90 FR 89 pgs. 19715-19716 - 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)
Type: NOTICEVolume: 90Number: 89Pages: 19715 - 19716
Pages: 19715, 19716Docket number: [EPA-HQ-OPPT-2021-0728; FRL-12357-01-OCSPP]
FR document: [FR Doc. 2025-08190 Filed 5-8-25; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
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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.
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: siu.carolyn@epa.gov.
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.
[top] 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)."
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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