The U.S. Environmental Protection Agency (EPA) released on December 30, 2020, the final risk evaluation for asbestos, part 1: chrysotile asbestos. Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six chrysotile asbestos use categories. EPA found no unreasonable risk to the environment.

EPA’s next step in the process required by the Toxic Substances Control Act (TSCA) is to develop a plan to reduce or eliminate the unreasonable risks found in the final risk evaluation. EPA states that it “is moving immediately to risk management for chrysotile asbestos and will work as quickly as possible to propose and finalize actions to protect against unreasonable risk.” The potential actions that EPA could take to address these risks include regulating how chrysotile asbestos is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of chrysotile asbestos, as applicable.

Background

TSCA Section 6, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), requires EPA to conduct risk evaluations to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.” The statute identifies the minimum components EPA must include in all risk evaluations. For each risk evaluation, EPA must publish a document that outlines the scope of the risk evaluation to be conducted, which includes the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations that EPA expects to consider. Each risk evaluation must also: (1) integrate and assess available information on hazards and exposure for the conditions of use of the chemical substance, including information on specific risks of injury to health or the environment and information on relevant potentially exposed or susceptible subpopulations; (2) describe whether aggregate or sentinel exposures were considered and the basis for that consideration; (3) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use; and (4) describe the weight of the scientific evidence for the identified hazards and exposure. The risk evaluation must not consider costs or other nonrisk factors. A detailed summary and analysis of the final risk evaluation rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”

Risk Evaluation for Chrysotile Asbestos

The final risk evaluation states that during development of part 1, the only asbestos fiber type that EPA identified as imported, processed, or distributed under the conditions of use in the United States is chrysotile, the serpentine variety. According to the final risk evaluation, chrysotile is the prevailing form of asbestos currently mined worldwide, and “so it is assumed that a majority of commercially available products fabricated overseas that contain asbestos are made with chrysotile. Any asbestos being imported into the U.S. in articles is believed to be chrysotile.” The other five forms of asbestos are now subject to a significant new use rule (SNUR), as reported in our April 18, 2019, memorandum, “EPA Announces Final SNUR for Asbestos Will ‘Close Loophole and Protect Consumers.’”

EPA evaluated the following categories of conditions of use of chrysotile asbestos in part 1 of the risk evaluation for asbestos: importing; processing; distribution in commerce; occupational and consumer uses (use of diaphragms in the chlor-alkali industry, sheet gaskets in chemical production facilities, oilfield brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets); and disposal. The final risk evaluation states that EPA reviewed the November 2019 decision of the U.S. Court of Appeals for the Ninth Circuit in Safer Chemicals Healthy Families v. EPA. Part 1 of the risk evaluation for asbestos does not reflect consideration of any legacy uses and associated disposal for chrysotile asbestos or other asbestos fiber types as a result of that decision. According to the final risk evaluation, EPA intends to consider legacy uses and associated disposal and other fiber types in part 2 of the asbestos risk evaluation.

EPA made the following risk evaluation findings. EPA stated that in making these unreasonable risk determinations, it considered the hazards and exposure, magnitude of risk, exposed population, severity of the hazard, uncertainties, and other factors.

• EPA found unreasonable risks to human health for uses of chrysotile asbestos:

  • Consumers and Bystanders: EPA found unreasonable risks to consumers and bystanders from all consumer uses of chrysotile asbestos. Most consumer products containing chrysotile asbestos have been discontinued. Consumer products still available and for which EPA found unreasonable risk include aftermarket automotive brakes/linings and certain gaskets. Risks to consumers can come from the inhalation of chrysotile asbestos; and

  • Workers and ONUs: Commercial chrysotile asbestos uses for which EPA found unreasonable risk to workers include chlor-alkali diaphragms, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets. Additionally, EPA found unreasonable risks to workers nearby but not in direct contact with chrysotile asbestos for the use of chlor-alkali diaphragms, sheet gaskets, brake blocks, and other gaskets. Risks to workers and ONUs can come from the inhalation of chrysotile asbestos.

• EPA found no unreasonable risks to the environment from any conditions of use. For all the conditions of use included in part 1 of the final risk evaluation, EPA found no unreasonable risks to the environment under any of the conditions of use.

Next Steps

EPA has started planning for part 2 of the risk evaluation for asbestos and will engage stakeholders as part of and following development of the draft scope document to identify any additional reasonably available information that is relevant to part 2. EPA intends to make the draft scope document available for public comment mid-year 2021. The draft scope document will be followed with a final scope document, a draft risk evaluation document for peer review and public comment, and then a final part 2 risk evaluation for asbestos. EPA states that this risk evaluation will consider chrysotile and the other five fiber types of asbestos described in the TSCA Title II definition: crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite, or actinolite.

Commentary

With the issuance of part 1 of the final risk evaluation for asbestos, risk management efforts will now commence covering the conditions of use for which EPA found unreasonable risk. EPA is required to issue a final Section 6(a) regulation within three and one half years, including potentially available extensions. In addition, for the conditions of use that were determined not to present an unreasonable risk, these decisions, which EPA issued by order under Section 6(i)(1) of TSCA, represent final agency actions that are subject to legal challenge. Generally consistent with the other risk evaluations issued to date, EPA did not evaluate hazards or exposures of chrysotile asbestos to the general population in the risk evaluation (i.e., from surface water, drinking water, ambient air, and disposal pathways) because those exposures fall under the jurisdiction of other environmental statutes administered by EPA. As a result, the unreasonable risk determinations for the relevant conditions of use do not account for these exposures to the general population.

Similarly, EPA did not evaluate hazards or exposures from chrysotile asbestos releases to terrestrial pathways for terrestrial organisms because those exposures fall under the jurisdiction of other environmental statutes administered by EPA, and as such the unreasonable risk determinations for relevant conditions of use do not account for exposures to terrestrial organisms. Considering the legal challenges filed to date on the Section 6(i)(1) orders issued as part of final risk evaluations on methylene chloride and the cyclic aliphatic bromide cluster (HBCD), legal challenges to the order may arise for the conditions of use that EPA determined do not present an unreasonable risk for reasons including EPA’s exclusion of general population exposure pathways and terrestrial pathways for terrestrial organisms.

EPA was wise to split the risk evaluation between the on-going uses that it had evaluated in its draft risk evaluation from the legacy uses that EPA had not previously reviewed. This way, EPA can proceed with risk management for the on-going uses while it evaluates the potential risks from legacy uses. The alternative would necessitate that EPA delay any action on the on-going uses until it completed the entire risk evaluation. That part 2 of the risk evaluation, focusing on legacy uses and associated disposal, will likely not be completed for some time and any risk management required to address any unreasonable risks found in part 2 would not be completed for years thereafter will likely not sit well with many environmental and public health advocates, however.

As with each of the risk evaluations completed to date, EPA found a number of conditions of use that present an unreasonable risk. In this case, EPA mostly only found risk when workers use no respiratory protection. In a handful of conditions of use, EPA found risk when workers use respiratory protection with basic respiratory protection and a few conditions of use when workers use more advanced respiratory protection. Probably the most concerning condition of use is aftermarket brake and clutch replacement, especially for consumers (who tend not to use respiratory protection).

Of note, on December 22, 2020, the U.S. District Court for the Northern District of California issued a ruling pertaining to two cases, ADAO v. EPA, 3:19-cv-871, and California v. EPA, No. 3:19-cv-3807, derivative of EPA’s denials of citizen petitions under TSCA Section 21 that requested EPA to collect additional information on asbestos under its TSCA Section 8(a) Chemical Data Reporting rule or a separate TSCA Section 8(a) rulemaking, respectively, to inform the on-going risk evaluation and for other purposes. After finding EPA to have acted arbitrarily and capriciously in violation of the Administrative Procedure Act in denying the petitions, the court granted the Plaintiffs’ Motion for Summary Judgment and directed EPA “to amend its CDR reporting rule pursuant to its authority under 15 U.S.C. § 2607(a)(1)(A) (i.e., under Section 8(a) of TSCA), to address the information-gathering deficiencies identified herein.” The deficiencies noted by the court, which the court referred to as “loopholes in the CDR reporting scheme [that] prevent EPA from receiving reasonably available information” necessary for risk evaluation and other purposes, include exemptions for asbestos when part of articles or as an impurity, and that processors are not required to report. Although the decision by the court was issued just a week before the issuance of the final part 1 of the risk evaluation, EPA’s lack of any mention of the decision in the risk evaluation is somewhat puzzling. Whether EPA will appeal this decision remains to be seen; EPA has 60 days to appeal the order, so if not appealed by the Trump Administration, the decision would fall to the Biden Administration. Although the court’s decision relates solely to asbestos reporting, the decision could have broader implications, including to the lengths EPA must go to obtain “reasonably available information” to inform the development of other risk evaluations.