Chemicals, Enforcement and Inspection

EPA Announces Changes to TSCA Risk Evaluations

On June 30, 2021, EPA announced policy changes for chemical risk evaluations conducted as required by the Toxic Substances Control Act.

This provides a new path forward for the first 10 chemicals to go through risk evaluation:

  • 1,4-Dioxane
  • 1-Bromopropane
  • Asbestos
  • Carbon Tetrachloride
  • Cyclic Aliphatic Bromide Cluster (HBCD)
  • Methylene Chloride
  • N-methylpyrrolidone (NMP)
  • Pigment Violet 29 (PV29)
  • Tetrachloroethylene (also known as perchloroethylene)
  • Trichloroethylene

According to EPA, the 1976 TSCA provides the agency authority to “require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides.”

The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Chemical Safety Act) was signed into law on June 22, 2016, and made important amendments to the TSCA, including:

  • Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines;
  • Risk-based chemical assessments;
  • Increased public transparency for chemical information; and
  • Consistent source of funding for EPA to carry out the responsibilities under the new law.

The policy changes announced on June 30, 2021, include:

  1. Expanding consideration of exposure pathways and implementing a fenceline community exposure screening level approach.

The previous administration’s risk evaluations of the first 10 chemicals did not assess air, water, or disposal exposures to the general public. The Biden administration believes these assessments are important, particularly for “fenceline” communities—those located near industrial facilities.

“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,” according to EPA. “Thus, EPA currently 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 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.”

The path forward for EPA will be determined by the results of these screenings.

“If this approach yields information that there is no unreasonable risk to these communities, EPA intends to move forward to proposed risk management rulemakings,” according to EPA. “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.

“Later this calendar year, 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,” according to EPA.

2. Evaluating based on the assumption of personal protective equipment (PPE).

Previous risk assessments assumed that workers were always provided PPE, which violations data shows is not always the case.

“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,” according to EPA. “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.

“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.”

3. Using a whole chemical approach vs. making determinations for every condition of use.

“Under the previous administration, EPA made separate unreasonable risk determinations for every condition of use of a chemical,” according to EPA. “For the first 10 chemicals under TSCA and for any similar chemical that presents significant risks across many uses, EPA will continue to assess and analyze each condition of use, but then the agency plans to make the determination of unreasonable risk just once for the whole chemical when it is clear the majority of the conditions of use warrant one determination. EPA intends to withdraw the previously issued orders for those conditions of use for which no unreasonable risk was found for all the first 10 risk evaluations. The agency then intends to issue revised unreasonable risk determinations for these chemicals as a ‘whole substance’ and seek public comment on this approach.”

EPA states it believes the current risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos) are “likely sufficient.” According to EPA, “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.”