The Toxic Substances Control Act (TSCA) has long been considered the “poster child” of failure as a chemical control law when it comes to asbestos regulation. The U.S. Environmental Protection Agency (EPA) in its latest approach to regulating “legacy” uses may well invite heightened scrutiny. The EPA announced in December the availability of the Draft Scope of the Risk Evaluation for Asbestos, Part 2. In it, the agency will evaluate conditions of use of asbestos were excluded from Part 1 as legacy uses and associated disposals, and use conditions of asbestos in talc and talc-containing products. This article summarizes the EPA’s approach.
Background
In 2019, the court in “Safer Chemicals, Healthy Families v. EPA” held that EPA’s risk evaluation of asbestos improperly excluded “legacy uses” or “associated disposals” from the conditions of use. The EPA, in response, determined the complete risk evaluation for asbestos would be issued in two parts. The agency released Part 1 in December 2020. Under the consent decree in another lawsuit, “Asbestos Disease Awareness Organization et al. v. Regan et al.,” the EPA must publish a final Part 2 risk evaluation for asbestos by December 1, 2024. The draft scope is the subject of the December notice.
The EPA adopted the definition of asbestos as defined by Title II of TSCA Section 202 as the “asbestiform varieties of — (A) chrysotile (serpentine), (B) crocidolite (riebeckite), (C) amosite (cummingtonite-grunerite), (D) anthophyllite, (E) tremolite, or (F) actinolite.” Given that Part 2 will focus on legacy uses of asbestos and associated disposals, “a unique consideration will be vermiculite, which was widely used in building materials in the past and was co-located with Libby Amphibole Asbestos (LAA; and its tremolite, winchite, and richterite constituents).” The agency will consider LAA and its constituents in Part 2.
Another commercially mined substance, talc, has been implicated as a potential source of asbestos exposure. Talc can be co-located geologically with asbestos. The EPA will determine relevant conditions of use of talc, including but not limited to any legacy use and associated disposal where asbestos is implicated.
The EPA plans to evaluate the industrial, commercial and consumer legacy uses and associated disposal of asbestos in Part 2 of the risk evaluation. The agency will assess conditions of use for the use and disposal phases of the lifecycle. Depending on where information implicates the presence of asbestos in talc, the conditions of use may also include manufacture, processing and distribution.
The EPA also plans to evaluate releases to the environment and human and environmental exposures resulting from the conditions of use of asbestos considered in the Part 2 risk evaluation. Additional information gathered through systematic review searches will also inform expected exposures. The EPA plans to evaluate exposure pathways, routes, receptors, and potentially exposed or susceptible subpopulations in Part 2.
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Discussion
A notable inclusion in the draft scope is the potentially exposed or susceptible subpopulation evaluation of “individuals who smoke.” It generally is known that smoking and asbestos interact synergistically; smokers exposed to asbestos are more likely to develop lung cancer than non-smokers with similar asbestos exposure levels. It is unclear whether smoking status will be a legally and scientifically defensible basis for increased susceptibility under TSCA.
Importantly, the draft scope presents the results of the updated “systematic review,” including over 100 citations for “environmental release” and approximately 300 “exposure” search results (including ambient air, soil, surface water, aquatic species, and terrestrial species). It is possible that Part 2 may conclude there is at least one unreasonable risk to the environment.
It is unclear how the EPA will calculate the very important “aggregate exposures” in occupational and residential settings. Stakeholders in possession of data that may inform the EPA’s updated exposure assessment, such as monitoring data from asbestos remediation projects or environmental monitoring, should submit that information to the docket prior to the February 14, 2022, comment period deadline.
Other TSCA stakeholders should continue to monitor the EPA’s update to the asbestos risk evaluation as well as anticipated updates to the risk evaluations for the “First 10” and the “Next 20” chemicals designated for evaluations, for further insight into how the agency will implement TSCA Section 6 going forward.