81 FR 80662 - Certain New Chemicals or Significant New Uses; Statements of Findings for October 2016

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 221 (November 16, 2016)

Page Range		80662-80664
FR Document		2016-27545

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 September 20, 2016 to October 24, 2016.

Federal Register, Volume 81 Issue 221 (Wednesday, November 16, 2016)

[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Pages 80662-80664]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27545]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0511; FRL-9954-84]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for October 2016

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Section 5(g) of the Toxic Substances Control Act (TSCA) 
requires

[[Page 80663]]

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 September 20, 2016 to October 24, 2016.

FOR FURTHER INFORMATION 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 20460-0001; 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-2016-0511, 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 September 20, 2016 to October 24, 2016.

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 
premanufacture notices (PMNs), microbial commercial activity notices 
(MCANs), and significant new use notices (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).
     Web site 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-16-0019; Chemical identity: Trichoderma reesei 
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-20.
    EPA Case Number: J-16-0020; Chemical identity: Trichoderma reesei 
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-21.
    EPA Case Number: J-16-0021; Chemical identity: Trichoderma reesei 
modified (generic name); Web site link: https://www.epa.gov/reviewing-
new-

[[Page 80664]]

chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-
determination-22.
    EPA Case Number: J-16-0022; Chemical identity: Trichoderma reesei 
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-23.
    EPA Case Number: J-16-0023; Chemical identity: Trichoderma reesei 
modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-24.
    EPA Case Number: P-16-0459; Chemical identity: Carbomonocyclic 
dicarboxylic acid, polymer with alkanedioic acid, substituted 
heteropolycycle, substituted carbomonocycle, alkyl alkenoate, 
alkanedioic acid, alkoxylated substituted dicarbomonocycle, alkoxylated 
substituted dicarbomonocycle, alkenoic acid, oxo alkyl initiated 
(generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-19.

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

    Dated: November 8, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2016-27545 Filed 11-15-16; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices 80663

EPA to publish in the Federal Register II. What action is the agency taking? unreasonable risk of injury to health or
a statement of its findings after its This document lists the statements of the environment. Such statements apply
review of TSCA section 5(a) notices findings made by EPA after review of to premanufacture notices (PMNs),
when EPA makes a finding that a new notices submitted under TSCA section microbial commercial activity notices
chemical substance or significant new 5(a) that certain new chemical (MCANs), and significant new use
use is not likely to present an substances or significant new uses are notices (SNUNs) submitted to EPA
unreasonable risk of injury to health or not likely to present an unreasonable under TSCA section 5.
the environment. Such statements apply Anyone who plans to manufacture
risk of injury to health or the
to premanufacture notices (PMNs), (which includes import) a new chemical
environment. This document presents
microbial commercial activity notices substance for a non-exempt commercial
statements of findings made by EPA
(MCANs), and significant new use purpose and any manufacturer or
during the period from September 20,
notices (SNUNs) submitted to EPA processor wishing to engage in a use of
2016 to October 24, 2016.
under TSCA section 5. This document a chemical substance designated by EPA
presents statements of findings made by III. What is the agency’s authority for as a significant new use must submit a
EPA on TSCA section 5(a) notices taking this action? notice to EPA at least 90 days before
during the period from September 20, TSCA section 5(a)(3) requires EPA to commencing manufacture of the new
2016 to October 24, 2016. review a TSCA section 5(a) notice and chemical substance or before engaging
make one of the following specific in the significant new use.
FOR FURTHER INFORMATION CONTACT:
findings: The submitter of a notice to EPA for
For technical information contact: which EPA has made a finding of ‘‘not
Greg Schweer, Chemical Control • The chemical substance or
significant new use presents an likely to present an unreasonable risk of
Divison (7405M), Office of Pollution injury to health or the environment’’
Prevention and Toxics, Environmental unreasonable risk of injury to health or
the environment; may commence manufacture of the
Protection Agency, 1200 Pennsylvania chemical substance or manufacture or
Ave. NW., Washington, DC 20460–0001; • The information available to EPA is
insufficient to permit a reasoned processing for the significant new use
telephone number: 202–564–8469; notwithstanding any remaining portion
email address: schweer.greg@epa.gov. evaluation of the health and
environmental effects of the chemical of the applicable review period.
For general information contact: The substance or significant new use; IV. Statements of Administrator
TSCA-Hotline, ABVI-Goodwill, 422 • The information available to EPA is Findings Under TSCA Section 5(a)(3)(C)
South Clinton Ave., Rochester, NY insufficient to permit a reasoned
14620; telephone number: (202) 554– In this unit, EPA provides the
evaluation of the health and following information (to the extent that
1404; email address: TSCA-Hotline@ environmental effects and the chemical
epa.gov. such information is not claimed as
substance or significant new use may Confidential Business Information
SUPPLEMENTARY INFORMATION: present an unreasonable risk of injury to (CBI)) on the PMNs, MCANs and
health or the environment; SNUNs for which, during this period,
I. General Information • The chemical substance is or will EPA has made findings under TSCA
A. Does this action apply to me? be produced in substantial quantities, section 5(a)(3)(C) that the new chemical
and such substance either enters or may substances or significant new uses are
This action is directed to the public reasonably be anticipated to enter the
in general. As such, the Agency has not not likely to present an unreasonable
environment in substantial quantities or risk of injury to health or the
attempted to describe the specific there is or may be significant or
entities that this action may apply to. environment:
substantial human exposure to the • EPA case number assigned to the
Although others may be affected, this substance; or TSCA section 5(a) notice.
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 • Web site 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 made without consideration of costs or risk’’ finding made by EPA under TSCA
by docket identification (ID) number other non-risk factors, including an section 5(a)(3)(C).
EPA–HQ–OPPT–2016–0511, is available unreasonable risk to a potentially EPA Case Number: J–16–0019;
at http://www.regulations.gov or at the exposed or susceptible subpopulation Chemical identity: Trichoderma reesei
Office of Pollution Prevention and identified as relevant under the modified (generic name); Web site link:
Toxics Docket (OPPT Docket), conditions of use. The term ‘‘conditions https://www.epa.gov/reviewing-new-
Environmental Protection Agency of use’’ is defined in TSCA section 3 to chemicals-under-toxic-substances-
Docket Center (EPA/DC), West William mean ‘‘the circumstances, as determined control-act-tsca/tsca-section-5a3c-
Jefferson Clinton Bldg., Rm. 3334, 1301 by the Administrator, under which a determination-20.
Constitution Ave. NW., Washington, chemical substance is intended, known, EPA Case Number: J–16–0020;
DC. The Public Reading Room is open or reasonably foreseen to be Chemical identity: Trichoderma reesei
from 8:30 a.m. to 4:30 p.m., Monday manufactured, processed, distributed in modified (generic name); Web site link:
asabaliauskas on DSK3SPTVN1PROD with NOTICES

through Friday, excluding legal commerce, used, or disposed of.’’ https://www.epa.gov/reviewing-new-
holidays. The telephone number for the EPA is required under TSCA section chemicals-under-toxic-substances-
Public Reading Room is (202) 566–1744, 5(g) to publish in the Federal Register control-act-tsca/tsca-section-5a3c-
and the telephone number for the OPPT a statement of its findings after its determination-21.
Docket is (202) 566–0280. Please review review of a TSCA section 5(a) notice EPA Case Number: J–16–0021;
the visitor instructions and additional when EPA makes a finding that a new Chemical identity: Trichoderma reesei
information about the docket available chemical substance or significant new modified (generic name); Web site link:
at http://www.epa.gov/dockets. use is not likely to present an https://www.epa.gov/reviewing-new-

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80664 Federal Register / Vol. 81, No. 221 / Wednesday, November 16, 2016 / Notices

chemicals-under-toxic-substances- Dated: November 14, 2016. (Pub. L. 92–463), the Centers for Disease
control-act-tsca/tsca-section-5a3c- Dawn Roberts, Control and Prevention (CDC),
determination-22. Management Analyst, NEPA Complianceannounces the following meeting of the
EPA Case Number: J–16–0022; aforementioned committee:
Division, Office of Federal Activities.
Chemical identity: Trichoderma reesei [FR Doc. 2016–27700 Filed 11–15–16; 8:45 am] TIMES AND DATES:
modified (generic name); Web site link: BILLING CODE 6560–50–P 10:00 a.m.–5:30 p.m., EST, December
https://www.epa.gov/reviewing-new- 14, 2016
chemicals-under-toxic-substances- 8:30 a.m.–3:30 p.m., EST, December 15,
control-act-tsca/tsca-section-5a3c- FEDERAL ELECTION COMMISSION 2016
determination-23. PLACE: Centers for Disease Control and
EPA Case Number: J–16–0023; Sunshine Act Meetings Prevention (CDC), Global
Chemical identity: Trichoderma reesei Communications Center, Building 19,
modified (generic name); Web site link: AGENCY: Federal Election Commission. Classrooms 256/257, 1600 Clifton Road
https://www.epa.gov/reviewing-new- DATE AND TIME: Thursday, November 17, NE., Atlanta, Georgia 30329
chemicals-under-toxic-substances- 2016 at 10:00 a.m. STATUS: Open to the public limited only
control-act-tsca/tsca-section-5a3c- PLACE: 999 E Street NW., Washington, by the space available. The meeting
determination-24. DC, (Ninth Floor).
EPA Case Number: P–16–0459; room will accommodate up to 40
STATUS: This meeting will be open to the people. Public participants should pre-
Chemical identity: Carbomonocyclic
public. register for the meeting as described
dicarboxylic acid, polymer with
alkanedioic acid, substituted ITEMS TO BE DISCUSSED: below.
Draft Advisory Opinion 2016–16: Gary Members of the public that wish to
heteropolycycle, substituted
Johnson 2012 attend this meeting in person should
carbomonocycle, alkyl alkenoate,
Draft Advisory Opinion 2016–17: pre-register by submitting the following
alkanedioic acid, alkoxylated
Libertarian Party of Michigan information by email, facsimile, or
substituted dicarbomonocycle,
Executive Committee, Inc. phone (see Contact Person for More
alkoxylated substituted
Draft Advisory Opinion 2016–18: Ohio Information) no later than 12:00 noon
dicarbomonocycle, alkenoic acid, oxo
Green Party (EST) on Tuesday, December 6, 2016:
alkyl initiated (generic name); Web site Draft Advisory Opinion 2016–19: • Full Name
link: https://www.epa.gov/reviewing- Libertarian Party of Colorado • Organizational Affiliation
new-chemicals-under-toxic-substances- Draft Advisory Opinion 2016–20: • Complete Mailing Address
control-act-tsca/tsca-section-5a3c- Christoph Mlinarchik, JD, CFCM • Citizenship
determination-19. Draft Advisory Opinion 2016–21: Great • Phone Number or Email Address
Authority: 15 U.S.C. 2601 et seq. America PAC Web conferencing information:
Dated: November 8, 2016. Proposed Amendments to Directive 52 Web ID: https://ophpr-
Proposed Final Audit Report the Utah bsc.adobeconnect.com/december2016/
Maria J. Doa,
Republican Party (A13–16) Dial in number: 888–942–9042
Director, Chemical Control Division, Office Management and Administrative Participant passcode: 3979208
of Pollution Prevention and Toxics.
Matters PURPOSE: This Board is charged with
[FR Doc. 2016–27545 Filed 11–15–16; 8:45 am]
Individuals who plan to attend and providing advice and guidance to the
BILLING CODE 6560–50–P
require special assistance, such as sign Secretary, Department of Health and
language interpretation or other Human Services (HHS), the Assistant
ENVIRONMENTAL PROTECTION reasonable accommodations, should Secretary for Health (ASH), the Director,
AGENCY contact Shelley E. Garr, Deputy Centers for Disease Control and
Secretary, at (202) 694–1040, at least 72 Prevention (CDC), and the Director,
[ER–FRL–9030–2] hours prior to the meeting date. Office of Public Health Preparedness
PERSON TO CONTACT FOR INFORMATION: and Response (OPHPR), concerning
Environmental Impact Statements;
Judith Ingram, Press Officer, Telephone: strategies and goals for the programs
Notice of Availability
(202) 694–1220. and research within OPHPR, monitoring
Responsible Agency: Office of Federal the overall strategic direction and focus
Shawn Woodhead Werth,
Activities, General Information (202) of the OPHPR Divisions and Offices,
564–7146 or http://www.epa.gov/nepa. Secretary and Clerk of the Commission. and administration and oversight of
Weekly receipt of Environmental Impact [FR Doc. 2016–27621 Filed 11–14–16; 11:15 am] peer review of OPHPR scientific
Statement BILLING CODE 6715–01–P programs. For additional information
Filed 11/07/2016 Through 11/11/2016 about the Board, please visit: http://
Pursuant to 40 CFR 1506.9. www.cdc.gov/phpr/science/
DEPARTMENT OF HEALTH AND counselors.htm.
Notice HUMAN SERVICES (HHS) MATTERS FOR DISCUSSION: Day one of the
Section 309(a) of the Clean Air Act meeting will cover briefings and BSC
requires that EPA make public its Centers for Disease Control and deliberation on the following topics:
comments on EISs issued by other Prevention Interval updates from OPHPR Divisions
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Federal agencies. EPA’s comment letters and Offices; updates on OPHPR’S policy
on EISs are available at: http:// Office of Public Health Preparedness
and Response (OPHPR) Board of agenda; PHPR research agenda; CDC
www.epa.gov/compliance/nepa/ surveillance strategies; and BSC liaison
eisdata.html. Scientific Counselors, Office of Public
HealthPreparedness and Response, representative updates to the Board
EIS No. 20160268, Final, OSM, PRO, highlighting organizational activities
(BSC, OPHPR)
Stream Protection Rule, Review Period relevant to the OPHPR mission.
Ends: 12/15/2016, Contact: Robin In accordance with section 10(a)(2) of Day two of the meeting will cover
Ferguson 202–208–2802. the Federal Advisory Committee Act briefings and BSC deliberation on the

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Document Created: 2016-11-16 00:57:16
Document Modified: 2016-11-16 00:57:16

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 20460-0001; telephone number: 202-564-8469; email
FR Citation		81 FR 80662