The U.S. Environmental Protection Agency (“EPA”) recently announced several significant policy changes affecting the first ten (10) existing chemical risk evaluations completed under the Toxic Substances Control Act (“TSCA”). Under these shifts EPA will reopen the evaluations to apply assumptions that could result in increased compliance and risk mitigation costs for chemical manufacturers and downstream users. EPA’s policy changes will not only affect the 10 evaluations, but also the next 20 ongoing chemical evaluations and their manufacturers. Involving counsel with eyes on the EPA chemical regulation landscape can assist companies make chemical manufacturing and use decisions during these volatile times.

Under the TSCA 2016 Amendments, EPA is required to evaluate existing chemical uses and to determine whether those uses are “not likely to present an unreasonable risk of injury to health or the environment, including to potentially exposed or susceptible subpopulations.” EPA completed the first 10 existing chemical risk evaluations in 2020-21 after several public comment opportunities and review by the TSCA Scientific Advisory Committee on Chemicals. The 10 chemicals are 1,4-dioxane, 1-bromopropane, asbestos, carbon tetrachloride, cyclic aliphatic bromide cluster (“HBCD”), methylene chloride, N-methylpyrrolidone (“NMP”), pigment violet 29, perchloroethylene, and trichloroethylene.

EPA now will reopen the evaluations to remove an assumption that workers are provided and use personal protective equipment (“PPE”). This change may 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, using presently undeveloped community risk assessment models. Further, EPA will remove consideration of chemical exposure control programs under other statutes potentially resulting in duplicative regulation.

Policy Change on PPE

In the completed evaluations, EPA assumed that PPE is always used in occupational settings, as required by applicable Occupational Safety and Health Administration (“OSHA”) rules, and found that some chemical uses did not pose an unreasonable risk. EPA is revisiting this assumption in light of “data on violations of PPE use suggest[ing] that assumptions that PPE is always provided to workers, and worn properly, are not justified.” This may change the conclusions about risk on some conditions of use for six of the 10 chemicals: methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane.

EPA already applied this policy change to the new chemical program. In March 2021, EPA announced that it will identify the absence of worker safeguards as “reasonably foreseen” conditions of use and mandate necessary protection through an enforceable TSCA section 5(e) order. Together, these announcements make clear that EPA may likely broaden its involvement in workplace activities by assuming in chemical evaluations that companies are not compliant with OSHA standards.

Policy Change on Fenceline Community and Other Risk Control Statutes

Where general population chemical exposures are regulated by other EPA-administered statutes, such as the Clean Air Act (“CAA”), Safe Drinking Water Act (“SDWA”), or Clean Water Act (“CWA”), the first 10 evaluations deferred to those statutory programs as already establishing appropriate protections for certain risks to human health and the environment. Finding that this deference “resulted in a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations,” EPA will reopen the 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 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 have not yet been developed. Given the current administration’s holistic emphasis on environmental justice, these models could incorporate new assumptions regarding fenceline risk and will benefit from the engagement of the regulated community in their development.

Next Steps

EPA’s policy changes will not only affect the reopened 10 chemical evaluations, but also the next 20 ongoing chemical evaluations and their manufacturers. As policies on chemical regulation continue to evolve at a rapid pace, companies may have questions about EPA’s risk evaluation process for high priority chemicals, ongoing developments in chemical regulatory activities, and critical issues on worker safety and supply chain. Involving counsel with first-hand knowledge of the changing landscape in EPA’s chemical regulation can provide invaluable guidance to a company making decisions during these volatile times.

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