TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals

Forms and Documents

Document Name	Status
1188-13_ Attachment 7-Consultations-ACC-SOCMA.pdf Supplementary Document	2019-07-17
1188.13_Attach6-consultations.docx Supplementary Document	2016-07-15
1188.13_Attach5-Response-to-Comments.pdf Supplementary Document	2016-07-15
1188.13_Attach4b-comment-SOCMA.pdf Supplementary Document	2016-07-15
1188.13_Attach4a-comment-ACC.pdf Supplementary Document	2016-07-15
1188.13_Attach3-SelectionCriteria.docx Supplementary Document	2016-07-15
1188.13_Attach2-regs.docx Supplementary Document	2016-07-15
1188.13_Attach1-statute.docx Supplementary Document	2016-07-15
1188-13 ss 2019-07-16.docx Supporting Statement A	2019-07-17

IC Document Collections

IC ID	Document Title	Status
24882	Chemical Verification Instruction	Modified
204560	Rule Familiarization	Modified
192551	Establishment of a Pay.gov Account	Removed
192550	CDX Electronic Signature Instruction	Removed
192549	CDX Registration, electronic signature & Pay.gov setup Instruction	Modified
188156	Customer Notification Instruction	Modified
188155	Submitting SNUNs Instruction	Modified

ICR Details

OMB Control No: 2070-0038	ICR Reference No: 201607-2070-001
Status: Active	Previous ICR Reference No: 201507-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1188.12
Title: TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals
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: 07/17/2019
	Date Received in OIRA: 07/26/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	07/31/2019
Responses	14	0	98
Time Burden (Hours)	137	0	736
Cost Burden (Dollars)	0	0	0

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Abstract: Section 5 of the Toxic Substances Control Act (TSCA) provides EPA with a regulatory mechanism to monitor and, if necessary, control significant new uses of chemical substances. Section 5 authorizes EPA to determine by rule (i.e., a significant new use rule or SNUR), after considering all relevant factors, that a use of a chemical substance represents a significant new use. If EPA determines that a use of a chemical substance is a significant new use, section 5 requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the substance for that use. EPA uses the information obtained through this collection to evaluate the health and environmental effects of the significant new use. EPA may take regulatory actions under TSCA section 5, 6 or 7 to control the activities for which it has received a SNUR notice. These actions include orders to limit or prohibit the manufacture, importation, processing, distribution in commerce, use or disposal of chemical substances. If EPA does not take action, section 5 also requires EPA to publish a Federal Register notice explaining the reasons for not taking action. This information collection addresses the reporting and recordkeeping requirements inherent in TSCA section 5 significant new use rules.

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Authorizing Statute(s): US Code: 15 USC 2604 Name of Law: Toxic Substances Control Act / Manufacturing and processing notices
  

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:
	80 FR 53151	09/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 48788	07/26/2016
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
Establishment of a Pay.gov Account
Chemical Verification
Submitting SNUNs
Customer Notification
CDX Registration, electronic signature & Pay.gov setup
Rule Familiarization
CDX Electronic Signature

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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	14	98	0	-12	-72	0
Annual Time Burden (Hours)	137	736	0	-831	232	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: Miscellaneous Actions

Short Statement: There is an decrease of 599 hours (from 736 hours to 137 hours) in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This change results from adjustment changes that updated the number of affected sites, average number of SNUNs submitted annually, from recalculating the average number of chemicals per SNUR, and correcting rounding errors in the burden estimate for completing a SNUN, and rule familiarization.

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Annual Cost to Federal Government: $51,655

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: 07/26/2016

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