Methylene Chloride (MC); Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability, 37942-37944 [2020-13581]
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37942
Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices
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Persons unable to file electronically
may mail similar pleadings to the
Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC
20426. Hand delivered submissions in
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assistance, contact the Federal Energy
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toll-free, (886) 208–3676 or TYY, (202)
502–8659.
Dated: June 18, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020–13628 Filed 6–23–20; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2015–0765; FRL–10011–20–
ORD]
Board of Scientific Counselors (BOSC)
Executive Committee Meeting–July
2020
Environmental Protection
Agency (EPA).
ACTION: Notice of public meeting.
AGENCY:
The Environmental Protection
Agency (EPA), Office of Research and
Development (ORD), gives notice of a
meeting of the Board of Scientific
Counselors (BOSC) Executive
Committee (EC) to review the Chemical
Safety and Sustainability and Health
and Environmental Risk Assessment
(CSS–HERA) Subcommittee’s report on
the Strategic Research Action Plan
(StRAP) of ORD’s HERA research
program. The committee will also
receive a briefing on ORD research on
SARS–COV–2 and EPA’s new approach
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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methods (NAMs) work plan to reduce
animal testing.
DATES: The videoconference meeting
will be held on Tuesday, July 7, 2020,
from 11:00 a.m. to 5:15 p.m. (EDT).
Meeting times are subject to change.
This meeting is open to the public.
Those who wish to attend must register
by July 6, 2020. Comments must be
received by July 6, 2020, to be
considered by the subcommittee.
Requests for the draft agenda or making
a presentation at the meeting will be
accepted until July 3, 2020.
ADDRESSES: Instructions on how to
connect to the videoconference will be
provided upon registration at https://
epa-bosc-executivecommittee.eventbrite.com. Attendees
should register no later than July 6,
2020.
Submit your comments to Docket ID
No. EPA–HQ–ORD–2015–0765 by one
of the following methods:
• www.regulations.gov: Follow the
online instructions for submitting
comments.
D Note: comments submitted to the
www.regulations.gov website are
anonymous unless identifying
information is included in the body of
the comment.
• Email: Send comments by
electronic mail (email) to: ORD.Docket@
epa.gov, Attention Docket ID No. EPA–
HQ–ORD–2015–0765.
D Note: comments submitted via
email are not anonymous. The sender’s
email will be included in the body of
the comment and placed in the public
docket which is made available on the
internet.
Instructions: All comments received,
including any personal information
provided, will be included in the public
docket without change and may be
made available online at
www.regulations.gov. Information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute
will not be included in the public
docket, and should not be submitted
through www.regulations.gov or email.
For additional information about the
EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/dockets/.
Public Docket: Publicly available
docket materials may be accessed
Online at www.regulations.gov.
Copyrighted materials in the docket are
only available via hard copy. The
telephone number for the ORD Docket
Center is (202) 566–1752.
FOR FURTHER INFORMATION CONTACT: The
Designated Federal Officer (DFO), Tom
Tracy, via phone/voice mail at: (202)
PO 00000
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Fmt 4703
Sfmt 4703
564–6518; or via email at: tracy.tom@
epa.gov. Any member of the public
interested in receiving a draft agenda,
attending the meeting, or making a
presentation at the meeting should
contact Tom Tracy.
SUPPLEMENTARY INFORMATION: The Board
of Scientific Counselors (BOSC) is a
federal advisory committee that
provides advice and recommendations
to EPA’s Office of Research and
Development on technical and
management issues of its research
programs. Meeting agenda and materials
will be posted to https://www.epa.gov/
bosc. Proposed agenda items for the
meeting include but are not limited to
the following: Review of the CSS–HERA
report, ORD research on SARS–COV–2,
and EPA’s NAMs work plan.
Information on Services Available:
For information on translation services,
access, or services for individuals with
disabilities, please contact Tom Tracy at
(202) 564–6518 or tracy.tom@epa.gov.
To request accommodation of a
disability, please contact Tom Tracy at
least ten days prior to the meeting to
give the EPA adequate time to process
your request.
Authority: Pub. L. 92–463, 1, Oct. 6, 1972,
86 Stat. 770.
Dated: June 19, 2020.
Mary Ross,
Director, Office of Science Advisor, Policy,
and Engagement.
[FR Doc. 2020–13620 Filed 6–23–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2019–0437; FRL–10011–
16]
Methylene Chloride (MC); Final Toxic
Substances Control Act (TSCA) Risk
Evaluation; Notice of Availability
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) is announcing the
availability of the final Toxic
Substances Control Act (TSCA) risk
evaluation of methylene chloride (MC).
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. EPA has determined that
specific conditions of use of methylene
SUMMARY:
E:\FR\FM\24JNN1.SGM
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Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices
chloride present an unreasonable risk of
injury to health. For those conditions of
use for which EPA has found an
unreasonable risk, EPA must move 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
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.
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2019–0437, 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. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
Please note that due to the public
health emergency the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
ADDRESSES:
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FOR FURTHER INFORMATION CONTACT:
For technical information contact: Dr.
Stan Barone, Office of Pollution
Prevention and Toxics (7403M),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
564–1169; email address: barone.stan@
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:
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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
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37943
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)–(ii) and (iv)–(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).
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 . . .’’ 40
CFR 702.47. Pursuant to TSCA section
6(i)(1), a determination of ‘‘no
unreasonable risk’’ shall be issued by
order and considered to be final Agency
action. 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). Subsection 5.4.1 of the final
risk evaluation for MC 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.
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 all
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 move to address those risks
through risk management measures
enumerated in 15 U.S.C. 2605(a). For
those conditions of use for which EPA
has found no unreasonable risk of injury
to health or the environment, the
Agency’s determination is a final
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37944
Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices
Agency action and is issued via order,
per 15 U.S.C. 2605(i)(1), in the risk
evaluation, subsection 5.4.1.
EPA is also announcing the
availability of the information required
to be provided publicly with each risk
evaluation. 40 CFR 702.51. Specifically,
EPA has provided:
• The scope document and problem
formulation (in Docket EPA–HQ–OPPT–
2016–0742);
• Draft risk evaluation, and final risk
evaluation (in Docket EPA–HQ–OPPT–
2019–0437);
• All notices, determinations,
findings, consent agreements, and
orders (in Docket EPA–HQ–OPPT–
2019–0437);
• Any information required to be
provided to the Agency under 15 U.S.C.
2603 (in Docket EPA–HQ–OPPT–2016–
0742 and Docket EPA–HQ–OPPT–2019–
0437);
• A nontechnical summary of the risk
evaluation (in Docket EPA–HQ–OPPT–
2019–0437);
• A list of the studies, with the results
of the studies, considered in carrying
out each risk evaluation (Risk
Evaluation for Methylene Chloride
(Dichloromethane, DCM) in Docket
EPA–HQ–OPPT–2019–0437);
• The final peer review report,
including the response to peer review
and public comments received during
peer review (in Docket EPA–HQ–OPPT–
2019–0437); and
• Response to public comments
received on the draft scope and the draft
risk evaluation (in Docket EPA–HQ–
OPPT–2019–0437).
II. TSCA Risk Evaluation
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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
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
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requirements in TSCA for the use of the
best available science, and ensure
decisions are based on the weight of
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-managingchemicals-under-tsca/risk-evaluationsexisting-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 EPA–HQ–OPPT–2019–0437.
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 EPA–
HQ–OPPT–2016–0732. Additionally,
information about the scope, problem
formulation, and draft risk evaluation
phases of the TSCA risk evaluation for
this chemical is at https://www.epa.gov/
assessing-and-managing-chemicalsunder-tsca/risk-evaluation-methylenechloride-0.
B. What is methylene chloride?
Methylene chloride (MC), also known
as dichloromethane and DCM, is a
volatile chemical used as a solvent in a
wide range of industrial, commercial
and consumer applications. The
primary uses for methylene chloride are
for paint removal, adhesives, metal
cleaning, aerosol solvents, chemical
processing and flexible polyurethane
foam manufacturing. Information from
the 2016 Chemical Data Reporting (CDR)
for MC indicates the reported
production volume is more than 260
million lbs per year (manufacture and
import).
Authority: 15 U.S.C. 2601 et seq.
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Dated: June 17, 2020.
Andrew Wheeler,
Administrator.
[FR Doc. 2020–13581 Filed 6–23–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–10010–92–Region 5]
Clean Air Act Operating Permit
Program; Petition for Objection to
State Operating Permit for Riverview
Energy Corporation; Petition for
Objection to State Operating Permit for
ESSROC Cement Corporation
Environmental Protection
Agency (EPA).
ACTION: Notice of final orders on
petitions for objection to two Clean Air
Act title V operating permits.
AGENCY:
The Environmental Protection
Agency (EPA) Administrator signed an
Order dated March 26, 2020, denying a
Petition dated August 6, 2019 from
Southwestern Indiana Citizens for
Quality of Life, Inc. and Valley Watch,
Inc. The Petition requested that EPA
object to a Clean Air Act (CAA) title V
operating permit issued by the Indiana
Department of Environmental
Management (IDEM) to Riverview
Energy Corporation for its direct coal
hydrogenation facility located in Dale,
Spencer County, Indiana. The EPA
Administrator also signed an Order
dated April 1, 2020, denying a Petition
dated January 4, 2017 from Vicki L.
Whittinghill. The Petition requested that
EPA object to a CAA title V operating
permit issued by IDEM to ESSROC
Cement Corporation for its Portland
cement manufacturing plant located in
Clark County, Indiana.
ADDRESSES: The final Orders, the
Petitions, and other supporting
information are available for public
inspection during normal business
hours at the following address: U.S.
Environmental Protection Agency,
Region 5, Air and Radiation Division, 77
West Jackson Boulevard, Chicago,
Illinois 60604. This facility is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding Federal holidays and
facility closures due to COVID–19. We
recommend that you telephone Michael
Langman, Environmental Scientist, at
(312) 886–6867 before visiting the
Region 5 office. Additionally, the final
Orders and Petitions are available
electronically at: https://www.epa.gov/
title-v-operating-permits/title-v-petitiondatabase.
SUMMARY:
E:\FR\FM\24JNN1.SGM
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Agencies
[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Pages 37942-37944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13581]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0437; FRL-10011-16]
Methylene Chloride (MC); Final Toxic Substances Control Act
(TSCA) Risk Evaluation; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final Toxic Substances Control Act (TSCA) risk
evaluation of methylene chloride (MC). 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. EPA has
determined that specific conditions of use of methylene
[[Page 37943]]
chloride present an unreasonable risk of injury to health. For those
conditions of use for which EPA has found an unreasonable risk, EPA
must move 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 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.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2019-0437, 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. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Dr. Stan Barone, Office of
Pollution Prevention and Toxics (7403M), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202) 564-1169; 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)-(ii) and (iv)-(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).
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 . . .'' 40 CFR 702.47. Pursuant to TSCA section
6(i)(1), a determination of ``no unreasonable risk'' shall be issued by
order and considered to be final Agency action. 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). Subsection 5.4.1 of the final risk
evaluation for MC 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.
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 all 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 move to address those
risks through risk management measures enumerated in 15 U.S.C. 2605(a).
For those conditions of use for which EPA has found no unreasonable
risk of injury to health or the environment, the Agency's determination
is a final
[[Page 37944]]
Agency action and is issued via order, per 15 U.S.C. 2605(i)(1), in the
risk evaluation, subsection 5.4.1.
EPA is also announcing the availability of the information required
to be provided publicly with each risk evaluation. 40 CFR 702.51.
Specifically, EPA has provided:
The scope document and problem formulation (in Docket EPA-
HQ-OPPT-2016-0742);
Draft risk evaluation, and final risk evaluation (in
Docket EPA-HQ-OPPT-2019-0437);
All notices, determinations, findings, consent agreements,
and orders (in Docket EPA-HQ-OPPT-2019-0437);
Any information required to be provided to the Agency
under 15 U.S.C. 2603 (in Docket EPA-HQ-OPPT-2016-0742 and Docket EPA-
HQ-OPPT-2019-0437);
A nontechnical summary of the risk evaluation (in Docket
EPA-HQ-OPPT-2019-0437);
A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation (Risk Evaluation for
Methylene Chloride (Dichloromethane, DCM) in Docket EPA-HQ-OPPT-2019-
0437);
The final peer review report, including the response to
peer review and public comments received during peer review (in Docket
EPA-HQ-OPPT-2019-0437); and
Response to public comments received on the draft scope
and the draft risk evaluation (in Docket EPA-HQ-OPPT-2019-0437).
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 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
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 EPA-HQ-OPPT-2019-0437. 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 EPA-HQ-
OPPT-2016-0732. Additionally, information about the scope, problem
formulation, and draft risk evaluation phases of the TSCA risk
evaluation for this chemical is at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-methylene-chloride-0.
B. What is methylene chloride?
Methylene chloride (MC), also known as dichloromethane and DCM, is
a volatile chemical used as a solvent in a wide range of industrial,
commercial and consumer applications. The primary uses for methylene
chloride are for paint removal, adhesives, metal cleaning, aerosol
solvents, chemical processing and flexible polyurethane foam
manufacturing. Information from the 2016 Chemical Data Reporting (CDR)
for MC indicates the reported production volume is more than 260
million lbs per year (manufacture and import).
Authority: 15 U.S.C. 2601 et seq.
Dated: June 17, 2020.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-13581 Filed 6-23-20; 8:45 am]
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