Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances

Forms and Documents

Document Name	Status
Form EPA Form 7710-25 Pre-Manufacture Notifications Form and Instruction	Modified
Form ESA and Authorizat CDX Electronic Signature Form	New
Form EPA Form 7710-56 Notice of Commencement Form and Instruction	Modified
Form EPA Form 6300-7 Tier I/Tier II Exemptions Form	Modified
Form EPA Form 6300-7 TSCA Experimental Release Applications (TERAs) Form	Modified
Form EPA Form 7710-25 Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	Modified
Form EPA Form 6300-7 Test-Marketing Exemptions (TMEs) Form	Modified
Form EPA Form Number 63 Microbial Commercial Activity Notices (MCANs) Form	Modified
Form EPA Form 7710-25 PMN-Related Significant New Use Notices (SNUNs) Form and Instruction	Modified
ICR0574-14-change-request.doc Justification for No Material/Nonsubstantive Change	2010-04-13
screen shots revised 080709.pdf Supplementary Document	2010-04-09
cdxguide.pdf Supplementary Document	2010-04-09
cdxhints.pdf Supplementary Document	2010-04-09
cdxguide.pdf Supplementary Document	2010-04-09
cdxhints.pdf Supplementary Document	2010-04-12
cdxhints.pdf Supplementary Document	2010-04-12
cdxhints.pdf Supplementary Document	2010-04-12
cdxhints.pdf Supplementary Document	2010-04-09
cdxhints.pdf Supplementary Document	2010-04-09

IC Document Collections

IC ID	Document Title	Status
24844	Pre-Manufacture Notifications Form and Instruction	Modified
192556	e-PMN Rule Familiarization	New
192555	Establishment of a Pay.gov account	New
192554	CDX Electronic Signature Form	New
192553	CDX Registration	New
183119	Notice of Commencement Form and Instruction	Modified
183118	Research and Development Exemption	Modified
183117	Instant Photographic Film Articles Exemption	Modified
183116	Polymer Exemption Post-Manufacture Annual Reports	Modified
183115	Non-Testing Activities under Section 5(e) Consent Orders	Modified
183114	Test Data Submissions under Section 5(e) Consent Orders	Modified
183113	Bona Fide Intent Notifications (Bona Fides)	Modified
183112	Tier I/Tier II Exemptions Form	Modified
183111	TSCA Experimental Release Applications (TERAs) Form	Modified
183110	Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	Modified
183109	Test-Marketing Exemptions (TMEs) Form	Modified
183108	Microbial Commercial Activity Notices (MCANs) Form	Modified
183107	PMN-Related Significant New Use Notices (SNUNs) Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 201004-2070-002
Status: Historical Active	Previous ICR Reference No: 200712-2070-005
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.14
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/07/2010
	Date Received in OIRA: 04/14/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	12/31/2011	12/31/2011
Responses	2,518	0	2,329
Time Burden (Hours)	117,512	0	148,084
Cost Burden (Dollars)	0	0	0

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Abstract: 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).

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Authorizing Statute(s): US Code: 15 USC 2605 Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 26353	05/09/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 71685	12/18/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
Pre-Manufacture Notifications	EPA Form 7710-25	Premanufacture Notice
PMN-Related Significant New Use Notices (SNUNs)	EPA Form 7710-25	Premanufacture Notice
Microbial Commercial Activity Notices (MCANs)	EPA Form Number 6300-07	EPA Biotech Form
Test-Marketing Exemptions (TMEs)	EPA Form 6300-7, EPA Form 7710-25	EPA Biotech Form ,   Premanufacture Notice
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	EPA Form 7710-25	Premanufacture Notice
TSCA Experimental Release Applications (TERAs)	EPA Form 6300-7	EPA Biotech Form
Tier I/Tier II Exemptions	EPA Form 6300-7	EPA Biotech Form
Bona Fide Intent Notifications (Bona Fides)
Test Data Submissions under Section 5(e) Consent Orders
Non-Testing Activities under Section 5(e) Consent Orders
Polymer Exemption Post-Manufacture Annual Reports
Instant Photographic Film Articles Exemption
Research and Development Exemption
Notice of Commencement	EPA Form 7710-56	Notice of Commencement of Manufacture or Import
CDX Registration
CDX Electronic Signature	ESA and Authorization Form 1, US EPA Electronic Signature Agreement, ESA and Authorization Form 2	Verification of Company Authorizing Official ,   Authorization And Verification For Section 5 Notice Support Submitter By Company Authorizing Official ,   US EPA Electronic Signature Agreement
Establishment of a Pay.gov account
e-PMN Rule Familiarization

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,518	2,329	0	0	189	0
Annual Time Burden (Hours)	117,512	148,084	0	-16,291	-14,281	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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 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.

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Annual Cost to Federal Government: $7,213,968

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 04/14/2010

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