Certain New Chemicals or Significant New Uses; Statements of Findings for July 2021, 52459-52460 [2021-20356]

Download as PDF Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices Frequency of response: Every four years. Estimated total average number of responses for each respondent: 7.38. Estimated total annual burden hours: 735,456 hours. Estimated total annual costs: $79,267,359. This includes an estimated burden cost of $79,267,359 and an estimated cost of $0 for capital investment or maintenance and operational costs. lotter on DSK11XQN23PROD with NOTICES1 III. Are there changes in the estimates from the last approval? There is an increase in total annual costs compared with that identified in the ICR currently approved by OMB. The primary reason for changes in respondent burden and cost are a result of changes from finalized regulatory actions in 2020. In addition, the increase in the respondent burden and agency costs were caused by an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead). Please refer to Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions. This change is an adjustment. In addition, OMB has requested that EPA move towards using the 18question format for ICR Supporting Statements used by other federal agencies and departments and is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. The Agency does not expect this change in format to result in substantive changes to the information collection activities or related estimated burden and costs. IV. What is the next step in the process for this ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT. Authority: 15 U.S.C. 2601 et seq. Dated: September 15, 2021. Michal Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2021–20355 Filed 9–20–21; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 21:03 Sep 20, 2021 Jkt 253001 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2021–0146; FRL–8682–04– OCSPP] Certain New Chemicals or Significant New Uses; Statements of Findings for July 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 July 1, 2021 to July 31, 2021. FOR FURTHER INFORMATION CONTACT: For technical information contact: Rebecca Edelstein, Chemical Control 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. SUMMARY: 52459 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 July 1, 2021 to July 31, 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 SUPPLEMENTARY INFORMATION: there is or may be significant or substantial human exposure to the I. General Information substance; or A. Does this action apply to me? • The chemical substance or significant new use is not likely to This action is directed to the public present an unreasonable risk of injury to in general. As such, the Agency has not health or the environment. attempted to describe the specific Unreasonable risk findings must be entities that this action may apply to. made without consideration of costs or Although others may be affected, this action applies directly to the submitters other non-risk factors, including an unreasonable risk to a potentially of the PMNs addressed in this action. exposed or susceptible subpopulation B. How can I get copies of this document identified as relevant under the and other related information? conditions of use. The term ‘‘conditions The docket for this action, identified of use’’ is defined in TSCA section 3 to by docket identification (ID) number mean ‘‘the circumstances, as determined EPA–HQ–OPPT–2021–0146, is available by the Administrator, under which a at http://www.regulations.gov. Due to chemical substance is intended, known, the public health concerns related to or reasonably foreseen to be COVID–19, the EPA Docket Center manufactured, processed, distributed in (EPA/DC) and Reading Room is closed commerce, used, or disposed of.’’ EPA is required under TSCA section to visitors with limited exceptions. The 5(g) to publish in the Federal Register staff continues to provide remote PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1 52460 Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices 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 EPA case No. Chemical identity Website link J–21–0014, J–21–0015, J–21– 0016, J–21–0017, J–21–0018. Chromosomally modified Saccharomyces cerevisiae (Generic Name). J–21–0019 .................................... Strain of Escherichia coli modified with genetically-stable, plasmid-borne DNA for the production of plasmid-borne DNA (Generic Name). Alkanedioic acid, dialkyl ester, polymer with dialkylalkanediol, alkyl (substituted alkyl)-alkanediol and heteropolycycle (Generic Name). P–21–0037: [1,1’-Biphenyl]-3,3’,4,4’-tetracarboxamide, N3,N3’,N4,N4’-tetraoctyl; CASRN: 2169674–18–2 (Specific).. P–21–0038: [1,1’-Biphenyl]-3,3’,4,4’-tetracarboxamide, N3, N3’, N4, N4’-tetradodecyl; CASRN: 2413095–68– 6 (Specific). 1-Propanethiol, 3-(triethoxysilyl)-, reaction products with polybutadiene; CASRN: 2109699–92–3 (Specific). P–21–0020 .................................... P–21–0037, ................................... P–21–0038 .................................... P–21–0085 .................................... lotter on DSK11XQN23PROD with NOTICES1 https://www.epa.gov/system/files/documents/202107/j-21-0014-0018_determination_noncbi_final.pdf. https://www.epa.gov/system/files/documents/202107/j-21-0019_determination_non-cbi_final.pdf. https://www.epa.gov/system/files/documents/202107/p-21-0020_determination_non-cbi_final.pdf. https://www.epa.gov/system/files/documents/202107/p-21-0037-0038_determination_noncbi_final.pdf. https://www.epa.gov/system/files/documents/202108/p-21-0085_determination_noncbi_final_1.pdf. of receipt and opportunity to comment on these applications. Dated: September 13, 2021. DATES: Comments must be received on Madison Le, or before October 21, 2021. Director, New Chemicals Division, Office of ADDRESSES: Submit your comments, Pollution Prevention and Toxics. identified by docket identification (ID) [FR Doc. 2021–20356 Filed 9–20–21; 8:45 am] number and the File Symbol of interest BILLING CODE 6560–50–P as shown in the body of this document, online at http://www.regulations.gov. Follow the online instructions for ENVIRONMENTAL PROTECTION submitting comments. Do not submit AGENCY electronically any information you [EPA–HQ–OPP–2021–0083; FRL–8793–02– consider to be Confidential Business OCSPP] Information (CBI) or other information whose disclosure is restricted by statute. Pesticide Product Registration; Additional instructions on commenting Receipt of Applications for New Active or visiting the docket, along with more Ingredients (September 2021) information about dockets generally, is available at https://www.epa.gov/ AGENCY: Environmental Protection dockets/about-epa-dockets. Agency (EPA). Due to the public health concerns ACTION: Notice. related to COVID–19, the EPA/DC and SUMMARY: EPA has received applications Reading Room is closed to visitors with to register pesticide products containing limited exceptions. The staff continues to provide remote customer service via active ingredients not included in any email, phone, and webform. For the currently registered pesticide products. latest status information on the EPA/DC Pursuant to the Federal Insecticide, and docket access, visit https:// Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice www.epa.gov/dockets. Authority: 15 U.S.C. 2601 et seq. VerDate Sep<11>2014 22:10 Sep 20, 2021 Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA 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 link 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). Jkt 253001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and Pollution Prevention Division (7511P), main telephone number: (703) 305– 7090, email address: BPPDFRNotices@ epa.gov; The mailing address for each contact person is: Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. As part of the mailing address, include the contact person’s name, division, and mail code. The division to contact is listed at the end of each pesticide petition summary. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52459-52460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20356]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0146; FRL-8682-04-OCSPP]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for July 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 July 1, 
2021 to July 31, 2021.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Rebecca Edelstein, Chemical 
Control 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 http://www.regulations.gov. 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 July 1, 2021 to July 31, 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.
    Unreasonable risk 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

[[Page 52460]]

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 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 link 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 No.            Chemical identity       Website link
------------------------------------------------------------------------
J-21-0014, J-21-0015, J-21-    Chromosomally          https://
 0016, J-21-0017, J-21-0018.    modified               www.epa.gov/
                                Saccharomyces          system/files/
                                cerevisiae (Generic    documents/2021-07/
                                Name).                 j-21-0014-
                                                       0018_determinatio
                                                       n_non-
                                                       cbi_final.pdf.
J-21-0019....................  Strain of Escherichia  https://
                                coli modified with     www.epa.gov/
                                genetically-stable,    system/files/
                                plasmid-borne DNA      documents/2021-07/
                                for the production     j-21-
                                of plasmid-borne DNA   0019_determinatio
                                (Generic Name).        n_non-
                                                       cbi_final.pdf.
P-21-0020....................  Alkanedioic acid,      https://
                                dialkyl ester,         www.epa.gov/
                                polymer with dialkyl-  system/files/
                                alkanediol, alkyl      documents/2021-07/
                                (substituted alkyl)-   p-21-
                                alkanediol and         0020_determinatio
                                heteropolycycle        n_non-
                                (Generic Name).        cbi_final.pdf.
P-21-0037,...................  P-21-0037: [1,1'-      https://
P-21-0038....................   Biphenyl]-3,3',4,4'-   www.epa.gov/
                                tetracarboxamide,      system/files/
                                N3,N3',N4,N4'-         documents/2021-07/
                                tetraoctyl; CASRN:     p-21-0037-
                                2169674-18-2           0038_determinatio
                                (Specific)..           n_non-
                               P-21-0038: [1,1'-       cbi_final.pdf.
                                Biphenyl]-3,3',4,4'-
                                tetracarboxamide,
                                N3, N3', N4, N4'-
                                tetradodecyl; CASRN:
                                2413095-68-6
                                (Specific).
P-21-0085....................  1-Propanethiol, 3-     https://
                                (triethoxysilyl)-,     www.epa.gov/
                                reaction products      system/files/
                                with polybutadiene;    documents/2021-08/
                                CASRN: 2109699-92-3    p-21-
                                (Specific).            0085_determinatio
                                                       n_non-
                                                       cbi_final_1.pdf.
------------------------------------------------------------------------

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

    Dated: September 13, 2021.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2021-20356 Filed 9-20-21; 8:45 am]
BILLING CODE 6560-50-P