this population.   

In sum, the evidence shows that DINP is known to be less potent, exposure to the vulnerable population is uncertain, and the cumulative risk assessment has dwindled to levels that cannot be stated with any degree of confidence or scientific certainty. For these reasons, I find that the Final Rule does not meet the “reasonable certainty”—or even the straight face—test.

The Commission Failed to Provide Proper Notice and Comment

I furthermore oppose the Final Rule because it is in no way a logical outgrowth of the proposed rule. It differs so significantly from the proposed rule in the fundamental basis, scientific rationale, and technical justification that I could not have seen this coming, nor could anyone else really, in looking at the NPR and the Final Rule.

After all, in the NPR, the Commission gave every impression that the agency would determine “reasonable certainty of no harm” and “necessary to protect the health of children” based upon the finding that 10% and 5% of the vulnerable populations (pregnant women and infants, respectively) demonstrated unacceptable risk. There was no notice, comment, or reason to expect that staff would make recommendations based upon regulating at the 99th percentile.

Now that the bottom has fallen out of the findings on which the NPR was based, the agency has merely moved the goal posts. The end result is a Final Rule that lacks any rational connection to the underlying factual findings. This is very definition of arbitrary and capricious rulemaking and, accordingly, I could not vote in favor of the Final Rule.

 

[1] 15 U.S.C. 2057c(b)(2)(B)(v).

[2] Id. (b)(3)(A).

[3] 79 FR 78322.

[4] See CPSC Report, “Estimated Phthalate Exposure and Risk to Women of Reproductive Age as Assessed Using 2013/2014 NHANES Biomonitoring Data” (Feb. 2017).

[5] Final Rule at 89.

[6] Id. at 73.