83_FR_13185 83 FR 13126 - Certain New Chemicals or Significant New Uses; Statements of Findings for January 2018

83 FR 13126 - Certain New Chemicals or Significant New Uses; Statements of Findings for January 2018

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 59 (March 27, 2018)

Page Range13126-13127
FR Document2018-06125

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, 2018 to January 31, 2018.

Federal Register, Volume 83 Issue 59 (Tuesday, March 27, 2018) 
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13126-13127]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06125]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0097; FRL-9975-29]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for January 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 January 1, 2018 to January 31, 2018.

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

[[Page 13127]]

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 January 1, 2018 to January 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 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-17-0015-0019; 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-81.
    EPA Case Number: J-17-0021; Chemical identity: Modified 
Saccharomyces cerevisiae (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-82.
    EPA Case Number: J-17-0022; Chemical identity: Modified Trichoderma 
reesei (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-83.
    EPA Case Number: J-17-0028; Chemical identity: Biofuel producing 
Saccharomyces cerevisiae modified, genetically stable (generic name); 
website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-84.

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

    Dated: March 14, 2018.
Greg Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division, 
Office of Pollution Prevention and Toxics.
[FR Doc. 2018-06125 Filed 3-26-18; 8:45 am]
 BILLING CODE 6560-50-P

13126 Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices Transmittal No. 17–20 This proposed sale will support the SECRET. The seeker/guidance control Notice of Proposed Issuance of Letter of foreign policy and national security section and the target detector are Offer Pursuant to Section 36(b)(1) of the objectives of the United States by CONFIDENTIAL and contain sensitive Arms Export Control Act, as amended helping to improve the security of a state-of-the-art technology. Manuals and friendly country which has been, and technical documentation that are (i) Prospective Purchaser: Government continues to be, an important force for necessary or support operational use of the United Arab Emirates (UAE) political stability and economic progress and organizational management are (ii) Total Estimated Value: in the Middle East. classified up to SECRET. Performance Major Defense Equipment * $ 240.0 mil- This potential sale will improve the and operating logic of the counter- lion UAE’s capability to meet current and countermeasures circuits are classified Other ................................... $ 30.4 million future threats and provide an enhanced SECRET. The hardware, software, and Total ............................. $270.4 million capability for its Air Force. The UAE data identified are classified to protect will use the enhanced capability to vulnerabilities, design and performance (iii) Description and Quantity or strengthen its homeland defense. The parameters and similar critical Quantities of Articles or Services under UAE will have no difficulty absorbing information. Consideration for Purchase: this equipment into its armed forces. 3. If a technologically advanced Major Defense Equipment (MDE): The proposed sale of this equipment adversary were to obtain knowledge of Three hundred (300) AIM–9X–2 and support does not alter the basic the specific hardware and software Sidewinder Block II Missiles military balance in the region. elements, the information could be used Forty (40) AIM–9X–2 Sidewinder The prime contractor will be to develop countermeasures that might Captive Air Training Missiles Raytheon Missile Systems Company, reduce weapon system effectiveness or (CATMs) Tucson, AZ. There are no known offset Thirty (30) AIM–9X–2 Sidewinder be used in the development of a system agreements proposed in connection with similar advanced capabilities. Block II Tactical Guidance Units with this potential sale. Fifteen (15) AIM–9X–2 CATM 4. All defense articles and services Implementation of this proposed sale listed in this transmittal have been Guidance Units will require U.S. Government or Non-MDE includes: authorized for release and export to the contractor representatives to travel to Government of the United Arab Also includes containers, spares, the UAE on a temporary basis for support equipment and missile Emirates (UAE). program technical support and support, U.S. Government and management oversight. [FR Doc. 2018–06110 Filed 3–26–18; 8:45 am] contractor technical assistance and There will be no adverse impact on BILLING CODE 5001–06–P other related logistics support, and U.S. defense readiness as a result of this other associated support equipment proposed sale. and services. ENVIRONMENTAL PROTECTION (iv) Military Department: Navy (ABJ) Transmittal No. 17–20 AGENCY (v) Prior Related Cases, if any: AE–P– Notice of Proposed Issuance of Letter of AAL (AIM–9M); and AE–P–ABA (AIM– [EPA–HQ–OPPT–2018–0097; FRL–9975–29] Offer Pursuant to Section 36(b)(1) of the 9–X2 (previously notified and offered Arms Export Control Act Certain New Chemicals or Significant but the customer allowed the LOA to New Uses; Statements of Findings for Annex expire)) January 2018 (vi) Sales Commission, Fee, etc., Paid, Item No. vii Offered, or Agreed to be Paid: None (vii) Sensitivity of Technology: AGENCY: Environmental Protection (vii) Sensitivity of Technology 1. The AIM–9X–2 Sidewinder Block II Agency (EPA). Contained in the Defense Article or missile represents a substantial increase ACTION: Notice. Defense Services Proposed to be Sold: in missile acquisition and kinematics See Attached Annex performance over the AIM–9M and SUMMARY: Section 5(g) of the Toxic (viii) Date Report Delivered to replaces the AIM–9X Block I missile Substances Control Act (TSCA) requires Congress: March 7, 2018 configuration. The missile includes a EPA to publish in the Federal Register * As defined in Section 47(6) of the high off-boresight seeker, enhanced a statement of its findings after its Arms Export Control Act. countermeasure rejection capability, review of TSCA section 5(a) notices POLICY JUSTIFICATION low drag/high angle of attack airframe when EPA makes a finding that a new and the ability to integrate the Helmet chemical substance or significant new Government of the United Arab Mounted Cueing System. The software use is not likely to present an Emirates (UAE)—AIM–9X–2 Sidewinder algorithms are the most sensitive unreasonable risk of injury to health or Block II Missiles portion of the AIM–9X–2 missile. The the environment. Such statements apply The UAE has requested the possible software continues to be modified via a to premanufacture notices (PMNs), sale of three hundred (300) AIM–9X–2 Pre-Planned Product Improvement (P3I) microbial commercial activity notices Sidewinder Block II missiles, forty (40) program in order to improve its counter- (MCANs), and significant new use AIM–9X–2 Sidewinder Captive Air countermeasure capabilities. No notices (SNUNs) submitted to EPA Training Missiles (CATMs), thirty (30) software source code or algorithms will under TSCA section 5. This document AIM–9X–2 Block II Tactical guidance be released. The missile is classified as presents statements of findings made by units, fifteen (15) AIM–9X–2 CATM CONFIDENTIAL. EPA on TSCA section 5(a) notices amozie on DSK30RV082PROD with NOTICES guidance units, containers, spares, 2. The AIM–9X–2 Sidewinder Block II during the period from January 1, 2018 support equipment and missile support, missile will result in the transfer of to January 31, 2018. U.S. Government and contractor sensitive technology and information. FOR FURTHER INFORMATION CONTACT: technical assistance and other related The equipment, hardware, and For technical information contact: logistics support, and other associated documentation are classified Greg Schweer, Chemical Control support equipment and services. The CONFIDENTIAL. The software and Divison (7405M), Office of Pollution total estimated cost is $270.4 million. operational performance are classified Prevention and Toxics, Environmental VerDate Sep<11>2014 18:07 Mar 26, 2018 Jkt 244001 PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1

Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices 13127 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 email address: schweer.greg@epa.gov. environmental effects of the chemical IV. Statements of Administrator For general information contact: The substance or significant new use; Findings Under TSCA Section 5(a)(3)(C) 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; I. General Information • The chemical substance is or will EPA has made findings under TSCA be produced in substantial quantities, section 5(a)(3)(C) that the new chemical A. Does this action apply to me? substances or significant new uses are and such substance either enters or may This action is directed to the public reasonably be anticipated to enter the not likely to present an unreasonable in general. As such, the Agency has not environment in substantial quantities or risk of injury to health or the attempted to describe the specific there is or may be significant or environment: entities that this action may apply to. 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 of the PMNs addressed in this action. • Chemical identity (generic name, if 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 and other related information? health or the environment. • Website link to EPA’s decision Unreasonable risk findings must be document describing the basis of the The docket for this action, identified ‘‘not likely to present an unreasonable by docket identification (ID) number made without consideration of costs or risk’’ finding made by EPA under TSCA EPA–HQ–OPPT–2018–0097, is available other non-risk factors, including an section 5(a)(3)(C). at http://www.regulations.gov or at the unreasonable risk to a potentially Office of Pollution Prevention and exposed or susceptible subpopulation EPA Case Number: J–17–0015–0019; Toxics Docket (OPPT Docket), identified as relevant under the Chemical identity: Saccharomyces Environmental Protection Agency conditions of use. The term ‘‘conditions cerevisiae modified (generic name); Docket Center (EPA/DC), West William of use’’ is defined in TSCA section 3 to website link: https://www.epa.gov/ Jefferson Clinton Bldg., Rm. 3334, 1301 mean ‘‘the circumstances, as determined reviewing-new-chemicals-under-toxic- Constitution Ave. NW, Washington, DC. by the Administrator, under which a substances-control-act-tsca/tsca-section- The Public Reading Room is open from chemical substance is intended, known, 5a3c-determination-81. 8:30 a.m. to 4:30 p.m., Monday through or reasonably foreseen to be manufactured, processed, distributed in EPA Case Number: J–17–0021; Friday, excluding legal holidays. The Chemical identity: Modified telephone number for the Public commerce, used, or disposed of.’’ EPA is required under TSCA section Saccharomyces cerevisiae (generic Reading Room is (202) 566–1744, and name); website link: https:// the telephone number for the OPPT 5(g) to publish in the Federal Register www.epa.gov/reviewing-new-chemicals- Docket is (202) 566–0280. Please review a statement of its findings after its under-toxic-substances-control-act-tsca/ the visitor instructions and additional review of a TSCA section 5(a) notice when EPA makes a finding that a new tsca-section-5a3c-determination-82. information about the docket available at http://www.epa.gov/dockets. chemical substance or significant new EPA Case Number: J–17–0022; use is not likely to present an Chemical identity: Modified II. What action is the Agency taking? unreasonable risk of injury to health or Trichoderma reesei (generic name); This document lists the statements of the environment. Such statements apply website link: https://www.epa.gov/ findings made by EPA after review of to PMNs, MCANs, and SNUNs reviewing-new-chemicals-under-toxic- notices submitted under TSCA section submitted to EPA under TSCA substances-control-act-tsca/tsca-section- 5(a) that certain new chemical section 5. 5a3c-determination-83. substances or significant new uses are Anyone who plans to manufacture EPA Case Number: J–17–0028; not likely to present an unreasonable (which includes import) a new chemical substance for a non-exempt commercial Chemical identity: Biofuel producing risk of injury to health or the Saccharomyces cerevisiae modified, environment. This document presents purpose and any manufacturer or processor wishing to engage in a use of genetically stable (generic name); statements of findings made by EPA a chemical substance designated by EPA website link: https://www.epa.gov/ during the period from January 1, 2018 as a significant new use must submit a reviewing-new-chemicals-under-toxic- to January 31, 2018. notice to EPA at least 90 days before substances-control-act-tsca/tsca-section- III. What is the Agency’s authority for commencing manufacture of the new 5a3c-determination-84. taking this action? chemical substance or before engaging Authority: 15 U.S.C. 2601 et seq. TSCA section 5(a)(3) requires EPA to in the significant new use. Dated: March 14, 2018. amozie on DSK30RV082PROD with NOTICES review a TSCA section 5(a) notice and The submitter of a notice to EPA for make one of the following specific which EPA has made a finding of ‘‘not Greg Schweer, findings: likely to present an unreasonable risk of Chief, New Chemicals Management Branch, • The chemical substance or injury to health or the environment’’ Chemical Control Division, Office of Pollution significant new use presents an may commence manufacture of the Prevention and Toxics. unreasonable risk of injury to health or chemical substance or manufacture or [FR Doc. 2018–06125 Filed 3–26–18; 8:45 am] the environment; processing for the significant new use BILLING CODE 6560–50–P VerDate Sep<11>2014 18:07 Mar 26, 2018 Jkt 244001 PO 00000 Frm 00009 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1


Document Created: 2018-03-27 01:26:47
Document Modified: 2018-03-27 01:26:47
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 Divison (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
FR Citation83 FR 13126 
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