Notice2025-12325

Agency Information Collection Activities; Proposed Renewal Collection and Request for Comment; Notification of Substantial Risk of Injury to Health and the Environment Under TSCA Section 8(e)

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Published
July 2, 2025

Issuing agencies

Environmental Protection Agency

Abstract

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): "Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e)" (EPA ICR No. 0794.18 and OMB Control No. 2070-0046). This ICR represents a renewal of an existing ICR that is currently approved through April 30, 2026. 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.

Full Text

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<title>Federal Register, Volume 90 Issue 125 (Wednesday, July 2, 2025)</title>
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[Federal Register Volume 90, Number 125 (Wednesday, July 2, 2025)]
[Notices]
[Pages 29005-29006]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12325]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0744; FRL-12649-01-OCSPP]


Agency Information Collection Activities; Proposed Renewal 
Collection and Request for Comment; Notification of Substantial Risk of 
Injury to Health and the Environment Under TSCA Section 8(e)

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): ``Notification 
of Substantial Risk of Injury to Health and the Environment under TSCA 
Section 8(e)'' (EPA ICR No. 0794.18 and OMB Control No. 2070-0046). 
This ICR represents a renewal of an existing ICR that is currently 
approved through April 30, 2026. 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 September 2, 2025.

[[Page 29006]]


ADDRESSES: Submit your comments, identified by docket identification 
(ID) number Docket ID No. EPA-HQ-OPPT-2015-0744, online at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.

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) 566-1204; email 
address: <a href="/cdn-cgi/l/email-protection#396a555c584a5458571772584d515c4b50575c795c4958175e564f"><span class="__cf_email__" data-cfemail="adfec1c8ccdec0ccc383e6ccd9c5c8dfc4c3c8edc8ddcc83cac2db">[email&#160;protected]</span></a>.

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: Notification of Substantial Risk of Injury to Health and the 
Environment under TSCA Section 8(e).
    EPA ICR No.: 0794.18.
    OMB Control No.: 2070-0046.
    ICR Status: This ICR is currently approved through April 30, 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 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: Section 8(e) of the Toxic Substances Control Act (TSCA) 
states, ``any person who manufactures, [imports] processes, or 
distributes in commerce a chemical substance or mixture and who obtains 
information which reasonably supports the conclusion that such 
substance or mixture presents a substantial risk of injury to health or 
the environment shall immediately inform the [EPA] Administrator of 
such information unless such person has actual knowledge that the 
Administrator has been adequately informed of such information.'' (15 
U.S.C. 2607(e)).
    EPA receives and screens TSCA section 8(e) submissions covering a 
large number of chemical substances and mixtures on a wide range of 
chemical toxicity/exposure information. Although EPA's receipt of TSCA 
section 8(e) information does not necessarily trigger immediate 
regulatory action under TSCA or other authorities administered by EPA, 
all section 8(e) submissions receive screening level evaluations by 
EPA's Office of Pollution Prevention and Toxics (OPPT) to identify 
priorities for further Agency action and appropriate referrals to other 
programs.
    TSCA Section 8(e) data on newly discovered chemical hazards/risks 
is available via EPA's ChemView <a href="https://chemview.epa.gov/chemview">https://chemview.epa.gov/chemview</a>. 
There is also public outreach and information access to section 8(e) 
data through the TSCA Public Docket.
    In addition, EPA is offering an electronic reporting option for use 
both by those who are required to submit a notification of substantial 
risk under section 8(e) and by those who wish voluntarily to submit 
``For Your Information'' (FYI) notices by registering and submitting 
information electronically using the Agency's Central Data Exchange 
(CDX), as described below.
    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:
    Respondents/affected entities: Entities potentially affected by 
this ICR include North American Industrial Classification System 
(NAICS) Codes 325--Chemicals and Allied Products Manufacturers and 
32411- Petroleum and Coal Products Manufacturing.
    Respondent's obligation to respond: Mandatory, as per 15 U.S.C. 
2607(e).
    Estimated number of potential respondents: 557.
    Frequency of response: On occasion.
    Total estimated average number of responses for each respondent: 
42.
    Total estimated burden: hours 27,883 (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated costs: $ 2,829,860 (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 an increase in industry reporting burden of 10,248 hours 
from that currently in the OMB inventory (from 17,635 to 27,883 hours). 
This reflects an overall increase in the number of section 8(e) 
submissions, which increased from 343 to 552. This change is an 
adjustment.

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: June 27, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and 
Pollution Prevention.
[FR Doc. 2025-12325 Filed 7-1-25; 8:45 am]
BILLING CODE 6560-50-P


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Indexed from Federal Register on July 2, 2025.

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