Electronic Reporting of TSCA Section 4, Section 5 NOC and Supporting Documents, 8(a) Preliminary Assessment Information Rule (PAIR), and 8(d) Submissions

Forms and Documents

Document Name	Status
TDD 9 21 OPPT MTS CDX CSPP Registration User Guide v1 0.pdf Supplementary Document	2013-11-22
2412ss02.docx Supporting Statement A	2013-11-22

IC Document Collections

IC ID	Document Title	Status
209480	Rule Familiarization	New
201974	New CDX Activities - TSCA Section 8(d) Health and Safety Data Submissions	Modified
201973	New CDX Activities - TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) Submissions	Modified
201972	New CDX Activities - TSCA Section 5 "Legacy" Notice of Commencement Submissions	Modified
201971	New CDX Activities - TSCA Section 4 Test Data Submissions	Modified

ICR Details

OMB Control No: 2070-0183	ICR Reference No: 201311-2070-003
Status: Historical Active	Previous ICR Reference No: 201204-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2412.02
Title: Electronic Reporting of TSCA Section 4, Section 5 NOC and Supporting Documents, 8(a) Preliminary Assessment Information Rule (PAIR), and 8(d) Submissions
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/25/2014
	Date Received in OIRA: 11/22/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2017	36 Months From Approved
Responses	706	0	0
Time Burden (Hours)	1,228	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: EPA promulgated a final rule that requires electronic reporting for information that must be submitted under Toxic Substances Control Act (TSCA) section 4 (pursuant to test rules and enforceable consent agreements (ECAs)), TSCA section 8(a) Preliminary Assessment Information Rule (PAIR), and TSCA section 8(d) Health and Safety Data Reporting rules. Additionally, EPA updated certain TSCA section 5 reporting regulations that would extend electronic reporting requirements to Notices of Commencement of Manufacture or Import (NOCs) and support documents (e.g., correspondence, amendment, and test data) relating to TSCA section 5 notices submitted to EPA before April 6, 2010. This rule-related Information Collection Request (ICR) addresses the incremental paperwork activities related to submitting sections 4, 5, 8(a) PAIR, and 8(d) data, reports, and other documents to EPA electronically and describes the changes that will ultimately be incorporated into the ICRs upon their renewal date that are currently approved under OMB Control No. 2070-0033, No. 2070-0012, No. 2070-0054, No. 2070-0004, and 2070-0012. (EPA ICR No. 1139.08 TSCA Section 4 Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Data Submission; EPA ICR No. 0574 Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances; EPA ICR No. 0586.11, TSCA 8(a) Preliminary Assessment Information Rule (PAIR); EPA ICR No. 0575.12 Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies; and EPA ICR No. 0574.15 Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances, respectively). In addition, OPPT initiated a voluntary pilot program to accept certain health and safety data submissions in an electronic format. The voluntary use of a cover sheet facilitates the submission of information by displaying certain basic data elements, permitting EPA more easily to identify, log, track, distribute, review and index submissions, and makes information publicly available to the mutual benefit of both industry and EPA. The specific reporting form used by this information collection is known as the TSCA Health & Safety Study Cover Sheet (EPA Form No. 7710-58). This rule-related ICR incorporates the data elements captured in the voluntary form and addresses the incremental paperwork activities related to submitting the form electronically and describes the changes that will be incorporated into the existing ICR approved under OMB Control No. 2070-0156 (EPA ICR No. 1780.05 Voluntary Cover Sheet for TSCA Submissions).

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Authorizing Statute(s): US Code: 15 USC 2601 et seq. 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:
2070-AJ75	Final or interim final rulemaking	78 FR 72818	12/04/2013

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 22707	04/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 72818	12/04/2013
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
New CDX Activities - TSCA Section 5 "Legacy" Notice of Commencement Submissions
New CDX Activities - TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) Submissions
New CDX Activities - TSCA Section 8(d) Health and Safety Data Submissions
Rule Familiarization
New CDX Activities - TSCA Section 4 Test Data Submissions

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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	706	0	0	706	0	0
Annual Time Burden (Hours)	1,228	0	0	1,228	0	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: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: EPA estimates that industry will incur a total of 1,228 hours in one-time burden as a result of new activities stemming from mandatory electronic reporting requirements. These new activities include rule familiarization, CDX registration, and CDX electronic signature agreements.

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Annual Cost to Federal Government: $209,406

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: 11/22/2013

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