Certain New Chemicals or Significant New Uses; Statements of Findings for February 2021, 33280-33281 [2021-13369]

Download as PDF 33280 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices To request accommodation of a disability, please contact Tom Tracy at least ten days prior to the meeting to give the EPA adequate time to process your request. Authority: Pub. L. 92–463, 1, Oct. 6, 1972, 86 Stat. 770. Mary Ross, Director, Office of Science Advisor, Policy and Engagement. [FR Doc. 2021–13613 Filed 6–23–21; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2021–0146; FRL–10023– 25] Certain New Chemicals or Significant New Uses; Statements of Findings for February 2021 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of certain TSCA notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to premanufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) submitted to EPA under TSCA. This document presents statements of findings made by EPA on such submissions during the period from February 1, 2021 to February 28, 2021. FOR FURTHER INFORMATION CONTACT: For technical information contact: Rebecca Edelstein, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: 202–564–1667 email address: edelstein.rebecca@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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? This action is directed to the public in general. As such, the Agency has not attempted to describe the specific VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 present an unreasonable risk of injury to health or the environment; • The chemical substance is or will be produced in substantial quantities, and such substance either enters or may B. How can I get copies of this document reasonably be anticipated to enter the and other related information? environment in substantial quantities or there is or may be significant or The docket for this action, identified substantial human exposure to the by docket identification (ID) number EPA–HQ–OPPT–2021–0146, is available substance; or • The chemical substance or at https://www.regulations.gov or at the significant new use is not likely to Office of Pollution Prevention and present an unreasonable risk of injury to Toxics Docket (OPPT Docket), health or the environment. Environmental Protection Agency These findings must be made without Docket Center (EPA/DC), West William consideration of costs or other non-risk Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. factors, including an unreasonable risk to a potentially exposed or susceptible The Public Reading Room is open from subpopulation identified as relevant 8:30 a.m. to 4:30 p.m., Monday through under the conditions of use. The term Friday, excluding legal holidays. The ‘‘conditions of use’’ is defined in TSCA telephone number for the Public section 3 to mean ‘‘the circumstances, as Reading Room is (202) 566–1744, and determined by the Administrator, under the telephone number for the OPPT which a chemical substance is intended, Docket is (202) 566–0280. known, or reasonably foreseen to be Due to the public health concerns manufactured, processed, distributed in related to COVID–19, the EPA Docket commerce, used, or disposed of.’’ Center (EPA/DC) and Reading Room is EPA is required under TSCA section closed to visitors with limited 5(g) to publish in the Federal Register exceptions. The staff continues to a statement of its findings after its provide remote customer service via review of a TSCA section 5(a) notice email, phone, and webform. For the when EPA makes a finding that a new latest status information on EPA/DC chemical substance or significant new services and docket access, visit https:// use is not likely to present an www.epa.gov/dockets. unreasonable risk of injury to health or II. What action is the Agency taking? the environment. Such statements apply to PMNs, MCANs, and SNUNs This document lists the statements of submitted to EPA under TSCA section findings made by EPA after review of 5. notices submitted under TSCA section Anyone who plans to manufacture 5(a) that certain new chemical (which includes import) a new chemical substances or significant new uses are substance for a non-exempt commercial not likely to present an unreasonable purpose and any manufacturer or risk of injury to health or the processor wishing to engage in a use of environment. This document presents a chemical substance designated by EPA statements of findings made by EPA as a significant new use must submit a during the period from February 1, 2021 notice to EPA at least 90 days before to February 28, 2021. commencing manufacture of the new chemical substance or before engaging III. What is the Agency’s authority for in the significant new use. taking this action? The submitter of a notice to EPA for TSCA section 5(a)(3) requires EPA to which EPA has made a finding of ‘‘not review a TSCA section 5(a) notice and likely to present an unreasonable risk of make one of the following specific injury to health or the environment’’ findings: may commence manufacture of the • The chemical substance or chemical substance or manufacture or significant new use presents an processing for the significant new use unreasonable risk of injury to health or notwithstanding any remaining portion the environment; of the applicable review period. • The information available to EPA is IV. Statements of Administrator insufficient to permit a reasoned Findings Under TSCA Section 5(a)(3)(C) evaluation of the health and environmental effects of the chemical In this unit, EPA provides the substance or significant new use; following information (to the extent that • The information available to EPA is such information is not claimed as Confidential Business Information insufficient to permit a reasoned (CBI)) on the PMNs, MCANs and evaluation of the health and SNUNs for which, during this period, environmental effects and the chemical EPA has made findings under TSCA substance or significant new use may entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action. PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment: EPA case number Chemical identity J–21–0002, J–21–0003 ......... Saccharomyces cerevisiae modified (Generic Name) ... P–20–0132 ............................ 1H-Pyrrole-2,5-dione, 3-methyl-, 1,1′-C36-alkylenebis-; CASRN: 2414071–06–8. P–20–0097 ............................ Butanedioic acid, monopolyisobutylene derivs., mixed dihydroxyalkyl and hydroxyalkoxyalkyl diesters (Generic Name). Aryl ether epoxide, homopolymer, ether with alkanolamine (Generic Name). P–20–0183 ............................ P–20–0136 ............................ Dated: June 9, 2021. Madison Le, Director, New Chemicals Division, Office of Pollution Prevention and Toxics. [FR Doc. 2021–13369 Filed 6–23–21; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OW–2013–0610; FRL–10025–15– OMS] Information Collection Request; Submitted to OMB for Review and Approval; Comment Request; Clean Water Act 404 State-Assumed Programs (Renewal); Correction Environmental Protection Agency (EPA). ACTION: Notice; correction. AGENCY: EPA published a notice in the Federal Register of May 27, 2021, requesting comment on a proposed Information Collection Request renewal (EPA ICR Number 0220.14, OMB Control Number 2040–0168) being submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. That notice contained errors which need to be corrected. DATES: Comments must be received on or before July 26, 2021. EPA is extending the comment period to provide the public with a full 30 days to review and comment on the docket and this revised notice. Comments already received in response to the original, May 27, 2021 will be considered but may also be SUMMARY: VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 https://www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca/tsca-section-5a3cdetermination-498. https://www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca/tsca-section-5a3cdetermination-497. https://www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca/tsca-section-5a3cdetermination-496. https://www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca/tsca-section-5a3cdetermination-495. https://www.epa.gov/reviewing-new-chemicals-undertoxic-substances-control-act-tsca/tsca-section-5a3cdetermination-492. supplemented with additional submissions if necessary. FOR FURTHER INFORMATION CONTACT: Kathy Hurld, Oceans, Wetlands and Communities Division, Environmental Protection Agency, 1200 Pennsylvania Ave. NW (4504T), Washington, DC 20460; telephone number: 202–564– 5700; email address:404g-rulemaking@ epa.gov. SUPPLEMENTARY INFORMATION: Correction In the Federal Register of May 27, 2021 in notice FR Doc. 2021–11276, beginning on page 28596, make the following corrections: 1. On page 25896, third column, in the ‘‘FOR FURTHER INFORMATION CONTACT:’’ section, the contact person listed was incorrect. Please contact Kathy Hurld using the contact information in the ‘‘FOR FURTHER INFORMATION CONTACT:’’ section of this document. 2. On page 28596, third column, and continuing on the first column of page 28597, in the ‘‘SUPPLEMENTARY INFORMATION:’’ section, correct the five full paragraphs of the ‘‘Abstract’’ section, to read as follow: ‘‘Abstract: Section 404(g) of the Federal Water Pollution Control Act (FWPCA/Clean Water Act (CWA)), authorizes states and tribes to assume the section 404 permit program for discharges of dredged or fill material into certain waters of the United States. This ICR covers the collection of information that EPA needs to perform its program approval and oversight responsibilities and that the state or tribe needs to implement its program. Request to assume CWA section 404 permit program. States and tribes must PO 00000 Frm 00076 Fmt 4703 • website address to EPA’s decision document describing the basis of the ‘‘not likely to present an unreasonable risk’’ finding made by EPA under TSCA section 5(a)(3)(C). Website address Arylcarboxylic acid, alkyl ester, polymer with alkanediol, ester with methyloxirane polymer with oxirane alkyl ether (Generic Name). Authority: 15 U.S.C. 2601 et seq. khammond on DSKJM1Z7X2PROD with NOTICES • EPA case number assigned to the TSCA section 5(a) notice. • Chemical identity (generic name if the specific name is claimed as CBI). 33281 Sfmt 4703 demonstrate that they meet the statutory and regulatory requirements at 40 CFR part 233 for an approvable program. Specified information and documents must be submitted by the state or tribe to EPA to request assumption and must be sufficient to enable EPA to conduct an analysis of the state or tribal program. The information contained in the assumption request submission is provided to the other involved federal agencies and to the general public for review and comment. Permit application information. States and tribes with assumed programs must be able to issue permits that assure compliance with all applicable statutory and regulatory requirements, including the CWA section 404(b)(1) Guidelines. Sufficient information must be provided in the application so that states or tribes and federal agencies reviewing the permit are able to evaluate, avoid, minimize, and compensate for any anticipated impacts resulting from the proposed project. EPA’s assumption regulations at 40 CFR 233.30 establish required and recommended elements that should be included in the state or tribe’s permit application, so that sufficient information is available to assess anticipated impacts. These minimum information requirements generally reflect the information that must be submitted when applying for a section 404 permit from the U.S. Army Corps of Engineers. (CWA section 404(h); CWA section 404(j); 40 CFR 230.10, 233.20, 233.21, 233.34, and 233.50; 33 CFR 325)). Annual report and program information. EPA has an oversight role for assumed section 404 permit programs to ensure that state or tribal programs comply with applicable E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33280-33281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13369]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0146; FRL-10023-25]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for February 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Toxic Substances Control Act (TSCA) requires EPA to 
publish in the Federal Register a statement of its findings after its 
review of certain TSCA notices when EPA makes a finding that a new 
chemical substance or significant new use is not likely to present an 
unreasonable risk of injury to health or the environment. Such 
statements apply to premanufacture notices (PMNs), microbial commercial 
activity notices (MCANs), and significant new use notices (SNUNs) 
submitted to EPA under TSCA. This document presents statements of 
findings made by EPA on such submissions during the period from 
February 1, 2021 to February 28, 2021.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Rebecca Edelstein, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: 202-564-1667 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. As such, the 
Agency has not attempted to describe the specific entities that this 
action may apply to. Although others may be affected, this action 
applies directly to the submitters of the PMNs addressed in this 
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0146, is available at https://www.regulations.gov or 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 Reading Room is closed to visitors with 
limited exceptions. The staff continues 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.

II. What action is the Agency taking?

    This document lists the statements of findings made by EPA after 
review of notices submitted under TSCA section 5(a) that certain new 
chemical substances or significant new uses are not likely to present 
an unreasonable risk of injury to health or the environment. This 
document presents statements of findings made by EPA during the period 
from February 1, 2021 to February 28, 2021.

III. What is the Agency's authority for taking this action?

    TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) 
notice and make one of the following specific findings:
     The chemical substance or significant new use presents an 
unreasonable risk of injury to health or the environment;
     The information available to EPA is insufficient to permit 
a reasoned evaluation of the health and environmental effects of the 
chemical substance or significant new use;
     The information available to EPA is insufficient to permit 
a reasoned evaluation of the health and environmental effects and the 
chemical substance or significant new use may present an unreasonable 
risk of injury to health or the environment;
     The chemical substance is or will be produced in 
substantial quantities, and such substance either enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities or there is or may be significant or substantial human 
exposure to the substance; or
     The chemical substance or significant new use is not 
likely to present an unreasonable risk of injury to health or the 
environment.
    These findings must be made without consideration of costs or other 
non-risk factors, including an unreasonable risk to a potentially 
exposed or susceptible subpopulation identified as relevant under the 
conditions of use. The term ``conditions of use'' is defined in TSCA 
section 3 to mean ``the circumstances, as determined by the 
Administrator, under which a chemical substance is intended, known, or 
reasonably foreseen to be manufactured, processed, distributed in 
commerce, used, or disposed of.''
    EPA is required under TSCA section 5(g) to publish in the Federal 
Register a statement of its findings after its review of a TSCA section 
5(a) notice when EPA makes a finding that a new chemical substance or 
significant new use is not likely to present an unreasonable risk of 
injury to health or the environment. Such statements apply to PMNs, 
MCANs, and SNUNs submitted to EPA under TSCA section 5.
    Anyone who plans to manufacture (which includes import) a new 
chemical substance for a non-exempt commercial purpose and any 
manufacturer or processor wishing to engage in a use of a chemical 
substance designated by EPA as a significant new use must submit a 
notice to EPA at least 90 days before commencing manufacture of the new 
chemical substance or before engaging in the significant new use.
    The submitter of a notice to EPA for which EPA has made a finding 
of ``not likely to present an unreasonable risk of injury to health or 
the environment'' may commence manufacture of the chemical substance or 
manufacture or processing for the significant new use notwithstanding 
any remaining portion of the applicable review period.

IV. Statements of Administrator Findings Under TSCA Section 5(a)(3)(C)

    In this unit, EPA provides the following information (to the extent 
that such information is not claimed as Confidential Business 
Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this 
period, EPA has made findings under TSCA

[[Page 33281]]

section 5(a)(3)(C) that the new chemical substances or significant new 
uses are not likely to present an unreasonable risk of injury to health 
or the environment:
     EPA case number assigned to the TSCA section 5(a) notice.
     Chemical identity (generic name if the specific name is 
claimed as CBI).
     website address to EPA's decision document describing the 
basis of the ``not likely to present an unreasonable risk'' finding 
made by EPA under TSCA section 5(a)(3)(C).

------------------------------------------------------------------------
         EPA case number           Chemical identity    Website address
------------------------------------------------------------------------
J-21-0002, J-21-0003............  Saccharomyces       https://
                                   cerevisiae          www.epa.gov/
                                   modified (Generic   reviewing-new-
                                   Name).              chemicals-under-
                                                       toxic-substances-
                                                       control-act-tsca/
                                                       tsca-section-5a3c-
                                                       determination-
                                                       498.
P-20-0132.......................  1H-Pyrrole-2,5-     https://
                                   dione, 3-methyl-,   www.epa.gov/
                                   1,1'-C36-           reviewing-new-
                                   alkylenebis-;       chemicals-under-
                                   CASRN: 2414071-06-  toxic-substances-
                                   8.                  control-act-tsca/
                                                       tsca-section-5a3c-
                                                       determination-
                                                       497.
P-20-0097.......................  Butanedioic acid,   https://
                                   monopolyisobutyle   www.epa.gov/
                                   ne derivs., mixed   reviewing-new-
                                   dihydroxyalkyl      chemicals-under-
                                   and                 toxic-substances-
                                   hydroxyalkoxyalky   control-act-tsca/
                                   l diesters          tsca-section-5a3c-
                                   (Generic Name).     determination-
                                                       496.
P-20-0183.......................  Aryl ether          https://
                                   epoxide,            www.epa.gov/
                                   homopolymer,        reviewing-new-
                                   ether with          chemicals-under-
                                   alkanolamine        toxic-substances-
                                   (Generic Name).     control-act-tsca/
                                                       tsca-section-5a3c-
                                                       determination-
                                                       495.
P-20-0136.......................  Arylcarboxylic      https://
                                   acid, alkyl         www.epa.gov/
                                   ester, polymer      reviewing-new-
                                   with alkanediol,    chemicals-under-
                                   ester with          toxic-substances-
                                   methyloxirane       control-act-tsca/
                                   polymer with        tsca-section-5a3c-
                                   oxirane alkyl       determination-
                                   ether (Generic      492.
                                   Name).
------------------------------------------------------------------------


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

    Dated: June 9, 2021.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2021-13369 Filed 6-23-21; 8:45 am]
BILLING CODE 6560-50-P


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