Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e)

Forms and Documents

Document Name	Status
Attach2.docx Supplementary Document	2013-05-07
Attach1.docx Supplementary Document	2013-05-07
0794ss13_rev02-10-2014.docx Supporting Statement A	2014-02-10

IC Document Collections

IC ID	Document Title	Status
44061	Initial TSCA Sec. 8(e) Submissions Instruction	Modified
208845	CDX Registration Activities Instruction	New
208844	Follow-up/Supplemental FYI Submissions Instruction	New
208843	Initial FYI Submissions Instruction	New
190403	Follow-up/Supplemental TSCA Sec. 8(e) Submissions Instruction	Modified

ICR Details

OMB Control No: 2070-0046	ICR Reference No: 201309-2070-002
Status: Historical Active	Previous ICR Reference No: 200908-2070-005
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0794.13
Title: Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e)
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: 02/27/2014
	Date Received in OIRA: 09/27/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2017	36 Months From Approved	02/28/2014
Responses	685	0	721
Time Burden (Hours)	18,518	0	30,515
Cost Burden (Dollars)	0	0	0

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Abstract: Section 8(e) of the Toxic Substances Control Act (TSCA) requires that any person who manufactures, imports, processes or distributes in commerce a chemical substance or mixture and which obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment must immediately inform EPA of such information. This information collection addresses the burden associated with industry submissions under TSCA section 8(e).

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Authorizing Statute(s): US Code: 15 USC 2607e Name of Law: Notice to Administrator of substantial risks
  

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:
	77 FR 71415	11/30/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 59670	09/27/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Initial TSCA Sec. 8(e) Submissions
Follow-up/Supplemental TSCA Sec. 8(e) Submissions
Initial FYI Submissions
Follow-up/Supplemental FYI Submissions
CDX Registration Activities

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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	685	721	0	0	-36	0
Annual Time Burden (Hours)	18,518	30,515	0	-330	-11,667	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: There is a decrease of 10,856 hours (30,515 to 19,659 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This decrease represents changes in the number of estimated submissions based on EPA's recent experience with TSCA section 8(e) notices plus the effects of optional electronic reporting. This change involves both a program change (electronic reporting) and an adjustment. The Supporting Statement provides additional detail concerning the change in burden estimate.

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Annual Cost to Federal Government: $310,832

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]? No

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: 09/27/2013

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