TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Final Rule)
Revision of a currently approved collection
No
Regular
Approved without change
01/17/2025
01/16/2025
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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2025
36 Months From Approved
12/31/2025
4,243
0
4,286
129,367
0
136,292
0
0
0
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 TSCAâs 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 EPAâs 1999 PBT policy.
US Code:
15 USC 2604
Name of Law: Toxic Substances Control Act / Manufacturing and processing notices
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 TSCAâs 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 EPAâs 1999 PBT policy
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 7710-25 Premanufacture Notice
1188ss15.docx
Points to Consider Guidance Document.pdf
Screen Shots.pptx
Existing Chemicals Activities