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[Federal Register Volume 89, Number 232 (Tuesday, December 3, 2024)]
[Notices]
[Pages 95777-95779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28285]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0254; FRL-9347-07-OCSPP]

Asbestos Part 2 Supplemental Evaluation Including Legacy Uses and 
Associated Disposals; Risk Evaluation Under the Toxic Substances 
Control Act (TSCA); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing the availability of the final supplemental risk evaluation 
under the under the Toxic Substances Control Act (TSCA) for asbestos 
Part 2: addressing legacy uses and associated disposal. The purpose of 
risk evaluations under TSCA is to determine whether a chemical 
substance presents an unreasonable risk of injury to health or the 
environment, without consideration of costs or non-risk factors, 
including unreasonable risk to potentially exposed or susceptible 
subpopulations identified as relevant to the risk evaluation by EPA, 
under the conditions of use. For the part 2 supplemental risk 
evaluation, the Agency evaluated legacy uses and associated disposals 
of asbestos including chrysotile asbestos, five additional fiber types, 
conditions of use for asbestos-containing talc that are subject to 
TSCA, and Libby asbestos. EPA used the best available science to 
prepare this final supplemental risk evaluation and determined, based 
on the weight of scientific evidence, that asbestos poses unreasonable 
risk to human health. Under TSCA, EPA must initiate risk management 
actions to address the unreasonable risk.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-EPA-HQ-OPPT-2021-0254, is available 
online at https://www.regulations.gov. Additional information about 
dockets generally, along with instructions for visiting the docket in-
person, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information: Peter Gimlin, Existing Chemicals Risk 
Management Division (7404M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 566-0515; email address: 
[email protected].
    For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
particular interest to those involved in the manufacture, processing, 
distribution, use, and disposal of asbestos-containing materials 
(ACMs), including construction professionals and individuals completing 
do-it-yourself (DIY) activities in buildings with ACMs, related 
industry trade organizations, non-governmental organizations with an 
interest in human and environmental health, state and local 
governments, Tribal Nations, and/or those interested in the assessment 
of risks involving chemical substances and mixtures regulated under 
TSCA. As such, the Agency has not attempted to describe all the 
specific entities that this action might apply to. If you need help 
determining applicability, consult the technical contact listed under 
FOR FURTHER INFORMATION CONTACT.

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

    TSCA section 6, 15 U.S.C. 2605, requires the Agency to conduct risk 
evaluations on chemical substances and identifies the minimum 
components EPA must include in all chemical substance risk evaluations. 
Each risk evaluation must be conducted consistent with the best 
available science, be based on the weight of scientific evidence, and 
consider reasonably available information per 15 U.S.C. 2625(h), (i), 
and (k). See also the implementing procedural regulations at 40 CFR 
part 702.

C. What action is the Agency taking?

    EPA is announcing the availability of the final supplemental risk 
evaluation for asbestos legacy uses and associated disposals of 
Asbestos (also referred to as the Asbestos Part 2 Risk Evaluation) 
(Ref. 1). The purpose of risk evaluations under TSCA is to determine 
whether a chemical substance presents an unreasonable risk of injury to 
health or the environment, without consideration of costs or non-risk 
factors, including unreasonable risk to potentially exposed

[[Page 95778]]

or susceptible subpopulations identified as relevant to the risk 
evaluation by EPA, under the conditions of use. The Agency has used the 
best available science to prepare this final risk evaluation and based 
on the weight of scientific evidence, determined that asbestos poses 
unreasonable risk to human health. Upon a determination of unreasonable 
risk, EPA must initiate risk management action as required pursuant to 
15 U.S.C. 2605(a) to address the unreasonable risk.

II. Background

    When EPA designated asbestos as one of the first 10 existing 
chemicals to undergo risk evaluation under TSCA (Ref. 1), the risk 
evaluation focused on chrysotile asbestos, which is the only type of 
asbestos fiber where manufacture (including import), processing, and 
distribution in commerce for use was known, intended, or reasonably 
foreseen in the U.S. In Safer Chemicals, Healthy Families v. EPA, 943 
F.3d 397 (9th Cir. 2019) the court held that EPA's Risk Evaluation 
Procedural Rule (82 FR 33726, July 20, 2017 (FRL-9964-38)) should not 
have excluded ``legacy uses'' (i.e., uses without ongoing or 
prospective manufacturing, processing, or distribution) and 
``associated disposals'' (i.e., future disposal of legacy uses) from 
the definition of conditions of use. As a result, the risk evaluation 
for asbestos was split into two parts.
    1. Asbestos (Part 1: Chrysotile Asbestos). (Ref. 2) The final risk 
evaluation for Asbestos (Part 1: Chrysotile Asbestos) was released in 
January 2021 (86 FR 89, January 4, 2021; FRL-10017-43), covering all 
intended, known, or reasonably foreseen import, processing, and 
distribution of chrysotile asbestos; uses of chrysotile asbestos that 
have been imported, processed, and distributed; and disposal of such 
chrysotile asbestos uses. The final rule to address the unreasonable 
risk identified in the Asbestos Part 1 Risk Evaluation was issued in 
March 2024 (89 FR 21970, March 28, 2024; FRL-8332-01-OCSPP).
    2. Asbestos Part 2: Supplemental Evaluation Including Legacy Uses 
and Associated Disposals of Asbestos. (Ref. 3) Legacy uses and 
associated disposals of chrysotile asbestos, five additional fiber 
types, conditions of use for asbestos-containing talc that are subject 
to TSCA, and Libby asbestos are the subject of the Asbestos Part 2 Risk 
Evaluation, which is scheduled to be finalized on or before December 1, 
2024, per the consent decree in the case Asbestos Disease Awareness 
Organization et al. v. Regan et al., 4:21-cv-03716 (N.D. Cal.).
    In the Asbestos Part 2 Risk Evaluation, EPA concludes that 
asbestos, as a chemical substance and as evaluated in parts 1 and 2 of 
the risk evaluation process under TSCA, presents an unreasonable risk 
of injury to health under its conditions of use. This single 
unreasonable risk determination for asbestos replaces the previous 
unreasonable risk determinations made for asbestos by individual 
conditions of use and supersedes the determination (and withdraws the 
associated order) of no unreasonable risk for the conditions of use 
identified in the TSCA section 6(i)(1) order in Section 5.3.1 of the 
December 2020 Risk Evaluation for Asbestos Part I: Chrysotile Asbestos 
(Ref. 4). This determination does not alter any of the underlying 
technical or scientific information that informs the risk 
characterization in part 1, and as such the hazard, exposure, and risk 
characterization sections of part 1 are not changed by this 
unreasonable risk determination for asbestos.
    The final Asbestos Part 2 Risk Evaluation addresses comments from 
the public on the draft risk evaluation, as well as from the public 
comment and letter peer reviewer on the White Paper: Quantitative Human 
Health Approach to be Applied in the Risk Evaluation for Asbestos Part 
2--Supplemental Evaluation Including Legacy Uses and Associated 
Disposals of Asbestos (Ref. 5). The responses to peer review and public 
comments (Refs. 8 and 9), along with the final Asbestos Part 2 Risk 
Evaluation (Ref. 1) and a nontechnical summary document (Ref. 6), are 
available in the docket.
    For more information about the TSCA risk evaluation process for 
existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.

III. Unreasonable Risk Determination

    EPA has determined that a single risk determination on the chemical 
substance asbestos is appropriate in order to protect health and the 
environment, because there are benchmark exceedances for multiple 
conditions of use (spanning across most aspects of the chemical life 
cycle, from manufacturing [including import], processing, industrial, 
commercial and consumer use, and disposal) for human health. 
Furthermore, the risk of severe health effects--specifically 
mesothelioma and lung, ovarian, and laryngeal cancers, along with non-
cancer effects--is associated with chronic inhalation exposures of 
asbestos. Because these chemical-specific properties cut across the 
conditions of use within the scope of the risk evaluation and a 
substantial portion of the conditions of use contribute to the 
unreasonable risk, it is therefore appropriate for the Agency to 
determine that the chemical substance presents an unreasonable risk. 
For those conditions of use assessed in the 2020 Risk Evaluation for 
Asbestos, Part 1: Chrysotile Asbestos (Ref. 4), EPA does not intend to 
amend, nor does a single risk determination on the chemical substance 
require, amending the underlying scientific analysis and the risk 
characterization.
    EPA has determined that asbestos presents an unreasonable risk of 
injury to human health under the conditions of use. The Agency has 
determined that the unreasonable risk to human health presented by 
asbestos is due to: (1) Cancer and non-cancer effects in workers, 
including ONUs and firefighters, from inhalation exposures; (2) Cancer 
and non-cancer effects in handlers and bystanders from inhalation 
exposures associated with handling of garments taken home from 
occupational exposure; (3) Cancer and non-cancer effects in consumers 
and bystanders from inhalation exposures; and (4) Cancer and non-cancer 
effects in the general population from inhalation exposures.
    Consistent with the statutory requirements of TSCA section 6(a), 
EPA will propose a risk management regulatory action to the extent 
necessary so that asbestos no longer presents an unreasonable risk to 
human health. The Agency expects to focus its risk management action on 
the conditions of use that significantly contribute to the unreasonable 
risk identified in the Asbestos Part 2 Risk Evaluation (Ref 3). 
However, it should be noted that under TSCA section 6(a), EPA is not 
limited to regulating the specific activities found to drive 
unreasonable risk and may select from among a suite of risk management 
requirements in TSCA section 6(a) related to manufacture (including 
import), processing, distribution in commerce, commercial use, and 
disposal as part of its regulatory options to address the unreasonable 
risk. As a general example, EPA may regulate upstream activities (e.g., 
processing, distribution in commerce) to address downstream activities 
(e.g., consumer uses) driving unreasonable risk, even if the upstream 
activities do not drive the unreasonable risk.
    TSCA requires EPA to initiate regulatory action to address those 
risks through risk management measures

[[Page 95779]]

enumerated in TSCA section 6(a), 15 U.S.C. 2605(a). The Agency is given 
a range of risk management options under TSCA--including labeling, 
recordkeeping or notice requirements, actions to reduce human exposure 
or environmental release, and a ban of the chemical or of certain uses. 
EPA will not be revisiting the risk management for the unreasonable 
risk that was identified in the Asbestos Part 1 Risk Evaluation (Ref. 
4) and that was addressed in the final rule that was issued in March 
2024 (89 FR 21970, March 28, 2024; FRL-8332-01-OCSPP).
    Like the prioritization and risk evaluation processes, there is an 
opportunity for public comment on any proposed risk management actions.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA) and Initiation of Risk Evaluation on 
High-Priority Substances; Notice of Availability. Federal Register. 
84 FR 71924, December 30, 2019 (FRL-10003-15).
2. EPA. Asbestos (Part 1: Chrysotile Asbestos); Final Toxic 
Substances Control Act (TSCA) Risk Evaluation; Notice of 
Availability. Federal Register. 86 FR 89, January 4, 2021 (FRL-
10017-43).
3. EPA. Asbestos Part 2 Supplemental Evaluation Including Legacy 
Uses and Associated Disposals; Draft Risk Evaluation Under the Toxic 
Substances Control Act; Notice of Availability, Webinar and Request 
for Comment. Federal Register. 89 FR 26878, April 16, 2023 (FRL-
9347-06-OCSPP).
4. EPA. Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos. 
December 2020. Office of Chemical Safety and Pollution Prevention. 
Washington, DC. December 2020. (EPA Document ID No. EPA-HQ-OPPT-
2021-0057-0007). https://www.regulations.gov/document/EPA-HQ-OPPT-2021-0057-0007.
5. EPA. Letter Peer Review; White Paper: Quantitative Human Health 
Approach To Be Applied in the Risk Evaluation for Asbestos Part 2; 
Notice of Availability and Request for Comment. Federal Register. 88 
FR 51309, August 3, 2023 (FRL-10017-43).
6. EPA. Nontechnical Summary of the TSCA Risk Evaluation for 
Asbestos (Part 2) November 2024. (EPA Document ID No. EPA-740-S-24-
006).
7. EPA. Asbestos Part 1; Chrysotile Asbestos; Regulation of Certain 
Conditions of Use Under the Toxic Substances Control Act (TSCA). 
Federal Register. 89 FR 21970, March 28, 2024 (FRL-8332-01-OCSPP).
8. EPA. Draft Comment Summary and Responses for Asbestos Part 2: 
Supplemental Evaluation Including Legacy Uses and Associated 
Disposals of Asbestos; Regulation Under the Toxic Substances Control 
Act. November 2024.
9. EPA. Draft Comment Summary and Responses for Letter Peer Review 
of White Paper: Quantitative Human Health Approach To Be Applied in 
the Risk Evaluation for Asbestos Part 2. November 2024.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: November 26, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-28285 Filed 12-2-24; 8:45 am]
BILLING CODE 6560-50-P
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