[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Pages 51940-51941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22394]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0097; FRL-9984-68]


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

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Greg Schweer, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-
564-8469; email address: [email protected].

[[Page 51941]]

    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 August 1, 2018 to August 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-18-0001; Chemical identity: Modified 
Corynebacterium glutamicum (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-93.
    EPA case number: J-18-0012; Chemical identity: Genetically modified 
yeast (generic name); website link: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/tsca-section-5a3c-determination-94.

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

    Dated: October 4, 2018.
Greg Schweer,
Chief, New Chemicals Management Branch, Chemical Control Division, 
Office of Pollution Prevention and Toxics.
[FR Doc. 2018-22394 Filed 10-12-18; 8:45 am]
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