n-Methylpyrrolidone (NMP); Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability, 86558-86560 [2020-28872]

Download as PDF 86558 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices TABLE 2—REGISTRANT OF CANCELLED PRODUCTS EPA company No. Company name and address 2596 ................................................ The Hartz Mountain Corporation, 400 Plaza Drive, Seacaucus, NJ 07094. III. Summary of Public Comments Received and Agency Response to Comments During the 30-day public comment period provided, EPA received no comments in response to the August 6, 2020 Federal Register notice announcing the Agency’s receipt of the request for voluntary cancellation of the products listed in Table 1 of Unit II. IV. Cancellation Order Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), EPA hereby approves the requested cancellation of the registrations identified in Table 1 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Table 1 of Unit II. are canceled. The effective date of the cancellations that are the subject of this notice is December 30, 2020. Any distribution, sale, or use of existing stocks of the products identified in Table 1 of Unit II. in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI. will be a violation of FIFRA. Hartz may not ‘‘release for shipment,’’ as that term is defined by 40 CFR 152.3, any product under EPA Reg. Nos. 2596– 78 and 2596–79 (dust products) as of December 30, 2020 and may not sell or distribute existing stocks of its dust products after March 31, 2021, except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal. Hartz may sell or distribute existing stocks of EPA Reg. No. 2596–63 (cat collar) until exhausted. Persons other than the registrants may sell, distribute, or use existing stocks of canceled products until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products. Authority: 7 U.S.C. 136 et seq. Dated: November 19, 2020. Mary Reaves, Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs. [FR Doc. 2020–28827 Filed 12–29–20; 8:45 am] BILLING CODE 6560–50–P V. What is the Agency’s authority for taking this action? ENVIRONMENTAL PROTECTION AGENCY Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, following the public comment period, the EPA Administrator may approve such a request. The notice of receipt for this action was published for comment in the Federal Register of August 6, 2020 ((volume 85 number 152) (FRL–10012– 80)). The comment period closed on September 8, 2020. [EPA–HQ–OPPT–2019–0236; FRL–10017– 18] VI. Provisions for Disposition of Existing Stocks Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The existing stocks provisions for the products subject to this order are as follows. VerDate Sep<11>2014 17:47 Dec 29, 2020 Jkt 253001 n-Methylpyrrolidone (NMP); 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 n-Methylpyrrolidone (NMP). 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, without consideration of costs or other nonrisk factors. EPA has determined that specific conditions of use of NMP present an unreasonable risk of injury to health. For those conditions of use for which EPA has SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 found an unreasonable risk, EPA must take regulatory action 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–2019–0236, 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. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Public Reading Room are closed to visitors with limited exceptions. The EPA/DC staff continue to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. ADDRESSES: FOR FURTHER INFORMATION CONTACT: For technical information contact: Seema Schappelle, Office of Pollution Prevention and Toxics (7403M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–8006; email address: schappelle.seema@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: E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 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 VerDate Sep<11>2014 17:47 Dec 29, 2020 Jkt 253001 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) through (ii) and (iv) through (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) Subsection 5.1.1 of the final risk evaluation for NMP 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. 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. 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). For purposes of TSCA section 19(a)(1)(A), the date of issuance of the TSCA section 6(i)(1) order for NMP shall be at 1:00 p.m. Eastern time (standard or daylight, as appropriate) on the date that is two weeks after the date when this notice is published in the Federal Register, which is in accordance with 40 CFR 23.5. 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 some of 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 initiate regulatory action to address those risks PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 86559 through risk management measures enumerated in 15 U.S.C. 2605(a). EPA also is announcing the availability of the information required to be provided publicly with each risk evaluation, which is available online at https://www.regulations.gov in the dockets identified. 40 CFR 702.51. Specifically, EPA has provided: • The scope document and problem formulation (in Docket ID No. EPA–HQ– OPPT–2016–0743); • Draft risk evaluation, and final risk evaluation (in Docket ID No. EPA–HQ– OPPT–2019–0236); • All notices, determinations, findings, consent agreements, and orders (in Docket ID No. EPA–HQ– OPPT–2019–0236); • Any information required to be provided to the Agency under 15 U.S.C. 2603 (in Docket ID No. EPA–HQ–OPPT– 2016–0743 and Docket ID No. EPA–HQ– OPPT–2019–0236); • A nontechnical summary of the risk evaluation (in Docket ID No. EPA–HQ– OPPT–2019–0236); • A list of the studies, with the results of the studies, considered in carrying out each risk evaluation (Risk Evaluation for N-methylpyrrolidone (NMP)) in Docket ID No. EPA–HQ– OPPT–2019–0236); • The final peer review report, including the response to peer review and public comments received during peer review (in Docket ID No. EPA–HQ– OPPT–2019–0236); and • Response to public comments received on the draft scope and the draft risk evaluation (in Docket ID No. EPA– HQ–OPPT–2019–0236). 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 review 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 E:\FR\FM\30DEN1.SGM 30DEN1 86560 Federal Register / Vol. 85, No. 250 / Wednesday, December 30, 2020 / Notices 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 the 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 ID No. EPA–HQ–OPPT–2019– 0236. 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 ID No. EPA–HQ–OPPT–2016–0743. Additionally, information about the scope, problem formulation, and draft risk evaluation phases of the TSCA risk evaluation for this chemical is available at EPA’s website at https:// www.epa.gov/assessing-and-managingchemicals-under-tsca/risk-evaluation-nmethylpyrrolidone-nmp-0. B. What is n-Methylpyrrolidone (NMP)? n-Methylpyrrolidone (CASRN 872– 50–4), also called n-methyl-2pyrrolidone, or 1-methyl-2-pyrrolidone, is a water-miscible, organic solvent that is often used as a substitute for halogenated solvents. NMP is widely used in the chemical manufacturing, petrochemical processing and electronics industries, and in semiconductor fabrication and lithium ion battery manufacturing {FMI, 2015, 3827469}. In the commercial sector, NMP is primarily used for producing and removing paints, coatings and adhesives. Other applications include use in solvents, reagents, sealers, inks and grouts, industrial, commercial and consumer uses and disposal. CDR data shows that the total aggregate VerDate Sep<11>2014 17:47 Dec 29, 2020 Jkt 253001 production volume for NMP decreased slightly from 164 to 160 million pounds between 2012 and 2015. Authority: 15 U.S.C. 2601 et seq. Andrew Wheeler, Administrator. [FR Doc. 2020–28872 Filed 12–29–20; 8:45 am] BILLING CODE 6560–50–P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act. Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than January 14, 2021. A. Federal Reserve Bank of Minneapolis (Chris P. Wangen, Assistant Vice President), 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: 1. Teresa L. Kuhn, Dilworth, Minnesota; to acquire control of voting shares of Bankshares of Hawley, Inc. (Bankshares), by becoming a trustee of Valley Premier Bank Employee Stock Ownership Plan and Trust, which owns Bankshares, and thereby indirectly owns Valley Premier Bank, all of Hawley, Minnesota. B. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 1. The Lynette G. Drake Trust, Lynette G. Drake and Alan D. Drake, as cotrustees, L Drake Commons LLC, Jeffrey Roberts, as manager, J Roberts Commons LLC, Lynette Drake, as manager; all of Bad Axe, Michigan; to join the Roberts Family Control Group, a group acting in concert, to retain voting shares of Northstar Financial Group, Inc., and thereby indirectly retain voting shares of Northstar Bank, both of Bad Axe, Michigan, and West Michigan Community Bank, Hudsonville, Michigan. In addition, The Jerry A. Peplinski Trust, Jerry A. Peplinski, as trustee, F Peplinski Commons LLC, Lynda Watchowski, as manager, J Peplinski Commons LLC, Frank A. Peplinski, as manager, D Peplinski Commons LLC, Jerry Peplinski, as manager, T Peplinski Commons LLC, David Peplinski, as manager, and L Watchowski Commons LLC, Terry Peplinski, as manager; all of Bad Axe, Michigan, to join the Peplinski Family Control Group, a group acting in concert, to retain voting shares of Northstar Financial Group, Inc., and thereby indirectly retain voting shares of Northstar Bank and West Michigan Community Bank. Board of Governors of the Federal Reserve System, December 23, 2020. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2020–28857 Filed 12–29–20; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB Board of Governors of the Federal Reserve System. ACTION: Approval of information collection. AGENCY: The Board of Governors of the Federal Reserve System (Board) has adopted two proposals to extend for three years, with revision, the Capital Assessments and Stress Testing Reports (FR Y–14A/Q/M; OMB No. 7100–0341). The revisions are effective for the December 31, 2020, as of date. FOR FURTHER INFORMATION CONTACT: Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452–3829. Office of Management and Budget (OMB) Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Pages 86558-86560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28872]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0236; FRL-10017-18]


n-Methylpyrrolidone (NMP); 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 n-Methylpyrrolidone (NMP). 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, without 
consideration of costs or other nonrisk factors. EPA has determined 
that specific conditions of use of NMP present an unreasonable risk of 
injury to health. For those conditions of use for which EPA has found 
an unreasonable risk, EPA must take regulatory action 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-2019-0236, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Public Reading Room are closed to visitors 
with limited exceptions. The EPA/DC staff continue to provide remote 
customer service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Seema Schappelle, Office of 
Pollution Prevention and Toxics (7403M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-8006; 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:

[[Page 86559]]

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) through (ii) and (iv) through 
(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)
    Subsection 5.1.1 of the final risk evaluation for NMP 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. 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. 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). For purposes of TSCA section 19(a)(1)(A), the date of 
issuance of the TSCA section 6(i)(1) order for NMP shall be at 1:00 
p.m. Eastern time (standard or daylight, as appropriate) on the date 
that is two weeks after the date when this notice is published in the 
Federal Register, which is in accordance with 40 CFR 23.5.

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 some of 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 initiate regulatory 
action to address those risks through risk management measures 
enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required 
to be provided publicly with each risk evaluation, which is available 
online at https://www.regulations.gov in the dockets identified. 40 CFR 
702.51. Specifically, EPA has provided:
     The scope document and problem formulation (in Docket ID 
No. EPA-HQ-OPPT-2016-0743);
     Draft risk evaluation, and final risk evaluation (in 
Docket ID No. EPA-HQ-OPPT-2019-0236);
     All notices, determinations, findings, consent agreements, 
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0236);
     Any information required to be provided to the Agency 
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0743 and Docket 
ID No. EPA-HQ-OPPT-2019-0236);
     A nontechnical summary of the risk evaluation (in Docket 
ID No. EPA-HQ-OPPT-2019-0236);
     A list of the studies, with the results of the studies, 
considered in carrying out each risk evaluation (Risk Evaluation for N-
methylpyrrolidone (NMP)) in Docket ID No. EPA-HQ-OPPT-2019-0236);
     The final peer review report, including the response to 
peer review and public comments received during peer review (in Docket 
ID No. EPA-HQ-OPPT-2019-0236); and
     Response to public comments received on the draft scope 
and the draft risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0236).

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 review 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

[[Page 86560]]

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 the 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 ID No. EPA-HQ-OPPT-2019-0236. 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 ID No. 
EPA-HQ-OPPT-2016-0743. Additionally, information about the scope, 
problem formulation, and draft risk evaluation phases of the TSCA risk 
evaluation for this chemical is available at EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-n-methylpyrrolidone-nmp-0.

B. What is n-Methylpyrrolidone (NMP)?

    n-Methylpyrrolidone (CASRN 872-50-4), also called n-methyl-2-
pyrrolidone, or 1-methyl-2-pyrrolidone, is a water-miscible, organic 
solvent that is often used as a substitute for halogenated solvents. 
NMP is widely used in the chemical manufacturing, petrochemical 
processing and electronics industries, and in semiconductor fabrication 
and lithium ion battery manufacturing {FMI, 2015, 3827469{time} . In 
the commercial sector, NMP is primarily used for producing and removing 
paints, coatings and adhesives. Other applications include use in 
solvents, reagents, sealers, inks and grouts, industrial, commercial 
and consumer uses and disposal. CDR data shows that the total aggregate 
production volume for NMP decreased slightly from 164 to 160 million 
pounds between 2012 and 2015.

    Authority: 15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2020-28872 Filed 12-29-20; 8:45 am]
BILLING CODE 6560-50-P
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