View Information Collection Request (ICR) Package

OMB Control No: 2070-0038	ICR Reference No: 202501-2070-008
Status: Active	Previous ICR Reference No: 202309-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1188.15
Title: TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Final Rule)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/17/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/16/2025
Terms of Clearance: Because the agency sought comments only on the changes associated with the regulation, the existing expiration date remains the same for this collection. In accordance with 1320.11(h), the agency is reminded to submit the ICR for OMB review on or before the date of Federal Register publication for the final rule. In accordance with 5 CFR 1320, the information collection is approved.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved	12/31/2025
Responses	4,243	0	4,286
Time Burden (Hours)	129,367	0	136,292
Cost Burden (Dollars)	0	0	0

Abstract: This revised information collection request updates addresses the reporting and recordkeeping requirements associated with the proposed rule to update the new chemicals procedural regulations at 40 CFR Parts 720, 721, 723, and 725 under the Toxic Substances Control Act (TSCA). The amendments included under this new chemicals procedural rule cover several goals, including in part to align the regulatory text with the amendments to TSCA’s new chemical review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016 (15 U.S.C. 2604); increase the quality of information initially submitted in new chemicals notices, to reduce the need to update risk assessments if new information is received later in the process, and, ultimately, to reduce the length of time that new chemicals are under review for notices submitted under TSCA section 5(a)(1); and to update the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs) to make perfluoroalkyl and polyfluoroalkyl substances (PFAS) ineligible for these exemptions and to codify the ineligibility for these exemptions of certain persistent, bioaccumulative, and toxic (PBT) chemical substances as described in EPA’s 1999 PBT policy.

Authorizing Statute(s): US Code: 15 USC 2604 Name of Law: Toxic Substances Control Act / Manufacturing and processing notices

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK65	Final or interim final rulemaking	89 FR 102773	12/18/2024

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	4,243	4,286	-43
Annual Time Burden (Hours)	129,367	136,292	-6,925
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: The change in estimate as a result of the proposed rule which updates the new chemicals procedural regulations at 40 CFR Parts 720, 721, 723, and 725. The amendments included under this new chemicals procedural rule cover several goals, including in part to align the regulatory text with the amendments to TSCA’s new chemical review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016 (15 U.S.C. 2604); increase the quality of information initially submitted in new chemicals notices, to reduce the need to update risk assessments if new information is received later in the process, and, ultimately, to reduce the length of time that new chemicals are under review for notices submitted under TSCA section 5(a)(1); and to update the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs) to make perfluoroalkyl and polyfluoroalkyl substances (PFAS) ineligible for these exemptions and to codify the ineligibility for these exemptions of certain persistent, bioaccumulative, and toxic (PBT) chemical substances as described in EPA’s 1999 PBT policy

Annual Cost to Federal Government: $31,761,353

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov

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