ACC’s High Phthalates Panel: “CPSC Continues to Ignore the Science on the High Phthalate DINP”

WASHINGTON (November 28, 2022) — Today, the American Chemistry Council’s (ACC) High Phthalates Panel (HPP) issued the following statement on the Consumer Product Safety Commission’s (CPSC) vote to issue a final resolution concerning the CPSC’s Restriction of DINP in Toys and Child Care Articles:

“We are deeply disappointed the CPSC continues to ignore the science on the High Phthalate DINP and shirk its responsibilities for appropriately reviewing this rule. CPSC has previously been admonished by a federal court for failing to adhere to proper process. Now, CPSC’s decision to issue a final determination ignores the state of the science as well as the serious socioeconomic consequences of this rule, all while producing no meaningful impact to public health.

“DINP is one of the most thoroughly studied compounds in the world. It has been reviewed by numerous international scientific panels for decades, and the conclusions are essentially the same each time: DINP, under normal use in commercial and consumer products, does not pose a risk to human health. There is no scientific justification to continue to maintain a restriction on DINP in toys and childcare articles.

“We believe CPSC’s process for chemical evaluation is fundamentally flawed. The public deserves better and we will be reaching out to federal policymakers to try to fix this mistake and to reform the program.

“We need to be clear, the Congressional mandate to the CPSC was whether to extend or remove the interim prohibition on the use of DINP in toys and childcare articles intended to be mouthed. The CPSC’s risk assessment does not provide the justification to make the interim prohibition permanent, let alone expand it to all toys and childcare articles, beyond Congressional intent and the Chronic Hazard Advisory Panel’s recommendation. Australia does not restrict DINP in toys and childcare articles because it found no associated risks to children. Even though Canada maintains a precautionary restriction on DINP use in mouthable toys and childcare articles, its 2020 risk assessment confirmed that there was no risk associated with the use of DINP in all toys and children’s articles.¹ Similar to Canada, the European Union restriction on toys and childcare articles is restricted to articles intended to be mouthed, consistent with Congressional intent. The EU found no reproductive/developmental risk to the use of DINP in toys. Rather, its restriction is based on rodent liver lesions that do not occur in humans. Overall, the CPSC’s restriction on DINP remains the most punitive, despite having no rationale.”

Background:

There is no scientific basis to support the restriction on DINP

Prior to CPSC finalizing the phthalates rule in October 2017, the National Academy of Sciences (NAS) published an extensive systematic review of phthalates and male reproductive effects,² using the National Toxicology Program’s standard procedure for conducting evidence evaluations for systematic review and evidence integration (human and animal data).³ This is considered a “gold-standard” approach for evaluating health effects. The NAS report concluded that:

• DINP does not cause any malformations of the male reproductive organs in animals or humans, even the most sensitive indicator, anogenital distance (AGD). This is in clear agreement with the conclusions of the European Chemicals Agency integrated reproductive hazard assessment of DINP that was published in 2018.⁴
• There is inadequate evidence that DINP exposure leads to reduction in fetal testosterone in humans as CPSC alleges. This is crucial, as the whole purpose of the restriction is intended to protect humans.

Although CPSC notes that it reviewed the NAS 2017 report in the final phthalates rule, CPSC minimizes the importance of the NAS document. Unlike CPSC, NAS developed effect-specific safe limits, most importantly for the most sensitive/critical endpoint, reduction in fetal testosterone in rodents (this is the only effect common to all 5 phthalates reviewed). This safe limit was developed using best available science and thus CPSC should have used this approach to test the validity of its conclusions.

We re-evaluated the CPSC’s risk assessment, using the NHANES 2013/2014 data and the NAS safe limits. Here is what we found:

• Using the traditional 95^th percentile approach, no risk was found for DINP alone or in the cumulative assessment.
• Zero women (out of 538) showed any evidence of risk with DINP alone.
• Only 1 out of 538 WORA showed potential for risk in the cumulative assessment; risk in this outlier individual was driven 94% by DEHP, which is already permanently restricted in toys and childcare articles by law.

Since CPSC has a history of using the most up-to-date biomonitoring data for its re-analysis, we repeated the same analysis in the most recent 2017/2018 National Health and Nutrition Examination Survey (NHANES) data in Women of Reproductive Age. Here is what we found:

• Using the traditional 95^th percentile approach, no risk was found for DINP alone or in the cumulative assessment.
• Zero women (out of 447) showed any evidence of risk with DINP alone or in the cumulative assessment.
• Zero pregnant women (out of 14) showed any evidence of risk with DINP alone or in the cumulative assessment.
• Zero male infants, 36-months of age (out of 50) showed any evidence of risk with DINP alone or in the cumulative assessment.

The CPSC has argued that the decline in phthalate exposures (specifically DINP) may be due to the impact of statutory prohibitions on phthalates in children’s products in the United States, as well as similar regulations in Europe and Canada.

With respect to the basis of the CPSC phthalate rule, this is inaccurate.

1. The CPSC’s phthalate rule is based entirely on exposures in women of reproductive age (15 – 45 years). According to the CPSC, toys and childcare articles account for <0.1% and 0%, respectively, of total DINP exposure to this cohort.
2. As CPSC rightly notes, manufacturers took voluntary action to remove phthalates from children’s products in 1999 and Europe adopted a restriction on use of DINP in children’s products “intended to be mouthed” in 2005 (California adopted a similar measure in 2007). Yet as CPSC is aware, DINP exposures in the US population peaked in 2011/2012 (12 years after the voluntary action by manufacturers), a clear indication that toys and childcare articles are not the drivers of DINP exposure in the US population.

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^{1. Canada continues to maintain a precautionary restriction on DINP in toys and childcare articles, but only in articles intended to be mouthed.}

^{2. Application of Systematic Review Methods in an Overall Strategy for Evaluating Low-Dose Toxicity from Endocrine Active Chemicals |The National Academies Press}

^{3. Handbook for Conducting Systematic Reviews for Health Effects Evaluations (nih.gov)}

^{4. Committee for Risk Assessment RAC Opinion proposing harmonised classification and labelling at EU level of 1, 2-Benzenedicarboxylic acid, di-C8-10-branched alkylesters, C9- rich; [1] di-“isononyl” phthalate; [2] [DINP] 56980740-fcb6-6755-d7bb-bfe797c36ee7 (europa.eu). Adopted 9 March 2018.}