[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commercial paint and coating removal, are withdrawn.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

[[Page 3934]]

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

[[Page 3935]]

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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