90 FR 140 pgs. 34867-34868 - Approval of a Test Marketing Exemption for a New Chemical Under the Toxic Substances Control Act (TSCA)
Type: NOTICEVolume: 90Number: 140Pages: 34867 - 34868
Pages: 34867, 34868Docket number: [EPA-HQ-OPPT-2025-0626]; FRL-12886-01-OCSPP]
FR document: [FR Doc. 2025-13908 Filed 7-23-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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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.
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 https://www.regulations.gov. Additional information about dockets generally, along with instructions for visiting the docket in-person, is available at https://www.epa.gov/dockets.
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: victor.meg@epa.gov.
[top] For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620;
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: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/exemptions-table.
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
• TME Application No.: T-24-0001.
• Date of Receipt: April 15, 2024.
• Notice of Receipt: May 21, 2024 (89 FR 44674; FRL-11683-04-OCSPP).
• Applicant: Zschimmer & Schwarz.
• Chemical: Isomerized alkane derivs. (generic name).
• Use: Raw material in ester manufacturing, to be fully consumed.
• Production Volume: 50,000 kilograms per year.
• Number of Customers: None.
• 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:
• A bill of lading accompanying each shipment must state that the use of the chemical is restricted to that approved in the TME.
• 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:
• Records of the quantity of the TME chemical produced and the date of manufacture;
• Records of dates of the shipments to each customer and the quantities supplied in each shipment; and
• 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]
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