REGULATORY MEMORANDUM

EPA Publishes Final Scope for Part 2 of Asbestos Risk Evaluation

The U.S. Environmental Protection Agency (EPA) published on June 29, 2022, the final scope of the risk evaluation to be conducted for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 38746. EPA will evaluate the conditions of use (COU) of asbestos, including other types of asbestos fibers in addition to chrysotile, that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any COUs of asbestos-containing talc. The final scope of the Part 2 risk evaluation includes the COUs, hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA plans to consider in conducting the risk evaluation.

Background

In 2019, the court in Safer Chemicals Healthy Families v. EPA, 943 F.3d 397 (9th Cir. 2019), held that EPA’s risk evaluation rule should not have excluded “legacy uses” or “associated disposals” from the COUs. Following the court ruling, EPA continued to develop the risk evaluation focused on chrysotile asbestos and determined that the complete risk evaluation for asbestos would be issued in two parts. As reported in our January 4, 2021, memorandum, EPA released the final risk evaluation for Asbestos, Part 1: Chrysotile Asbestos in December 2020, allowing EPA “to expeditiously move into risk management for the unreasonable risk identified in Part 1.” Under the consent decree in the case Asbestos Disease Awareness Organization et al v. Regan et al, 4:21-cv-03716 (N.D. Cal.), EPA is required to publish a final Part 2 Risk Evaluation for Asbestos on or before December 1, 2024.

Final Scope of Asbestos Part 2 Risk Evaluation

For the purposes of scoping and risk evaluation, EPA states that it initially adopted the definition of asbestos as defined by Title II of the Toxic Substances Control Act (TSCA) Section 202 as the “asbestiform varieties of six fiber types -- chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.” EPA states that given that, Part 2 of the risk evaluation will focus on legacy asbestos uses and associated disposals, broader considerations are warranted, and a “unique consideration” is the co-location of asbestos geologically with commercially mined substances. In particular, Libby Amphibole Asbestos (LAA) is known to be present with a silicate, mica-like mineral called vermiculite, extracted from an open pit mine near Libby, Montana, until its closure in 1990. Vermiculite was widely used in building materials that will be an important focus of the evaluation of legacy uses of asbestos. Thus, LAA (and its tremolite, winchite, and richterite constituents) will be considered in Part 2 of the risk evaluation. EPA notes that another commercially mined substance, talc, has been implicated as a potential source of asbestos exposure. Talc can also be co-located geologically with asbestos, where asbestos can remain in small or trace amounts following extraction. Thus, EPA will determine the relevant COUs of asbestos-containing talc, including but not limited to any “legacy use” and “associated disposal” where asbestos is implicated.

According to the final scope, EPA plans to evaluate the industrial, commercial, and consumer legacy uses and associated disposal of asbestos in Part 2 of the risk evaluation. EPA states that legacy asbestos uses “are uses for which manufacture (including import), processing, and distribution no longer occur, but the uses are still known, intended, or reasonably foreseen to occur,” and associated disposals are disposals from legacy uses. In Part 2, EPA will evaluate the COUs for the use and disposal phases of the life cycle. EPA states that depending on where information implicates the presence of asbestos in talc, the COUs may include manufacture, processing, and distribution. EPA notes that it did not revise the COUs provided in the draft scope, but did make some clarifications based on public comments. More information on the draft scope is available in our December 30, 2021, memorandum.

EPA plans to evaluate releases to the environment, as well as human and environmental exposures resulting from the COUs of asbestos that EPA plans to consider in Part 2 of the risk evaluation. EPA states that additional information gathered through systematic review searches will also inform expected exposures.

EPA considered reasonably available information and comments received on the draft scope document in determining the human and environmental exposure pathways, routes, receptors, and PESS for inclusion in the final scope. As a result, EPA plans to evaluate the following human and environmental exposure pathways, routes, receptors, and PESS in the scope of Part 2 of the risk evaluation:

  • Occupational Exposure: EPA plans to evaluate exposures to workers and occupational non-users (ONU) via the inhalation, dermal, and oral route associated with the use and disposal of asbestos, to include any implicated COUs for asbestos-containing talc. EPA plans to analyze dermal exposure for workers and ONUs to asbestos fibers that deposit on surfaces;
     
  • Consumer and Bystander Exposure: EPA plans to evaluate inhalation, dermal, and oral exposure to asbestos for consumers and bystanders from the use of asbestos in construction, paint, electrical, and metal products; asbestos in furnishing, cleaning, treatment care products; asbestos in packaging, paper, plastic, toys, hobby products; asbestos in automotive, fuel, agriculture, outdoor use products; and asbestos in products not described by other codes; and the direct contact and/or mouthing of products or articles containing asbestos for consumers. In addition, EPA will evaluate any implicated COUs for asbestos-containing talc;
     
  • General Population Exposures: For the COUs within the scope of Part 2 of the risk evaluation for asbestos, EPA plans to evaluate general population exposure to asbestos via the oral route from drinking water, surface water, groundwater, and soil; via the inhalation route from particulate in ambient air; and via the dermal route from contact with drinking water, surface water, groundwater, and soil;
     
  • PESS: EPA plans to consider children, workers, including firefighters, ONUs, consumers, individuals who smoke, and bystanders as receptors and PESS in Part 2 of the risk evaluation, as well as any other PESS identified in the screening and evaluation of the reasonably available information; and
     
  • Environmental Exposure: For the COUs within the scope of Part 2 of the risk evaluation for asbestos, EPA plans to evaluate exposure to asbestos for aquatic and terrestrial receptors.
     

Assumption about the Use of PPE

According to EPA’s June 29, 2022, press release, EPA will not assume that personal protective equipment (PPE) will always be properly used in occupational settings in its future risk determinations, including for Part 2 of the risk evaluation for asbestos, even though some facilities might be using PPE as one means to reduce workers’ exposures. EPA states that it understands that there could be occupational safety protections in place at workplace locations. Not assuming use of PPE “reflects EPA’s recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, their employers are out of compliance with OSHA standards, or because OSHA has not issued a permissible exposure limit,” however. EPA states that its decision “should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable OSHA standards. Use of PPE and other ways industry protects its workers, will be assessed during the risk evaluation but will only be considered during risk management as a potential way to address unreasonable risks.”

Commentary

The Asbestos Part 2 risk evaluation will be interesting to observe as it evolves. EPA is meeting its obligation to review legacy uses of asbestos, but it is not clear what regulatory action EPA might take if EPA finds that asbestos that is already in place in, for example, buildings, presents an unreasonable risk. EPA regulations regarding asbestos remediation are already stringent and include, for example, reporting requirements for releases (including disposal) of friable asbestos in quantities as low as 1 pound (i.e., 0.454 kg), and re-entry requirements following the removal of asbestos-containing materials (e.g., average concentration of five asbestos air samples in affected space is not statistically different than the average concentration of five asbestos air samples in an unaffected space and the average of three field blanks).

Advocates may object that EPA is excluding use of talc as a cosmetic product from the COU of asbestos but, as EPA states, talc (and any asbestos impurity) when used as a cosmetic is excluded from the definition of a chemical substance under TSCA and thus beyond TSCA authority. On the other hand, EPA is evaluating the presence of asbestos as an impurity in talc used for non-cosmetic purposes, such as talc in toy crime-scene kits. It remains to be seen how EPA will address the potential for asbestos impurity in other mined materials. For example, will EPA assume that all vermiculite, a component in a variety of products, contains or may contain a certain level of asbestos? Or will EPA limit this assumption to vermiculite produced prior to 1990?

It is notable that EPA states that it has identified additional information through “systematic review.” EPA has been criticized for inadequate systematic review in its initial risk evaluations, but has stated that its reviews were “sufficient” to support reissuing the risk determinations in final to inform risk management (in, for example, the updated cyclic aliphatic bromide cluster (HBCD) risk evaluation) without re-assessing the systematic review. Interestingly, the final scope of Asbestos Part 2 states that the literature strategy employed included “reevaluation of all references used in Part 1.” It is unclear, however, why EPA would have to reevaluate existing references from Asbestos Part 1, since it already concluded in the proposed risk management rule that its risk evaluation that was based on the now defunct 2018 Application of Systematic Review in TSCA Risk Evaluations satisfied the scientific standards under TSCA Section 26. This begs the question whether EPA is doing so in Asbestos Part 2 preemptively to avoid anticipated challenges to its systematic review in Asbestos Part 1, where the adequacy and selection of information sources appeared to be based on whether they supported a predetermined outcome.

Beyond the issues with systematic review, it will be interesting to see how EPA evaluates exposure data in Asbestos Part 2. As readers may recall, EPA used various substitution methods for “non-detect” observations in Asbestos Part 1, including substitution with the full detection limit. This approach is, however, inconsistent with the best available science, as articulated by EPA in its 2008 Directive titled Framework for Investigating Asbestos-Contaminated Superfund Sites.

Bergeson & Campbell, P.C. (B&C®) acknowledges the difficult position that EPA is in with regard to completing its risk evaluations within the statutory deadlines. This goal is further complicated by EPA’s continued position of having to “build the plane as it flies it.” For example, EPA is test-driving a draft systematic review protocol on Asbestos Part 2 that was issued in 2021, evaluated by the TSCA Science Advisory Committee on Chemicals (SACC) in 2022, yet not final as of the date of this posting. To complicate matters, EPA will likely be fielding challenges, both administrative and legal, on Asbestos Part 1 that could impact Asbestos Part 2, once it issues in final the risk management rule for Asbestos Part 1. We anticipate that potential challenges to the risk management rule on Asbestos Part 1 will serve as a litmus test for EPA’s interpretation of the best available science and weight of scientific evidence under TSCA Section 26. As noted above, however, B&C questions whether EPA’s position that its decisions on the first ten risk evaluations, as exemplified in the HBCD revised risk determination, were “sufficient” will survive legal challenge, recognizing that TSCA requires use of the “best available science,” not “sufficient available science.”

B&C encourages stakeholders to follow EPA’s work on existing chemical substances, including those substances that may not be part of their portfolios (e.g., asbestos). We recognize the burden of doing so, however, each decision that EPA makes in its risk evaluations has the potential to set precedents for its assessments on other existing chemical substances. The short list of issues discussed above relating to systematic review and EPA’s approach to evaluating “non-detect” observations, provide substantive examples of EPA’s decision-making that suggest insufficient rigor and questionable statutory compliance in its evaluations. Therefore, we encourage readers to review Asbestos Part 2, to consider generally applicable issues that may impact their chemistries, and to consider submitting public comments when EPA issues the draft Asbestos Part 2 risk evaluation.

 
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