Agency Information Collection Activities; Proposed Renewal Collection and Request for Comment; Consolidation of Certain Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA), 19715-19716 [2025-08190]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Pages 19715-19716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08190]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0728; FRL-12357-01-OCSPP]


Agency Information Collection Activities; Proposed Renewal 
Collection and Request for Comment; Consolidation of Certain Reporting 
and Recordkeeping Under Section 8 of the Toxic Substances Control Act 
(TSCA)

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): ``Consolidation 
of Certain Reporting and Recordkeeping Under Section 8 of the Toxic 
Substances Control Act (TSCA) (EPA ICR No. 2703.02 and OMB Control No. 
2070-0224).'' This ICR represents a renewal of an existing ICR that is 
currently approved through November 30, 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. EPA is also 
consolidating two ICRs covering reporting and recordkeeping activities 
under TSCA Section 8(a) to streamline the presentation of the paperwork 
burden estimates for these various activities and eliminate any 
duplication.

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

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0728, through the Federal eRulemaking 
Portal 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/.

FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Mission Support Division 
(7602M), Office of Program Support, Office of Chemical Safety and 
Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 719-1649; 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: Consolidation of Certain Reporting and Recordkeeping Under 
Section 8 of the Toxic Substances Control Act (TSCA).
    EPA ICR No.: 2703.02.
    OMB Control No.: 2070-0224.
    ICR status: This ICR is currently approved through November 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: This ICR covers reporting and recordkeeping requirements 
in TSCA section 8, for persons who manufacture, import, or process 
chemical substances, mixtures, or categories, or distribute them in 
commerce. The purpose of the ICR activities is to collect data that 
will help EPA evaluate the potential for human health and environmental 
risks caused by the manufacture, processing, and distribution in 
commerce of chemical substances, mixtures, or categories.
    The TSCA section 8(a) Preliminary Assessment Information Rule 
(PAIR) requires manufacturers and importers of certain chemical 
substances to submit information about production, use, and/or 
exposure-related data. Under TSCA section 8(a), persons who 
manufacture, import, or process certain chemical substances or 
mixtures, or propose to manufacture, import, or process certain 
chemical substances or mixtures, are subject to chemical-specific rules 
promulgated under TSCA section 8(a). A chemical-specific ``8(a) rule'' 
requires more detailed and more types of information than is required 
by a PAIR rule. For example, a chemical-specific ``8(a) rule'' might 
require information that includes, but is not limited to, chemical 
names, categories of use, production volume, byproducts of chemical 
production, existing data on health and environmental effects, exposure 
data, and disposal information. EPA is consolidating two TSCA section 
8(a) chemical specific rules into this ICR: including the reporting and 
recordkeeping requirements for persons who manufacture or process 
chemical substances as nanoscale materials under the authority of 
section 8(a) of the TSCA (40 CFR 704.20) covered by ``Chemical-Specific 
Rules under the Toxics Substances Control Act Section 8(a); Certain 
Nanoscale Materials (Renewal) (EPA ICR No. 2517.04; OMB Control No. 
2070-0194), and the one-time asbestos reporting and recordkeeping 
requirements (40 CFR 704.180), which is covered by the ``TSCA Section 
8(a) Reporting and Recordkeeping Requirements for Asbestos (Final Rule) 
(EPA ICR No. 2711.02; OMB Control No. 2070-0222).''

[[Page 19716]]

    Under TSCA section 8(c), persons who manufacture, import, process, 
or distribute in commerce any chemical substance or mixture must keep 
records of significant adverse reactions to health or the environment, 
as determined by the Administrator by rule. Allegations of adverse 
reactions to the health of employees be kept for thirty years, and all 
other allegations be kept for five years. The rule also prescribes the 
conditions under which a firm must submit or make the records available 
to a duly designated representative of the Administrator.
    Finally, under TSCA section 8(d), persons, who manufacture, import, 
process, or distribute in commerce (or propose to manufacture, import, 
process, or distribute in commerce) certain chemical substances and 
mixtures, are required to submit to EPA lists and copies of health and 
safety studies which relate to health and/or environmental effects of 
the chemical substances and mixtures. To comply with an ``8(d)'' rule, 
respondents must search their records to identify any health and safety 
studies in their possession, make copies of relevant studies, list 
studies that are currently in progress, and submit this information to 
EPA.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to be between 
0.4 to 106.4 hours per response. Burden is defined in 5 CFR 1320.3(b).
    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 are manufacturers (including imports) or processors of 
chemical substances of mixtures. A list of potentially affected 
entities with North American Industrial Classification System (NAICS) 
codes provided to assist in determining potential applicability in 
question 12.
    Respondent's obligation to respond: Mandatory, as per TSCA Section 
8 and 40 CFR 703, 704; 712; 716; 717; 766, and 792.
    Forms: EPA Forms 7710-25, 7710-35, 7710-51, and 9600-07.
    Frequency of response: On Occasion.
    Total estimated number of potential respondents: 13,595.
    Total estimated average number of responses for each respondent: 
193.
    Total estimated annual burden hours: 106,522 hours.
    Total estimated annual respondent costs: $9,138,943, which includes 
$0 for capital investment or maintenance and operational costs.

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

    This ICR renewal includes the consolidation of multiple ICRs. 
Accordingly, for this particular ICR, the overall number of hours will 
increase to reflect the consolidation whereas EPA will retire the ICRs 
that are being consolidated into this ICR (i.e., an increase of 647 
hours in information collection activities associated with Chemical-
Specific Rules under TSCA section 8(a); Certain Nanoscale Materials 
(OMB Control No. 2070-0194) and TSCA section 8(a) Reporting and 
Recordkeeping Requirements for Asbestos (OMB Control No. 2070-0222)). 
EPA also notes that a recent TSCA section 8(d) rulemaking, published on 
December 13, 2024 (89 FR 100756), incorporated an increase of 
associated burden arising out of a requirement to report studies 
showing any measurable content of the subject chemicals. In response to 
that proposed rulemaking, stakeholders provided information indicating 
that the file search burden would incur additional burden. Accordingly, 
for that rulemaking, EPA increased the associated estimate for file 
search in the economic analysis for the rule. This increase in burden 
would apply only where the Agency, via the applicable regulations, 
requires reporting of studies at any measurable content. EPA does not 
anticipate promulgating 8(d) rules requiring such reporting in this 
ICR's renewal period. These changes are the result of a program 
adjustment. Thus, any 8(d) rules promulgated during this renewal period 
would not reflect this increase in burden.

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. 2025-08190 Filed 5-8-25; 8:45 am]
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