Notice2025-23972
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Renewal)
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
December 30, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (EPA ICR Number 1188.16, OMB Control Number 2070-0038) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through December 31, 2025. Public comments were previously requested via the Federal Register on May 9, 2025 during a 60-day comment period. This notice allows for an additional 30 days for public comments.
Full Text
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[Federal Register Volume 90, Number 246 (Tuesday, December 30, 2025)]
[Notices]
[Pages 61147-61148]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23972]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2021-0660; FRL-13157-01-OMS]
Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; TSCA Section 5 Premanufacture Review of New Chemical
Substances and Significant New Use Rules for New and Existing Chemical
Substances (Renewal)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), TSCA Section 5 Premanufacture
Review of New Chemical Substances and Significant New Use Rules for New
and Existing Chemical Substances (EPA ICR Number 1188.16, OMB Control
Number 2070-0038) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through December 31, 2025. Public comments were previously requested
via the Federal Register on May 9, 2025 during a 60-day comment period.
This notice allows for an additional 30 days for public comments.
DATES: Comments may be submitted on or before January 29, 2026.
ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OPPT-2021-0728, to EPA online
[[Page 61148]]
using <a href="http://www.regulations.gov">www.regulations.gov</a> (our preferred method), or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460.
EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
<a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Katherine Sleasman, Office of Program
Support (Mail Code 7602M), Office of Chemical Safety and Pollution
Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number: 202-566-1204; email address:
<a href="/cdn-cgi/l/email-protection#b7c4dbd2d6c4dad6d999dcd6c3dfd2c5ded9d2f7d2c7d699d0d8c1"><span class="__cf_email__" data-cfemail="493a252c283a2428276722283d212c3b20272c092c3928672e263f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR
which is currently approved through December 31, 2025. An agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
Public comments were previously requested via the Federal Register
on May 9, 2025, during a 60-day comment period (90 FR 19713). This
notice allows for an additional 30 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at <a href="http://www.regulations.gov">www.regulations.gov</a> or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone for the Docket Center is 202-566-1744.
For additional information about EPA's public docket, visit <a href="http://www.epa.gov/dockets">http://www.epa.gov/dockets</a>.
Abstract: TSCA section 5 requires manufactures (which includes
import) of a ``new chemical substance'' (i.e., a chemical not listed on
the TSCA section 8(b) Inventory) must provide a premanufacture notice
(PMN) to EPA at least 90 days prior to commencing manufacture of that
chemical and that EPA review such notice and take appropriate action.
Under TSCA, the term ``chemical substance'' includes microorganisms;
the 90-day notice for microorganisms is a Microbial Commercial Activity
Notice (MCAN).
Under TSCA section 5, EPA is authorized to determine that a use of
a chemical substance is a significant new use and promulgate a
significant new use rule (SNUR). In certain instances, persons may
pursue a significant new use, thus they must submit a notice and
undergo a review. TSCA section 5 requires a significant new use notice
(SNUN) from any person who proposes to manufacture or process a
chemical for a use EPA determined to be a ``significant new use.''
TSCA section 5 requires EPA to make one of five possible
determinations before concluding its review of submitted notices about
risk to human health & the environment from the manufacture,
processing, distribution in commerce, use and/or disposal of new
chemical substances or significant new uses. EPA's determination on a
new chemical substance or new use will dictate how and to what extent
the chemical's manufacture, processing, distribution, use, and/or
disposal may be restricted. If EPA fails to make a timely
determination, fees may be refunded; however, EPA's obligation to make
a determination remains. EPA requires the submitter of a PMN or MCAN
inform EPA when non-exempt commercial manufacture of the substance in
question begins by submitting a Notice of Commencement; EPA would then
add the new chemical substance to the TSCA section 8(b) Inventory.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b), and regulations that interpret TSCA section 12(b) at 40
CFR part 707; and the associated paperwork activities and burdens
approved under OMB Control No. 2070-0030 (EPA ICR No. 0795.16),
``Notification of Chemical Exports--TSCA Section 12(b)''.
Existing chemicals are chemicals already listed on the TSCA
Inventory; and therefore ``existing chemical SNURs'' are often written
to require notice for significant new uses of chemicals already in
commerce.
Form number(s): 7710-23, 7710-25, 7710-56, 6300-7.
Respondents/affected entities: Potentially affected entities
include processors; e.g., entities identified by the North American
Industrial Classification System (NAICS) codes 325, Chemicals and
Allied Products Manufacturers, and 324, Petroleum Refining.
Respondent's obligation to respond: Mandatory (CFR 720, 721, 723 &
725).
Estimated number of respondents: 4,234 (total).
Frequency of response: On occasion.
Total estimated burden: 128,367 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
Total estimated cost: $45,183,758 (per year), which includes $0
annualized capital or operation & maintenance costs.
Changes in the estimates: There is no change in the burden hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB.
Courtney Kerwin,
Deputy Director, Data & Enterprise Programs Division.
[FR Doc. 2025-23972 Filed 12-29-25; 8:45 am]
BILLING CODE 6560-50-P
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