This past March, the U.S. Environmental Protection Agency (EPA) issued its first final risk management rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of chrysotile asbestos to human health under certain conditions of use (COUs). Even if asbestos isn’t in your supply chain, don’t hit the brakes on reading further. All TSCA stakeholders need to understand this rule because it is a template for how the agency will address risk management under TSCA Section 6.
Background
The EPA is required under TSCA to prioritize, evaluate and manage unreasonable risks from COUs of active, high-priority existing chemicals. Asbestos is one of the “First 10” existing chemicals the EPA reviewed, even though it took almost eight years. As of May 2024, all persons are prohibited from the manufacture (including import) of chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for diaphragms in the chlor-alkali industry and a variety of other uses. Beginning five years after the effective date of the final rule, all persons are prohibited from processing, distributing in commerce, and commercial use of chrysotile asbestos for diaphragms in the chlor-alkali industry, except as provided in the rule.
The final rule is specific to the few operations in the United States processing chrysotile asbestos. Section 751.505(c) permits a person to process, distribute in commerce, and commercially use chrysotile asbestos for diaphragms in the chlor-alkali industry at no more than two facilities until eight years after the final rule’s effective date if they meet certain conditions. Section 751.505(d) permits an entity that meets certain criteria to process and distribute in commerce and commercially use chrysotile asbestos for diaphragms in the chlor-alkali industry at not more than one facility until 12 years after the final rule, if they meet certain conditions.
Many other prohibitions and restrictions exist on other COUs for manufacturing, processing and distributing chrysotile asbestos. For example, beginning two years after the final rule’s effective date, all persons are prohibited from manufacturing (including importing), processing, distributing in commerce, and commercial use of chrysotile asbestos, including any chrysotile asbestos-containing products or articles, for use in sheet gaskets for chemical production, except as provided by the EPA. Sheet gaskets already installed and in use as of the compliance date are not subject to the prohibition. Similar provisions for chrysotile asbestos apply to brake linings, gaskets for consumer use, and other products.
Interim Workplace Controls
For most COUs taking effect in five or more years after the final rule in May 2024, the EPA requires owners or operators to comply with an eight-hour existing chemical exposure limit (ECEL). This begins six months after the final rule. The derivation and implementation of the ECEL is an important aspect of the final rule. This requirement applies to processing and industrial use of chrysotile asbestos in bulk form or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and industrial use of chrysotile asbestos sheet gaskets for titanium dioxide production. Once a facility has completed the phaseout of chrysotile asbestos and it’s no longer used in its operations, interim requirements like the ECEL no longer apply.
TSCA risk management requirements could incorporate Occupational Safety and Health Administration (OSHA) standards. For chrysotile asbestos, the EPA’s approach for interim controls seeks to align with certain elements of the existing OSHA standard for regulating asbestos under 29 C.F.R. Sections 1910.1001 and 1926.1101.
According to the EPA, the OSHA permissible exposure limit (PEL) and ancillary requirements “have established a long-standing precedent for exposure limit threshold requirements within the regulated community.” The EPA acknowledges it’s applying a “lower, more protective” ECEL under the final rule. The agency did not establish medical surveillance requirements but noted companies must follow OSHA medical surveillance requirements of 0.1 fiber per cubic centimeter of air as an eight-hour time-weighted average level.
Disposal
The EPA also established asbestos-containing waste disposal provisions that cross-reference existing EPA and OSHA regulations. The EPA requires that for the chrysotile asbestos diaphragm COU and oilfield brake blocks, other vehicle friction products, and any commercial use of other gaskets and aftermarket automotive brakes and linings COUs, regulated entities must adhere to waste disposal requirements in OSHA’s Asbestos General Industry Standard in 29 C.F.R. Section 1910.1001, including Section 1910.1001(k)(6) requiring waste, scrap, debris, bags, containers, equipment, and clothing contaminated with asbestos that are consigned for disposal to be disposed of in sealed impermeable bags or other closed, impermeable containers.
For the chrysotile asbestos sheet gaskets COU, regulated entities must adhere to waste disposal requirements described in OSHA’s Asbestos Safety and Health Regulations for Construction in 29 C.F.R. Section 1926.1101. Other conditions apply.
Discussion
This historic rule is important for several reasons. First, the rule applies to the few, limited ongoing uses of chrysotile asbestos that weren’t banned in the 1980s. It does not apply to the asbestos types that may already be in place, such as in old buildings. The EPA’s Asbestos Part 2 risk evaluation will address the potential risk from legacy uses and associated disposal activities. That work is underway.
Second, the EPA concluded that for the limited, ongoing uses of chrysotile asbestos, the only way to mitigate the risk of ongoing import, processing, use and disposal is to ban chrysotile asbestos, except for the narrow use in brakes on specialized, large cargo aircraft operated by the National Aeronautics and Space Administration (NASA). This is TSCA’s most restrictive measure and seldom used under TSCA.
Third, importantly, the EPA concluded in the proposed rule that the use of chrysotile asbestos in chlor-alkali production doesn’t present an unreasonable risk if protective measures are used, such as engineering controls, glove boxes and personal protective equipment (PPE). In the final rule, the EPA claims chrysotile asbestos must be banned because the necessary PPE may not be used correctly. This is a critically important take-home message. If this logic prevails, they agency may be in the position to ban any substance it determines an unreasonable risk when PPE isn’t used.
Stated differently, under this construction, the EPA will need to ban nearly every substance it reviews because those substances will be deemed to pose an unreasonable risk from routine, unprotected inhalation and/or dermal exposures. The EPA seems to be interpretating TSCA to mean that under some circumstances, an employee at a covered facility may decide not to use protective measures or wear PPE correctly, and that because of this possibility, the agency can’t reduce an unreasonable risk by imposing workplace protective measures. While the EPA might view asbestos as a special case, it didn’t clarify its argument in the rule.
Several unresolved issues with the rule are likely to resurface as the basis for any potential challenges. The first issue is the EPA’s use of the now rescinded 2018 Application of Systematic Review in TSCA Risk Evaluations. It is unclear whether the EPA fulfilled its obligations of complying with the scientific standards under TSCA Section 26.
Second, the EPA’s derivation of an inhalation unit risk (IUR) for chrysotile asbestos and its subsequent use of the IUR for establishing an ECEL are questionable, and the EPA’s use of certain studies is controversial. The EPA limited the scope of the peer review, which some contend creates an appearance of favoring a pre-determined outcome that undermines the integrity of the science used in the agency’s decision-making. Either outcome is inconsistent with the scientific standards under TSCA Section 26 and the agency’s recently updated draft Scientific Integrity Policy.
Third, this rule’s unreasonable risk determination seems questionable. The EPA referenced its 1994 Guidelines for Statistical Analysis of Occupational Exposure Data as the justification for evaluating monitoring samples that were below the limit of detection. Yet, the approach in the 1994 guidelines conflicts with the EPA’s more recent 2008 Framework for Investigating Asbestos-Contaminated Superfund Sites.
While it is unclear if the rule will be challenged, most think it will be. This is, after all, the first final rule under TSCA Section 6(a) and will be precedent setting for other risk management rules. This rule is not just about asbestos; it reflects how the EPA will manage risks for existing chemical substances the EPA identifies as high-priority substances under TSCA Section 6.
