Agency Information Collection Activities; Proposed Renewal Collection and Request for Comment; TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances, 19713-19714 [2025-08191]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Pages 19713-19714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08191]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0660; FRL-8903-01-OCSPP]


Agency Information Collection Activities; Proposed Renewal 
Collection and Request for Comment; TSCA Section 5 Premanufacture 
Review of New Chemical Substances and Significant New Use Rules for New 
and Existing Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces the availability of and solicits public comment on 
the following Information Collection Request (ICR) that EPA is planning 
to submit to the Office of Management and Budget (OMB) ``TSCA Section 5 
Premanufacture Review of New Chemical Substances and Significant New 
Use Rules for New and Existing Chemical Substances (EPA ICR No. 1188.16 
and OMB Control No. 2070-0038).'' This ICR represents a renewal of an 
existing ICR that is currently approved through December 31, 2025. 
Before submitting the ICR to OMB for review and approval under the PRA, 
EPA is soliciting comments on specific aspects of the information 
collection that is summarized in this document. The ICR and 
accompanying material are available in the docket for public review and 
comment.

DATES: Comments must be received on or before July 8, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number Docket ID No. EPA-HQ-OPPT-2021-0660, online at https://www.regulations.gov. Follow the online instructions for submitting 
comments. Do not submit electronically any information you consider to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Additional instructions on 
commenting or visiting the docket, along with more information about 
dockets generally, is available at https://www.epa.gov/dockets.

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 20460-0001; telephone number: (202) 566-1206; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), 
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply 
to?

    Title: TSCA Section 5 Premanufacture Review of New Chemical 
Substances and Significant New Use Rules for New and Existing Chemical 
Substances.
    EPA ICR No.: 1188.16.
    OMB Control No.: 2070-0038.
    ICR Status: This ICR is currently approved through December 31, 
2025. Under the PRA, 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. The OMB control numbers 
for EPA's regulations in title 40 of the Code of Federal Regulations 
(CFR), after appearing in the Federal Register when approved, are 
displayed either by publication in the Federal Register or by other 
appropriate means, such as on

[[Page 19714]]

the related collection instrument or form, if applicable. The display 
of OMB control numbers for certain EPA regulations is consolidated in 
40 CFR part 9.
    Abstract: TSCA section 5 requires that any person who proposes to 
manufacture (which includes import) 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 action as appropriate. 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 opt 
to pursue that significant new use, in which case they must submit a 
notice and undergo a review. For such circumstances, TSCA section 5 
requires a significant new use notice (SNUN) from any person who 
proposes to manufacture or process a chemical for a use that is 
determined by EPA to be a ``significant new use.''
    TSCA section 5 requires EPA to make one of five possible 
determinations before the conclusion of its review of the submitted 
notices regarding risk to human health and 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, nothing relieves EPA of 
its obligation to make a determination. EPA requires that the submitter 
of a PMN or MCAN inform EPA when non-exempt commercial manufacture of 
the substance in question actually 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) appear 
at 40 CFR part 707 and the associated paperwork activities and burdens 
are approved under OMB Control No. 2070-0030, ICR entitled 
``Notification of Chemical Exports--TSCA Section 12(b),'' identified by 
EPA ICR No. 0795.16.
    Existing chemicals are chemicals that are already listed on the 
TSCA Inventory and therefore ``existing chemical SNURs'' are generally 
written to require notice for significant new uses of chemicals that 
are already in commerce.
    The ICR, which is available in the docket along with other related 
materials, provides a detailed explanation of the collection activities 
and the burden estimate that is only briefly summarized here:
    Form number(s): 7710-23, 7710-25, 7710-56 and 6300-7.
    Respondents/affected entities: Entities potentially affected by 
this ICR 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, 15 U.S.C. 2604. 40 
CFR parts 720, 721, 723 and 725.
    Estimated number of potential respondents: 4,243.
    Frequency of response: On occasion.
    Total estimated average number of responses for each respondent: 1.
    Total estimated burden: 128,367 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated costs: $45,183,758 (per year), includes $0 
annualized capital investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There is no change in the burden hours in the total estimated 
respondent burden compared with that identified in the ICR currently 
approved by OMB.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to 
announce the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the person listed under FOR 
FURTHER INFORMATION CONTACT.
    Authority: 44 U.S.C. 3501 et seq.

    Dated: May 2, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and 
Pollution Prevention.
[FR Doc. 2025-08191 Filed 5-8-25; 8:45 am]
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