PRHE to EPA: Protect people from harmful phthalates

Main Takeaways

• Phthalates are plasticizers that are widely used and present in everyone’s bodies. They can increase the risk of health harms including preterm birth, metabolic disorders and infertility; the government urgently needs to enact regulations that will stop harmful exposures.

• EPA’s recent draft risk evaluations under the Toxic Substances Control Act (TSCA) severely underestimate exposure, health hazard, and risk of high-priority phthalates.

• EPA can and must use best available scientific methods to improve its assessments and ensure that they more accurately capture real-world phthalate exposures that support actions to protect the public, including pregnant women, children, workers, and highly impacted communities, from the health harms of phthalates.
  

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PRHE’s Associate Director of Science and Policy, Dr. Rashmi Joglekar, warned that the Agency has “failed to uphold the best available science across every phase of the risk evaluation process” for the four high-priority phthalate evaluations in her testimony before EPA’s Science Advisory Committee on Chemicals (SACC). This begins with EPA’s failure “to rely on gold-standard systematic review methods to identify and evaluate relevant health effects studies for all four phthalates in a manner consistent with the best available science.”  As a result, the phthalate evaluations did not use all available scientific evidence to identify health harms.

Joglekar shared several concerns:

• EPA relied on old science and used an outdated literature search that hasn’t been updated since 2019, 6 years ago.  

• More recent epidemiologic studies, published between 2019-2023, were only considered if they were submitted to the EPA docket.  

• Almost all the toxicology studies published since 2020 were excluded from consideration.  

“Of the studies EPA identified as relevant, the Agency inappropriately excluded at least 733 relevant health effects studies from consideration for DEHP, and 446 for DBP due to a flawed “further filtering” process. For many of these exclusions, EPA failed to provide any scientific justification,” Joglekar said. 

Even among the small number of studies EPA did review, it systematically dismissed the findings of nearly all of them. For DEHP, EPA downplayed studies on male and female reproductive harms and metabolic and neurotoxicity, despite these same studies being used by other regulatory bodies to establish health-protective risk values. Notably, some of these studies documented harm at exposure levels more than 100 times lower than EPA’s selected toxicity thresholds. By discounting this scientific evidence, EPA will significantly underestimate the true hazards.

Joglekar also highlighted major flaws in EPA’s exposure and risk calculations:

“EPA’s draft risk evaluations for DEHP and DBP also failed to assess the full range of reasonably foreseeable exposure scenarios, as required by TSCA… leading to a significant underestimation of risk, especially for workers, children, and other potentially exposed or susceptible subpopulations (PESS),” said Joglekar.  

“EPA also failed to rely on best available methods to quantify non-cancer risks for DEHP and DBP, leading to serious underestimations of risk,” Joglekar testified.  

EPA currently relies on a flawed non-cancer risk calculation method that assumes a “safe” level of exposure. Joglekar explained that PRHE applied methods developed by the World Health Organization (WHO) to  calculate the risk of male reproductive harm from chronic DEHP and DBP exposures, and found that EPA’s current approach equates to a 1-in-80 risk for DEHP and a 1-in-36 risk for DBP as acceptable – risk levels far higher than the 1-in-1,000,000 risk level EPA typically applies to protect from cancer risks.  

Finally, Joglekar cautioned that EPA “is ignoring risks to 50% of the human population” by continuing “a dangerous pattern of failing to consider high-end exposure scenarios for workers and consumers in its unreasonable risk determinations for DEHP and DBP”.

PRHE urged the SACC to recommend that EPA: 

• Implement a gold-standard systematic review methodology that comprehensively evaluates all relevant health effects studies from all evidence streams, and does not arbitrarily exclude studies based on perceived methodological limitations or subjective judgments about study quality;  

• Quantify the health impacts of phthalates exposures for all relevant health endpoints, including those beyond male reproductive toxicity like neurodevelopmental toxicity and female reproductive toxicity; 

• Utilize science-based uncertainty factors to adequately account for increased susceptibility, particularly among populations like Black women who experience disproportionate exposures to phthalates and non-chemical stressors; 

• Rely on WHO methods for quantifying the risk of non-cancer health harms, including male reproductive harm; and

• Quantify risk based on exposure scenarios that protect the whole population, not just 50% of the population.

Click here to watch Joglekar’s full testimony.