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

Forms and Documents

Document Name	Status
0794-16_Attach3-consultations.docx Supplementary Document	2017-02-15
0794-16_ResponseToComments.pdf Supplementary Document	2017-02-15
0794-16_Attach1-statute.docx Supplementary Document	2017-02-15
0794-16_ss_2019-10-08.docx Supporting Statement A	2019-10-10

IC Document Collections

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

ICR Details

OMB Control No: 2070-0046	ICR Reference No: 201702-2070-001
Status: Active	Previous ICR Reference No: 201309-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0794.16
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: 10/11/2019
	Date Received in OIRA: 03/21/2017
Terms of Clearance: The agency is reminded to include a burden statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	572	0	685
Time Burden (Hours)	21,412	0	18,518
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. EPA routinely disseminates TSCA section 8(e) data it receives to other federal agencies to provide information about newly discovered chemical hazards and risks.

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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:
	81 FR 43601	07/05/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 12590	03/06/2017
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	572	685	0	0	-113	0
Annual Time Burden (Hours)	21,412	18,518	0	0	2,894	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: Changes are due to adjusted estimates of the number of respondents.

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Annual Cost to Federal Government: $284,052

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 03/21/2017

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