83_FR_46337 83 FR 46160 - Certain New Chemicals or Significant New Uses; Statements of Findings for April to July 2018

83 FR 46160 - Certain New Chemicals or Significant New Uses; Statements of Findings for April to July 2018

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 177 (September 12, 2018)

Page Range46160-46161
FR Document2018-19873

Section 5(g) of the Toxic Substances Control Act (TSCA) requires EPA to publish in the Federal Register a statement of its findings after its review of TSCA section 5(a) 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 section 5. This document presents statements of findings made by EPA on TSCA section 5(a) notices during the period from April 1, 2018 to July 31, 2018.

Federal Register, Volume 83 Issue 177 (Wednesday, September 12, 2018)
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Notices]
[Pages 46160-46161]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19873]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0097; FRL-9983-06]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for April to July 2018

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5(g) of the Toxic Substances Control Act (TSCA) 
requires EPA to publish in the Federal Register a statement of its 
findings after its review of TSCA section 5(a) 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 section 5. This document 
presents statements of findings made by EPA on TSCA section 5(a) 
notices during the period from April 1, 2018 to July 31, 2018.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Greg Schweer, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-8469; 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-2018-0097, is available at http://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. Please review the visitor instructions and additional information 
about the docket available at http://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 April 1, 2018 to July 31, 2018.

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

[[Page 46161]]

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 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 Number: J-18-0002-0003; Chemical identity: Saccharomyces 
cerevisiae modified (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-90.
    EPA Case Number: P-18-0142; Chemical identity: Alkanoic acid, 
alkyl-, alkyl ester, polymer with substituted alkenoates, alkenoic 
acid, alkyl peroxoate-initiated; polymer exemption flag (generic name); 
website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-91.
    EPA Case Number: P-16-0510; Chemical identity: Oxirane, 2-methyl-, 
polymer with oxirane, bis[2-[(1-oxo-2-propen-1-yl)amino]propyl] ether 
(CASRN: 1792208-65-1); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-92.

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

    Dated: September 4, 2018.
Greg Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division, 
Office of Pollution Prevention and Toxics.
[FR Doc. 2018-19873 Filed 9-11-18; 8:45 am]
 BILLING CODE 6560-50-P



                                               46160                   Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices

                                               copy of the comment that does not                       ingredients: Thymol, eugenol, and                     14620; telephone number: (202) 554–
                                               contain the information claimed as CBI                  geraniol. Product type: Fungicide.                    1404; email address: TSCA-Hotline@
                                               must be submitted for inclusion in the                  Proposed use: Grapes (table, wine, and                epa.gov.
                                               public docket. Information so marked                    raisin). Contact: BPPD.                               SUPPLEMENTARY INFORMATION:
                                               will not be disclosed except in                           5. File Symbol: 92331–U. Docket ID
                                               accordance with procedures set forth in                 number: EPA–HQ–OPP–2018–0521.                         I. General Information
                                               40 CFR part 2.                                          Applicant: Eden Research plc, 6 Priory                A. Does this action apply to me?
                                                 2. Tips for preparing your comments.                  Ct., Priory Court Business Park, Poulton,
                                               When preparing and submitting your                      Cirencester, GL7 5JB, United Kingdom                     This action is directed to the public
                                               comments, see the commenting tips at                    (c/o SciReg, Inc., 12733 Director’s Loop,             in general. As such, the Agency has not
                                               http://www.epa.gov/dockets/                             Woodbridge, VA 22192). Active                         attempted to describe the specific
                                               comments.html.                                          ingredients: Thymol and geraniol.                     entities that this action may apply to.
                                                                                                       Product type: Nematocide. Proposed                    Although others may be affected, this
                                               II. Registration Applications                                                                                 action applies directly to the submitters
                                                                                                       use: Fruiting vegetables and cucurbits.
                                                  EPA has received applications to                     Contact: BPPD.                                        of the PMNs addressed in this action.
                                               register new uses for pesticide products
                                               containing currently registered active                    Authority: 7 U.S.C. 136 et seq.                     B. How can I get copies of this document
                                               ingredients. Pursuant to the provisions                   Dated: August 14, 2018.                             and other related information?
                                               of FIFRA section 3(c)(4) (7 U.S.C.                      Delores Barber,                                          The docket for this action, identified
                                               136a(c)(4)), EPA is hereby providing                    Director, Information Technology and                  by docket identification (ID) number
                                               notice of receipt and opportunity to                    Resources Management Division, Office of              EPA–HQ–OPPT–2018–0097, is available
                                               comment on these applications. Notice                   Pesticide Programs.                                   at http://www.regulations.gov or at the
                                               of receipt of these applications does not               [FR Doc. 2018–19869 Filed 9–11–18; 8:45 am]           Office of Pollution Prevention and
                                               imply a decision by the Agency on these                 BILLING CODE 6560–50–P                                Toxics Docket (OPPT Docket),
                                               applications.                                                                                                 Environmental Protection Agency
                                                                                                                                                             Docket Center (EPA/DC), West William
                                               III. New Uses
                                                                                                       ENVIRONMENTAL PROTECTION                              Jefferson Clinton Bldg., Rm. 3334, 1301
                                                  1. EPA Registration Numbers: 264–                    AGENCY                                                Constitution Ave. NW, Washington, DC.
                                               1143 and 264–1141. Docket ID number:                                                                          The Public Reading Room is open from
                                                                                                       [EPA–HQ–OPPT–2018–0097; FRL–9983–06]
                                               EPA–HQ–OPP–2013–0226. Applicant:                                                                              8:30 a.m. to 4:30 p.m., Monday through
                                               Bayer CropScience LP, P.O. Box 12014,                   Certain New Chemicals or Significant                  Friday, excluding legal holidays. The
                                               2 TW Alexander Dr., Research Triangle                   New Uses; Statements of Findings for                  telephone number for the Public
                                               Park, NC 27709. Active ingredient:                      April to July 2018                                    Reading Room is (202) 566–1744, and
                                               Flupyradifurone. Product type:                                                                                the telephone number for the OPPT
                                               Insecticide. Proposed use: tobacco.                     AGENCY: Environmental Protection                      Docket is (202) 566–0280. Please review
                                               Contact: RD.                                            Agency (EPA).                                         the visitor instructions and additional
                                                  2. File Symbol: 92331–E. Docket ID                   ACTION: Notice.                                       information about the docket available
                                               number: EPA–HQ–OPP–2018–0521.                                                                                 at http://www.epa.gov/dockets.
                                               Applicant: Eden Research plc, 6 Priory                  SUMMARY:   Section 5(g) of the Toxic
                                               Ct., Priory Court Business Park, Poulton,               Substances Control Act (TSCA) requires                II. What action is the Agency taking?
                                               Cirencester, GL7 5JB, United Kingdom                    EPA to publish in the Federal Register                   This document lists the statements of
                                               (c/o SciReg, Inc., 12733 Director’s Loop,               a statement of its findings after its                 findings made by EPA after review of
                                               Woodbridge, VA 22192). Active                           review of TSCA section 5(a) notices                   notices submitted under TSCA section
                                               ingredient: Thymol. Product type:                       when EPA makes a finding that a new                   5(a) that certain new chemical
                                               Fungicide and nematocide. Proposed                      chemical substance or significant new                 substances or significant new uses are
                                               use: For manufacturing or formulating                   use is not likely to present an                       not likely to present an unreasonable
                                               of products to be used on grapes (table,                unreasonable risk of injury to health or              risk of injury to health or the
                                               wine, and raisin), fruiting vegetables,                 the environment. Such statements apply                environment. This document presents
                                               and cucurbits. Contact: BPPD.                           to premanufacture notices (PMNs),                     statements of findings made by EPA
                                                  3. File Symbol: 92331–G. Docket ID                   microbial commercial activity notices                 during the period from April 1, 2018 to
                                               number: EPA–HQ–OPP–2018–0519.                           (MCANs), and significant new use                      July 31, 2018.
                                               Applicant: Eden Research plc, 6 Priory                  notices (SNUNs) submitted to EPA
                                               Ct., Priory Court Business Park, Poulton,               under TSCA section 5. This document                   III. What is the Agency’s authority for
                                               Cirencester, GL7 5JB, United Kingdom                    presents statements of findings made by               taking this action?
                                               (c/o SciReg, Inc., 12733 Director’s Loop,               EPA on TSCA section 5(a) notices                         TSCA section 5(a)(3) requires EPA to
                                               Woodbridge, VA 22192). Active                           during the period from April 1, 2018 to               review a TSCA section 5(a) notice and
                                               ingredient: Eugenol. Product type:                      July 31, 2018.                                        make one of the following specific
                                               Fungicide. Proposed use: For                            FOR FURTHER INFORMATION CONTACT:                      findings:
                                               manufacturing or formulating of                            For technical information contact:                    • The chemical substance or
                                               products to be used on grapes (table,                   Greg Schweer, Chemical Control                        significant new use presents an
                                               wine, and raisin). Contact: BPPD.                       Division (7405M), Office of Pollution                 unreasonable risk of injury to health or
                                                  4. File Symbol: 92331–R. Docket ID                   Prevention and Toxics, Environmental                  the environment;
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                                               numbers: EPA–HQ–OPP–2018–0519                           Protection Agency, 1200 Pennsylvania                     • The information available to EPA is
                                               and EPA–HQ–OPP–2018–0521.                               Ave. NW, Washington, DC 20460–0001;                   insufficient to permit a reasoned
                                               Applicant: Eden Research plc, 6 Priory                  telephone number: (202) 564–8469;                     evaluation of the health and
                                               Ct., Priory Court Business Park, Poulton,               email address: schweer.greg@epa.gov.                  environmental effects of the chemical
                                               Cirencester, GL7 5JB, United Kingdom                       For general information contact: The               substance or significant new use;
                                               (c/o SciReg, Inc., 12733 Director’s Loop,               TSCA-Hotline, ABVI-Goodwill, 422                         • The information available to EPA is
                                               Woodbridge, VA 22192). Active                           South Clinton Ave. Rochester, NY                      insufficient to permit a reasoned


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                                                                       Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices                                                 46161

                                               evaluation of the health and                            Confidential Business Information                     DATES:  The meeting of the Board will be
                                               environmental effects and the chemical                  (CBI)) on the PMNs, MCANs and                         held at the offices of the Farm Credit
                                               substance or significant new use may                    SNUNs for which, during this period,                  Administration in McLean, Virginia, on
                                               present an unreasonable risk of injury to               EPA has made findings under TSCA                      September 19, 2018, from 10:00 a.m.
                                               health or the environment;                              section 5(a)(3)(C) that the new chemical              until such time as the Board concludes
                                                  • The chemical substance is or will                  substances or significant new uses are                its business.
                                               be produced in substantial quantities,                  not likely to present an unreasonable                 FOR FURTHER INFORMATION CONTACT: Dale
                                               and such substance either enters or may                 risk of injury to health or the                       Aultman, Secretary to the Farm Credit
                                               reasonably be anticipated to enter the                  environment:                                          System Insurance Corporation Board,
                                               environment in substantial quantities or                   • EPA case number assigned to the                  (703) 883–4009, TTY (703) 883–4056,
                                               there is or may be significant or                       TSCA section 5(a) notice.                             aultmand@fca.gov.
                                               substantial human exposure to the                          • Chemical identity (generic name, if
                                               substance; or                                                                                                 ADDRESSES: Farm Credit System
                                                                                                       the specific name is claimed as CBI).
                                                  • The chemical substance or                             • Website link to EPA’s decision                   Insurance Corporation, 1501 Farm
                                               significant new use is not likely to                    document describing the basis of the                  Credit Drive, McLean, Virginia 22102.
                                               present an unreasonable risk of injury to               ‘‘not likely to present an unreasonable               Submit attendance requests via email to
                                               health or the environment.                              risk’’ finding made by EPA under TSCA                 VisitorRequest@FCA.gov. See
                                                  Unreasonable risk findings must be                                                                         SUPPLEMENTARY INFORMATION for further
                                                                                                       section 5(a)(3)(C).
                                               made without consideration of costs or                     EPA Case Number: J–18–0002–0003;                   information about attendance requests.
                                               other non-risk factors, including an                    Chemical identity: Saccharomyces                      SUPPLEMENTARY INFORMATION: Parts of
                                               unreasonable risk to a potentially                      cerevisiae modified (generic name);                   this meeting of the Board will be open
                                               exposed or susceptible subpopulation                    website link: https://www.epa.gov/                    to the public (limited space available),
                                               identified as relevant under the                        reviewing-new-chemicals-under-toxic-                  and parts will be closed to the public.
                                               conditions of use. The term ‘‘conditions                substances-control-act-tsca/tsca-section-             Please send an email to VisitorRequest@
                                               of use’’ is defined in TSCA section 3 to                5a3c-determination-90.                                FCA.gov at least 24 hours before the
                                               mean ‘‘the circumstances, as determined                    EPA Case Number: P–18–0142;                        meeting. In your email include: name,
                                               by the Administrator, under which a                     Chemical identity: Alkanoic acid,                     postal address, entity you are
                                               chemical substance is intended, known,                  alkyl-, alkyl ester, polymer with                     representing (if applicable), and
                                               or reasonably foreseen to be                            substituted alkenoates, alkenoic acid,                telephone number. You will receive an
                                               manufactured, processed, distributed in                 alkyl peroxoate-initiated; polymer                    email confirmation from us. Please be
                                               commerce, used, or disposed of.’’                       exemption flag (generic name); website                prepared to show a photo identification
                                                  EPA is required under TSCA section                   link: https://www.epa.gov/reviewing-                  when you arrive. If you need assistance
                                               5(g) to publish in the Federal Register                 new-chemicals-under-toxic-substances-                 for accessibility reasons, or if you have
                                               a statement of its findings after its                   control-act-tsca/tsca-section-5a3c-                   any questions, contact Dale Aultman,
                                               review of a TSCA section 5(a) notice                    determination-91.                                     Secretary to the Farm Credit System
                                               when EPA makes a finding that a new                        EPA Case Number: P–16–0510;                        Insurance Corporation Board, at (703)
                                               chemical substance or significant new                   Chemical identity: Oxirane, 2-methyl-,                883–4009. The matters to be considered
                                               use is not likely to present an                         polymer with oxirane, bis[2-[(1-oxo-2-                at the meeting are:
                                               unreasonable risk of injury to health or                propen-1-yl)amino]propyl] ether
                                               the environment. Such statements apply                                                                        Closed Session
                                                                                                       (CASRN: 1792208–65–1); website link:
                                               to PMNs, MCANs, and SNUNs                               https://www.epa.gov/reviewing-new-                      • Confidential Report on System
                                               submitted to EPA under TSCA section                     chemicals-under-toxic-substances-                     Performance
                                               5.                                                      control-act-tsca/tsca-section-5a3c-
                                                  Anyone who plans to manufacture                                                                            Open Session
                                                                                                       determination-92.
                                               (which includes import) a new chemical                                                                        A. Approval of Minutes
                                               substance for a non-exempt commercial                     Authority: 15 U.S.C. 2601 et seq.
                                               purpose and any manufacturer or                           Dated: September 4, 2018.                              • June 14, 2018 (Open and Closed)
                                               processor wishing to engage in a use of                 Greg Schweer,                                         B. Business Reports
                                               a chemical substance designated by EPA                  Chief, New Chemicals Management Branch,
                                               as a significant new use must submit a                  Chemical Control Division, Office of Pollution          • Quarterly Financial Reports
                                               notice to EPA at least 90 days before                   Prevention and Toxics.                                  • Report on Insured and Other
                                               commencing manufacture of the new                       [FR Doc. 2018–19873 Filed 9–11–18; 8:45 am]           Obligations
                                               chemical substance or before engaging                   BILLING CODE 6560–50–P
                                                                                                                                                               • Quarterly Report on Annual
                                               in the significant new use.                                                                                   Performance Plan
                                                  The submitter of a notice to EPA for
                                               which EPA has made a finding of ‘‘not                                                                         C. New Business
                                                                                                       FARM CREDIT SYSTEM INSURANCE
                                               likely to present an unreasonable risk of
                                                                                                       CORPORATION                                             • Annual Performance Plan FY 2020–
                                               injury to health or the environment’’                                                                         2021
                                               may commence manufacture of the                         Regular Meeting; Farm Credit System                     • Proposed 2020 and 2021 Budgets
                                               chemical substance or manufacture or                    Insurance Corporation Board                             • Insurance Fund Progress Review
                                               processing for the significant new use                                                                        and Setting of Premium Range Guidance
                                               notwithstanding any remaining portion                   AGENCY: Farm Credit System Insurance                  for 2019
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                                               of the applicable review period.                        Corporation.
                                                                                                                                                               Dated: September 7, 2018
                                                                                                       ACTION: Notice, regular meeting.
                                               IV. Statements of Administrator                                                                               Dale Aultman,
                                               Findings Under TSCA Section 5(a)(3)(C)                  SUMMARY:  Notice is hereby given of the               Secretary, Farm Credit System Insurance
                                                 In this unit, EPA provides the                        regular meeting of the Farm Credit                    Corporation Board.
                                               following information (to the extent that               System Insurance Corporation Board                    [FR Doc. 2018–19849 Filed 9–11–18; 8:45 am]
                                               such information is not claimed as                      (Board).                                              BILLING CODE 6710–01–P




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Document Created: 2018-09-12 02:06:54
Document Modified: 2018-09-12 02:06:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFor technical information contact: Greg Schweer, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
FR Citation83 FR 46160 

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