Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Renewal)
Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Renewal)
Per 5 CFR 1320.5, the agency is reminded to display a valid OMB Control number. Per 5 CFR 1320.8, the agency is reminded to include a burden statement.
Inventory as of this Action
Requested
Previously Approved
12/31/2022
36 Months From Approved
11/30/2019
4,541
0
2,854
192,156
0
118,555
0
0
0
This ICR covers the information collection activities that implement the statutory mandates in section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016, 15 U.S.C. 2604, and the implementing regulations codified in 40 CFR parts 700, 720, 721, 723, and 725. Specifically, TSCA section 5 requires that any person who proposes to manufacture (which includes import) a new chemical substance (i.e., a chemical substance not listed on the TSCA section 8(b) Inventory) or a significant new use of a chemical substance (as identified by EPA rule) must provide a notice to EPA at least 90 days prior to commencing the manufacture of that chemical substance. EPA must review the notice, make an affirmative determination on the safety of the new chemical substance or significant new use, and, if appropriate, regulate the chemical substance to address any unreasonable risks identified before it can proceed to the marketplace. The submitter of a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN) is also required to inform EPA when non-exempt commercial manufacture of the substance in question actually begins by submitting a Notice of Commencement (NOC).
This renewal reflects an increase in the total estimated respondent burden of 15,860 hours (from 118,555 hours to 134,415 hours) from that currently in the OMB inventory. This increase is driven by several changes. First, the mix of the estimated number of each type of notice changed, based on the most recent EPA data available. While the net effect of these changes was that the number of notices decreased by 440, increases in the types of notices with a high associated unit burden (such as Section 5(e)/5(f) Order Test and Non-Testing Section 5(e)/5(f) Order) led to a net increase in burden. Similarly, the estimated number of annual CDX registrants also increased (from 392 submissions to 2,855 submissions), reflecting the most recent EPA data available. This change results in increased burden of 1,626 hours. This ICR also integrates corrections to rounding errors and recordkeeping unit burden estimates for PMNs, SNUNs, LVEs, and LoREXs. This ICR removes 276 hours of rule familiarization attributed to the change request submitted for the 2015 amendment to the ePMN rule.
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 EPA Form 7710-25 Pre-Manufacture Notifications
0574-18 Attachment P.docx
0574-18 Attachment O.pdf
Pre-Manufacture Notifications