[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]
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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.
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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 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 http://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 http://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 http://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 http://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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