83 FR 5769 - Certain New Chemicals or Significant New Uses; Statements of Findings for October 2017

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range		5769-5770
FR Document		2018-02661

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 October 1, 2017 to October 31, 2017.

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018)

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5769-5770]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02661]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0141; FRL-9972-05]

Certain New Chemicals or Significant New Uses; Statements of
Findings for October 2017

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 October 1, 2017 to October 31, 2017.

FOR FURTHER INFORMATION CONTACT:
For technical information contact: Greg Schweer, Chemical Control
Divison (7405M), Office of Pollution Prevention and Toxics,
Environmental

[[Page 5770]]

Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: 202-564-8469; email address:
schweer.greg@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:

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-2017-0141, 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 October 1, 2017 to October 31, 2017.

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 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-17-0014; Chemical identity: organic acid
producing yeast, modified, genetically stable; website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-75.

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

Dated: January 24, 2018.
Greg Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division,
Office of Pollution Prevention and Toxics.
[FR Doc. 2018-02661 Filed 2-8-18; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5769

Although others may be affected, this substantial human exposure to the • Chemical identity (generic name, if
action applies directly to the submitters substance; or the specific name is claimed as CBI).
of the PMNs addressed in this action. • The chemical substance or • website link to EPA’s decision
significant new use is not likely to document describing the basis of the
B. How can I get copies of this document present an unreasonable risk of injury to ‘‘not likely to present an unreasonable
and other related information? health or the environment. risk’’ finding made by EPA under TSCA
The docket for this action, identified Unreasonable risk findings must be section 5(a)(3)(C).
by docket identification (ID) number made without consideration of costs or EPA Case Number: P–17–0390;
EPA–HQ–OPPT–2017–0141, is available other non-risk factors, including an Chemical identity: Carbomonocyclic
at http://www.regulations.gov or at the unreasonable risk to a potentially dicarboxylic acid, polymer with
Office of Pollution Prevention and exposed or susceptible subpopulation alkenedioic acid, substituted
Toxics Docket (OPPT Docket), identified as relevant under the heteropolycycle, substituted
Environmental Protection Agency conditions of use. The term ‘‘conditions heteromonocycle, alkanediol,
Docket Center (EPA/DC), West William of use’’ is defined in TSCA section 3 to alkanedioic acid, alkoxylated
Jefferson Clinton Bldg., Rm. 3334, 1301 mean ‘‘the circumstances, as determined substituted dicarbomonocycle,
Constitution Ave. NW, Washington, DC. by the Administrator, under which a alkoxylated substituted
The Public Reading Room is open from chemical substance is intended, known, dicarbomonocycle and alkanetriol,
8:30 a.m. to 4:30 p.m., Monday through or reasonably foreseen to be carbomonocyclic carboxylate alkanoate
Friday, excluding legal holidays. The manufactured, processed, distributed in (generic name); website link: https://
telephone number for the Public commerce, used, or disposed of.’’ www.epa.gov/reviewing-new-chemicals-
Reading Room is (202) 566–1744, and EPA is required under TSCA section under-toxic-substances-control-act-tsca/
the telephone number for the OPPT 5(g) to publish in the Federal Register tsca-section-5a3c-determination-77.
Docket is (202) 566–0280. Please review a statement of its findings after its Authority: 15 U.S.C. 2601 et seq.
the visitor instructions and additional review of a TSCA section 5(a) notice
when EPA makes a finding that a new Dated: January 24, 2018.
information about the docket available
at http://www.epa.gov/dockets. chemical substance or significant new Greg Schweer,
use is not likely to present an Chief, New Chemicals Management Branch,
II. What action is the agency taking? unreasonable risk of injury to health or Chemical Control Division, Office of Pollution
the environment. Such statements apply Prevention and Toxics.
This document lists the statements of
findings made by EPA after review of to PMNs, MCANs, and SNUNs [FR Doc. 2018–02662 Filed 2–8–18; 8:45 am]
notices submitted under TSCA section submitted to EPA under TSCA BILLING CODE 6560–50–P

5(a) that certain new chemical section 5.
substances or significant new uses are Anyone who plans to manufacture
not likely to present an unreasonable (which includes import) a new chemical ENVIRONMENTAL PROTECTION
risk of injury to health or the substance for a non-exempt commercial AGENCY
environment. This document presents purpose and any manufacturer or [EPA–HQ–OPPT–2017–0141; FRL–9972–05]
statements of findings made by EPA processor wishing to engage in a use of
during the period from November 1, a chemical substance designated by EPA Certain New Chemicals or Significant
2017 to November 30, 2017. as a significant new use must submit a New Uses; Statements of Findings for
notice to EPA at least 90 days before October 2017
III. What is the agency’s authority for commencing manufacture of the new
taking this action? chemical substance or before engaging AGENCY: Environmental Protection
in the significant new use. Agency (EPA).
TSCA section 5(a)(3) requires EPA to
The submitter of a notice to EPA for ACTION: Notice.
review a TSCA section 5(a) notice and
make one of the following specific which EPA has made a finding of ‘‘not
likely to present an unreasonable risk of SUMMARY: Section 5(g) of the Toxic
findings: Substances Control Act (TSCA) requires
injury to health or the environment’’
• The chemical substance or EPA to publish in the Federal Register
may commence manufacture of the
significant new use presents an a statement of its findings after its
chemical substance or manufacture or
unreasonable risk of injury to health or review of TSCA section 5(a) notices
processing for the significant new use
the environment; when EPA makes a finding that a new
notwithstanding any remaining portion
• The information available to EPA is of the applicable review period. chemical substance or significant new
insufficient to permit a reasoned use is not likely to present an
evaluation of the health and IV. Statements of Administrator unreasonable risk of injury to health or
environmental effects of the chemical Findings Under TSCA Section 5(a)(3)(C) the environment. Such statements apply
substance or significant new use; In this unit, EPA provides the to premanufacture notices (PMNs),
• The information available to EPA is following information (to the extent that microbial commercial activity notices
insufficient to permit a reasoned such information is not claimed as (MCANs), and significant new use
evaluation of the health and Confidential Business Information notices (SNUNs) submitted to EPA
environmental effects and the chemical (CBI)) on the PMNs, MCANs and under TSCA section 5. This document
substance or significant new use may SNUNs for which, during this period, presents statements of findings made by
present an unreasonable risk of injury to EPA has made findings under TSCA EPA on TSCA section 5(a) notices
sradovich on DSK3GMQ082PROD with NOTICES

health or the environment; section 5(a)(3)(C) that the new chemical during the period from October 1, 2017
• The chemical substance is or will substances or significant new uses are to October 31, 2017.
be produced in substantial quantities, not likely to present an unreasonable FOR FURTHER INFORMATION CONTACT:
and such substance either enters or may risk of injury to health or the For technical information contact:
reasonably be anticipated to enter the environment: Greg Schweer, Chemical Control
environment in substantial quantities or • EPA case number assigned to the Divison (7405M), Office of Pollution
there is or may be significant or TSCA section 5(a) notice. Prevention and Toxics, Environmental

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5770 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices

Protection Agency, 1200 Pennsylvania • The information available to EPA is notwithstanding any remaining portion
Ave. NW, Washington, DC 20460–0001; insufficient to permit a reasoned of the applicable review period.
telephone number: 202–564–8469; evaluation of the health and
IV. Statements of Administrator
email address: schweer.greg@epa.gov. environmental effects of the chemical
Findings Under TSCA Section 5(a)(3)(C)
For general information contact: The substance or significant new use;
TSCA-Hotline, ABVI-Goodwill, 422 • The information available to EPA is In this unit, EPA provides the
South Clinton Ave., Rochester, NY insufficient to permit a reasoned following information (to the extent that
14620; telephone number: (202) 554– evaluation of the health and such information is not claimed as
1404; email address: TSCA-Hotline@ environmental effects and the chemical Confidential Business Information
epa.gov. substance or significant new use may (CBI)) on the PMNs, MCANs and
SUPPLEMENTARY INFORMATION: present an unreasonable risk of injury to SNUNs for which, during this period,
health or the environment; EPA has made findings under TSCA
I. General Information • The chemical substance is or will section 5(a)(3)(C) that the new chemical
A. Does this action apply to me? be produced in substantial quantities, substances or significant new uses are
and such substance either enters or may not likely to present an unreasonable
This action is directed to the public reasonably be anticipated to enter the risk of injury to health or the
in general. As such, the Agency has not environment in substantial quantities or environment:
attempted to describe the specific there is or may be significant or
entities that this action may apply to. • EPA case number assigned to the
substantial human exposure to the TSCA section 5(a) notice.
Although others may be affected, this substance; or
action applies directly to the submitters • The chemical substance or • Chemical identity (generic name, if
of the PMNs addressed in this action. significant new use is not likely to the specific name is claimed as CBI).
B. How can I get copies of this document present an unreasonable risk of injury to • Website link to EPA’s decision
and other related information? health or the environment. document describing the basis of the
Unreasonable risk findings must be ‘‘not likely to present an unreasonable
The docket for this action, identified risk’’ finding made by EPA under TSCA
by docket identification (ID) number made without consideration of costs or
section 5(a)(3)(C).
EPA–HQ–OPPT–2017–0141, is available other non-risk factors, including an
at http://www.regulations.gov or at the unreasonable risk to a potentially EPA Case Number: J–17–0014;
Office of Pollution Prevention and exposed or susceptible subpopulation Chemical identity: organic acid
Toxics Docket (OPPT Docket), identified as relevant under the producing yeast, modified, genetically
Environmental Protection Agency conditions of use. The term ‘‘conditions stable; website link: https://
Docket Center (EPA/DC), West William of use’’ is defined in TSCA section 3 to www.epa.gov/reviewing-new-chemicals-
Jefferson Clinton Bldg., Rm. 3334, 1301 mean ‘‘the circumstances, as determined under-toxic-substances-control-act-tsca/
Constitution Ave. NW, Washington, DC. by the Administrator, under which a tsca-section-5a3c-determination-75.
The Public Reading Room is open from chemical substance is intended, known, Authority: 15 U.S.C. 2601 et seq.
8:30 a.m. to 4:30 p.m., Monday through or reasonably foreseen to be
manufactured, processed, distributed in Dated: January 24, 2018.
Friday, excluding legal holidays. The Greg Schweer,
telephone number for the Public commerce, used, or disposed of.’’
EPA is required under TSCA section Chief, New Chemicals Management Branch,
Reading Room is (202) 566–1744, and Chemical Control Division, Office of Pollution
the telephone number for the OPPT 5(g) to publish in the Federal Register
Prevention and Toxics.
Docket is (202) 566–0280. Please review a statement of its findings after its [FR Doc. 2018–02661 Filed 2–8–18; 8:45 am]
the visitor instructions and additional review of a TSCA section 5(a) notice
information about the docket available when EPA makes a finding that a new BILLING CODE 6560–50–P

at http://www.epa.gov/dockets. chemical substance or significant new
use is not likely to present an
II. What action is the Agency taking? unreasonable risk of injury to health or
This document lists the statements of the environment. Such statements apply FEDERAL ELECTION COMMISSION
findings made by EPA after review of to PMNs, MCANs, and SNUNs
submitted to EPA under TSCA section Sunshine Act Meeting
notices submitted under TSCA section
5(a) that certain new chemical 5.
Anyone who plans to manufacture FEDERAL REGISTER CITATION NOTICE OF
substances or significant new uses are PREVIOUS ANNOUNCEMENT: 83 FR 2639
not likely to present an unreasonable (which includes import) a new chemical
risk of injury to health or the substance for a non-exempt commercial PREVIOUSLY ANNOUNCED TIME AND DATE OF
environment. This document presents purpose and any manufacturer or THE MEETING: Tuesday, January 23, 2018
statements of findings made by EPA processor wishing to engage in a use of at 10:00 a.m.
during the period from October 1, 2017 a chemical substance designated by EPA
as a significant new use must submit a This meeting
CHANGES IN THE MEETING:
to October 31, 2017. was continued on Tuesday, February 6,
notice to EPA at least 90 days before
III. What is the Agency’s authority for commencing manufacture of the new 2018.
taking this action? chemical substance or before engaging * * * * *
in the significant new use.
sradovich on DSK3GMQ082PROD with NOTICES

TSCA section 5(a)(3) requires EPA to CONTACT FOR MORE INFORMATION: Judith
review a TSCA section 5(a) notice and The submitter of a notice to EPA for Ingram, Press Officer, Telephone: (202)
make one of the following specific which EPA has made a finding of ‘‘not 694–1220.
findings: likely to present an unreasonable risk of
• The chemical substance or injury to health or the environment’’ Laura E. Sinram,
significant new use presents an may commence manufacture of the Deputy Secretary of the Commission.
unreasonable risk of injury to health or chemical substance or manufacture or [FR Doc. 2018–02708 Filed 2–7–18; 11:15 am]
the environment; processing for the significant new use BILLING CODE 6715–01–P

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Document Created: 2018-02-09 00:11:58
Document Modified: 2018-02-09 00:11:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		For technical information contact: Greg Schweer, Chemical Control Divison (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation		83 FR 5769