July 12, 2021

Taking a Five-Year-Old to Court: EPA’s First 10 Risk Evaluations Meet the Bench

Posted on July 12, 2021 by Alexandra Dapolito Dunn

The 2016 Lautenberg Amendments turning five on June 22, 2021 provides a perfect opportunity to reflect on how this ambitious and bold statute is growing up –­ and faring in the courts. Tracking the body of law building up around the Amendments is, for now, a manageable exercise. The list includes, for example, a case requiring EPA to repropose rules involving the “active/inactive” chemical inventory and confidential business information claims, ongoing asbestos data collection cases, and a major decision in 2019 over the “Risk Evaluation Framework Rule” which, after deferring most issues as unripe, held that in the existing chemical risk evaluations EPA must assess legacy chemical uses and associated disposals.

Under the Amendments, between June 2020 and January 2021, EPA finalized the first 10 existing chemical risk assessments. Across the 10 evaluations the EPA team was incredibly busy – providing 22 opportunities for public comment, receiving and responding to 45,956 public comments, and holding nine weeks of public peer review by EPA’s Science Advisory Committee on Chemicals. In the final 10 risk evaluations, EPA found over 256 chemical conditions of use posed “unreasonable risk” – those findings are now the subject of EPA risk management rulemakings. EPA’s “no unreasonable risk” findings, however, are final agency actions subject to legal challenge, and challenged they were.

So which chemical risk evaluations have been challenged? Three cases have been filed involving 1,4-dioxane, three over cyclic aliphatic bromide cluster (HBCD), four over asbestos, and two over methylene chloride. No cases were filed over 1-bromopropane, carbon tetrachloride, N-methylpyrrolidone (NMP), pigment violet 29 (PV29), perchloroethylene (aka tetrachloroethylene), or trichlorethylene. In the cumulative 12 filed cases, petitioners challenge the risk evaluations on either or both of the following grounds: that the risk evaluations fail to consider the full spectrum of a chemical’s past and ongoing use or disposal; and/or the risk evaluations fail to factor in how certain subpopulations may be at a greater risk of chemical exposure and health issues arising from exposure. Additional complaints include that the final evaluations were rushed and error ridden, that they inappropriately chose not to examine certain exposure pathways by deferring to other statutes, or that EPA should ban certain chemical uses all together.

As petitioners line up in court, EPA is taking proactive steps to address their concerns – perhaps to render these cases ultimately unnecessary. On June 30, EPA announced several policy changes and plans to reopen the final evaluations. In reopening, EPA will remove an assumption that workers are provided and use personal protective equipment (PPE), which could expand risk management regulation to several chemical uses previously found not to present an “unreasonable risk” with the mitigating effect of PPE. EPA also will revise the evaluations to include fenceline community risk assessment scenarios – which might respond to challengers concerned with subpopulation exposures.

Particularly interesting, where general population chemical exposures are regulated by other EPA-administered statutes, such as the Clean Air Act, Safe Drinking Water Act, or Clean Water Act, the first 10 evaluations deferred to those statutory programs as already establishing appropriate protections for certain risks to human health and the environment. But in the face of coalitions challenging the first 10 evaluations, EPA seems to have taken a step back, stating its deference “resulted in a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations.” EPA now will reopen the final evaluations of 1,4-dioxane, methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-bromopropane to account for potential fenceline community exposures.

This policy change regarding statutory deference may conflict with TSCA Section 9, which provides that EPA should coordinate TSCA actions with those taken under other EPA-administered environmental laws to reduce duplicative requirements. The shift also could elevate TSCA risk evaluations over risk assessments conducted under the CAA, SDWA, or CWA. Further, the models that EPA will use to conduct fenceline community exposures in the context of a comprehensive, nationally focused, risk evaluation have not been developed. Of course, with the current administration’s focus on environmental justice, resources for community modeling are likely to be found. And, while these policy changes unfold, the regulated community that will have to comply with any final regulations is engaging with EPA to scope out what operations under TSCA risk management rules might look like.   

The past five years have been quite a ride for the 2016 Lautenberg Amendments. And while many would agree that an adversarial courtroom is not the best environment for a five-year-old, for the Amendments, it seems going to court – sometimes – is all a part of growing up.