[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Proposed Rules]
[Pages 3932-3935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00115]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2016-0163; EPA-HQ-OPPT-2016-0387 and EPA-HQ-OPPT-2016-
0231; FRL-10018-67]
RIN 2070-AK03; 2070-AK11 and 2070-AK07
Withdrawal of Proposed Rules; Discontinuing Three Rulemaking
Efforts Listed in the Semiannual Regulatory Agenda
AGENCY: Environmental Protection Agency (EPA).
ACTION: Withdrawal of proposed rules.
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SUMMARY: The Environmental Protection Agency (EPA) is withdrawing the
proposed regulatory requirements described in the three proposed rules
that are identified in this document. This document summarizes the
proposed rules and provides a brief explanation for the Agency's
decision not to finalize the proposed actions.
DATES: As of January 15, 2021, the proposed rule published on December
16, 2016 (81 FR 91592; FRL-9949-86); the proposed rule published on
January 19, 2017 (82 FR 7432; FRL-9950-08); and the portion of the
proposed rule published on January 19, 2017 (82 FR 7464; FRL-9958-57)
that pertains to n-Methylpyrrolidone (NMP) and methylene chloride in
commercial paint and coating removal, are withdrawn.
ADDRESSES: The dockets are available at http://www.regulations.gov or
at the EPA Docket Center (EPA/DC), 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, for the OPP
Docket it is (703) 305-5805, 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 Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the information on EPA/DC
services, submitting comments and docket access, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Katherine Sleasman (7101M), Mission
Support Division, Office of Program Support, Office of Chemical Safety
and Pollution Prevention, 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001; telephone number: (703) 347-0409; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the public in general and may be of
particular interest to those persons who follow proposed rules issued
under section 6(a) of the Toxic Substances Control Act (TSCA), 15
U.S.C. 2605. Since others may also be interested, the Agency has not
attempted to describe all the specific entities potentially interested.
II. Why is EPA issuing this withdrawal of proposed rules?
This document serves the following purposes:
1. It announces to the public that EPA is withdrawing certain
proposed rules for which the Agency no longer intends to issue a final
rule; and
2. It officially terminates the ongoing rulemaking activities,
which allows the Agency to close out the individual rulemaking entries
for these actions that appear in EPA's Semiannual Regulatory Agenda.
All agencies publish Semiannual Regulatory Agendas describing
regulatory actions they are developing or have recently completed.
These agendas are published in the Federal
[[Page 3933]]
Register, usually during the spring and fall of each year, as part of
the Unified Agenda of Federal Regulatory and Deregulatory Actions
(Semiannual Regulatory Agenda). The Agency publishes the EPA Semiannual
Regulatory Agenda to update the public about: Regulations and major
policies currently under development, reviews of existing regulations
and major policies, and rules and major policies completed or canceled
since the last Semiannual Regulatory Agenda.
The Semiannual Regulatory Agenda is often used as a tool to solicit
interest and participation from stakeholders. As such, EPA believes
that the public is best served by a Semiannual Regulatory Agenda that
reflects active rulemaking efforts. The withdrawal of these inactive
rulemaking efforts will streamline EPA's Semiannual Regulatory Agenda
and allow the public to better identify and focus on those rulemaking
activities that are active.
For the individual reasons described in this document, the Agency
has decided not to complete these actions at this time. By withdrawing
the proposed rules, the Agency is eliminating the pending nature of
those prior regulatory actions and clarifying its intent for future
risk management action concerning these chemicals. Specifically, EPA is
initiating separate risk management actions to address unreasonable
risks identified for these chemicals following the recent issuance of
final risk evaluations under TSCA section 6(b) for trichloroethylene
(TCE), methylene chloride (MC) (for portions related to commercial
paint and coating removal), and NMP.
III. Which proposed rules are being withdrawn?
This unit identifies the proposed regulatory actions that are being
withdrawn and provides a summary of what was proposed. The ``RIN''
refers to the regulatory identification number assigned to the
rulemaking effort in the Semiannual Regulatory Agenda.
EPA issued three proposed rules under sections 6(a) and 26(l)(4) of
the TSCA, 15 U.S.C. 2605(a) and 2625(l)(4) (82 FR 7464; FRL-9958-57);
(81 FR 91592; FRL-9949-86); (82 FR 7432; FRL-9950-08). Two of the
actions proposed to address unreasonable risks that EPA had
preliminarily identified with certain uses of TCE, which is a volatile
organic compound widely used in industrial and commercial processes
with some uses in consumer and commercial products; and one of the
actions proposed to address unreasonable risks that EPA had
preliminarily identified with certain uses of NMP and MC, which are
solvents used in a variety of applications, including paint and coating
removal (although the Agency is only withdrawing the portions related
to NMP and MC commercial paint and coating removal).
A. Trichloroethylene (TCE); Regulation of Certain Uses Under TSCA Sec.
6(a); Proposed Rule; RIN 2070-AK03
On December 16, 2016 (81 FR 91592; FRL-9949-86), EPA issued a
proposed rule under TSCA section 6(a), 15 U.S.C. 2605(a), to address
unreasonable risks that EPA had preliminarily determined exist with
certain uses of TCE: Aerosol degreasing and spot cleaning in dry
cleaning. EPA proposed to prohibit the manufacture, processing, and
distribution in commerce of TCE for use in aerosol degreasing and for
use in spot cleaning in dry cleaning facilities; to prohibit commercial
use of TCE for aerosol degreasing and for spot cleaning in dry cleaning
facilities; to require manufacturers, processors, and distributors,
except for retailers of TCE for any use, to provide downstream
notification of these prohibitions throughout the supply chain; and to
require limited recordkeeping.
The rulemaking docket for this action is available under docket ID
number EPA-HQ-OPPT-2016-0163.
B. Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under
TSCA Section 6(a); Proposed Rule; RIN 2070-AK11
On January 19, 2017 (82 FR 7432; FRL-9950-08), EPA issued a
proposed rule under TSCA section 6(a), 15 U.S.C. 2605(a), to address
unreasonable risks that EPA had preliminarily determined exist with use
of TCE in vapor degreasing. EPA proposed to prohibit the manufacture
(including import), processing, and distribution in commerce of TCE for
use in vapor degreasing; to prohibit commercial use of TCE in vapor
degreasing; to require manufacturers, processors, and distributors,
except for retailers of TCE for any use, to provide downstream
notification of these prohibitions throughout the supply chain; and to
require limited recordkeeping.
The rulemaking docket for this action is available under docket ID
number EPA-HQ-OPPT-2016-0387.
C. n-Methylpyrrolidone (NMP); Regulation of Certain Uses Under TSCA
Section 6(a); Proposed Rule; RIN 2070-AK07
On January 19, 2017 (82 FR 7464; FRL-9958-57), EPA issued a
proposed rule under TSCA section 6(a), 15 U.S.C. 2605(a), to address
risks that EPA had preliminarily identified with certain uses of NMP,
which is a solvent used in a variety of applications, including paint
and coating removal. EPA preliminarily identified significant health
risks associated with NMP use in commercial and consumer paint and
coating removal and EPA proposed a determination that these are
unreasonable risks. EPA co-proposed two different options: one co-
proposal was to prohibit the manufacture (including import),
processing, and distribution in commerce of NMP for all consumer and
commercial paint and coating removal; to prohibit the use of NMP for
all commercial paint and coating removal; to require downstream
notification of these prohibitions throughout the supply chain; to
require recordkeeping; and to provide a time-limited exemption from
these proposed regulations on NMP for coating removal uses critical for
national security. As an alternate proposal, EPA proposed that (1)
commercial users of NMP for paint and coating removal establish a
worker protection program for dermal and respiratory protection and not
use paint and coating removal products that contain greater than 35
percent NMP by weight (except for product formulations destined to be
used by Department of Defense (DoD) or its contractors performing work
only for DoD projects); and (2) processors of products containing NMP
for paint and coating removal reformulate products such that these
products do not exceed a maximum of 35 percent NMP by weight, identify
gloves that provide effective protection for the formulation, and
provide warning and instruction labels on the products. The rulemaking
docket for this action is available under docket ID number EPA-HQ-OPPT-
2016-0231. This withdrawal applies to provisions related to NMP of the
proposed rule that published on January 19, 2017.
D. Methylene chloride (MC); Regulation of Certain Uses Under TSCA
Section 6(a); Proposed Rule; RIN 2070-AK07
The proposed rule on January 19, 2017 (82 FR 7464; FRL-9958-57),
which was identified under RIN 2070-AK07, also proposed requirements
for MC. Requirements addressing the use of MC for consumer paint and
coating removal were subsequently finalized under RIN 2070-AK07 (see 84
FR 11420, March 27, 2019) (FRL-9989-29). The Agency also announced an
advance notice of proposed rulemaking on March 27, 2019, (84 FR 11466;
FRL-9989-30) to solicit public input on training, certification, and
limited access requirements that could address any
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unreasonable risks that EPA could potentially find to be presented by
MC when used for commercial paint and coating removal. This withdrawal
only applies to provisions of the January 19, 2017 proposed rule
related to commercial paint and coating removal of MC. The rulemaking
docket for this action is available under docket ID number EPA-HQ-OPPT-
2016-0231.
IV. Why are these proposed rules being withdrawn?
The 2016 and 2017 proposed rules addressed a limited number of
conditions of use (COUs) for TCE, MC and NMP pursuant to TSCA sections
6(a) and 26(l)(4). The COUs not otherwise addressed by final regulatory
action that were the subject of the earlier EPA risk assessments and
proposed rules, as well as additional COUs for these chemical
substances, were evaluated as part of the first ten risk evaluations
conducted under TSCA section 6(b). Final risk evaluations for all three
substances have been issued recently under TSCA section 6(b) and,
consistent with the statute, EPA is proceeding to initiate regulatory
action to address the unreasonable risks identified in the final risk
evaluations for TCE (85 FR 37942, June 24, 2020; FRL-10011-16); MC (85
FR 75010, November 24, 2020; FRL-10016-91; FRL-9989-29); and NMP (the
announcement is scheduled to publish in the Federal Register on
December 30, 2020 and can be identified under FRL-10017-18). As a
result, the retention of the inactive prior proposals on the Agency's
regulatory agenda is not necessary; indeed, retaining these inactive
proposals could be duplicative or could create unnecessary public
confusion about the extent and nature of the regulatory actions the
Agency intends to take to address unreasonable risks identified for
these chemical substances. Furthermore, EPA is withdrawing the proposed
rules to promote regulatory efficiency because it is impossible for EPA
to finalize the rules as proposed and at the same time meet its
statutory obligation under TSCA section 6 for risk management
rulemaking following finalization of risk evaluations in which EPA
makes findings of unreasonable risk. If EPA were to finalize the 2016
and 2017 rules as proposed, the Agency would be leaving out efforts to
address additional COUs for these chemical substances that were
determined to present unreasonable risk as part of the TSCA section
6(b) risk evaluations. EPA would not be able to say that its
obligations under TSCA section 6 were met with regard to these chemical
substances without issuing supplemental proposed and final rules for
the additional COUs determined to present unreasonable risks in the
TSCA section 6(b) risk evaluations. While the Agency has discretion to
undertake multiple risk management actions with regard to unreasonable
risks associated with different COUs for a single chemical substance
(and, in fact, did so to address the acute unreasonable risks
associated with MC in consumer paint and coating removal), it is more
efficient to take risk management action on multiple COUs at once where
unreasonable risks are identified, particularly where regulatory
approaches to different COUs can be combined. In addition, where EPA
has completed risk evaluations for chemical substances, EPA believes
the Agency will be able to more efficiently address obligations under
TSCA section 6(c) (requirements applicable to promulgation of TSCA
section 6(a) rules), section 26 (including requirements related to best
available science and weight of scientific evidence), and other
requirements applicable to TSCA section 6(a) rulemakings through a
single rulemaking process, rather than supplementing prior proposals.
Therefore, EPA will initiate regulatory actions to address all of the
COUs determined to present unreasonable risks for a given chemical
substance and will withdraw the earlier proposed actions.
EPA proposed these rules under TSCA section 6(a), which provides
authority for EPA to ban or restrict the manufacture (including
import), processing, distribution in commerce, use, and disposal of
chemical substances, with certain limitations. TSCA section 26(l)(4)
authorizes EPA to issue rules under TSCA section 6(a) for chemicals
listed in the 2014 Update to the TSCA Work Plan for Chemical
Assessments for which EPA published completed risk assessments prior to
June 22, 2016, consistent with the scope of the completed risk
assessment and other applicable requirements of TSCA section 6.
In the June 2014 TSCA Work Plan Chemical Risk Assessment for TCE,
EPA characterized risks from the use of TCE in commercial degreasing
and in some consumer uses. On December 16, 2016, based on the 2014 Risk
Assessment for TCE, EPA preliminarily determined that these risks are
unreasonable risks and proposed regulatory action; specifically, EPA
proposed to prohibit the manufacture, processing, distribution in
commerce, or commercial use of TCE in spot cleaning in dry cleaning
facilities and aerosol degreasing (81 FR 91592; FRL-9949-86). On
January 19, 2017, EPA proposed to address the unreasonable risks from
TCE when used in vapor degreasing (82 FR 7432; FRL-9950-08). These uses
of TCE were subsequently identified as conditions of use within the
scope of the risk evaluation for TCE under TSCA section 6(b). EPA
issued the final risk evaluation for TCE in November 2020 (85 FR 75010,
November 24, 2020; FRL-10016-91) which determined that 52 out of 54
conditions of use of TCE present unreasonable risks of injury to
health. EPA is withdrawing the 2016 and 2017 proposed rules on TCE for
the reasons discussed earlier in this section. For more information
about TCE and details about the risk evaluation for TCE, see the TSCA
website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-trichloroethylene-tce-0#riske valuation.
In the March 2015 TSCA Work Plan Chemical Risk Assessment for NMP,
EPA characterized risks from use of this chemical in paint and coating
removal. On January 19, 2017, based on the 2015 Risk Assessment for
NMP, EPA preliminarily determined that the use of NMP in commercial and
consumer paint and coating removal poses an unreasonable risk of injury
to health, and proposed options for addressing that risk. The uses of
NMP in commercial and consumer paint and coating removal were
identified as conditions of use within the scope of the risk evaluation
for NMP under TSCA section 6(b). EPA issued the final risk evaluation
for NMP in December 2020 (the announcement is scheduled to publish in
the Federal Register on December 30, 2020 and can be identified under
FRL-10017-18). EPA evaluated commercial and consumer use of NMP in
paint and coating removal as COUs in the scope of the risk evaluation,
along with other COUs for NMP. In response to public and peer review
comments on the draft risk evaluation, EPA modified its approach for
calculating dose-response, which resulted in a change in the point of
departure and modified risk estimates for many COUs, including modified
risk estimates for the use of NMP in consumer paint and coating
removal. These changes are discussed in the Executive Summary and in
Section 3.2, for the points of departure, of the final NMP risk
evaluation and differ from the preliminary determination of
unreasonable risk in the draft NMP risk evaluation and the 2017
proposed NMP rule. EPA is withdrawing the 2017 proposed rule on NMP,
i.e., those portions of the proposal not related to
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the final rule on MC in consumer paint and coating removal, for the
reasons discussed earlier in this section. The withdrawal of this
rulemaking effort may have an immediate effect on other TSCA
requirements for NMP. Withdrawal of the proposal would terminate export
notification requirements for NMP. However, the Agency believes
withdrawing the proposal will clarify which action the Agency is
currently pursuing, and reduce the need for additional, piecemeal or
supplemental risk management actions as a result of the final
determinations in the risk evaluation conducted under TSCA section
6(b). As noted in Unit V., the Agency is initiating risk management
action on this chemical. For more information about NMP and details
about the risk evaluation for NMP, see the TSCA website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-n-methylpyrrolidone-nmp-0.
On March 27, 2019, in the final rule for MC in consumer paint and
coating removal (RIN 2070-AK07), EPA explained that the Agency was not
finalizing the proposed risk determination or proposed regulation for
MC commercial paint and coating removal as part of that action. Similar
to NMP, EPA evaluated commercial use of MC in paint and coating removal
as a COU in the scope of the TSCA section 6(b) risk evaluation for MC,
along with other COUs. EPA issued the final risk evaluation for MC on
June 24, 2020 (85 FR 37942; FRL-10011-16). For more information about
MC and details about the risk evaluation for MC, see the TSCA website
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/final-risk-evaluation-methylene-chloride.
V. How does EPA intend to proceed?
Given the subsequent issuance of final risk evaluations under TSCA
for TCE, MC and NMP that incorporated the COUs which the three proposed
rules would have addressed, and the initiation of new rulemakings for
TCE, MC and NMP following issuance of the final risk evaluations in
which EPA made findings of unreasonable risk, EPA has determined that
the previous proposed rules should be withdrawn. The next step in the
process required by TSCA section 6 is addressing the unreasonable risks
determined in the risk evaluations through rulemaking. EPA has
initiated new rulemaking efforts to address the unreasonable risks
determined in the final risk evaluations and has one year to propose
and take public comments on any risk management actions. Although these
new rulemaking efforts did not commence in time to be included in the
Fall 2020 edition of the EPA's Unified Regulatory Plan and Agenda,
these rulemaking efforts will appear in the Spring 2021 edition of
EPA's semiannual Regulatory Agenda. As part of this effort, EPA will
consider comments received on the previously-referenced ANPRM issued in
2019 soliciting input on training, certification and limited access
requirements that could address the unreasonable risks associated with
methylene chloride in commercial paint and coating removal.
For these reasons, EPA is withdrawing the proposed rule that
published on December 16, 2016 (81 FR 91592; FRL-9949-86); the proposed
rule that published on January 19, 2017 (82 FR 7432; FRL-9950-08); and
the provisions related to NMP and to MC in commercial paint and coating
removal in the proposed rule that published on January 19, 2017 (82 FR
7464; FRL-9958-57).
Authority: 15 U.S.C. 2601 et seq.
Andrew Wheeler,
Administrator.
[FR Doc. 2021-00115 Filed 1-14-21; 8:45 am]
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