[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
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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]
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