Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements,[...]

Agency Information Collection Activities; Proposed Renewal Collection and Request for Comment; Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions From Testing Requirement (Renewal)

DATES:

Comments must be received on or before October 13, 2026.

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: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement (Renewal).

EPA ICR No.: 1139.52.

OMB Control No.: 2070-0033.

ICR Status: This ICR is currently approved through March 31, 2027. 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 the information collection activities associated with the submission of information to EPA pursuant to TSCA section 4 regulatory actions. (15 U.S.C. 2603). Under TSCA, EPA has the authority to issue regulatory actions designed to gather or develop health and safety information and exposure information on chemical substances and mixtures, and to control unreasonable risks associated with new and existing chemical substances. TSCA section 4 authorities allow EPA to require the development of information related to chemicals and the use of prescribed "protocols and methodologies" in order to inform EPA and other federal agencies about chemical risks, which in turn will inform decision makers for purposes of prioritization for risk evaluation, risk evaluation and risk management of those chemicals as necessary.

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): 9600-034.

Respondents/affected entities: Entities potentially affected by this ICR are manufacturers (including imports) or processors of chemical substances of mixtures, e.g., entities identified by North American Industrial Classification System Codes 325 and 324.

Respondent's obligation to respond: Mandatory, per 15 U.S.C. 2603.

Estimated number of potential respondents: 353.

Frequency of response: On occasion.

Total estimated average number of responses for each respondent: 1.5.

Total estimated burden: 119,546 hours (three-year total). Burden is defined at 5 CFR 1320.3(b).

Total estimated costs: $10,802,906 (three-year total), includes $202,722,312 annualized capital investment or maintenance and operational costs.

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

There is an increase of 7,451 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This change, reflects EPA's updating of number of actions per year using the assumptions in the 2024 TSCA Fees Rule (89 FR 12961 February 21, 2024 (FRL-79110-05-OCSPP)). Based upon revised estimates, the estimated number of test orders initiated per year increased from 10 to 14, while both the number of test rules and enforceable consent agreements decreased from 0.5 to 0.33 per year. 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. )