TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Proposed Rule)
Revision of a currently approved collection
No
Regular
Comment filed on proposed rule and continue
11/29/2023
09/29/2023
In accordance with 1320.10(a), the agency is reminded to submit the ICR for OMB review the day of Federal Register publication for the proposed rule.
In accordance with 5 CFR 1320, OMB is filing comment and withholding approval at this time. The agency shall examine public comment in response to the proposed rulemaking and include in the supporting statement of the next ICR--to be submitted to OMB at the final rule stage--a description of how the agency has responded to any public comments on the ICR, including comments on maximizing the practical utility of the collection and minimizing the burden.
In accordance with 5 CFR 1320, OMB is filing comment and withholding approval at this time. The agency shall examine public comment in response to the proposed rulemaking and include in the supporting statement of the next ICR--to be submitted to OMB at the final rule stage--a description of how the agency has responded to any public comments on the ICR, including comments on maximizing the practical utility of the collection and minimizing the burden. Given that the cost estimates presented rely largely on non-public data, the agency is requested to work with OMB to increase the amount of quality supporting information underlying the cost estimates before this information collection is submitted for renewal. Lastly, the supporting statement submitted at final rule stage should include any changes that occurred between the proposed and final rule related to this ICR.
OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2025
36 Months From Approved
12/31/2025
4,286
0
4,286
136,292
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 amendments included under this new chemicals procedural rule 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.
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.