EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk to Human Health

On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft document titled “Draft Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos” (the Draft Asbestos Part 2). 89 Fed. Reg. 26878. EPA is evaluating legacy uses and associated disposals of asbestos, including chrysotile asbestos, five additional fiber types, asbestos-containing talc, and Libby asbestos. EPA states that it has used the best available science to determine preliminarily that asbestos poses unreasonable risk to human health. EPA will hold a webinar on May 13, 2024, to provide an overview of its risk evaluation. To receive the webcast meeting link and audio teleconference information before the meeting, registration had to be completed by 12:00 p.m. (EDT) on April 25, 2024. Requests for special accommodations  are due by 5:00 p.m. (EDT) on May 6, 2024. Comments are due June 17, 2024. EPA has entered into a consent decree to complete the final risk evaluation by December 1, 2024.

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 for asbestos should not have excluded “legacy uses” or “associated disposals” from the conditions of use (COU). 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 “Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos” (Asbestos Part 1) 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.

On July 25, 2023, EPA issued a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) regarding reporting and recordkeeping requirements for asbestos. The final rule requires certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles, including as an impurity, in the four years prior to the date of publication of the final rule to report electronically certain exposure-related information. More information is available in our July 12, 2023, memorandum.

EPA issued a final rule on March 28, 2024, to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain COUs. 89 Fed. Reg. 21970. The final rule prohibits the manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms in the chlor-alkali industry; chrysotile asbestos-containing sheet gaskets in chemical production; chrysotile asbestos-containing brake blocks in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; other chrysotile asbestos-containing vehicle friction products; and other chrysotile asbestos-containing gaskets. It also prohibits the manufacture (including import), processing, and distribution in commerce for consumer use of aftermarket automotive chrysotile asbestos-containing brakes/linings; and other chrysotile asbestos-containing gaskets. The final rule also includes disposal and recordkeeping requirements for these COUs. More information is available in our March 28, 2024, memorandum.

Findings of the Draft Asbestos Part 2

This draft document presents Part 2 of the risk evaluation of asbestos, focusing on supplemental analyses, including legacy uses of asbestos and associated disposals and a limited consideration of talc containing asbestos. EPA notes that under the July 2023 one-time asbestos reporting rule, exposure-related information — including information on the presence, types, and quantities of asbestos (including asbestos that is a component of a mixture) and asbestos-containing articles that have been manufactured (including imported) or processed — will be provided to EPA in 2024, which will be considered in the final Part 2 risk evaluation.

The uses of asbestos evaluated include a wide range of exposure scenarios and potentially exposed or susceptible subpopulations (PESS). EPA notes that one legacy use of asbestos is as a fire retardant in building materials, which do not pose a risk until disturbed, but can be released during construction, modification, or demolition of asbestos-containing materials (ACM) in homes, school, or commercial buildings. EPA states that relevant uses of imported talc products that may contain asbestos (i.e., fillers and putties with talc containing asbestos and crayons with talc containing asbestos) were also considered, but there were no reasonably available information identified to provide evidence that import of these products is ongoing. According to EPA, the PESS with greatest risk from asbestos exposure include those with occupational exposure, individuals exposed through do-it-yourself (DIY) activities, children, and those who smoke with risk to respiratory effects.

In the Draft Asbestos Part 2, EPA’s assessment preliminarily determines that the following asbestos COUs contribute to the unreasonable risks of cancer and non-cancer health effects:

• Industrial/commercial use — chemical substances in construction, paint, electrical, and metal products — construction and building materials covering large surface areas — paper articles; metal articles; stone plaster, cement, glass, and ceramic articles;

• Industrial/commercial use — chemical substances in construction, paint, electrical, and metal products — machinery, mechanical appliances, electrical/electronic articles;

• Industrial/commercial use — chemical substances in construction, paint, electrical, and metal products — other machinery, mechanical appliances, electronic/electronic articles;

• Industrial/commercial use — chemical substances in furnishing, cleaning, treatment care products — construction and building materials covering large surface areas — fabrics, textiles, and apparel;

• Industrial/commercial use — chemical substances in furnishing, cleaning, treatment care products — furniture and furnishings — stone, plaster, cement, glass, ceramic articles, metal articles, and rubber articles;

• Consumer use — chemical substances in construction, paint, electrical, and metal products — construction and building materials covering large surface areas — paper articles; metal articles; stone, plaster, cement, glass, and ceramic articles;

• Consumer use — chemical substances in construction, paint, electrical, and metal products — fillers and putties;

• Consumer use — chemical substances in furnishing, cleaning, treatment care products — furniture and furnishings — stone, plaster, cement, glass, and ceramic articles; metal articles; or rubber articles; and

• Disposal — distribution for disposal.

EPA states that the unreasonable risk is due to exposures to: (1) people who handle asbestos products; (2) exposed workers taking asbestos home; (3) non-professional DIY exposure scenarios; and (4) the general population within the vicinity of activities releasing asbestos to the environment.

EPA preliminarily determined that the following asbestos COUs were not found to contribute to unreasonable risks of cancer and non-cancer health effects:

• Industrial/commercial use — chemical substances in construction, paint, electrical, and metal products — fillers and putties;

• Industrial/commercial use — chemical substances in construction, paint, electrical, and metal products — solvent-based/water-based paint;

• Industrial/commercial use — chemical substances in products not described by other codes — other (aerospace applications): based on the description of activities related to aerospace applications;

• Industrial/commercial use — mining of non-asbestos commodities — mining of non-asbestos commodities: based on data and information from the Mine Safety and Health Administration (MSHA) and stakeholders, EPA has determined that exposure to asbestos is unlikely;

• Industrial/ commercial use — laboratory chemicals — laboratory chemicals: based on EPA analysis of vermiculite products, EPA does not expect any significant asbestos releases or occupational exposures;

• Industrial/commercial use — chemical substances in automotive, fuel, agriculture, outdoor use products — lawn and garden care products: based on EPA analysis of vermiculite products, EPA does not expect any significant asbestos releases or occupational exposures; and

• Consumer use — chemical substances in automotive, fuel, agriculture, outdoor use products — lawn and garden care products: based on EPA analysis of vermiculite products, EPA does not expect any significant asbestos exposures to consumers.

EPA states that a single unreasonable risk determination is made for asbestos as a chemical substance that includes both the COUs evaluated in the 2020 Asbestos Part 1 and the COUs evaluated in this draft risk evaluation. EPA based its unreasonable risk determination on the existing risk characterization section of the 2020 Asbestos Part 1 (Section 4) and does not involve additional technical or scientific analysis. EPA also based the draft risk determination for asbestos as a chemical substance on the risk estimates (Sections 4 and 5) presented for the COUs (Section 1.1.2) in this Draft Asbestos Part 2.

Commentary

The Acta Group (Acta^®) commends EPA for completing the Draft Asbestos Part 2. We are concerned, however, that EPA’s ambitious schedule for completing its draft risk evaluations is compromising the scientific decision-making basis that informs these documents. Like other risk evaluations and risk management rules proposed or published in final, this risk evaluation suffers from some of the same scientific concerns, lack of transparency, and questionable documentation regarding the use of the best available science.

EPA stated the following in the Draft Asbestos Part 2 as support of its adherence with the weight of scientific evidence requirements under TSCA and comments received on its systematic review approaches by the U.S. National Academy of Sciences, Engineering, and Medicine (NASEM), the TSCA Science Advisory Committee on Chemicals, and the public:

In response to recommendations for chemical specific systematic review protocols, the Draft Risk Evaluation for Asbestos Part 2 – Systematic Review Protocol [citation omitted] (also referred to as the “Asbestos Part 2 Systematic Review Protocol”) describes clarifications and updates to approaches outlined in the 2021 Draft Systematic Review Protocol that reflect NASEM, SACC and public comments as well as chemical specific risk evaluation needs.

It is unclear, however, which systematic review protocol was used. EPA cites to its rescinded 2018 document titled “Application of Systematic Review in TSCA Risk Evaluations” (the 2018 SR Document) as the basis for its evaluation of occupational monitoring studies in the Draft Asbestos Part 2. EPA rescinded the 2018 SR Document because of NASEM’s conclusion that it did not meet the criteria of “comprehensive, workable, objective, and transparent” and that “[t]he OPPT approach to systematic review does not adequately meet the state-of-practice.” For discussion, see our memorandum dated December 21, 2021.

EPA’s reference to the 2018 SR Document may represent isolated mistakes in the Draft Asbestos Part 2, although the 2018 SR Document was used for EPA’s 2020 Asbestos Part 1, which informed EPA’s conclusions in the Draft Asbestos Part 2. EPA proceeded with drafting the Draft Asbestos Part 2 despite comments submitted by the American Industrial Hygiene Association (AIHA) on EPA’s 2022 “Draft Scope of the Risk Evaluation for Asbestos Part 2” cautioning against doing so. AIHA’s comments state:

It is premature to move forward with Part 2 of the Asbestos Risk Evaluation before the completion of the revised systematic review and before Part 1 is revised to provide a comprehensive, workable, objective, and transparent risk evaluation that meets the standard of care established by the new systematic review process.

AIHA further stated that:

To continue with Part 2, which incorporates a flawed Part 1 Asbestos Risk Evaluation, is inefficient and would not be consistent with EPA’s stated goal of meeting statutory obligations, being guided by the best available science, ensuring the integrity of Federal decision-making, and protecting human health and the environment.

We acknowledge that EPA is under a court-ordered deadline to complete its Part 2 risk evaluation and EPA is struggling to complete all TSCA Section 6 obligations. The lack of a “comprehensive, workable, objective, and transparent” process to ensure that EPA is relying on reasonably available information, the best available science, and the weight of scientific evidence undermines the basis for EPA’s risk evaluations and risk management rules. Acta further acknowledges that in future risk evaluations, this will be a moot point because EPA removed the definitions of best available science and weight of scientific evidence in its final, updated framework rule. This is a decision we and many others cautioned against. For discussion, see our memorandum dated October 30, 2023.

An example is that EPA used its 1994 document titled “Guidelines for Statistical Analysis of Occupational Exposure Data” (the 1994 Statistical Guidance) for data sets in the Draft Asbestos Part 2 even though the Office of Pollution Prevention and Toxics (OPPT) discussed the scoping document for the Draft Asbestos Part 2 with EPA’s Office of Land and Emergency Management (OLEM, formerly the Office of Solid Waste and Emergency Response), yet it did not apply OLEM’s 2008 “Framework for Investigating Asbestos-Contaminated Superfund Sites” nor did EPA explain why it selected a much older framework. A public commenter raised this issue on the draft version of Asbestos Part 1. EPA’s response was non-substantive and simply reiterated its use of the 1994 Statistical Guidance.

Surprisingly, EPA included the use of a 3× database deficiency uncertainty factor (UF_D) as part of its non-cancer dose-response considerations in the Draft Asbestos Part 2. This appears to be a new policy decision on EPA’s part, since it has not historically used a UF_D in its TSCA risk evaluations. EPA can apply additional uncertainty factors as part of its TSCA risk evaluations as a matter of science policy. EPA should, however, announce this decision and state the scientific basis for the values used. It has not done so.

The Draft Asbestos Part 2 represents a step forward with EPA’s advancement of its TSCA risk evaluations for protecting human health and the environment, and we are not surprised that EPA found some COUs to present an unreasonable risk. EPA’s assessment may also change after it receives the results of the asbestos reporting rule.

The next challenge for EPA will be how it deploys its risk management authority. Because Asbestos Part 2 focuses on legacy uses — COUs related to asbestos that have been in-place for decades — EPA will have few regulatory levers to pull. This is especially true given the current protective measures required under TSCA, the U.S. Occupational Safety and Health Administration (OSHA), and the Clean Air Act. EPA will be challenged to find protective measures that it can apply to DIY renovators and, if it does propose effective measures, how EPA will enforce them.