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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0038
ICR Reference No:
202309-2070-001
Status:
Historical Inactive
Previous ICR Reference No:
202206-2070-002
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
1188.14
Title:
TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Proposed Rule)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule and continue
Conclusion Date:
11/29/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/29/2023
Terms of Clearance:
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.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2025
36 Months From Approved
12/31/2025
Responses
4,286
0
4,286
Time Burden (Hours)
136,292
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
Proposed rulemaking
88 FR 34100
05/26/2023
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
16
IC Title
Form No.
Form Name
Bona Fide Intent Notifications (Bona Fides)
CDX Registration
Instant Photographic Film Articles
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)
Microbial Commercial Activity Notices (MCAN)
Notice of Commencement
Polymer Exemption Post-Manufacture Annual Reports
7710-56
NOC Form
Premanufacture Notice
7710-25
PMN Form
Research and Development Exemption
7710-25
PMN Form
Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing
7710-25
PMN Form
Section 5(e) Orders with Triggered Testing
7710-25
PMN Form
Significant New Use Notice (SNUN)
TSCA Experimental Release Applications (TERA)
Test Marketing Exemptions (TME)
7710-25
PMN Form
Tier 1 Exemptions
Tier II Exemptions
6300-07
BioTech
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Changing Regulations
Short Statement:
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.
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
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/29/2023
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