# Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use Under Section 6(a) of the Toxic Substances Control Act (TSCA)

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-07601

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** April 12, 2022
- **Citation:** 87 FR 21706

## Text

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2021-0057; FRL-8332-02-OCSPP]
RIN 2070-AK86
Asbestos Part 1: Chrysotile Asbestos; Regulation of Certain Conditions of Use Under Section 6(a) of the Toxic Substances Control Act (TSCA)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing a rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to health it has identified for conditions of use of chrysotile asbestos following completion of the TSCA Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos. TSCA requires that EPA address the unreasonable risks of injury to health and environment by rule and to apply requirements to the extent necessary so that chrysotile asbestos no longer presents such risks. Therefore, to address the unreasonable risk identified in the TSCA Risk Evaluation for Asbestos, Part 1 from chrysotile asbestos, EPA is proposing to prohibit manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms for use in the chlor-alkali industry, chrysotile asbestos-containing sheet gaskets used in chemical production, chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products, and other chrysotile asbestos-containing gaskets. EPA also is proposing to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA is also proposing disposal and recordkeeping requirements for these conditions of use.

DATES:

Comments must be received on or before June 13, 2022.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0057, using the Federal eRulemaking Portal at
https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is open to visitors by appointments. For the latest status information on EPA/DC services and docket access, visit
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact:
Peter Gimlin, Existing Chemicals Risk Management Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-0515; email address:
Gimlin.peter@epa.gov.

For general information contact:
The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address:
TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may be potentially affected by this proposed action if you manufacture (including import), process, distribute in commerce, use, or dispose of chrysotile asbestos. TSCA section 3(9) defines the term “manufacture” to mean to import into the customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States), produce, or manufacture. Therefore, unless expressly stated otherwise, importers of chrysotile asbestos are subject to any proposed provisions regulating manufacture of chrysotile asbestos. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Oil and Gas Extraction (NAICS code 211).

• Chemical Manufacturing (NAICS code 325).

• Fabricated Metal Product Manufacturing (NAICS code 332).

• Transportation Equipment Manufacturing (NAICS code 336).

• Gasket, Packing, and Sealing Device Manufacturing (NAICS code 339991).

• Motor Vehicle and Motor Vehicle Parts and Supplies Merchant Wholesalers (NAICS code 4231).

• Motor Vehicle and Parts Dealers (NAICS code 441).

• Automotive Repair and Maintenance (NAICS code 8111).

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by TSCA are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

Asbestos (including chrysotile asbestos) is already subject to TSCA section 6(a) (40 CFR part 763, subparts G and I) rules that trigger the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b); see also 40 CFR 721.20). Any person who exports or intends to export asbestos (including chrysotile asbestos) must comply with the export notification requirements in 40 CFR part 707, subpart D. Pursuant to TSCA section 12(a)(2), this proposed rule would apply to the chemical substance, mixture, or article even if being manufactured, processed, or distributed in commerce solely for export from the United States because a determination has been made that the chemical substance, mixture, or article presents an unreasonable risk to health within the United States or to the environment of the United States.

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the technical information contact listed under
FOR FURTHER INFORMATION CONTACT
.

B. What is the Agency's authority for taking this action?

Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to

the risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements listed in section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk.

C. What action is the Agency taking?

EPA determined in the Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos (Ref. 1), that chrysotile asbestos presents an unreasonable risk of injury to health based upon the following conditions of use:

• Processing and Industrial use of Chrysotile Asbestos Diaphragms in the Chlor-alkali Industry;

• Processing and Industrial Use of Chrysotile Asbestos-Containing Sheet Gaskets in Chemical Production;

• Industrial Use and Disposal of Chrysotile Asbestos-Containing Brake Blocks in Oil Industry;

• Commercial Use and Disposal of Aftermarket Automotive Chrysotile Asbestos-Containing Brakes/Linings;

• Commercial Use and Disposal of Other Chrysotile Asbestos-Containing Vehicle Friction Products;

• Commercial Use and Disposal of Other Chrysotile Asbestos-Containing Gaskets;

• Consumer Use and Disposal of Aftermarket Automotive Chrysotile Asbestos-Containing Brakes/Linings;

• Consumer Use and Disposal of Other Chrysotile Asbestos-Containing Gaskets.

A detailed description of these conditions of use is provided in Unit III.B.2. Accordingly, to address the identified unreasonable risk, EPA is proposing pursuant to TSCA section 6(a) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk for or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA is proposing that these prohibitions would take effect two years after the effective date of the final rule. EPA is also proposing pursuant to TSCA section 6(a) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of: Chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products (not including the NASA Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA is proposing that these prohibitions would take effect 180 days after the effective date of the final rule. EPA is further proposing pursuant to TSCA section 6(a) to prohibit manufacture (including import), processing, and distribution in commerce of: Aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA is proposing that these prohibitions would take effect 180 days after the effective date of the final rule. EPA is also proposing disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. EPA does not intend the proposed prohibitions on processing or distribution in commerce to prohibit any processing or distribution in commerce incidental to disposal of the chrysotile asbestos waste in accordance with the proposed requirements.

EPA is requesting public comment on this proposal.

D. Why is the Agency taking this action?

Under TSCA section 6(a), “[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule . . . apply one or more of the [section 6(a)] requirements to such substance or mixture to the extent necessary so that the chemical substance no longer presents such risk.” Chrysotile asbestos was the subject of a risk evaluation under TSCA section 6(b)(4)(A) that was issued in December 2020 (Ref. 1). In that risk evaluation, EPA determined that chrysotile asbestos presents unreasonable risk of injury to health under certain conditions of use evaluated. As a result, EPA is proposing to take action to ensure that chrysotile asbestos no longer presents such risk for the chrysotile uses evaluated under part 1 of the risk evaluation. The unreasonable risk is described in Unit III.B.1. and the conditions of use that are the subject of this proposed regulation and that were found to drive the unreasonable risk in the Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos are described in Unit III.B.2.

E. What are the estimated incremental impacts of this action?

EPA has prepared an Economic Analysis of the potential incremental impacts associated with this rulemaking that can be found in the rulemaking docket (Ref. 2).

1. Background

Asbestos usage in the nation has been declining for decades and current domestic consumption of raw asbestos is less than 0.1% of peak consumption in the early 1970s. Chlor-alkali producers are the only industry in the U.S. known to fabricate products from raw chrysotile asbestos. In addition, EPA has concluded that imports of a few asbestos-containing products are intended, known, or reasonably foreseen to occur; while the total quantity of asbestos in those products is uncertain, it is believed to be relatively small (see Appendix C of the Risk Evaluation).

2. Costs

Three firms own a total of ten chlor-alkali plants in the U.S. that still use asbestos diaphragms to produce chlorine and sodium hydroxide (also known as caustic soda). As one of these ten plants is expected to close in 2022, before the expected effective date of the final rule, EPA has only estimated the costs and benefits for the nine remaining plants that would be impacted by this rule. The nine remaining plants range in age from 40 to 123 years old, although some have had new capacity added as recently as 16 years ago, and others may have had recent refurbishments. The share of total production using asbestos diaphragm cells has been declining over time. The diaphragm cells in these plants currently represent about one-third of U.S. chlor-alkali production capacity. EPA's analysis supports a high probability that these firms will respond to the proposed rule by converting their asbestos diaphragm cells to membrane cells, which do not use asbestos. The use of membrane cells has increased over time and they currently account for nearly half of U.S. capacity. (The remaining capacity uses non-asbestos diaphragms or other miscellaneous processes.) A more detailed discussion of the expected impacts of conversion from asbestos-containing diaphragm cells to membrane cells, which use an increased concentration of per- and polyfluoroalkyl substances (PFAS) compounds relative to the amount of PFAS compounds contained in asbestos-containing diaphragms, is located in Unit III.B.4.

Converting the asbestos diaphragm cells to membrane cells in response to the proposed rule is predicted to require an incremental investment of approximately $1.8 billion across all nine plants predicted to be using asbestos diaphragms when the rule goes

into effect. Membrane cells are much more energy efficient than diaphragm cells, so, despite the upfront capital cost, that conversion is expected to result in significant savings that would accrue over many years. The expected energy savings are included in the estimated net annualized costs. Membrane cells also produce a higher grade of caustic soda that has historically commanded a higher price than the product from diaphragm cells. EPA anticipates that most of the conversions to membrane cells would occur in the coming decades even without the proposed rule, following existing trends in the chlor-alkali industry to transition away from asbestos. Compared to this baseline trend, the incremental net effect of the proposed rule on the chlor-alkali industry over a 20-year period using a 3 percent discount rate is estimated to range from an annualized cost of about $49 million per year to annualized savings of approximately $35 million per year, depending on whether the higher grade of caustic soda produced by membrane cells continues to command a premium price. Using a 7 percent discount rate, the incremental annualized net effect ranges from a cost of $87 million per year to savings of approximately $40,000 per year, again depending on whether there are revenue gains from the caustic soda production.

EPA also estimates that approximately 1,800 sets of automotive brakes or brake linings containing asbestos may be imported into the U.S. each year, representing 0.002% of the total U.S. market for aftermarket brakes. The cost of a prohibition would be minimal due to the ready availability of alternative products that are only slightly more expensive (an average cost increase of $4 per brake). The proposed rule is estimated to result in total annualized costs for aftermarket automotive brakes of approximately $25,000 per year using a 3% discount rate and $18,000 per year using a 7% discount rate.

EPA did not have information to estimate the costs of prohibiting asbestos for the remaining uses subject to the proposed rule (sheet gaskets used in chemical production, brake blocks in the oil industry, other vehicle friction products, or other gaskets), so there are additional unquantified costs. EPA believes that the use of these asbestos-containing products has declined over time, and that they are now used in at most small segments of the industries. For these remaining categories, EPA requests comment on the number of entities that manufacture (including import), process, distribute in commerce, or use products or articles containing asbestos. EPA also requests comment on the costs of the rule to these entities.

3. Benefits

EPA's Economic Analysis for the rule quantified the benefits from avoided cases of lung cancer, mesothelioma, ovarian cancer, and laryngeal cancer due to reduced asbestos exposures to workers, occupational non-users (ONUs), and DIYers related to the rule's requirements for chlor-alkali diaphragms, sheet gaskets for chemical production, and aftermarket brakes. The combined national quantified benefits of avoided cancer cases associated with these products are approximately $3,100 per year using a 3% discount rate and $1,200 per year using a 7% discount rate, based on the cancer risk estimates from the Part 1 risk evaluation. EPA did not estimate the aggregate benefits of the requirements for oilfield brake blocks, other vehicle friction products or other gaskets because the Agency did not have sufficient information on the number of individuals likely to be affected by the rule. Thus, there may be additional unquantified benefits from reducing exposures associated with these uses.

There are also unquantified benefits due to other avoided adverse health effects associated with asbestos exposure including respiratory effects (
e.g.,
asbestosis, non-malignant respiratory disease, deficits in pulmonary function, diffuse pleural thickening and pleural plaques) and immunological and lymphoreticular effects.

In addition to the benefits of avoided adverse health effects associated with chrysotile asbestos exposure, the proposed rule is expected to generate significant benefits from reduced air pollution associated with electricity generation. Chlor-alkali production is one of the most energy-intensive industrial operations. Since membrane cells are more energy efficient than diaphragm cells, converting diaphragm cells to membrane cells reduces electricity consumption and thus the level of pollutants associated with electric power generation, including carbon dioxide, particulate matter, sulfur dioxide, and nitrogen oxides. Based on a sensitivity screening-level analysis that EPA conducted, converting asbestos diaphragm cells to membrane cells could yield tens of millions of dollars per year in environmental and health benefits from reduced emissions of particulate matter, sulfur dioxide, nitrogen oxides, and carbon dioxide. EPA's Economic Analysis, which can be found in the rulemaking docket (Ref. 2), contains more information on the potential magnitude of these monetized benefits from reduced criteria air pollutants and carbon dioxide emissions as well as caveats about the limitations of the screening-level analysis that EPA conducted.

4. Small Entity Impacts

As described in more detail in Unit VIII.C and in the Economic Analysis of this rulemaking (Ref. 2), EPA estimates that the proposed rule would affect at least 15 small entities, of which 12 are businesses supplying aftermarket brakes incurring costs between $778 and $11,523 per firm (depending on the number of brake replacements they perform). Nine of the brake replacement firms have a cost impact of less than 1% of their annual revenues. Of the three small entities estimated to be affected by the rule that are not supplying aftermarket brakes, two manufacture sheet gaskets for chemical production and one imports oilfield brake blocks. EPA was unable to estimate the magnitude of the impacts for these small entities. Chlor-alkali plants account for nearly all of the quantified costs of the rule, and none of the firms operating chlor-alkali plants are small businesses. No small businesses have been identified as using sheet gaskets for chemical production or brake blocks in the oil industry, but small businesses do supply these products to end users that are not small. Asbestos-free products in these applications reportedly do not last as long as items containing asbestos. As a result, the proposed rule could increase revenues for the affected small business suppliers if they sell a larger volume of non-asbestos products to the end users as replacements. For the remaining use categories (aftermarket automotive brakes, other gaskets, and other vehicle friction products), EPA has not identified firms (of any size) manufacturing, processing, distributing or using products containing asbestos. To the extent that there are any small businesses engaged in these activities, there are likely only a few firms facing a small cost increase for asbestos-free products, and any such cost increase can probably be passed on to consumers. EPA requests public comments regarding the number of small businesses subject to the rule, including use categories for which EPA did not identify any affected small businesses, and on the potential impacts of the rule on these small businesses.

5. Environmental Justice

This rule would increase the level of environmental protection for all affected populations without having any disproportionately high and adverse

health or environmental effects on any population, including any minority or low-income populations. There are pre-existing environmental justice concerns in communities surrounding some of the affected chlor-alkali facilities and one other chemical manufacturer affected by this rule due to high levels of polluting industrial activities and a high proportion of minority residents. This rule is not expected to increase these pre-existing environmental justice concerns. Unit III.A.1 discusses outreach conducted to advocates of minority or low-income communities that might be subject to disproportionate exposure to chrysotile asbestos.

Both asbestos-containing diaphragm cells and membrane cells use per- and polyfluorinated substances (PFAS) compounds. EPA lacks information to determine whether this proposed regulation would increase usage and associated release of PFAS compounds at chlor-alkali facilities that currently rely on asbestos-containing diaphragms, chlor-alkali facilities that do not currently use asbestos-containing diaphragms that may expand their production as a result of the regulation, upstream facilities that produce membranes, or upstream facilities that produce PFAS fibers used in non-asbestos diaphragms.

6. Effects on State, Local, and Tribal Governments

This action has federalism implications because regulation under TSCA section 6(a) may preempt state law. It does not impose costs on small governments or have tribal implications.

II. Background

A. Overview of Chrysotile Asbestos

Asbestos is defined in section 202 of TSCA Title II as: “Asbestiform varieties of six fiber types—chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.” EPA used this definition of asbestos at the onset of the asbestos risk evaluation in 2016. However, EPA determined that chrysotile asbestos is the only type of asbestos where import, processing, and distribution in commerce for use is known, intended, or reasonably foreseen in the U.S. As such, EPA assessed these non-legacy conditions of use of chrysotile asbestos in the December 2020 Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos (Ref. 1). Following a decision by the Ninth Circuit Court of Appeals (
Safer Chemicals Healthy Families
v.
EPA,
943 F.3d 397 (9th Cir. 2019)) concerning legacy use and associated disposal of asbestos, conditions of use that were not included in the Part 1 risk evaluation, EPA began developing a supplemental risk evaluation to address legacy and associated disposal conditions of use. The Risk Evaluation for Asbestos, Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos will include evaluation of those conditions of use of chrysotile asbestos, the five amphibole fiber types identified in the TSCA Title II definition (crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite and actinolite) and Libby Amphibole Asbestos (mainly consisting of tremolite, winchite, and richterite). Additionally, some talc deposits and articles containing talc have been shown to contain asbestos. Thus, it is recognized that certain uses of talc may present the potential for asbestos exposure. Where EPA identifies reasonably available information demonstrating the presence of asbestos in talc, where such talc applications fall under TSCA authority, those talc containing asbestos impurities will be evaluated in Part 2 of the risk evaluation for asbestos.

This proposed rule would only apply to chrysotile asbestos (Chemical Abstract Services Registry Number 132207-32-0). Chrysotile asbestos is a hydrated magnesium silicate mineral, with relatively long and flexible crystalline fibers that are capable of being woven. Chrysotile asbestos fibers used in most commercial applications consist of aggregates and usually contain a broad distribution of fiber lengths. Chrysotile asbestos fiber bundle lengths usually range from a fraction of a millimeter to several centimeters, and diameters range from 0.1 to 100 µm. More information on the physical and chemical properties of chrysotile asbestos is in Section 1.1 of the Risk Evaluation (Ref. 1).

EPA evaluated the conditions of use associated with six ongoing use categories of chrysotile asbestos (chlor-alkali diaphragms, sheet gaskets used in chemical production, oilfield brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets). There is no domestic mining of asbestos. All imported raw asbestos is chrysotile asbestos and is used in the manufacture of chlor-alkali diaphragms. According to the United States Geological Survey (USGS), 300 metric tons of chrysotile asbestos were imported in 2020 (Ref. 3).

B. Regulatory Actions Pertaining to Chrysotile Asbestos

Chrysotile asbestos is subject to numerous federal laws and regulations in the United States and is also subject to regulatory actions by states and other countries. The following is a summary of the laws and regulatory actions pertaining to chrysotile asbestos implemented by EPA, other federal agencies, states, and other countries or via international treaties and agreements. None of these actions addresses the unreasonable risks under TSCA that this proposed rule would address. For a full description see the Appendix A of the Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos (Ref. 1).

1. EPA Actions Pertaining to Chrysotile Asbestos

EPA has taken the following actions pertaining to chrysotile asbestos under its various authorities:

•
Asbestos Hazard Emergency Response Act (AHERA):
The Asbestos-Containing Materials in Schools regulation (40 CFR part 763, subpart E (1987)) requires local education agencies to inspect their school buildings for asbestos-containing building material, prepare asbestos management plans and perform asbestos response actions to prevent or reduce asbestos hazards. Public school districts and non-profit private schools, including charter schools and schools affiliated with religious institutions (collectively called local education agencies) are subject to the rule's requirements. AHERA defines asbestos as the asbestiform varieties of chrysotile (serpentine), crocidolite (riebeckite), amosite (cummingtonite-grunerite), anthophyllite, tremolite or actinolite.

•
Toxic Substances Control Act:
In 1989, EPA issued a final rule entitled
Asbestos: Manufacture, Importation, Processing, and Distribution in Commerce Prohibitions; Final Rule,
(54 FR 29460 (1989)) banning most asbestos-containing products. In 1991, a federal court vacated and remanded most of the final rule, thereby permitting manufacture (including import), processing, or distribution in commerce for the majority of the asbestos-containing products.
Corrosion Proof Fittings
v.
EPA,
947 F.2d 1201 (5th Cir., 1991). Manufacture (including import), processing, and distribution in commerce of the following products remain banned by the rule under TSCA: Corrugated paper, rollboard, commercial paper, specialty paper, and flooring felt. In addition, the 1989 rule continues to ban the manufacture (including import), processing, and distribution in commerce for use of asbestos in products that have not historically contained asbestos, referred to in the 1989 rule as “new uses” of asbestos, and

defined by 40 CFR 763.163 as “commercial uses of asbestos not identified in part 763.165 the manufacture, importation or processing of which would be initiated for the first time after August 25, 1989.”

Through the authority of section 6 of TSCA, EPA extended worker protection requirements to state and local government employees involved in asbestos work who were not previously covered by existing Occupational Safety and Health Administration (OSHA) occupational health standards for asbestos through the
Asbestos Worker Protection Rule
(40 CFR part 763, subpart G (2000)).

•
Restriction on Discontinued Uses of Asbestos; Significant New Use Rule (SNUR).
In 2019, EPA promulgated a significant new use rule under section 5(a)(2) of TSCA to ensure that any discontinued uses of asbestos cannot reenter commerce without prior EPA review (84 FR 17345, April 25, 2019). These new provisions at 40 CFR 721.11095 require persons subject to the rule to notify EPA at least 90 days before commencing any manufacturing (including importing) or processing of asbestos or asbestos-containing products covered under the rule. These uses are designated significant new uses and, as such, cannot be resumed unless EPA is notified and makes a required determination and takes action, as appropriate, under TSCA section 5.

•
Asbestos Information Act of 1988 (AIA):
The AIA, Public Law 100-577, helped provide transparency and identify the companies making certain types of asbestos-containing products by requiring manufacturers to report production to the EPA.

•
Emergency Planning and Community Right-To-Know Act
(EPCRA): Under Section 313, the Toxics Release Inventory (TRI) requires reporting of environmental releases of friable asbestos at a concentration level of 0.1% or greater. Also, within EPCRA, friable asbestos is designated as a hazardous substance subject to an Emergency Release Notification at 40 CFR 355.40 with a reportable quantity of 1 pound.

•
Clean Air Act:
Asbestos has been designated a hazardous air pollutant (HAP) under the CAA. In 1973, EPA promulgated the Asbestos National Emission Standard for Hazardous Air Pollutants (NESHAP) (40 CFR part 61, subpart M). The regulation requires, among other requirements, that some manufacturing and fabricating operations either cannot emit visible emissions into the outside air or must follow air cleaning procedures and generally must seal asbestos-containing waste material from regulated activities in a leak-tight container while wet, label, and dispose of properly in a landfill permitted to receive asbestos waste.

•
Clean Water Act
(CWA): CWA defines asbestos as a toxic pollutant per 33 U.S.C. Section 1317. Each toxic pollutant listed in that section is subject to effluent limitations guidelines based on the best available technology economically achievable for the applicable category or class of point sources established in accordance with the CWA. The effluent limitations guidelines for the asbestos manufacturing point source category are in 40 CFR part 427.

•
Resource Conservation and Recovery Act
(RCRA): RCRA gives EPA the authority to control hazardous wastes from cradle to grave, including generation, transportation, treatment, storage and disposal. Asbestos is not regulated as a hazardous waste under RCRA Subtitle C. Asbestos is a non-hazardous solid waste regulated under Subtitle D of RCRA. Regulations established under Subtitle D ban open dumping of waste and set minimum federal criteria for the operation of municipal waste and industrial waste landfills, including design criteria, location restrictions, financial assurance, corrective action (cleanup), and closure requirements. States play a lead role in implementing these regulations and may set more stringent requirements.

•
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA): The
Designation of Hazardous Substances Rule
(40 CFR 302.4) designates asbestos as a hazardous substance with a reportable quantity in Superfund regulations. The regulation also sets forth reportable quantities for asbestos under the Clean Water Act and the Resource Conservation and Recovery Act.

•
Safe Drinking Water Act:
Established
National Primary Drinking Water Regulations
(NPDWR) (40 CFR part 141, subpart G (1991)). NPDWR are enforceable drinking water standards expressed as Maximum Contaminant Levels (MCLs) or treatment techniques. The MCLs are the maximum level of contaminants that are allowed in public water systems in the United States. In 40 CFR 141.62, EPA set the maximum contaminant level for asbestos in community water systems and non-transitory, non-community water systems at 7 million fibers/liter (longer than 10 µm).

2. Other Pertinent Federal Actions Pertaining to Chrysotile Asbestos

Actions by other federal agencies related to chrysotile asbestos include:

•
Occupational Safety and Health Administration
(OSHA). OSHA has established a permissible exposure limit (PEL) for asbestos of 0.1 fibers per cubic centimeter (cc) of air as an eight-hour time weighted average (TWA), with an excursion limit of 1.0 asbestos fibers per cubic centimeter over a 30-minute period. Among other requirements, OSHA requires assessments of workplaces covered by one of three standards (General Industry (29 CFR 1910.1001); Shipyards (29 CFR 1915.1001); Construction (29 CFR 1926.1101)) to be completed to determine if asbestos is present and if the work will generate airborne fibers. Further, monitoring is required to detect if asbestos exposure is at or above the PEL TWA or excursion limit for workers who are, or may be, expected to be exposed to asbestos. Monitoring frequency depends on work classification and exposure. Unit II.C. describes EPA's general approach to considering OSHA occupational health standards in TSCA risk evaluations and TSCA risk management actions.

•
The National Institute for Occupational Safety and Health (NIOSH),
part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services, is a research agency focused on the study of worker safety and health. NIOSH has established a Recommended Exposure Limit (REL) for asbestos. For asbestos fibers >5 micrometers long and a length-to-width ratio equal to or greater than 3:1, NIOSH recommends a REL of 100,000 fibers per cubic meter of air (100,000 f/m3), which is equal to 0.1 fiber per cubic centimeter of air (f/cc), as determined by a 400-liter air sample in accordance with NIOSH Analytical Method 7400.
NIOSH Pocket Guide to Chemical Hazards, Appendix C.
The NIOSH Recommended Exposure Limit (REL) is a non-mandatory, recommended occupational exposure limit. This 0.1 f/cc level is consistent with OSHA's PEL, as well as the 0.1 f/cc Threshold Limit Value (TLV) guidance from the American Conference of Governmental Industrial Hygienists (ACGIH), a private not-for-profit scientific association.

•
Consumer Product Safety Commission (CPSC).
CPSC is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency's jurisdiction. The CPSC has

banned or restricted the following asbestos-containing products: Emberizing materials (ash and embers), patching compounds, and asbestos-containing garments for general use (16 CFR part 1305; 16 CFR part 1304 and 16 CFR 1500.17(a)(7)).

•
Mine Safety and Health Administration (MSHA).
MSHA adopted an asbestos standard for exposure limits from airborne contaminants (30 CFR parts 56 and 57 (subpart D)). In these exposure limits, MSHA identifies respiratory protection requirements for mine workers in both surface and underground mines (Ref. 1).

3. State Actions Pertaining to Chrysotile Asbestos

Pursuant to AHERA, many states have adopted EPA's Asbestos Model Accreditation Plan (MAP) (Appendix C to 40 CFR part 763, subpart E) for asbestos abatement professionals who perform work in schools and public and commercial buildings. Thirty-nine states have EPA-approved MAP programs and separately twelve states have also applied to and received a waiver from EPA to oversee implementation of the Asbestos-Containing Materials in Schools Rule (40 CFR part 763, subpart E) pursuant to AHERA. States also implement regulations pursuant to the Asbestos NESHAP regulations (40 CFR part 61, subpart M). While the asbestos MAP and asbestos NESHAP regulations set minimum national standards, states are free to impose more stringent regulations. Also, both California and Washington prohibit the use of more than 0.1% of asbestos in brake pads and require laboratory testing of brake pads and labeling to certify compliance with their regulations.

A list of state regulations that are independent of the federal AHERA and NESHAP requirements that states implement is in Appendix A of the Risk Evaluation (Ref. 1).

4. International Actions Pertaining to Chrysotile Asbestos

Asbestos is regulated internationally; nearly 60 nations have banned or significantly limited the use of asbestos.

The European Union (EU) first prohibited five uses of asbestos in 1991 and added chrysotile asbestos prohibitions for numerous uses in 1999, with a full ban implemented on January 1, 2005. In 2006, the EU established the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and renewed its position on asbestos (
Regulation (EC) No 1907/2006 of the European Parliament and of the Council, 18 December 2006
). Regulation (EC) No. 2016/1005 amended REACH Article XVII to formally phase out the use of diaphragms containing chrysotile asbestos for electrolysis installations (
i.e.,
chlor-alkali facilities) by July 1, 2025.

Canada promulgated a regulation to ban asbestos effective December 30, 2018 (Ref. 4). The regulation prohibited the import, sale and use of asbestos, as well as the manufacture, import, sale and use of products containing asbestos. Canada added several limited exclusions, including an allowance for the import and use of asbestos for chlor-alkali facilities using asbestos diaphragm technology until December 31, 2029.

C. Consideration of OSHA Occupational Health Standards in TSCA Risk Evaluations and TSCA Risk Management Actions

TSCA requires EPA to evaluate whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator, under the conditions of use (COUs). COUs are the circumstances, as determined by the Administrator, under which a chemical is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. If EPA determines through risk evaluation that a chemical substance presents an unreasonable risk, TSCA section 6 requires EPA to issue regulations applying one or more control requirements to the extent necessary so that the chemical substance no longer presents such risk. Although EPA must consider, and in some cases factor in to the extent practicable, non-risk factors as part of TSCA section 6(a) rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still ensure that the selected regulatory requirements apply “to the extent necessary so that the chemical substance or mixture no longer presents [unreasonable] risk.” This risk-based requirement is distinguishable from approaches mandated by other laws, including the Occupational Safety and Health Act (OSH Act), which includes both significant risk and feasibility (technical and economic) assessments in its rulemaking.

Congress intended for EPA to consider occupational risks from chemicals it evaluates under TSCA, among other potential exposures, as relevant and appropriate. As noted previously, section 6(b) of TSCA requires EPA to evaluate risks to potentially exposed or susceptible subpopulations identified as relevant by the Administrator. TSCA section 3(12) defines the term “potentially exposed or susceptible subpopulation” as “a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.”

The OSH Act similarly requires OSHA to evaluate risk to workers prior to promulgating new or revised standards and requires OSHA standards to substantially reduce significant risk to the extent feasible, even if workers are exposed over a full working lifetime.
See
29 U.S.C. 655(b)(5);
Indus. Union Dep't, AFL-CIO
v.
Am. Petroleum Inst.,
448 U.S. 607, 642 (1980) (plurality opinion).

Thus, the standards for chemical hazards that OSHA promulgates under the OSH Act share a broadly similar purpose with the standards that EPA promulgates under section 6(a) of TSCA. The control measures OSHA and EPA require to satisfy the objectives of their respective statutes may also, in many circumstances, overlap or coincide. However, as this section outlines, there are important differences between EPA's and OSHA's regulatory approaches and jurisdiction, and EPA considers these differences when deciding whether and how to account for OSHA requirements when evaluating and addressing potential unreasonable risk to workers so that compliance requirements are clearly explained to the regulated community. To that end, EPA has also aligned with ancillary requirements of OSHA standards, to the extent possible, by cross referencing them.

1. OSHA Requirements

OSHA's mission is to ensure that employees work in safe and healthful conditions. The OSH Act establishes requirements that each employer comply with the General Duty Clause of the Act (29 U.S.C. 654(a)), as well as with occupational safety and health standards issued under the Act.

a. General Duty Clause of the OSH Act

The General Duty Clause of the OSH Act requires employers to keep their workplace free from recognized hazards that are causing or are likely to cause death or serious physical harm to employees. The General Duty Clause is cast in general terms, and does not establish specific requirements like

exposure limits, personal protective equipment requirements (PPE), or other specific protective measures that EPA could potentially consider when developing its risk evaluations or risk management requirements. OSHA, under limited circumstances, has cited the General Duty Clause for exposure to chemicals. To prove a violation of the General Duty Clause, OSHA must prove employer or industry recognition of the hazard, the hazard was causing or likely to cause death or serious physical harm, and a feasible method to eliminate or materially reduce the hazard was available. In rare situations, OSHA has cited employers for violation of the General Duty Clause where exposures were below a chemical-specific PEL. In such situations, OSHA must demonstrate that the employer had actual knowledge that the PEL was inadequate to protect its employees from death or serious physical harm. Because of the heavy evidentiary burden on OSHA to establish violations of the General Duty Clause, it is not frequently used to cite employers for employee exposure to chemical hazards.

b. OSHA Standards

OSHA standards are issued pursuant to the OSH Act and are found in title 29 of the Code of Federal Regulations. There are separate standards for general industry, construction, maritime and agriculture sectors, as well as general standards applicable to a number of sectors (
e.g.,
OSHA's Respiratory Protection standard). OSHA has numerous standards that apply to chemical manufacturers and processors, as well as downstream employers whose employees may be occupationally exposed to hazardous chemicals.

OSHA sets legally enforceable limits on the airborne concentrations of hazardous chemicals, referred to as permissible exposure limits (PELs), to protect workers against the health effects of exposure to hazardous substances (29 CFR 1910 subpart Z, 1915 subpart Z, 1926 subparts D and Z). Under section 6(a) of the OSH Act, OSHA was permitted an initial two-year window after the passage of the Act to adopt “any national consensus standard and any established Federal standard.” 29 U.S.C. 655(a). OSHA used this authority in 1971 to establish PELs that were adopted from federal health standards originally set by the Department of Labor through the Walsh-Healy Act, in which approximately 400 occupational exposure limits were selected based on the American Conference of Governmental Industrial Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In addition, about 25 exposure limits recommended by the American Standards Association (now called the American National Standards Institute) (ANSI) were adopted as PELs.

Following the two-year window provided under section 6(a) of the OSH Act for adoption of national consensus and existing Federal standards, OSHA has issued health standards following the requirements in section 6(b) of the Act. OSHA has established approximately 30 PELs under section 6(b)(5) as part of comprehensive substance-specific standards that include additional requirements for protective measures such as use of PPE, establishment of regulated areas, exposure assessment, hygiene facilities, medical surveillance, and training. These ancillary provisions in substance specific OSHA standards further mitigate residual risk that could be present due to exposure at the PEL.

Many OSHA PELs have not been updated since they were established in 1971 (The asbestos PEL was last updated in 1994). Yet, in many instances, scientific evidence has accumulated suggesting that the current limits are not sufficiently protective. As stated on OSHA's annotated PELs web page, OSHA has recognized that many of its PELs are outdated and inadequate for ensuring protection of worker health (Ref. 5). In addition, health standards issued under section 6(b)(5) of the OSH Act must reduce significant risk only to the extent that it is technologically and economically feasible. OSHA's legal requirement to demonstrate that its section 6(b)(5) standards are technologically and economically feasible often precludes OSHA from imposing exposure control requirements sufficient to ensure that the chemical substance no longer presents a significant risk to workers. In sum, the great majority of OSHA's chemical standards are outdated or do not eliminate significant risk contemplated by the Supreme Court's interpretation of the OSH Act.
See Am. Petroleum Inst.,
448 U.S. at 655. They would, in either case, be unlikely to address unreasonable risk to workers within the meaning of TSCA, since TSCA section 6(b) unreasonable risk determinations may account for unreasonable risk to more sensitive endpoints and working populations than OSHA's risk evaluations typically contemplate, and EPA is obligated to apply TSCA section 6(a) risk management requirements to the extent necessary so that the unreasonable risk is no longer presented.

Because the requirements and application of TSCA and OSHA regulatory analyses differ, it is appropriate that EPA conduct risk evaluations and, where it finds unreasonable risk to workers, develop risk management requirements for chemical substances that OSHA also regulates, and it is expected that EPA's findings and requirements may sometimes diverge from OSHA's. However, it is also appropriate that EPA consider the chemical standards that OSHA has already developed, so as to limit the compliance burden to employers by aligning management approaches required by the agencies, where alignment will adequately address unreasonable risk to workers. The following section discusses EPA's consideration of OSHA standards in its risk evaluation and management strategies under TSCA.

2. Consideration of OSHA Standards in TSCA Risk Evaluations

When characterizing the risk during risk evaluation under TSCA, EPA believes it is appropriate to evaluate the levels of risk present in baseline scenarios where no mitigation measures are assumed to be in place for the purpose of determining unreasonable risk (see Unit II.C.2.a). (It should be noted that, there are some cases where baseline scenarios may reflect certain mitigation measures, such as in instances where exposure estimates are based on monitoring data at facilities that have existing engineering controls in place.) In addition, EPA believes it is appropriate to also evaluate the levels of risk present in scenarios considering applicable OSHA requirements (
e.g.,
chemical-specific PELs and/or chemical-specific health standards with PELs and additional ancillary provisions) as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. By characterizing risks using scenarios that reflect different levels of mitigation, EPA risk evaluations can help inform potential risk management actions by providing information that could be used during risk management to tailor risk mitigation appropriately to address any unreasonable risk identified (see Unit II.C.2.b and Unit II.C.3).

a. Risk Characterization for Unreasonable Risk Determination

When undertaking unreasonable risk determinations as part of TSCA risk evaluations, EPA cannot assume as a general matter that an applicable OSHA requirement or industry practice is consistently and always properly applied. Mitigation scenarios included in the EPA risk evaluation (
e.g.,

scenarios considering use of PPE) likely represent what is happening already in some facilities. However, the Agency cannot assume that all facilities will have adopted these practices for the purposes of making the TSCA risk determination.

Therefore, EPA conducts baseline assessments of risk and makes its determination of unreasonable risk from a baseline scenario that is not based on an assumption of compliance with OSHA standards, including any applicable exposure limits or requirements for use of respiratory protection or other PPE. Making unreasonable risk determinations based on the baseline scenario should not be viewed as an indication that EPA believes there are no occupational safety protections in place at any location, or that there is widespread noncompliance with applicable OSHA standards. Rather, it reflects EPA's recognition that unreasonable risk may exist for subpopulations of workers that may be highly exposed because they are not covered by OSHA standards, such as self-employed individuals and public sector workers who are not covered by a State Plan, or because their employer is out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA notwithstanding existing OSHA requirements.

b. Risk Evaluation To Inform Risk Management Requirements

In addition to the baseline scenario described previously, EPA risk evaluations may characterize the levels of risk present in scenarios considering applicable OSHA requirements (
e.g.,
chemical-specific PELs and/or chemical-specific health standards with PELs and additional ancillary provisions) as well as scenarios considering industry or sector best practices for industrial hygiene that are clearly articulated to the Agency. EPA's evaluation of risk under scenarios that, for example, incorporate use of engineering or administrative controls, or personal protective equipment, serves to inform its risk management efforts. By characterizing risks using scenarios that reflect different levels of mitigation, EPA risk evaluations can help inform potential risk management actions by providing information that could be used during risk management to tailor risk mitigation appropriately to address worker exposures where the Agency has found unreasonable risk. In particular, as discussed below, EPA can use the information developed during its risk evaluation to determine whether alignment of EPA's risk management requirements with existing OSHA requirements or industry best practices will adequately address unreasonable risk as required by TSCA.

In the TSCA Risk Evaluation for Asbestos, Part 1 for chrysotile asbestos, EPA presented risk estimates based on workers' exposures with and without respiratory protection. EPA determined that even when respirators are used by workers, unreasonable risk would remain in some of the conditions of use evaluated. In risk management, EPA is not relying only on the use of respirators to reduce exposures to workers so that chrysotile asbestos does not present unreasonable risk, since for some conditions of use respirators are not a viable regulatory option (
e.g.,
the respirator alone does not reduce exposures enough so that asbestos does not present unreasonable risk). In addition, EPA is considering the NIOSH/OSHA hierarchy of controls when developing risk management actions, and therefore use of respirators might only be suitable after other steps have been taken by the facilities to reduce exposures.

3. Consideration of OSHA Standards in TSCA Risk Management Actions

When undertaking risk management actions, EPA: 1. Develops occupational risk mitigation measures to address any unreasonable risks identified by EPA, striving for consistency with applicable OSHA requirements and industry best practices, including appropriate application of the hierarchy of controls, when those measures would address an unreasonable risk; and 2. Ensures that EPA requirements apply to all potentially exposed workers in accordance with TSCA requirements. Consistent with TSCA section 9(d), EPA consults and coordinates TSCA activities with OSHA and other relevant Federal agencies for the purpose of achieving the maximum applicability of TSCA while avoiding the imposition of duplicative requirements.

Informed by the mitigation scenarios and information gathered during the risk evaluation and risk management process, the Agency might propose rules that require risk management practices that may be already common practice in many or most facilities. Adopting clear, comprehensive regulatory standards will foster compliance across all facilities (ensuring a level playing field) and assure protections for all affected workers, especially in cases where current OSHA standards may not apply or not be sufficient to address the unreasonable risk.

For evaluation scenarios which involve OSHA chemical-specific PELs, EPA's risk evaluation in some cases may illustrate that limiting exposure to OSHA's PEL would result in risk levels below the benchmark under the TSCA standard under certain conditions of use. In these cases, TSCA risk management requirements could incorporate and reinforce requirements in OSHA standards and ensure that risks are addressed, including for circumstances where OSHA requirements are not applicable (
e.g.,
public sector workers) by asserting TSCA compliance/enforcement as well. EPA's risk evaluation may also find unreasonable risk under TSCA associated with some occupational conditions of use, even when the applicable OSHA requirements are being met. In these cases, EPA would need to develop risk management requirements beyond those included in OSHA's standards.

D. Summary of EPA's Risk Evaluation Activities on Chrysotile Asbestos

In July 2017, EPA published a scope of the chrysotile asbestos risk evaluation (82 FR 31592, July 7, 2017), and after receiving public comment, published a problem formulation in June 2018 (83 FR 26998, June 11, 2018). In March 2020, EPA released a draft risk evaluation for asbestos, and in December 2020, following public comment and peer review by the Science Advisory Committee on Chemicals (SACC), EPA finalized the Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos (Ref. 1).

In the Risk Evaluation for Asbestos Part 1: Chrysotile Asbestos, EPA evaluated risks associated with the conditions of use involving six non-legacy use categories of chrysotile asbestos including: Chlor-alkali diaphragms, sheet gaskets in chemical production, other gaskets, oilfield brake blocks, aftermarket automotive brake/linings, and other vehicle friction products. EPA evaluated the conditions of use within these categories, including manufacture (including import), processing, distribution, commercial use, consumer use, and disposal (Ref. 1). Descriptions of these conditions of use are included in Unit III.B.2.

The risk evaluation identified potential adverse health effects associated with exposure to chrysotile asbestos, including the risk of mesothelioma, lung cancer, and other cancers from chronic inhalation. A further discussion of the chrysotile asbestos hazards is included in Unit III.B.1. The chrysotile asbestos conditions of use that EPA determined drive the chemical substance's unreasonable risk to health include

processing and industrial use of diaphragms in the chlor-alkali industry; processing and industrial use of sheet gaskets used in chemical production; industrial use and disposal of brake blocks in the oil industry; commercial use and disposal of aftermarket automotive brakes/linings; commercial use and disposal of other vehicle friction products; commercial use and disposal of other gaskets; consumer use and disposal of aftermarket automotive brakes/linings; and consumer use and disposal of other gaskets. This determination includes unreasonable risk of injury to health to both workers and occupational non-users (ONUs) during occupational exposures, and to consumers and bystanders during exposures to consumer uses.

EPA determined that there are no conditions of use that drive unreasonable risk to the environment.

As previously discussed, following the November 2019 decision of the Ninth Circuit Court of Appeals in
Safer Chemicals Healthy Families
v.
EPA,
943 F.3d 397, the agency will also, in parallel to pursuing risk management to address unreasonable risk identified in the Risk Evaluation for Asbestos, Part 1, conduct a Part 2 of the Asbestos Risk Evaluation: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. Legacy uses and associated disposals for asbestos are conditions of use for which manufacture (including import), processing, and distribution in commerce for a use no longer occur, but where use (
e.g.,
in situ building material) and disposal are still known, intended, or reasonably foreseen to occur.

Part 2 of the Risk Evaluation for Asbestos is currently underway. The October 13, 2021, consent decree in the case
Asbestos Disease Awareness Organization et al
v.
Regan et al,
4:21-cv-03716-PJH (N.D. Cal.) requires the agency to publish a final Part 2 asbestos risk evaluation on or before December 1, 2024. EPA published a draft scope for the Part 2 asbestos risk evaluation on December 29, 2021 (86 FR 74088).

The Risk Evaluation for Asbestos, Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos will include evaluation of the legacy uses and associated disposals of chrysotile asbestos and the five amphibole fiber types described in the TSCA Title II definition in addition to Libby Amphibole Asbestos (mainly consisting of tremolite, winchite, and richterite). Additionally, where EPA identifies reasonably available information demonstrating the presence of asbestos in talc that fall under TSCA authority, talc containing asbestos impurities will be evaluated in Part 2.

As part of the problem formulation for asbestos, EPA found that exposures to the general population may occur from the conditions of use considered in Part 1 of the asbestos risk evaluation (Ref. 6). EPA determined, in Part 1 of the asbestos risk evaluation, that exposure to the general population via surface water, drinking water, ambient air, and disposal pathways falls under the jurisdiction of other environmental statutes administered by EPA. The Agency, therefore, at that time explained that it was tailoring the scope of the Part 1 risk evaluation for asbestos using authorities in TSCA sections 6(b) and 9(b)(1). As such, EPA did not evaluate hazards or exposures to the general population and the unreasonable risk determinations made in Part 1 of the asbestos risk evaluation do not account for exposures to the general population. However, EPA expects that any potential exposures to the general population would be adequately addressed through the proposed prohibition on the manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos to address the unreasonable risk posed to workers, ONUs, consumers and bystanders. EPA does plan to address exposures to the general population for the conditions of use evaluated in Part 2 of the risk evaluation.

EPA also concluded that, based on the reasonably available information in the published literature provided by industries using asbestos and reporting to EPA databases, there were minimal or no releases of asbestos to surface water associated with the conditions of use that EPA evaluated in Part 1. Therefore, EPA concluded that there is low or no risk to aquatic and sediment-dwelling organisms from exposure to chrysotile asbestos. Terrestrial pathways, including biosolids from wastewater treatment plants, were excluded from the analysis at the problem formulation stage (Refs. 1 and 6). However, EPA expects that any potential exposures to terrestrial species, as with the general population, would be adequately addressed through the proposed prohibition on the manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos.

III. Regulatory Approach

A. Background

Under TSCA section 6(a), if the Administrator determines through a TSCA section 6(b) risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the Agency's risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements to the extent necessary so that the chemical substance no longer presents such risk.

The TSCA section 6(a) requirements can include one or more of, the following actions:

• Prohibit, limit, or otherwise restrict, the manufacturing, processing, or distribution in commerce of the substance or mixture (TSCA section 6(a)(1)).

• Prohibit, limit, or otherwise restrict, the manufacturing, processing, or distribution in commerce of the substance or mixture for particular uses or above a specific concentration for a particular use (TSCA section 6(a)(2)).

• Require clear and adequate minimum warning and instructions with respect to use, distribution in commerce, or disposal of the substance or mixture (TSCA section 6(a)(3)).

• Require record keeping, monitoring or testing by manufacturers and processors (TSCA 6(a)(4)).

• Prohibit or regulate any manner or method of commercial use of the substance or mixture (TSCA section 6(a)(5)).

• Prohibit or otherwise regulate any manner or method of disposal of the substance or mixture by certain persons (TSCA section 6(a)(6)).

• Direct manufacturers or processors to give notice of the determination of unreasonable risk to distributors, users, and the public and replace or repurchase the substance or mixture (TSCA section 6(a)(7)).

As described in Unit III.B., EPA analyzed how the TSCA section 6(a) requirements could be applied so that the unreasonable risk found to be presented in Part 1 of the risk evaluation for chrysotile asbestos is no longer presented. TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating TSCA section 6(a) rules, to include a statement of effects addressing certain issues, including the effects of the chemical substance on health and the environment; the magnitude of exposure of the chemical substance to humans and the environment; the benefits of the chemical substance for various uses; and the reasonably ascertainable economic consequences of the rule, including consideration of the likely

effects of the rule on the national economy, small business, technological innovation, the environment and public health; and the costs and benefits and the cost effectiveness of the regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator. As a result, EPA is proposing a regulatory action and requesting comment on an alternative regulatory action, which are discussed in Unit IV. EPA is requesting public comment on all aspects of the proposed regulatory action and the primary alternative regulatory action.

Under the authority of TSCA section 6(g), EPA may consider granting a time-limited exemption for a specific condition of use for which EPA finds: That the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; that compliance with the proposed requirement would significantly disrupt the national economy, national security, or critical infrastructure; or that the specific condition of use of the chemical substance, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. EPA is not proposing to grant an exemption from the rule requirements. EPA is aware that chlor-alkali chemicals are used in sectors important to the national economy and operation of critical infrastructure to protect human health, for uses such as drinking water treatment. Sectors include: Water and Wastewater Systems Sector, Chemical Sector, Critical Manufacturing Sector, Defense Industrial Base Sector, Emergency Services Sector, Energy Sector, Food and Agriculture Sector, and Healthcare and Public Health sector. EPA is requesting public comment regarding the need and rationale for exemptions from the proposed rule pursuant to the provisions of TSCA section 6(g).

TSCA section 6(c)(2)(C) requires that, in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use and in setting an appropriate transition period for such action, EPA considers, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute when the proposed prohibition or restriction takes effect. Unit III.B.4. includes more information regarding EPA's consideration of alternatives.

1. Consultations

EPA conducted consultations and outreach in preparing for this proposed regulatory action. The Agency held a federalism consultation on May 13, 2021, as part of this rulemaking process and pursuant to Executive Order 13132. During the consultation EPA met with state and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development (Ref. 7). During the consultation, participants and EPA discussed the authority given under TSCA section 6 regarding prohibition, how alternatives may be treated in rulemaking, and which activities would be potentially regulated in the proposed rule (Ref. 7).

On May 24, 2021, and June 3, 2021, EPA held tribal consultations for Part 1: Chrysotile Asbestos. Tribal officials were given the opportunity to meaningfully interact with EPA risk managers concerning the current status of risk management. EPA received questions during both meetings held during the consultation period concerning potential risks to workers, consumers, and general population (Ref. 8).

EPA also conducted outreach to advocates of communities that might be subject to disproportionate exposure to chrysotile asbestos, such as minority populations, low-income populations and indigenous peoples. EPA's environmental justice (EJ) consultation occurred from June 1 through August 13, 2021. On June 1 and 9, 2021, EPA held public meetings as part of this consultation. These meetings were held pursuant to and in compliance with Executive Orders 12898 and 14008. EPA received several comments following the EJ meetings. Commenters expressed concerns that consumers who live near chlor-alkali facilities and Do-It-Yourself (DIY) auto workers could be exposed unless chrysotile asbestos is banned (Ref. 9).

Units VIII.C., VIII.E., VIII.F., VIII.J. provide more information regarding the consultations.

2. Other Stakeholder Consultations

In addition to the consultations described in Units VIII.C., VIII.E., VIII.F., and VIII.J. on February 3, 2021, EPA held a public webinar (Ref. 10) and also attended a Small Business Administration roundtable on February 5, 2021, where EPA staff provided an overview of the TSCA risk management process and the findings in the Part 1 risk evaluation (EPA-HQ-OPPT-2021-0057). Attendees of these meetings were given an opportunity to voice their concerns on both the risk evaluation and the risk management process.

Furthermore, EPA engaged in discussions with industry, non-governmental organizations, other national governments, asbestos experts and users of chrysotile asbestos. Summaries of external meetings held during the development of this proposed rule are in the docket. These meetings helped to inform how long industry would need to implement a prohibition, how companies currently protect workers, and the extent to which each industry uses asbestos-free technology. Additionally, discussions with the Canadian government helped EPA to better understand how Canada approached its 2018 regulation to prohibit asbestos use (such as the asbestos-containing products covered in the prohibition and the chosen prohibition effective dates) to better inform this proposed rule (Refs. 4 and 11). The purpose of these stakeholder discussions was to hear from importers, processors, distributors, users, academics, advisory councils, and members of the public health community about the conditions of use evaluated for chrysotile asbestos; substitute chemicals or alternative methods; engineering control measures and personal protective equipment currently in use or potentially feasible for adoption; and other risk reduction approaches that may have already been adopted or considered for the evaluated conditions of use.

B. Regulatory Assessment of Chrysotile Asbestos Under Part 1

This Unit describes the additional information that EPA considered in deciding the proposed regulatory approach for chrysotile asbestos, so that chrysotile asbestos would no longer present an unreasonable risk under the conditions of use evaluated under Part 1 of the risk evaluation. This Unit describes the unreasonable risk, the conditions of use of chrysotile asbestos that are the focus of this regulation, and how EPA is proposing to apply the TSCA section 6(a) requirements, including the consideration of alternatives in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use.

1. Description of Unreasonable Risk

The health endpoint driving EPA's determination of unreasonable risk for chrysotile asbestos under the conditions of use is cancer from inhalation exposure (Ref. 1). This unreasonable risk includes the risk of mesothelioma,

lung cancer, and other cancers from chronic inhalation. An inhalation unit risk (IUR), which is an estimate of the carcinogenic risk associated with a unit concentration of air, was developed for chrysotile asbestos. The IUR was based on epidemiological studies on mesothelioma and lung cancer in cohorts of workers using chrysotile asbestos in commerce. Since there was no exposure-response data for cancer of the ovary and laryngeal cancer effects, a direct estimate of risk from ovarian and laryngeal cancer could not be made for the unit risk calculation. An adjustment factor for ovarian and laryngeal cancer effects was applied to risk value estimates to correct for the negative bias in the risk values derived from only lung cancer and mesothelioma. And, as discussed in Section 4.2.1 of the Risk Evaluation (Ref. 1), for workers and ONUs exposed in a workplace, EPA used as a benchmark extra risks of 1 cancer per 10,000 people. At this risk level 1×10-4 (1E-4), if the noncancer effects (
e.g.,
asbestosis and pleural thickening) of chrysotile asbestos are similar to Libby Amphibole Asbestos, the non-cancer effects of chrysotile asbestos are likely to contribute additional risk to the overall health risk of chrysotile asbestos beyond the risk of cancer. Thus, the overall health risks of chrysotile asbestos are underestimated based on cancer risk alone.

For processing and industrial use of chrysotile asbestos diaphragms, EPA found unreasonable risk to workers from chronic inhalation exposure to chrysotile asbestos, based on industry data including personal air monitoring (
i.e.,
worker breathing zone results) and area air monitoring (
i.e.,
fixed location air monitoring results) that led to the high-end risk estimates exceeding the 1E-4 risk benchmark (Ref. 1).

For both the processing (
i.e.,
gasket cutting) and industrial use activities of chrysotile asbestos-containing sheet gaskets for chemical production, EPA found unreasonable risk to workers and ONUs from chronic inhalation exposure to chrysotile asbestos based on monitoring data provided by industry and data in the published literature (Ref. 1).

For the industrial use and disposal of chrysotile asbestos-containing oilfield brake blocks, EPA found unreasonable risk to workers and ONUs from chronic inhalation exposure to chrysotile asbestos based on a 1988 study of Norway's offshore petroleum industry (Ref. 1).

For the commercial use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings and other vehicle friction products (except for the NASA Super Guppy Turbine aircraft use), EPA found unreasonable risk to workers and ONUs from chronic inhalation exposure to chrysotile asbestos based on published literature and OSHA data (Section 2.3.1.8.1 of the Risk Evaluation). EPA determined, based on exposure data provided by NASA to EPA (Section 2.3.1.8.2 of the Risk Evaluation), that the use and disposal of chrysotile asbestos-containing brakes for NASA's Super Guppy Turbine aircraft did not present an unreasonable risk of injury to health or the environment.

For the commercial use and disposal of other chrysotile asbestos-containing gaskets, EPA found unreasonable risk to workers and ONUs from chronic inhalation exposure to chrysotile asbestos based on exposure scenarios from occupational monitoring data for asbestos-containing gasket replacement activities in vehicles.

For consumer use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings and other chrysotile asbestos-containing gaskets, EPA found unreasonable risk to consumers and bystanders from chronic inhalation exposure to chrysotile asbestos, using as a benchmark cancer risk level of 1x10-6 (1E-6) for consumers and bystanders.

EPA also noted in the Part 1 asbestos risk evaluation that it is possible for industrial workers or consumers working with aftermarket automotive products or other types of asbestos-containing gaskets to cause unintentional exposure to individuals in their residence due to take-home exposure from contaminated clothing or other items. While EPA did not identify or receive information which could inform such an exposure scenario and does not currently have models which can adequately evaluate and address this pathway, take-home exposures were considered pathways in the Part 1 risk evaluation for asbestos that could increase risk to populations associated with the workers, ONUs, consumers or bystanders.

Unit V.A. summarizes the health effects and the magnitude of the exposures (Ref. 1).

The regulatory actions proposed, and alternatives, so that chrysotile asbestos no longer presents this unreasonable risk, are in Unit IV.

2. Description of Conditions of Use

This Unit describes the conditions of use subject to this proposed regulatory action.

Although EPA identified both industrial and commercial uses in Part 1 of the risk evaluation for purposes of distinguishing scenarios, the Agency clarified then and clarifies now that EPA interprets the authority over “any manner or method of commercial use” under TSCA section 6(a)(5) to reach both.

The conditions of use subject to this proposed regulatory action do not include any legacy uses or associated disposal for chrysotile asbestos or other asbestos fiber types. EPA will consider legacy uses and associated disposals in Part 2 of the risk evaluation for asbestos (Ref. 1).

a. Processing and industrial use of chrysotile asbestos diaphragms in the chlor-alkali industry:

Chrysotile asbestos is imported and used by the chlor-alkali industry for the fabrication of semi-permeable diaphragms. The chrysotile asbestos diaphragms are used in an industrial process for the production of chorine and sodium hydroxide (caustic soda). Asbestos is chemically inert and able to effectively separate chlorine and sodium hydroxide in electrolytic cells. The chlor-alkali chemical production process involves the separation of the sodium and chloride atoms of salt in saltwater (brine) via electricity to produce sodium hydroxide (caustic soda), hydrogen, and chlorine. This reaction occurs in an electrolytic cell. The cell contains two compartments separated by a semi-permeable diaphragm, which is made mostly of chrysotile asbestos. The diaphragm prevents the reaction of the caustic soda with the chlorine and allows for the separation of both materials for further processing. Diaphragms are typically used for 1-3 years before they must be replaced (Ref. 1).

b. Processing and industrial use of chrysotile asbestos-containing sheet gaskets in chemical production:

Sheet gaskets are used to form a leakproof seal between fixed components. Chrysotile asbestos-containing gaskets are used primarily in industrial applications with extreme operating conditions, such as high temperatures, high pressures, and the presence of chlorine or other corrosive substances. Such extreme production conditions are found in many chemical manufacturing and processing operations, including: The manufacture of titanium dioxide and chlorinated hydrocarbons; polymerization reactions involving chlorinated monomers; and steam cracking at petrochemical facilities. Chrysotile asbestos-containing gaskets are fabricated from sheets composed of 80% (minimum) chrysotile asbestos fully encapsulated in styrene butadiene rubber. The chrysotile asbestos-containing sheets are imported

into the U.S. in large rolls where they are cut to shape by a fabricator and subsequently used at titanium dioxide manufacturing facilities. Installed gaskets typically remain in use anywhere from a few weeks to three years (Ref. 1).

c. Industrial use and disposal of chrysotile asbestos-containing brake blocks in oil industry:

The rotary drilling rig of an oil well uses a drawworks hoisting machine to raise and lower the traveling blocks during drilling. The drawworks is a permanently installed component of a mobile drilling rig. The drawworks consists of a large-diameter steel spool, a motor, a main brake, a reduction gear, and an auxiliary brake. The brake of the drawworks hoisting machine is an essential component that is engaged when no motion of the traveling block is desired. Chrysotile asbestos-containing brake blocks are imported for use in some drawworks, reportedly most often on larger drilling rigs. Spent brake blocks must periodically be replaced by workers in the oilfield industry who maintain the rig (Ref. 1).

d. Commercial use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings:

The two primary types of automobile brakes are drum brakes and disc brakes, and chrysotile asbestos has been found in both, in linings for drum brake assemblies and pads in disc brake assemblies. Disc brakes are much more common today than drum brakes, but many passenger vehicles have a combination of disc brakes for the front wheels and drum brakes for the rear wheels. Chrysotile asbestos fibers offer many properties that are desired for brake linings and brake pads, and up through the 1990s many new automobiles manufactured in the United States had brake assemblies with asbestos-containing components. However, by 2000, asbestos was no longer used in the brakes of virtually any original equipment manufacturer (OEM) automobiles sold domestically. Asbestos in automotive parts is not currently banned in the U.S., and asbestos-containing brake products may be imported and sold in the United States. The quantity of asbestos-containing brake parts imported is unknown. Therefore, asbestos could be found in the United States: (1) In vehicles on the road that have asbestos-containing brakes, whether from older and vintage vehicles or aftermarket parts; and (2) in vehicles that have new asbestos-containing brakes installed by establishments or individuals that use certain imported products. Brakes must be repaired and replaced periodically, which involves activities that create dust and potential occupational exposure to asbestos (Ref. 1).

e. Commercial use and disposal of other chrysotile asbestos-containing vehicle friction products:

While EPA has verified that U.S. automotive manufacturers are not installing asbestos-containing brakes on new cars for domestic distribution, EPA identified a company that claimed to import asbestos-containing brakes and then install them on cars in the United States for export only. Following completion of the risk evaluation, and during the risk management phase following publication of the final risk evaluation, this company disavowed this practice (Ref. 12).

In addition, there is a limited use of asbestos-containing brakes for a special, large transport plane, the “Super-Guppy” Turbine (SGT) aircraft, owned and operated by the National Aeronautics and Space Administration (NASA). The SGT aircraft is a specialty cargo plane that transports oversized equipment, and it is considered a mission-critical vehicle. Only one SGT aircraft is in operation today, and NASA acquired it in 1997. The SGT aircraft averages approximately 100 flights per year. When not in use, it is hangered and maintained at a NASA facility in El Paso, Texas. The SGT aircraft has eight landing gear systems, and each system has 32 brake blocks, which contain chrysotile asbestos. Potential worker exposures are associated with servicing the brakes. As explained in the risk evaluation, the following two conditions of use do not present unreasonable risk, and therefore do not require mitigation by this proposed regulation: Use of chrysotile asbestos-containing brakes for a specialized, large NASA transport plane; and the disposal of chrysotile asbestos-containing brakes for a specialized, large NASA transport plane (Ref. 1).

f. Commercial use and disposal of other asbestos-containing gaskets:

EPA also identified the use of chrysotile asbestos-containing gaskets in the exhaust system of a specific type of utility vehicle manufactured and available for purchase in the United States. The utility vehicle manufacturer purported at the time to receive the pre-cut gaskets which are then installed during manufacture of the vehicle. The gaskets may be removed during servicing of the exhaust system. EPA determined that workers and ONUs who install the gaskets during assembly and workers who may repair these vehicles are exposed to asbestos (Ref. 1).

g. Consumer use and disposal of aftermarket automotive chrysotile asbestos-containing brakes/linings:

As discussed in Unit III.B.2.d., asbestos could be found in the United States: (1) In vehicles on the road that have asbestos-containing brakes, whether from original manufacturers (primarily for older and vintage vehicles) or aftermarket parts; and (2) in vehicles that have new asbestos-containing brakes installed by establishments or individuals that use certain imported products. Brakes must be repaired and replaced periodically, activities which create dust and exposure to asbestos for consumers and bystanders who perform their own do-it-yourself automobile maintenance and repairs on asbestos-containing components (Ref. 1).

h. Consumer use and disposal of other asbestos-containing gaskets:

As discussed in Unit III.B.2.f., EPA also identified the use of chrysotile asbestos-containing gaskets in the exhaust system of a specific type of utility vehicle manufactured and available for purchase in the United States. The gaskets may be removed during servicing of the exhaust system. EPA determined that do-it-yourself consumers who may repair these vehicles and bystanders are exposed to asbestos (Ref. 1).

3. Description of TSCA Section 6(a) Requirements Considered To Address Unreasonable Risk

EPA examined which requirements or combination of requirements under TSCA section 6(a), as described in Unit III, have the potential to reduce the risk to workers, occupational non-users (ONUs), consumers and bystanders so that chrysotile asbestos no longer presents unreasonable risk. As required by TSCA, as amended, in selecting among these requirements, EPA factored in, to the extent practicable, considerations including the effects of the chemical on health and the environment, the benefits of the chemical substance for various uses, and the reasonably ascertainable economic consequences of the rule, including the effect of the rule on the national economy, small business, technological innovation, the environment and public health; the costs and benefits of the proposed regulatory action and one or more primary regulatory alternative regulatory actions considered; and the cost effectiveness of the proposed regulatory action and of the one or more primary alternative regulatory actions considered. See Unit V for further discussion related to TSCA section

(c)(2)(A) considerations, including the statement of effects of the proposed rule with respect to these considerations.

EPA developed a proposed regulatory action and one primary alternative regulatory action, which are described in Units IV.A. and IV.B. To identify and select a regulatory action, EPA considered the route of exposure driving the unreasonable risk (inhalation) and the exposed population. For consumer conditions of use, EPA considered how it could exercise its authority under TSCA to regulate the manufacturing, processing, and distribution in commerce of chrysotile asbestos at different levels in the supply chain to eliminate or restrict the availability of chrysotile asbestos and chrysotile asbestos-containing products for consumer use to effectively address the unreasonable risk to consumers and bystanders. EPA also considered the regulatory authority under TSCA and other statutes such as OSHA, CPSA, and other EPA-administered statutes to examine (1) whether there are opportunities for identified risk from chrysotile asbestos to be addressed under other statutes, such that a referral may be warranted under TSCA section 9(a) or section 9(b), or (2) whether TSCA section 6(a) regulation could include alignment of requirements and definitions to minimize confusion to the regulated entities and the general public.

In addition, EPA considered other TSCA requirements such as the consideration of alternatives when recommending prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as outlined in Unit III.B.4.), and the requirements in TSCA section 6(d)(1)(B) for compliance dates (described in the proposed and primary alternative regulatory actions in Unit IV.).

To the extent information was reasonably available, when selecting regulatory actions, EPA considered the pollution prevention actions and the hierarchy of controls adopted by OSHA and NIOSH, with the goal of identifying risk management control methods that are permanent, feasible, and effective. EPA also considered how to address the unreasonable risk while providing flexibility to the regulated entities, given the functionality and the performance efficacy of chrysotile asbestos. EPA considered the information presented in the risk evaluation, additional input from stakeholders (as described in Unit III.A.) and anticipated compliance strategies from regulated entities.

EPA evaluated regulatory options under TSCA section 6(a) to address the unreasonable risk found to be presented by chrysotile asbestos under the conditions of use evaluated in the Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos. EPA is proposing a prohibition of the manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos in bulk form and as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production (descriptions of these conditions of use are in Unit III.B.2.) two years following the effective date of the final rule, which is 60 days after final rule promulgation. Associated with that prohibition, EPA considered and is proposing interim recordkeeping requirements and is proposing to cross reference existing disposal regulations. The proposed prohibition, recordkeeping requirements, and cross referencing are described in more detail in Unit IV.A. Similarly, EPA evaluated and is proposing a prohibition of the manufacture (including import), processing, distribution in commerce and industrial or commercial use of chrysotile asbestos-containing brake blocks used in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; other vehicle friction products; and asbestos-containing gaskets 180 days after the effective date of the final rule. EPA is further proposing pursuant to TSCA section 6(a) to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use 180 days after the effective date of the final rule. EPA also is proposing disposal and recordkeeping requirements for these conditions of use. EPA does not intend the proposed prohibitions on processing or distribution in commerce to prohibit any processing or distribution in commerce incidental to disposal of the chrysotile asbestos waste in accordance with the proposed requirements.

EPA considered alternative regulatory requirements that would reduce exposures in occupational settings and address consumer and bystander exposure so that chrysotile asbestos no longer presents unreasonable risk. A possible requirement under TSCA section 6(a) that EPA considered was the use of respirators; however, EPA determined that respirators were not adequate for all conditions of use that are driving unreasonable risk, and EPA also would like to consider the NIOSH/OSHA hierarchy of controls instead of consideringly only respirators as part of management of occupational exposures. Other possible requirements under TSCA section 6(a) such as limiting the weight fraction or size of the items containing chrysotile asbestos, were not considered since those seemed impracticable for the conditions of use under consideration. Other possible requirements under TSCA section 6(a) that EPA considered in combination under the primary alternative regulatory action, such as labels, warning signs, and recordkeeping, are discussed in Unit IV.B.

The primary alternative option EPA considered for the chlor-alkali diaphragm and sheet gasket categories was a prohibition to take effect over a longer time (five years), and the establishment of a risk-based performance standard, known as an existing chemical exposure limit (ECEL) to reduce inhalation exposures by workers and occupational non-users during that period prior to the prohibition. EPA developed an 8-hour time-weighted average (TWA) ECEL in support of risk management efforts on chrysotile asbestos under TSCA section 6(a). EPA calculated the ECEL to be 0.005 fibers/cc (f/cc) for inhalation exposures to chrysotile asbestos as an 8-hour TWA (Ref. 13).

Requirements to meet an ECEL would not include requirements for specific engineering or administrative controls; rather, the ECEL is a performance-based exposure limit that would allow regulated entities to determine how to most effectively meet the ECEL based on what works best for their workplace, while following the hierarchy of controls to the extent feasible (
e.g.,
preferential use of methods which prevent generation or release of asbestos in the workplace rather than relying on respiratory protection to meet the ECEL; see Unit IV.B.1, Exposure Controls).

In general, industrial and commercial facilities are already familiar with the concept of permissible exposure limits (PELs) required by OSHA. Based on their familiarity with the PELs and corresponding methods of compliance, some industrial and commercial facilities may be able to implement an ECEL. EPA recognizes that an ECEL will require time and resources to prepare for and therefore did not propose to include it for the two-year interim period prior to the proposed prohibition date. It is also unknown whether facilities could, under the ECEL provision, routinely monitor at or below the ECEL or ECEL-action level with reasonable certainty. Additionally, there are uncertainties regarding whether

facilities would need to routinely rely on the use of respiratory protection considering the engineering and administrative controls already in place and the effectiveness of the respiratory protection to ensure that air concentrations above the ECEL do not result in unreasonable risk (see Section 2.3.1.2 of the Risk Evaluation). For these reasons, EPA did not include in the proposed regulation requirements to meet an ECEL. However, the ECEL is included as an interim exposure reduction measure in the primary alternative regulatory action, based on the longer interim period prior to prohibition considered in the primary alternative regulatory action. Details of the ECEL requirement included in the primary alternative regulatory action, including how facilities could demonstrate compliance, are described in Unit IV.B.

In addition, EPA considered other requirements, such as requiring monitoring and recordkeeping to demonstrate compliance with the ECEL, or downstream notification to communicate the date of prohibition for manufacturing, processing and distribution in commerce. These requirements are described in Unit IV.B.

As required under TSCA section 6(d), any rule under TSCA section 6(a) must specify the date of compliance, which shall be as soon as practicable with a reasonable transition period but begin no later than five years after the date of promulgation of the rule. These proposed compliance dates are detailed in Unit IV.A.

Because a determination has been made that chrysotile asbestos presents an unreasonable risk to health within the United States or to the environment of the United States, pursuant to TSCA section 12(a)(2), this proposed rule would apply to chrysotile asbestos even if being manufactured, processed, or distributed in commerce solely for export from the United States.

After considering the different regulatory requirements under TSCA section 6(a), consideration of alternatives (described in Unit III.B.4.), compliance dates, and other requirements under TSCA section 6(c), EPA developed the proposed regulatory action described in Unit IV.A. and a primary alternative regulatory action described in Units IV.B.1., IV.B.5, IV.B.6, and IV.B.7.

4. Consideration of Alternatives in Deciding Whether To Prohibit or Substantially Restrict Chrysotile Asbestos

In selecting among prohibitions and other restrictions available under TSCA section 6(a), EPA must under section 6(c)(2)(A) and (B) consider and factor in, to the extent practicable, the health and environmental effects and exposures of the chemical, the benefits of the chemical for various uses and the reasonably ascertainable economic consequences of the rule (described in Unit V.). Further, under TSCA section 6(c)(2)(C) and based on the information published under TSCA section 6(c)(2)(A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, EPA must also consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect.

a. Health and environmental effects of the chemical alternatives or substitute methods:

In considering the potential chemical alternatives or substitute methods for chrysotile asbestos for the conditions of use evaluated in the risk evaluation, EPA notes that chrysotile asbestos is not currently the primary substance most commonly used in these conditions of use, nor has it been for the last decade. Chlor-alkali asbestos diaphragms, sheet gaskets for chemical production, aftermarket automotive breaks, oilfield brake blocks, other gaskets and other friction products containing chrysotile asbestos are relatively uncommon in the market space, as described in the risk evaluation. There are a number of alternatives to asbestos in these conditions of use that make up the majority of the market share and have been preferentially used for some time, in part as a result of the known severe and adverse health effects related to asbestos exposure. Based on the information published under TSCA section 6(c)(2)(A), EPA does not expect any adverse impacts to human health and the environment to result from the further reduction of asbestos in these conditions of use when compared to the continued use of asbestos.

EPA acknowledges that substitute technologies for asbestos-containing diaphragms in chlor-alkali production use an increased concentration of per- and polyfluoroalkyl substances (PFAS) relative to the amount of PFAS compounds contained in asbestos-containing diaphragms. As discussed in the Economic Analysis, the three types of chlor-alkali production technologies commonly used in the United States vary in their use of PFAS. Non-asbestos diaphragms have a higher concentration of polytetrafluoroethylene (PTFE, a polymeric perfluorinated substance) than asbestos-containing diaphragms, and non-asbestos membranes are made of PTFE, perfluorinated carboxylic acids and perfluorosulfonic acids. Therefore, the transition away from asbestos-containing diaphragms could result in greater usage and release of PFAS. EPA lacks information to determine whether increased usage is likely to cause increased release of PFAS at chlor-alkali facilities that currently rely on asbestos-containing diaphragms, chlor-alkali facilities that do not currently use asbestos-containing diaphragms that may expand their production as a result of the regulation, upstream facilities that produce membranes, or upstream facilities that produce perfluorinated fibers used in non-asbestos diaphragms. EPA requests public comment with monitoring data and other information that would allow the Agency to assess how a transition away from asbestos containing diaphragms may affect exposures to PFAS released by chlor-alkali facilities. Despite these uncertainties about possible greater use and release of PFAS, EPA believes the benefits of removing chrysotile asbestos, a known human carcinogen that causes an aggressive and deadly cancer (mesothelioma), from continued use in the United States, are significant even though there are uncertainties regarding the potential additional exposure to PFAS that might result from this action.

b. Technical feasibility, economic feasibility, and reasonable availability of the chemical alternatives or substitute methods:

As mentioned, there are a number of alternatives to asbestos in these conditions of use that make up the majority of the market share and have been preferentially used for some time. EPA received input from stakeholders regarding their concerns about alternatives to chrysotile asbestos. EPA expects non-asbestos diaphragms and membrane cells will be the likely substitutes to asbestos diaphragms. Each chlor-alkali industry member consulted expressed concerns about the economic feasibility of transitioning to asbestos free technology (Refs. 14, 15, 16, 17, and 20), indicating that would take a significant amount of time. Several stakeholders provided feedback on alternatives to chrysotile asbestos for the sheet gasket use in chemical production. Generally, these stakeholders described how the transition from asbestos use for titanium dioxide production would require significant capital investment. One stakeholder noted they have a titanium dioxide production facility

located in Taiwan that uses asbestos-free gaskets. The stakeholder, however, stated that the technology used in the Taiwan facility would not suit certain domestic titanium dioxide plants because the large diameter flanges in the domestic plants result in performance issues with the asbestos-free gaskets (Ref. 14). Non-asbestos technologies already dominate the market for other gaskets, oilfield brake blocks, brakes and other friction products. Although, stakeholders indicated the advantages of using asbestos (
e.g.,
asbestos in automotive drum brakes advantages include thermal stability, flexibility, resistance to wear, and low cost), and limitations of the non-asbestos replacements (
e.g.,
non-asbestos replacements in brake blocks have a useful life half that of products containing asbestos, are more expensive than asbestos-containing products, and are subject to sudden failure) (Ref. 2). Non-asbestos aftermarket automotive brakes are estimated to cost an average of $4 more than brakes containing asbestos. Asbestos-free brake blocks are also more expensive than those containing asbestos according to a company importing asbestos brake blocks. EPA was unable to identify any companies currently supplying or using other gaskets or other friction products containing asbestos, so the Agency does not have information on the cost differentials between products that contain asbestos and those that are asbestos-free. Additional information is available in the risk evaluation (Ref. 1) and economic analysis (Ref. 2).

IV. Proposed and Primary Alternative Regulatory Actions

This Unit describes EPA's proposed regulatory action to address the unreasonable risk identified for chrysotile asbestos under certain conditions of use in EPA's Risk Evaluation for Asbestos Part 1, so that chrysotile asbestos no longer presents such risk (Ref. 1). In addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider the cost and benefits and the cost effectiveness of the proposed regulatory action and one or more primary alternative regulatory actions. In the case of chrysotile asbestos, the proposed regulatory option is described in Unit IV.A. and the primary alternative regulatory action is described in Unit IV.B.

A. Proposed Regulatory Action

EPA is proposing under TSCA section 6(a) to: Prohibit manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos in bulk form or as part of: 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; and other vehicle friction products. EPA is also proposing to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use and other chrysotile asbestos-containing gaskets for consumer use. EPA is also proposing disposal requirements and recordkeeping requirements under which regulated parties would document compliance with the proposed disposal requirements. EPA does not intend the proposed prohibitions on processing or distribution in commerce to prohibit any processing or distribution in commerce incidental to disposal of the chrysotile asbestos waste in accordance with the proposed requirements.

Under this proposed approach and pursuant to TSCA section 6(d)(1), the manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk form or as part of diaphragms in the chlor-alkali industry and for asbestos-containing sheet gaskets used in chemical production would be prohibited two years after the effective date of the final rule. Manufacture (including import), processing, distribution in commerce, and commercial use of: Chrysotile asbestos-containing brake blocks in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; other chrysotile asbestos-containing vehicle friction products; and asbestos-containing gaskets would be prohibited 180 days after the effective date of the final rule. Disposal and recordkeeping requirements would take effect 180 days after the effective date of the final rule. As noted in Unit III.B.2.e, these prohibitions would not apply to chrysotile asbestos in the NASA Super Guppy Turbine aircraft, which is a condition of use for which EPA did not make a determination of unreasonable risk.

EPA requests comment on any suggestions to address the unreasonable risk identified while recognizing that chrysotile asbestos is a natural occurring fiber that may be unintentionally present (
e.g.,
by incorporating a
de minimis
level). In particular, in lieu of proposing a
de minimis
provision for chrysotile asbestos with this proposed rule, EPA requests comment on incorporating a
de minimis
provision for chrysotile asbestos where the regulatory requirements of the rule would apply: (1) Only at concentrations in a product greater than or equal to 0.1% by weight; (2) at any concentration in a product, if intentionally added; or (3) above another
de minimis
level.

Other national governments, in their prohibitions of asbestos, have used threshold levels or other provisions to limit the regulation of products that contain trace amounts of chrysotile asbestos present as unintentional or naturally occurring fibers in other material obtained from mineral sources, such as brake pads and other friction materials (Ref. 4).

1. Prohibition on manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk form or as part of chrysotile asbestos diaphragms in the chlor-alkali industry and for chrysotile asbestos-containing sheet gaskets in chemical production.

EPA consulted with several companies who manufacture, process, distribute, and use chrysotile asbestos diaphragms in the chlor-alkali industry and process and use chrysotile asbestos-containing sheet gaskets in chemical production. Each company stated that while alternatives may exist, they could take many years to implement. EPA considered this information while developing the proposed regulatory option and compliance timeframes.

EPA proposes to prohibit manufacturing (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos under TSCA sections 6(a)(2) and 6(a)(5) in bulk form or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and for chrysotile asbestos-containing sheet gaskets used in chemical production. The prohibition would take effect two years from the effective date of the final rule. Pursuant to TSCA section 6(d)(1), when EPA elects to ban or phase-out a chemical substance, the start of the ban or phaseout must be as soon as practicable but not later than five years after the date of promulgation of the rule, and the date for full implementation must be as soon as practicable thereafter. EPA believes safer, economically viable alternatives are available for these conditions of use. Specifically, for the chrysotile asbestos diaphragms, EPA is aware of one company already transitioning to exclusive use of alternative technologies such as membrane and non-asbestos diaphragm technologies. All three domestic companies that use chrysotile

asbestos diaphragms currently also use membrane or non-asbestos diaphragms at their chlor-alkali facilities. The plants range in age from 40 to 123 years old, although some have had new capacity added as recently as 16 years ago, and others may have had recent refurbishments. EPA understands from industry stakeholder consultations that there are no plans to build new chlor-alkali plants that use chrysotile asbestos technology for the production of chlorine and caustic soda (Refs. 14, 15, and 16). One of the three remaining chlor-alkali companies that continue to use chrysotile-asbestos technology domestically stated to EPA in 2017 that they plan to voluntarily discontinue the use chrysotile asbestos (Ref. 18).

Globally, the chlor-alkali industry has transitioned away from chrysotile asbestos diaphragms to membrane-based technology or asbestos-free diaphragm technology due to prohibitions or impending prohibitions of chrysotile asbestos and the advantages of asbestos-free technology including greater energy efficiency, and reduced waste handling and disposal costs for asbestos-free materials. Only one chlor-alkali plant that uses chrysotile asbestos technology remains in operation in the European Union (EU), but it will phase-out of chrysotile asbestos use no later than 2025 to comply with the EU prohibition on chrysotile asbestos use by that date (Ref. 19). One chlor-alkali plant utilizing chrysotile asbestos technology remains in operation in Canada (Ref. 11). The Canadian government prohibited chrysotile asbestos use in the chlor-alkali industry with a compliance date of no later than the end of 2029.

EPA considers the proposed two-year effective date for the prohibition on manufacturing (including import), processing, distribution in commerce, and use of chrysotile asbestos in bulk form and as part of chrysotile asbestos diaphragms in the chlor-alkali industry to be achievable by the industry, thus meeting the “as soon as practicable” requirement of TSCA section 6(d)(1). EPA believes an aggressive transition away from chrysotile asbestos will spur adoption of superior technology and that potential supply disruptions could be addressed in the shorter term through increased importing of caustic soda and derivatives of chlorine and caustic soda, and over time with increased production at existing non-asbestos diaphragm or membrane-based chlor-alkali plants. However, EPA is aware that public drinking water and wastewater systems have experienced substantial price increases for chlor-alkali products related to supply shortages and COVID pandemic impacts. EPA has insufficient information to fully assess the impact of this proposed rule on the cost or availability of water treatment chemicals. EPA requests public comment on the potential impact of changes in supply on the availability and cost of water treatment chemicals, including both chlorine and caustic soda used directly in water treatment as well as the potential impact on the cost of other water treatment chemicals derived from chlorine or caustic soda.

Chrysotile asbestos-containing sheet gaskets are used in limited chemical production applications, particularly for the manufacture of titanium dioxide. EPA believes alternative gaskets are available that can meet the high-temperature and pressure conditions for which the chrysotile asbestos-containing gaskets are currently used. At least one manufacturer of titanium dioxide uses only asbestos-free gaskets (Ref. 14) and the two-year transition away from existing use of chrysotile gaskets should be feasible based on the availability of these substitutes.

EPA requests comment on whether the proposed prohibition date would both provide a reasonable transition period and be as soon as practicable under TSCA section 6(d)(1). EPA requests specific information to support or refute its assumption that plants using asbestos diaphragms will convert to non-asbestos technologies, and the timeframes required for such conversions. EPA is requesting comments on potential alternative transition strategies and timing to implement those strategies. EPA is requesting specific information regarding potential barriers to achieving the proposed prohibition date while considering the supply of chlor-alkali chemicals and on the potential impact of this transition on the market price of chlor-alkali chemicals.

2. Prohibition on manufacture (including import), processing, distribution in commerce, and commercial use of: Chrysotile asbestos-containing brake blocks in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; asbestos-containing vehicle friction products; and other asbestos-containing gaskets.

EPA is proposing under TSCA section 6(a)(2) and 6(a)(5) to prohibit manufacturing (including import), processing, distribution in commerce and commercial use of: Chrysotile asbestos-containing brake blocks in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; other asbestos-containing vehicle friction products (excluding the NASA SGT use); and other asbestos-containing gaskets. Based upon discussions with trade groups and industry representatives (Refs. 14, 15, 16, 17, 20 and 21), EPA believes chrysotile asbestos is almost entirely phased out for these product categories. Thus, these prohibitions would not only address the unreasonable risk EPA has identified, but also, for this reason, upon consideration of the TSCA section 6(c)(2)(A) factors can achieve that statutory requirement without an undue economic burden on these industries overall. EPA is proposing that the prohibition take effect 180 days after the effective date of the final rule for these categories of use. In the context of these specific uses of chrysotile asbestos, which EPA believes are almost entirely phased out, EPA has no information indicating that these proposed compliance dates are not practicable; however, EPA is requesting public comment regarding the timing of the prohibition . This additional amount of time from the proposed regulatory option is meant to account for stakeholders who may not have engaged with EPA in advance of this proposed rule, and who may potentially have difficulty immediately transitioning away from chrysotile asbestos in the manufacture, processing, distribution, and use, of chrysotile asbestos-containing brake blocks, chrysotile asbestos-containing aftermarket automotive brakes and linings, other chrysotile asbestos-containing vehicle friction products and other chrysotile asbestos-containing gaskets.

3. Prohibition on manufacture (including import), processing, and distribution in commerce for aftermarket automotive chrysotile asbestos-containing brakes/linings and other asbestos-containing gaskets for consumer use.

EPA is proposing under TSCA section 6(a)(2) to prohibit the manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use and of other chrysotile asbestos-containing gaskets for consumer use. EPA is proposing that the prohibition on manufacture (including import), processing and distribution in commerce for consumer use take effect 180 days after the effective date of the final rule for these categories of use, identical to the equivalent proposed prohibition on manufacture (including import), processing, and distribution in commerce of chrysotile asbestos for commercial use. EPA has no information indicating that the proposed compliance dates for these

prohibitions are not practicable for these consumer use-related categories. While EPA does not have the authority under TSCA section 6(a)(5) to regulate consumer use or under TSCA section 6(a)(6) to regulate disposal by someone other than a manufacturer, processor, or a person who uses or disposes of the substance commercially, prohibiting the manufacture (including import), processing, and distribution in commerce of these products for both commercial and consumer uses will remove them from the market and therefore effectively eliminate new instances of consumer use and the associated disposals from such use.

4. Other requirements.

a. Disposal:

EPA proposes to cross reference existing EPA and OSHA regulations that address asbestos-containing waste disposal. By following these existing regulations, worker and ONU exposure to chrysotile asbestos during disposal can be prevented.

For this rule, EPA proposes that for each condition of use, regulated entities must adhere to waste disposal requirements described in OSHA's Asbestos General Industry Standard in 29 CFR 1910.1001, including 1910.1001(k)(6), which requires 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. EPA expects regulated entities to follow these requirements for unused and end-of-use products containing chrysotile asbestos

Additionally, for the chrysotile asbestos diaphragm condition of use, as well as oilfield brake blocks, other vehicle friction products, and any commercial use of other gaskets and aftermarket automotive brakes and linings, EPA is proposing to cross-reference the disposal requirements of Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP) (40 CFR part 61, subpart M) at 40 CFR 61.150. The asbestos NESHAP reduces exposure to airborne asbestos by generally requiring sealing of asbestos-containing waste material from regulated activities in a leak-tight container and disposing of it in a landfill permitted to receive asbestos waste. EPA is not proposing to cross-reference this same NESHAP waste disposal provision for the disposal of chrysotile asbestos-containing waste from sheet gasket processing and use, because EPA did not find unreasonable risk for the disposal of sheet gaskets. However, EPA is requesting comment on this, since, according to industry communications to EPA, they already follow these work practices.

EPA is also proposing to require that, upon disposal, each manufacturer (including importer), processor, and distributor of chrysotile asbestos, including as part of products and articles, for consumer uses subject to this proposed regulation, dispose of such items in accordance with specified disposal provisions. These consumer uses are afterma

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2022-07601. Public record. Not legal advice.