[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 89-91]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29109]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0501; FRL-10017-43]


Asbestos (Part 1: Chrysotile Asbestos); Final Toxic Substances 
Control Act (TSCA) Risk Evaluation; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final Toxic Substances Control Act (TSCA) risk 
evaluation of Asbestos Part 1 (Chrysotile Asbestos). The purpose of 
conducting risk evaluations under TSCA is to determine whether a 
chemical substance presents an unreasonable risk of injury to health or 
the environment under the conditions of use, including an unreasonable 
risk to a relevant potentially exposed or susceptible subpopulation, 
without consideration of costs or other nonrisk factors. EPA has 
determined that specific conditions of use of Chrysotile Asbestos 
present an unreasonable risk of injury to health. For those conditions 
of use for which EPA has found an unreasonable risk, EPA must take 
regulatory action to address that unreasonable risk through risk 
management measures enumerated in TSCA. EPA has also determined that 
specific conditions of use do not present unreasonable risk of injury 
to health or the environment. For those conditions of use for which EPA 
has found no

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unreasonable risk to health or the environment, the Agency's 
determination is a final Agency action and is issued via order in the 
risk evaluation. EPA is currently developing Part 2 of the TSCA risk 
evaluation for Asbestos which will evaluate risk of injury to health or 
the environment for legacy uses and associated disposals of asbestos. 
The Agency plans to release a draft scope for Part 2 of the risk 
evaluation for Asbestos for public comment mid-year 2021.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2019-0501, is available online 
at https://www.regulations.gov or in-person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Public Reading Room are closed to visitors 
with limited exceptions. The EPA/DC staff continue to provide remote 
customer service via email, phone, and webform. 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: Collin Beachum, Office of 
Pollution Prevention and Toxics (7403M), Environmental Protection 
Agency, 109 T.W. Alexander Drive, Research Triangle Park, NC 27711; 
(919) 541-7554; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may 
be of interest to persons who are or may be interested in risk 
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq. 
Since other entities may also be interested in this final risk 
evaluation, the EPA has not attempted to describe all the specific 
entities that may be affected by this action.

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

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk 
evaluations to ``determine whether a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other nonrisk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant to the risk evaluation by the Administrator, 
under the conditions of use.'' 15 U.S.C. 2605(b)(4)(A). TSCA sections 
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements 
applicable to this process, including provisions that provide 
instruction on chemical substances that must undergo evaluation, the 
minimum components of a TSCA risk evaluation, and the timelines for 
public comment and completion of the risk evaluation. TSCA also 
requires that EPA operate in a manner that is consistent with the best 
available science, make decisions based on the weight of the scientific 
evidence and consider reasonably available information. 15 U.S.C. 
2625(h), (i), and (k). TSCA section 6(i) directs that a determination 
of ``no unreasonable risk'' shall be issued by order and considered to 
be a final Agency action, while a determination of ``unreasonable 
risk'' is not considered to be a final Agency action. 15 U.S.C. 
2605(i).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) Integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation must not consider costs or other nonrisk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii).
    The statute requires that the risk evaluation process be completed 
within a specified timeframe and provide an opportunity for public 
comment on a draft risk evaluation prior to publishing a final risk 
evaluation. 15 U.S.C. 2605(b)(4).
    Subsection 5.3.1 of the final risk evaluation for Asbestos Part 1 
(Chrysotile Asbestos) constitutes the order required under TSCA section 
6(i)(1), and the ``no unreasonable risk'' determinations in that 
subsection are considered to be a final Agency action effective on the 
date of issuance of the order. In conducting risk evaluations, ``EPA 
will determine whether the chemical substance presents an unreasonable 
risk of injury to health or the environment under each condition of 
use[ ] within the scope of the risk evaluation, either in a single 
decision document or in multiple decision documents. '' 40 CFR 702.47. 
Under EPA's implementing regulations, ``[a] determination by EPA that 
the chemical substance, under one or more of the conditions of use 
within the scope of the risk evaluation, does not present an 
unreasonable risk of injury to health or the environment will be issued 
by order and considered to be a final Agency action, effective on the 
date of issuance of the order.'' 40 CFR 702.49(d). For purposes of TSCA 
section 19(a)(1)(A), the date of issuance of the TSCA section 6(i)(1) 
order for Asbestos Part 1 (Chrysotile Asbestos) shall be at 1:00 p.m. 
Eastern time (standard or daylight, as appropriate) on the date that is 
two weeks after the date when this notice is published in the Federal 
Register, which is in accordance with 40 CFR 23.5.

C. What action is EPA taking?

    EPA is announcing the availability of the risk evaluation of the 
chemical substance identified in Unit II. In this risk evaluation EPA 
has made unreasonable risk determinations on some of the conditions of 
use within the scope of the risk evaluation for this chemical. For 
those conditions of use for which EPA has found an unreasonable risk of 
injury to health or the environment, EPA must initiate regulatory 
action to address those risks through risk management measures 
enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required 
to be provided publicly with each risk evaluation, which is available 
online at

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https://www.regulations.gov in the dockets identified. 40 CFR 702.51. 
Specifically, for the risk evaluation of Asbestos Part 1 (Chrysotile 
Asbestos), EPA has provided:
     The scope document and problem formulation (in Docket ID 
No. EPA-HQ-OPPT-2016-0736);
     Draft risk evaluation and final risk evaluation (in Docket 
ID No. EPA-HQ-OPPT-2019-0501);
     All notices, determinations, findings, consent agreements, 
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0501);
     Any information required to be provided to the Agency 
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0736 and Docket 
ID No. EPA-HQ-OPPT-2019-0501);
     A nontechnical summary of the risk evaluation (in Docket 
ID No. EPA-HQ-OPPT-2019-0501);
     A list of the studies, with the results of the studies, 
considered in carrying out each risk evaluation in Docket ID No. EPA-
HQ-OPPT-2019-0501);
     The final peer review report, including the response to 
peer review and public comments received during peer review (in Docket 
ID No. EPA-HQ-OPPT-2019-0501); and
     Response to public comments received on the draft scope 
and the draft risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0501).

II. TSCA Risk Evaluation

A. What is EPA's risk evaluation process for existing chemicals under 
TSCA?

    The risk evaluation process is the second step in EPA's existing 
chemical review process under TSCA, following prioritization and before 
risk management. As this chemical is one of the first ten chemical 
substances undergoing risk evaluation, the chemical substance was not 
required to go through prioritization (81 FR 91927, December 19, 2016) 
(FRL-9956-47). The purpose of conducting risk evaluations is to 
determine whether a chemical substance presents an unreasonable risk of 
injury to health or the environment under the conditions of use, 
including an unreasonable risk to a relevant potentially exposed or 
susceptible subpopulation. As part of this process, EPA must evaluate 
both hazard and exposure, not consider costs or other nonrisk factors, 
use reasonably available information and approaches in a manner that is 
consistent with the requirements in TSCA for the use of the best 
available science, and ensure decisions are based on the weight of the 
scientific evidence.
    The specific risk evaluation process that EPA has established by 
rule to implement the statutory process is set out in 40 CFR part 702 
and summarized on EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on 
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702, 
subpart B is being followed for the first ten chemical substances 
undergoing risk evaluation to the maximum extent practicable.
    Prior to the publication of this final risk evaluation, a draft 
risk evaluation was subject to peer review and public comment. EPA 
reviewed the report from the peer review committee and public comments 
and has amended the risk evaluation in response to these comments as 
appropriate. The public comments, peer review report, and EPA's 
response to comments is in Docket ID No. EPA-HQ-OPPT-2019-0501. Prior 
to the publication of the draft risk evaluation, EPA made available the 
scope and problem formulation, and solicited public input on uses and 
exposure. EPA's documents and the public comments are in Docket ID No. 
EPA-HQ-OPPT-2016-0736. Additionally, information about the scope, 
problem formulation, and draft risk evaluation phases of the TSCA risk 
evaluation for this chemical is available at EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-asbestos-0.

B. Definition of asbestos?

    For the purposes of the Risk Evaluation for Asbestos under TSCA 
Section 6(a), EPA is using the TSCA section 202 definition of asbestos; 
which is--``asbestiform varieties of six fiber types--chrysotile 
(serpentine), crocidolite (riebeckite), amosite (cummingtonite-
grunerite), anthophyllite, tremolite or actinolite.'' Part 1 of the 
Risk Evaluation for Asbestos is focused on Chrysotile Asbestos, as this 
is the only fiber type currently being imported, processed, or 
distributed for use in the United States. It is used in diaphragms, 
sheet gaskets, other gaskets, oilfield brake blocks, aftermarket 
automotive brakes/linings, and other vehicle friction products. Part 1 
of the Risk Evaluation for Asbestos presents risk determinations for 
Chrysotile Asbestos attributable to these conditions of use.

C. Risk Evaluation for Asbestos Part 2: Legacy Uses and Associated 
Disposals of Asbestos

    As a result of the court decision in Safer Chemicals Healthy 
Families v. EPA, 943 F.3d 397 (9th Cir. 2019), EPA will evaluate legacy 
uses and associated disposals for Asbestos in Part 2 of the Risk 
Evaluation which is under expedited development. Legacy uses and 
associated disposals of Asbestos are conditions of use for which 
manufacture, import, processing and distribution no longer occur but 
where use and disposal, respectively, are still known, intended, or 
reasonably foreseen to occur. Part 2 of the Risk Evaluation for 
Asbestos will consider all six fiber types of Asbestos described in the 
TSCA definition.
    Part 2 of the Risk Evaluation for Asbestos will begin with a draft 
scope document that will be made available for public comment. EPA will 
engage external stakeholders, where appropriate, to obtain reasonably 
available information related to legacy uses and associated disposals, 
including in situ in older buildings or still present in older 
equipment that has not exceeded its useful life.

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

Andrew Wheeler,
Administrator.
[FR Doc. 2020-29109 Filed 12-31-20; 8:45 am]
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