82 FR 19046 - Certain New Chemicals or Significant New Uses; Statements of Findings for February 2017

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range		19046-19047
FR Document		2017-08246

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 January 1, 2017 to February 28, 2017.

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017)

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19046-19047]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08246]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0141; FRL-9960-36]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 January 1, 2017 to February 28, 2017.

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-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 January 1, 2017 to February 28, 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 sub mitted 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

[[Page 19047]]

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-17-0001-0005; Chemical identity: Saccharomyces 
cerevisiae modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-40.
    EPA Case Number: J-17-0006; Chemical identity: Saccharomyces 
cerevisiae modified (generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-42.
    EPA Case Number: P-17-0144; Chemical identity: Amines, C36-
alkylenedi-, polymers with octahydro-4,7-methano-1H-indenedimethanamine 
and pyromellitic dianhydride, maleated (CASRN: 2020378-57-6); Web site 
link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-41.
    EPA Case Number: P-17-0158; Chemical identity: Perylene bisimide 
(generic name); Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-43.
    EPA Case Number: P-17-0160; Chemical identity: 2-Propenoic acid, 
alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-
2-propenamide and alkyl 2-propenoate (generic name); Web site link: 
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-44.
    EPA Case Number: P-17-0161; Chemical identity: 2-Propenoic acid, 
alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-
2-propenamide, ethenylbenzene and alkyl 2-propenoate (generic name); 
Web site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-44.
    EPA Case Number: P-17-0182; Chemical identity: Alkyldioic acid, 
polymer with 2,2-dimethyl-1,3-propanediol, heteropolycyclic carboxy 
acid anhydride and 1,3-propanediol (generic name); Web site link: 
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-45.
    EPA Case Number: P-17-0185; Chemical identity: Fatty acids, C18-
unsatd., dimers, hydrogenated, polymers with C18-unsatd. fatty acid 
trimers, alkylenediamine and hydroxyalkanoic acid (generic name); Web 
site link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-46.

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

    Dated: March 29, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2017-08246 Filed 4-24-17; 8:45 am]
 BILLING CODE 6560-50-P

19046 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices

aromatic vinyl monomer, cycloaliphatic to premanufacture notices (PMNs), statements of findings made by EPA
lactone, and alkyl carboxylic acid, microbial commercial activity notices during the period from January 1, 2017
Azobis [aliphatic nitrile] initiated (MCANs), and significant new use to February 28, 2017.
(generic name); Web site link: https:// notices (SNUNs) submitted to EPA
III. What is the Agency’s authority for
www.epa.gov/reviewing-new-chemicals- under TSCA section 5. This document
taking this action?
under-toxic-substances-control-act-tsca/ presents statements of findings made by
tsca-section-5a3c-determination-39. EPA on TSCA section 5(a) notices TSCA section 5(a)(3) requires EPA to
EPA Case Number: P–17–0019; during the period from January 1, 2017 review a TSCA section 5(a) notice and
Chemical identity: Hydroxyl alkyl to February 28, 2017. make one of the following specific
acrylate ester, polymer with acrylates, FOR FURTHER INFORMATION CONTACT: findings:
aromatic vinyl monomer, cycloaliphatic For technical information contact: • The chemical substance or
lactone, and alkyl carboxylic acid, Greg Schweer, Chemical Control significant new use presents an
peroxide initiated (generic name); Web Division (7405M), Office of Pollution unreasonable risk of injury to health or
site link: https://www.epa.gov/ Prevention and Toxics, Environmental the environment;
reviewing-new-chemicals-under-toxic- Protection Agency, 1200 Pennsylvania • The information available to EPA is
substances-control-act-tsca/tsca-section- Ave. NW., Washington, DC 20460–0001; insufficient to permit a reasoned
5a3c-determination-39. telephone number: 202–564–8469; evaluation of the health and
EPA Case Number: P–17–0020; email address: schweer.greg@epa.gov. environmental effects of the chemical
Chemical identity: Hydroxyl alkyl For general information contact: The substance or significant new use;
acrylate ester, polymer with acrylates, TSCA-Hotline, ABVI-Goodwill, 422 • The information available to EPA is
aromatic vinyl monomer, cycloaliphatic South Clinton Ave., Rochester, NY insufficient to permit a reasoned
lactone, and alkyl carboxylic acid, 14620; telephone number: (202) 554– evaluation of the health and
peroxide initiated (generic name); Web 1404; email address: TSCA-Hotline@ environmental effects and the chemical
site link: https://www.epa.gov/ epa.gov. substance or significant new use may
reviewing-new-chemicals-under-toxic- present an unreasonable risk of injury to
SUPPLEMENTARY INFORMATION: health or the environment;
substances-control-act-tsca/tsca-section-
5a3c-determination-39. I. General Information • The chemical substance is or will
EPA Case Number: P–17–0021; be produced in substantial quantities,
A. Does this action apply to me? and such substance either enters or may
Chemical identity: Hydroxyl alkyl
acrylate ester, polymer with acrylates, This action is directed to the public reasonably be anticipated to enter the
aromatic vinyl monomer, cycloaliphatic in general. As such, the Agency has not environment in substantial quantities or
lactone, and alkyl carboxylic acid, attempted to describe the specific there is or may be significant or
Azobis [aliphatic nitrile] initiated entities that this action may apply to. substantial human exposure to the
(generic name); Web site link: https:// Although others may be affected, this substance; or
www.epa.gov/reviewing-new-chemicals- action applies directly to the submitters • The chemical substance or
under-toxic-substances-control-act-tsca/ of the PMNs addressed in this action. significant new use is not likely to
tsca-section-5a3c-determination-39. present an unreasonable risk of injury to
B. How can I get copies of this document health or the environment.
Authority: 15 U.S.C. 2601 et seq. and other related information? Unreasonable risk findings must be
Dated: February 13, 2017. The docket for this action, identified made without consideration of costs or
Maria J. Doa, by docket identification (ID) number other non-risk factors, including an
Director, Chemical Control Division, Office EPA–HQ–OPPT–2017–0141, is available unreasonable risk to a potentially
of Pollution Prevention and Toxics. at http://www.regulations.gov or at the exposed or susceptible subpopulation
[FR Doc. 2017–08250 Filed 4–24–17; 8:45 am] Office of Pollution Prevention and identified as relevant under the
BILLING CODE 6560–50–P
Toxics Docket (OPPT Docket), conditions of use. The term ‘‘conditions
Environmental Protection Agency of use’’ is defined in TSCA section 3 to
Docket Center (EPA/DC), West William mean ‘‘the circumstances, as determined
ENVIRONMENTAL PROTECTION Jefferson Clinton Bldg., Rm. 3334, 1301 by the Administrator, under which a
AGENCY Constitution Ave. NW., Washington, chemical substance is intended, known,
DC. The Public Reading Room is open or reasonably foreseen to be
[EPA–HQ–OPPT–2017–0141; FRL–9960–36] from 8:30 a.m. to 4:30 p.m., Monday manufactured, processed, distributed in
through Friday, excluding legal commerce, used, or disposed of.’’
Certain New Chemicals or Significant EPA is required under TSCA section
New Uses; Statements of Findings for holidays. The telephone number for the
February 2017 Public Reading Room is (202) 566–1744, 5(g) to publish in the Federal Register
and the telephone number for the OPPT a statement of its findings after its
AGENCY: Environmental Protection Docket is (202) 566–0280. Please review review of a TSCA section 5(a) notice
Agency (EPA). the visitor instructions and additional when EPA makes a finding that a new
ACTION: Notice. information about the docket available chemical substance or significant new
at http://www.epa.gov/dockets. use is not likely to present an
SUMMARY: Section 5(g) of the Toxic unreasonable risk of injury to health or
Substances Control Act (TSCA) requires II. What action is the Agency taking? the environment. Such statements apply
asabaliauskas on DSK3SPTVN1PROD with NOTICES

EPA to publish in the Federal Register This document lists the statements of to PMNs, MCANs, and SNUNs
a statement of its findings after its findings made by EPA after review of submitted to EPA under TSCA section
review of TSCA section 5(a) notices notices submitted under TSCA section 5.
when EPA makes a finding that a new 5(a) that certain new chemical Anyone who plans to manufacture
chemical substance or significant new substances or significant new uses are (which includes import) a new chemical
use is not likely to present an not likely to present an unreasonable substance for a non-exempt commercial
unreasonable risk of injury to health or risk of injury to health or the purpose and any manufacturer or
the environment. Such statements apply environment. This document presents processor wishing to engage in a use of

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Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19047

a chemical substance designated by EPA EPA Case Number: P–17–0160; stay clear of the suspended loads of a
as a significant new use must submit a Chemical identity: 2-Propenoic acid, crane.)
notice to EPA at least 90 days before alkyl-, alkyl ester, polymer with alkyl 2- Any person attending this meeting
commencing manufacture of the new propenoate, dialkyloxoalkyl-2- who requires special accessibility
chemical substance or before engaging propenamide and alkyl 2-propenoate features and/or auxiliary aids, such as
in the significant new use. (generic name); Web site link: https:// sign language interpreters, must inform
The submitter of a notice to EPA for www.epa.gov/reviewing-new-chemicals- the Commission in advance of those
which EPA has made a finding of ‘‘not under-toxic-substances-control-act-tsca/ needs. Subject to 29 CFR 2706.150(a)(3)
likely to present an unreasonable risk of tsca-section-5a3c-determination-44. and 2706.160(d).
injury to health or the environment’’ EPA Case Number: P–17–0161;
may commence manufacture of the Chemical identity: 2-Propenoic acid, CONTACT PERSON FOR MORE INFORMATION:
chemical substance or manufacture or alkyl-, alkyl ester, polymer with alkyl 2- Emogene Johnson (202) 434–9935/(202)
processing for the significant new use propenoate, dialkyloxoalkyl-2- 708–9300 for TDD, Relay/1–800–877–
notwithstanding any remaining portion propenamide, ethenylbenzene and alkyl 8339 for toll free.
of the applicable review period. 2-propenoate (generic name); Web site PHONE NUMBER FOR LISTENING TO
IV. Statements of Administrator link: https://www.epa.gov/reviewing- ARGUMENT: 1–(866) 867–4769, Passcode:
Findings Under TSCA Section 5(a)(3)(C) new-chemicals-under-toxic-substances- 129–339.
control-act-tsca/tsca-section-5a3c-
In this unit, EPA provides the determination-44. Sarah L. Stewart,
following information (to the extent that EPA Case Number: P–17–0182; Deputy General Counsel.
such information is not claimed as Chemical identity: Alkyldioic acid, [FR Doc. 2017–08415 Filed 4–21–17; 11:15 am]
Confidential Business Information polymer with 2,2-dimethyl-1,3- BILLING CODE 6735–01–P
(CBI)) on the PMNs, MCANs and propanediol, heteropolycyclic carboxy
SNUNs for which, during this period, acid anhydride and 1,3-propanediol
EPA has made findings under TSCA (generic name); Web site link: https:// FEDERAL MINE SAFETY AND HEALTH
section 5(a)(3)(C) that the new chemical www.epa.gov/reviewing-new-chemicals- REVIEW COMMISSION
substances or significant new uses are under-toxic-substances-control-act-tsca/
not likely to present an unreasonable tsca-section-5a3c-determination-45. [BAC 6735–01]
risk of injury to health or the EPA Case Number: P–17–0185;
environment: Chemical identity: Fatty acids, C18- Sunshine Act Notice
• EPA case number assigned to the unsatd., dimers, hydrogenated,
TSCA section 5(a) notice. April 21, 2017.
polymers with C18-unsatd. fatty acid
• Chemical identity (generic name, if trimers, alkylenediamine and TIME AND DATE: 10:00 a.m., Thursday,
the specific name is claimed as CBI). hydroxyalkanoic acid (generic name); June 29, 2017.
• Web site link to EPA’s decision Web site link: https://www.epa.gov/
document describing the basis of the PLACE: The Richard V. Backley Hearing
reviewing-new-chemicals-under-toxic-
‘‘not likely to present an unreasonable Room, Room 511N, 1331 Pennsylvania
substances-control-act-tsca/tsca-section-
risk’’ finding made by EPA under TSCA Avenue NW., Washington, DC 20004
5a3c-determination-46.
section 5(a)(3)(C). (enter from F Street entrance).
EPA Case Number: J–17–0001–0005; Authority: 15 U.S.C. 2601 et seq.
STATUS: Open.
Chemical identity: Saccharomyces Dated: March 29, 2017.
cerevisiae modified (generic name); Web Maria J. Doa, MATTERS TO BE CONSIDERED: The
site link: https://www.epa.gov/ Commission will hear oral argument in
Director, Chemical Control Division, Office
reviewing-new-chemicals-under-toxic- of Pollution Prevention and Toxics. the matter Secretary of Labor v. Sims
substances-control-act-tsca/tsca-section- Crane, Inc., Docket No. SE 2015–315.
[FR Doc. 2017–08246 Filed 4–24–17; 8:45 am]
5a3c-determination-40. (Issues include whether the Judge erred
BILLING CODE 6560–50–P
EPA Case Number: J–17–0006; in interpreting the standard providing
Chemical identity: Saccharomyces that miners must stay clear of the
cerevisiae modified (generic name); Web suspended loads of a crane.)
site link: https://www.epa.gov/ FEDERAL MINE SAFETY AND HEALTH
REVIEW COMMISSION Any person attending this oral
reviewing-new-chemicals-under-toxic- argument who requires special
substances-control-act-tsca/tsca-section- Sunshine Act Notice accessibility features and/or auxiliary
5a3c-determination-42. aids, such as sign language interpreters,
EPA Case Number: P–17–0144; April 21, 2017. must inform the Commission in advance
Chemical identity: Amines, C36- TIME AND DATE: 10:00 a.m., Friday, June of those needs. Subject to 29 CFR
alkylenedi-, polymers with octahydro- 30, 2017. 2706.150(a)(3) and 2706.160(d).
4,7-methano-1H-indenedimethanamine
PLACE: The Richard V. Backley Hearing CONTACT PERSON FOR MORE INFORMATION:
and pyromellitic dianhydride, maleated
(CASRN: 2020378–57–6); Web site link: Room, Room 511N, 1331 Pennsylvania Emogene Johnson (202) 434–9935/(202)
https://www.epa.gov/reviewing-new- Avenue NW., Washington, DC 20004 708–9300 for TDD Relay/1–800–877–
chemicals-under-toxic-substances- (enter from F Street entrance). 8339 for toll free.
asabaliauskas on DSK3SPTVN1PROD with NOTICES

control-act-tsca/tsca-section-5a3c- STATUS: Open.
PHONE NUMBER FOR LISTENING TO
determination-41. MATTERS TO BE CONSIDERED: The ARGUMENT: 1–(866) 867–4769, Passcode:
EPA Case Number: P–17–0158; Commission will consider and act upon 129–339.
Chemical identity: Perylene bisimide the following in open session: Secretary
(generic name); Web site link: https:// of Labor v. Sims Crane, Inc., Docket No. Sarah L. Stewart,
www.epa.gov/reviewing-new-chemicals- SE 2015–315. (Issues include whether Deputy General Counsel.
under-toxic-substances-control-act-tsca/ the Judge erred in interpreting the [FR Doc. 2017–08414 Filed 4–21–17; 11:15 am]
tsca-section-5a3c-determination-43. standard providing that miners must BILLING CODE P

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Document Created: 2017-04-25 02:18:49
Document Modified: 2017-04-25 02:18:49

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 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
FR Citation		82 FR 19046