Notice2025-08190
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)
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Published
May 9, 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): "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.
Full Text
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<title>Federal Register, Volume 90 Issue 89 (Friday, May 9, 2025)</title>
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[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Pages 19715-19716]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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/">https://www.epa.gov/</a>.
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: <a href="/cdn-cgi/l/email-protection#1c6f7569327f7d6e737065725c796c7d327b736a"><span class="__cf_email__" data-cfemail="26554f5308454754494a5f486643564708414950">[email 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: 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]
BILLING CODE 6560-50-P
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