Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances
ICR 201004-2070-002 · OMB 2070-0012 · Historical Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 2070-0012 can be found here:
Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances
No material or nonsubstantive change to a currently approved collection
On January 6, 2010, EPA promulgated a final rule entitled, "TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations" (75 FR 773). The final rule amends the Toxic Substances Control Act (TSCA) section 5 reporting regulations at subpart D of 40 CFR parts 700, 720, 721, 723, and 725. The amendments establish electronic reporting regulations for certain notification requirements under TSCA section 5, including Premanufacture and Significant New Use Notifications (PMNs and SNUNs). The final rule streamlines and reduces the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA by phasing in the requirement that respondents submit certain TSCA section 5 notices and support documents to EPA electronically using the Agency's Central Data Exchange (CDX). The rule also established requirements regarding the use of CDX, including user registration, authorization, and electronic signature. EPA also now requires that respondents include a payment identification number on the PMN form to enable EPA to link user fee payments with specific submissions. The payment identification number may be a check number, a wire transfer number, or a pay.gov transaction number. Lastly, EPA no longer requires that designated Agents sign the PMN form.
OMB approved the rule-related ICR on March 29, 2010 under OMB Control No. 2070-0173. The rule-related ICR addresses the paperwork activities associated with the amended reporting and recordkeeping requirements and the incremental program change burdens, specifically:
* Rule familiarization,
* Registering with EPA's electronic reporting portal (the Central Data Exchange, or CDX),
* Obtaining a CDX electronic signature (including authentication of identity and verifying authorization of the CDX registrant to submit on behalf of the company), and,
* Setting up a Pay.gov account (not required by the rule) if respondents wished to make payments for the existing TSCA fees electronically.
With this Justification for No Material/Nonsubstantive Change package, EPA is making three distinct changes to the ICR. First, EPA transferring certain information collection activities and related burden recently approved under OMB Control No. 2070-0173 to this ICR (i.e., OMB Control No. 2070-0012) Second, EPA is adjusting the baseline number of annual responses for five of the currently approved based on a change in the way the number of annual responses were estimated in the "Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule," versus previous practice. Last, EPA is effectuating program change burden reductions related to the clerical level efficiencies of electronic submission. Each of these changes was analyzed and described in the "Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule," as well as the "Impact Analysis of the Final e-PMN Rule on Paperwork Burdens Approved under Existing EPA ICRs." Upon approval of this Change package, and a companion Change package submitted under OMB Control No. 2070-0038, EPA intends to discontinue the recently approved rule-related ICR (OMB Control No. 2070-0173).
US Code:
15 USC 2605
Name of Law: Toxic Substances Control Act
The program change burden reductions described in this Change request are related to the clerical level efficiencies of electronic submission as ultimately required by final rule rule amendments promulgated on January 6, 2010. Each of the program changes were analyzed and described in the "Economic Analysis of the Amendments to TSCA Section 5 Premanufacture and Significant New Use Notification Requirements Final Rule," as well as the "Impact Analysis of the Final e-PMN Rule on Paperwork Burdens Approved under Existing EPA ICRs" (identified as Appendix 1 of the rule-related ICR), and are summarized in the attached justification. EPA estimates that the implementation of electronic reporting will save respondents between approximately 4 and 14 hours of clerical/administrative per response, and that corresponding recordkeeping burdens will be reduced by 50 percent, as respondents experience efficiencies in creating, submitting, and storing TSCA section 5 notices and supporting documents electronically.
$7,213,968
No
No
No
Uncollected
No
Uncollected
Angela Hofmann
Reginfo record details
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:
(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
ICR0574-14-change-request.doc
screen shots revised 080709.pdf
Pre-Manufacture Notifications