Notice2025-13908
Approval of a Test Marketing Exemption for a New Chemical Under the Toxic Substances Control Act (TSCA)
Primary source
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Published
July 24, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or the Agency) is providing notice of its approval of an application for test marketing exemption (TME) under the Toxic Substances Control Act (TSCA). EPA has designated this application as T-24-0001. The test marketing conditions are described in the TME application and in this document.
Full Text
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<title>Federal Register, Volume 90 Issue 140 (Thursday, July 24, 2025)</title>
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[Federal Register Volume 90, Number 140 (Thursday, July 24, 2025)]
[Notices]
[Pages 34867-34868]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13908]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2025-0626]; FRL-12886-01-OCSPP]
Approval of a Test Marketing Exemption for a New Chemical Under
the Toxic Substances Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
providing notice of its approval of an application for test marketing
exemption (TME) under the Toxic Substances Control Act (TSCA). EPA has
designated this application as T-24-0001. The test marketing conditions
are described in the TME application and in this document.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2025-0626, 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: Meg Victor, New Chemicals Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 343-9193; email address:
<a href="/cdn-cgi/l/email-protection#addbc4ced9c2df83c0c8caedc8ddcc83cac2db"><span class="__cf_email__" data-cfemail="acdac5cfd8c3de82c1c9cbecc9dccd82cbc3da">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620;
[[Page 34868]]
telephone number: (202) 554-1404; email address: <a href="/cdn-cgi/l/email-protection#5501061614781d3a21393c3b30153025347b323a23"><span class="__cf_email__" data-cfemail="42161101036f0a2d362e2b2c27022732236c252d34">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action provides information directed to the public in general
and to the chemical manufacturer that submitted to EPA the TME
application designated T-24-0001.
B. What action is the Agency taking?
This document provides notice of EPA's approval of an application
for test marketing exemption (TME) under the Toxic Substances Control
Act (TSCA). EPA also provides information on its website about
exemption applications reviewed under TSCA, including exemption
applications received, the date of receipt, and the status and
effective date of EPA's decision on its website at: <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/exemptions-table">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/exemptions-table</a>.
C. What is the Agency's authority for taking this action?
TSCA section 5(h)(1) authorizes EPA to exempt persons from
premanufacture notification (PMN) requirements and permit them to
manufacture (which includes import) new chemicals for test marketing
purposes, if the Agency finds that the manufacture, processing,
distribution in commerce, use, and disposal of the chemicals for test
marketing purposes will not present any unreasonable risk of injury to
health or the environment, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified by the
Administrator for the specific conditions of use identified in the
application. EPA's regulations implementing TSCA section 5(h)(1) are at
40 CFR 720.38.
TSCA section 5(h)(6) requires EPA to publish in the Federal
Register notice of receipt of an application for a TME and of the
disposition of the application. The implementing regulation (40 CFR
720.38(d)) requires EPA to publish a notice in the Federal Register
explaining the reasons for approval or denial.
II. Summary of Test Marketing Exemption Application
<bullet> TME Application No.: T-24-0001.
<bullet> Date of Receipt: April 15, 2024.
<bullet> Notice of Receipt: May 21, 2024 (89 FR 44674; FRL-11683-
04-OCSPP).
<bullet> Applicant: Zschimmer & Schwarz.
<bullet> Chemical: Isomerized alkane derivs. (generic name).
<bullet> Use: Raw material in ester manufacturing, to be fully
consumed.
<bullet> Production Volume: 50,000 kilograms per year.
<bullet> Number of Customers: None.
<bullet> Test Marketing Period: 365 days, commencing on first day
of commercial manufacture.
III. EPA Approval of the Test Marketing Exemption
EPA approved the TME application designated as T-24-0001 on
December 19, 2024. EPA determined that test marketing the new chemical
substance, under the conditions set out in the TME application, will
not present any unreasonable risk of injury to health or the
environment, including to a potentially exposed or susceptible
subpopulation identified by the Administrator for the specific
conditions of use identified in the application.
The test marketing period, production volume, number of customers,
and use must not exceed specifications in the application. All other
conditions and restrictions described in the application and in this
document must also be met.
A. What restrictions apply to this TME?
EPA may impose restrictions considered appropriate by the Agency on
test marketing activities and may modify or revoke this TME upon
receipt of any information that indicates the test marketing activity
may present an unreasonable risk of injury to health or the
environment. The following additional restrictions apply to this TME:
<bullet> A bill of lading accompanying each shipment must state
that the use of the chemical is restricted to that approved in the TME.
<bullet> The applicant shall maintain the following records for 5
years after the date they are created and shall make them available for
inspection or copying in accordance with TSCA section 11:
<bullet> Records of the quantity of the TME chemical produced and
the date of manufacture;
<bullet> Records of dates of the shipments to each customer and the
quantities supplied in each shipment; and
<bullet> Copies of the bill of lading that accompanies each
shipment of the TME chemical.
B. What was EPA's risk assessment for this TME?
EPA did not identify unreasonable risks to health or the
environment for the test market chemical under the intended conditions
of use described in the TME application. EPA estimated that the
chemical has high environmental toxicity; however, the chemical
substance will not be released to water. Additionally, EPA identified
potential risks to workers, which are addressed by the personal
protective equipment requirements in the Safety Data Sheet for the
chemical substance. Therefore, the test market activities will not
present any unreasonable risk of injury to human health or the
environment, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified by the Administrator for the
specific conditions of use identified in the application.
C. Can EPA change its decision on this TME in the future?
The Agency reserves the right to rescind approval or modify the
conditions and restrictions of an exemption upon the receipt or
evaluation of any information, new or existing, that indicates the test
marketing activities may present an unreasonable risk of injury to
human health or the environment.
Authority: 15 U.S.C. 2601 et seq.
Dated: July 21, 2025.
Tyler Lloyd,
Acting Supervisor, New Chemicals Risk Management Branch 3, New
Chemicals Division, Office of Pollution Prevention and Toxics.
[FR Doc. 2025-13908 Filed 7-23-25; 8:45 am]
BILLING CODE 6560-50-P
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