EPA Announces Path Forward for TSCA Chemical Risk Evaluations
On June 30, following an agency review of the prior administration’s policies, the U.S. Environmental Protection Agency (EPA) announced several policy changes surrounding risk evaluations issued under the Toxic Substances Control Act (TSCA), including changes affecting the agency’s first 10 chemical risk evaluations, completed in 2020. EPA states that these actions will ensure chemicals are used safely and all communities are protected.
The EPA review followed the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review, including President Biden’s Executive Order: Protecting Public Health and Environment and Restoring Science to Tackle to Climate Crisis. That order directs federal agencies to review their actions to ensure that they meet statutory obligations, are guided by the best available science, ensure the integrity of federal decision-making, and protect human health and the environment
TSCA requires EPA to review the risks associated with high-priority chemicals already on the market, then take action to manage any unreasonable risks found. The agency’s June 30 announcement includes the following changes, as set forth below in an EPA press release.
Expanding Consideration of Exposure Pathways and Fenceline Community Exposure Using a Screening Level Approach
EPA stated in its announcement that, under the previous administration, the first 10 risk evaluations did not assess air, water, or disposal exposures to the general population because these exposure pathways were already regulated, or could be regulated, under other EPA-administered statutes such as the Clean Air Act, Safe Drinking Water Act, or Clean Water Act. The approach to exclude certain exposure pathways also resulted in a failure to address potential exposures consistently and comprehensively to potentially exposed or susceptible subpopulations, including fenceline communities (i.e., communities near industrial facilities), according to EPA.
EPA elaborated that in the original risk evaluation for 1,4-dioxane – and in a supplemental assessment – EPA did not evaluate certain exposure pathways or populations that could be considered potentially exposed or susceptible subpopulations. As such, EPA intends to re-open and update the 1,4-dioxane risk evaluation to consider whether to include additional exposure pathways, like drinking water and ambient air, and conditions of use where 1,4-dioxane is generated as a byproduct that were excluded from the supplemental and final risk evaluations. The agency plans to take public comment on any potential revisions to the 1,4-dioxane risk evaluation before finalizing them.
For six of the first 10 chemicals, EPA plans to further examine whether the policy decision to exclude certain exposure pathways from the risk evaluations will lead to a failure to identify and protect fenceline communities. These six chemicals are methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-bromopropane.
To determine if these six chemicals do present unreasonable risks to these communities, EPA says it is developing a screening-level approach to conduct ambient air and surface water fenceline assessments. This approach will use existing data and information to determine if there is the potential for unreasonable risk to fenceline communities associated with air and water exposures.
If this approach yields information that there is no unreasonable risk to these communities, EPA intends to move forward to proposed risk management rulemakings. Alternatively, if the agency finds through the application of the screening-level approach that there may be unreasonable risk to these communities that cannot be addressed without supplementing the risk evaluation or through the risk management approaches the agency is already considering, EPA will conduct a more comprehensive exposure assessment of fenceline communities and supplement the risk evaluation for that chemical with the new information.
EPA plans to make these screening approaches and methods, and their application to one or more chemicals, available for public comment and have them peer reviewed by the Scientific Advisory Committee on Chemicals later in 2021.
Use of Personal Protective Equipment
In its announcement, EPA states that in the final risk evaluations for the first 10 chemicals, the previous administration generally assumed that workers were always provided, and used, personal protective equipment (PPE) appropriately. However, data on violations of PPE use suggest that assumptions that PPE is always provided to workers, and worn properly, are not justified. As such, the agency believes that continued use of this assumption could result in risk evaluations that underestimate the risk, and in turn, risk management rules may not provide the needed protections.
EPA is therefore revisiting the assumption that PPE is always used in occupational settings when making risk determinations for a chemical. Instead, the agency plans to consider information on use of PPE, or other ways industry protects its workers, as a potential way to address unreasonable risk during the risk management process.
EPA notes that the first 10 risk evaluations already include exposure analysis with and without PPE. Therefore, removing this assumption does not create need for new analysis. However, this shift could change some of the conclusions about risk on some conditions of use for six of the first 10 chemicals for which “no unreasonable risk” findings were made based on the use of PPE. Specifically, this shift could impact conclusions about risk for some conditions of use for methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane.
Chemicals Moving to Risk Management
EPA stated that it has reviewed the risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos). EPA currently believes the risk evaluations are likely sufficient to inform the risk management approaches being considered and these approaches will be protective. Moving forward, EPA intends to reissue the risk determinations that amend the approach to PPE and include a whole chemical risk determination for these three chemicals. The agency is also working expeditiously on risk management, and believes the proposed rules for these three chemicals will likely be the first of the 10 to be ready for release.
Whole Chemical Approach
Under the previous administration, EPA made separate unreasonable risk determinations for every condition of use of a chemical. The current administration plans on making one determination of unreasonable risk for each chemical, when it is clear that a majority of conditions of use warrant that determination. EPA states that it will continue to evaluate each condition of use separately, but the final agency determination of “unreasonable risk” will be for the chemical in its entirety, rather than each use. For the first 10 chemicals, EPA will withdraw final determinations for conditions of use with findings of “no unreasonable risk” to issue findings of “unreasonable risk” for each chemical, where justified. EPA will seek comments on this approach. To date, EPA has not identified a comment period.
Contact ACA’s Riaz Zaman for more information.