[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52459-52460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20356]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0146; FRL-8682-04-OCSPP]


Certain New Chemicals or Significant New Uses; Statements of 
Findings for July 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Toxic Substances Control Act (TSCA) requires EPA to 
publish in the Federal Register a statement of its findings after its 
review of certain TSCA 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. This document presents statements of 
findings made by EPA on such submissions during the period from July 1, 
2021 to July 31, 2021.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Rebecca Edelstein, Chemical 
Control Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: 202-564-1667 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-2021-0146, is available at http://www.regulations.gov. Due to the public health concerns related to 
COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to 
visitors with limited exceptions. The staff continues to provide remote 
customer service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://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 July 1, 2021 to July 31, 2021.

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

[[Page 52460]]

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 No.            Chemical identity       Website link
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J-21-0014, J-21-0015, J-21-    Chromosomally          https://
 0016, J-21-0017, J-21-0018.    modified               www.epa.gov/
                                Saccharomyces          system/files/
                                cerevisiae (Generic    documents/2021-07/
                                Name).                 j-21-0014-
                                                       0018_determinatio
                                                       n_non-
                                                       cbi_final.pdf.
J-21-0019....................  Strain of Escherichia  https://
                                coli modified with     www.epa.gov/
                                genetically-stable,    system/files/
                                plasmid-borne DNA      documents/2021-07/
                                for the production     j-21-
                                of plasmid-borne DNA   0019_determinatio
                                (Generic Name).        n_non-
                                                       cbi_final.pdf.
P-21-0020....................  Alkanedioic acid,      https://
                                dialkyl ester,         www.epa.gov/
                                polymer with dialkyl-  system/files/
                                alkanediol, alkyl      documents/2021-07/
                                (substituted alkyl)-   p-21-
                                alkanediol and         0020_determinatio
                                heteropolycycle        n_non-
                                (Generic Name).        cbi_final.pdf.
P-21-0037,...................  P-21-0037: [1,1'-      https://
P-21-0038....................   Biphenyl]-3,3',4,4'-   www.epa.gov/
                                tetracarboxamide,      system/files/
                                N3,N3',N4,N4'-         documents/2021-07/
                                tetraoctyl; CASRN:     p-21-0037-
                                2169674-18-2           0038_determinatio
                                (Specific)..           n_non-
                               P-21-0038: [1,1'-       cbi_final.pdf.
                                Biphenyl]-3,3',4,4'-
                                tetracarboxamide,
                                N3, N3', N4, N4'-
                                tetradodecyl; CASRN:
                                2413095-68-6
                                (Specific).
P-21-0085....................  1-Propanethiol, 3-     https://
                                (triethoxysilyl)-,     www.epa.gov/
                                reaction products      system/files/
                                with polybutadiene;    documents/2021-08/
                                CASRN: 2109699-92-3    p-21-
                                (Specific).            0085_determinatio
                                                       n_non-
                                                       cbi_final_1.pdf.
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    Authority: 15 U.S.C. 2601 et seq.

    Dated: September 13, 2021.
Madison Le,
Director, New Chemicals Division, Office of Pollution Prevention and 
Toxics.
[FR Doc. 2021-20356 Filed 9-20-21; 8:45 am]
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