Notice2025-05821
Certain New Chemicals or Significant New Uses; Statements of Findings for January 2025
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 4, 2025
Issuing agencies
Environmental Protection Agency
Abstract
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 submissions 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 January 1, 2025 to January 31, 2025. This document also presents statements of findings on submissions made by EPA during earlier time periods that were inadvertently omitted from notices for those time periods that were identified during a quality control review.
Full Text
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<title>Federal Register, Volume 90 Issue 64 (Friday, April 4, 2025)</title>
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[Federal Register Volume 90, Number 64 (Friday, April 4, 2025)]
[Notices]
[Pages 14837-14838]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05821]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2025-0077; FRL-12476-01-OCSPP]
Certain New Chemicals or Significant New Uses; Statements of
Findings for January 2025
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 submissions 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 January
1, 2025 to January 31, 2025. This document also presents statements of
findings on submissions made by EPA during earlier time periods that
were inadvertently omitted from notices for those time periods that
were identified during a quality control review.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2025-0077, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Rebecca Edelstein, New Chemical
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:
<a href="/cdn-cgi/l/email-protection#fd989998918e89989493d38f989f989e9e9cbd988d9cd39a928b"><span class="__cf_email__" data-cfemail="5a3f3e3f36292e3f333474283f383f39393b1a3f2a3b743d352c">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#5501061614781d3a21393c3b30153025347b323a23"><span class="__cf_email__" data-cfemail="0c585f4f4d21446378606562694c697c6d226b637a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information that is directed to the public in
general.
B. What action is the Agency taking?
This document lists the statements of findings made by EPA after
review of submissions 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 reporting
period, and several made by EPA during earlier time periods that were
inadvertently omitted from notices for those time periods that were
identified during a quality control review.
C. What is the Agency's authority for taking this action?
TSCA section 5(a)(3) requires EPA to review a submission under TSCA
section 5(a) and make one of several specific findings pertaining to
whether the substance may present unreasonable risk of injury to health
or the environment. Among those potential findings is that the chemical
substance or significant new use is not likely to present an
unreasonable risk of injury to health or the environment per TSCA
Section 5(a)(3)(C).
TSCA section 5(g) requires EPA to publish in the Federal Register a
statement of its findings after its review of a submission under TSCA
section 5(a) 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.
[[Page 14838]]
II. Statements of Findings Under TSCA Section 5(a)(3)(C)
In this unit, EPA identifies the PMNs, MCANs and SNUNs for which
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.
For the findings made during this period, the following list
provides the EPA case number assigned to the TSCA section 5(a)
submission and the chemical identity (generic name if the specific name
is claimed as Confidential Business Information (CBI)), and the date
the findings were made:
<bullet> P-24-0124, Alkyl alkenoic acid, alkyl ester, polymer with
substituted carbomonocycle, substituted alkyl alkyl alkenoate
phosphate, substituted alkyl alkyl alkenoate, alkyl alkenoate,
heteromonocycle polymer, substitutes alkenyl substituted alkyl ester,
alkyl substituted alkyl alkanoate initiated (Generic Name); Decision
date: 01/29/2025.
In addition, the following list provides the same information for
those cases where EPA made the findings during earlier time periods
that were inadvertently omitted from notices for those time periods as
identified during a quality control review:
<bullet> J-19-0026-0027, Biofuel-producing modified
microorganism(s), with chromosomally-borne modifications (Generic
Name). Decision date: 01/23/2020.
<bullet> J-23-0005-0006, Microorganisms genetically transformed to
express an enzyme (Generic Name). Decision date: 11/27/2023.
<bullet> P-23-0028, Gelatin and maltodextrin crosslinked with
linear and cyclic aliphatic polyisocyanates (Generic Name). Decision
date: 12/14/2023.
<bullet> P-23-0101, Glycerides from fermentation of genetically
modified microorganism, epoxidized (Generic Name). Decision date: 11/
13/2024.
<bullet> P-23-0102, Glycerides from fermentation of genetically
modified microorganism (Generic Name). Decision date: 06/07/2024.
<bullet> P-23-0103, Glycerides from fermentation of genetically
modified microorganism, epoxidized, reaction products with ethanol
(Generic Name). Decision date: 11/13/2024.
<bullet> P-23-0143, L-Lysine, N-(3-carboxy-1-oxopropyl) derivs.,
sodium salts; CASRN 1917323-94-4. Decision date: 08/22/2024.
<bullet> P-24-0005, [1,1'-Biphenyl]-4,4'-diol, reaction products
with 4-cyclohexylphenol and 2,4,6-trichloro-1,3,5-triazine; CASRN
2561414-35-3. Decision date: 07/16/2024.
<bullet> P-24-0106-0107, Glycerides, alkyl, epoxidized, alkyl
esters (Generic Name). Decision date: 12/19/2024.
To access 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), look up the specific case number at <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/chemicals-determined-not-likely</a>.
Authority: 15 U.S.C. 2601 et seq.
Dated: March 25, 2025.
Shari Z. Barash,
Director, New Chemicals Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2025-05821 Filed 4-3-25; 8:45 am]
BILLING CODE 6560-50-P
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