Document ID: EPA-HQ-OPPT-2019-0437-0081
Agency: epa
Document Type: Notice
Title: Methylene Chloride (MC); Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability
Posted Date: 2020-06-24T04:00Z

[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: 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: 

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]
BILLING CODE 6560-50-P