Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. (Renewal)

Forms and Documents

Document Name	Status
Form EPA Form 7710-25 Pre-Manufacture Notifications Form	Modified
Form 7710-56 Notice of Commencement Form	New
Form 7710-25 Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	New
Form 7710-25 Test-Marketing Exemptions (TMEs) Form and Instruction	New
Form 7710-25 PMN-Related Significant New Use Notices (SNUNs) Form and Instruction	New
Attachment I.doc Supplementary Document	2007-12-11
Attachment F.doc Supplementary Document	2007-12-11
Attachment H.pdf Supplementary Document	2007-12-11
Attachment G.pdf Supplementary Document	2007-12-11
Attachment J.doc Supplementary Document	2007-12-11
Attachment E.doc Supplementary Document	2007-12-11
Attachment D.doc Supplementary Document	2007-12-11
Attachment C.doc Supplementary Document	2007-12-11
Attachment B.doc Supplementary Document	2007-12-11
Attachment A.doc Supplementary Document	2007-12-11
0574ss13-revised-2008-12-17.doc Supporting Statement A	2008-12-17

IC Document Collections

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

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 200712-2070-005
Status: Historical Active	Previous ICR Reference No: 200409-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.13
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/22/2008
	Date Received in OIRA: 12/18/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	12/31/2008
Responses	2,329	0	1,674
Time Burden (Hours)	148,084	0	163,791
Cost Burden (Dollars)	0	0	0

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Abstract: TSCA requires businesses to notify the Agency 90 days prior to the manufacture or import of a new chemical substance or an existing chemical substance for a significant new use. EPA reviews the information to evaluate the effects of the chemical on human health and the environment. The submitter is free to manufacture or import the new chemical substance if the Agency takes no further regulatory action within 90 days of receipt of the notification. Submitters can also apply for certain exemptions with shorter review times.

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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: 14

IC Title	Form No.	Form Name
Pre-Manufacture Notifications	EPA Form 7710-25, EPA Form 7710-25	Premanufacture Notice (part 1) ,   Premanufacture Notice (part 2)
PMN-Related Significant New Use Notices (SNUNs)	7710-25	Premanufacture Notice
Microbial Commercial Activity Notices (MCANs)
Test-Marketing Exemptions (TMEs)	7710-25	Premanufacture Notice
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	7710-25	Premanufacture Notice
TSCA Experimental Release Applications (TERAs)
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	7710-56	Notice of Commencement of Manufacture or Import
Tier I/Tier II Exemptions
Bona Fide Intent Notifications (Bona Fides)

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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	2,329	1,674	0	0	655	0
Annual Time Burden (Hours)	148,084	163,791	0	0	-15,707	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: No

Burden Reduction Due to:

Short Statement:

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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]? Uncollected

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)? Uncollected

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: 12/18/2007

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