TSCA Section 8(b) Reporting Requirements for TSCA Inventory Notifications (Supplemental Proposed Rule)

Forms and Documents

Document	Type	Status	Availability
Form 9600-06 Form B - Future Submissions with Full CBI Substantiation	Form and Instruction	New	Available
Form 9600-5 Ongoing Reporting for Manufacturers and Processors	Form and Instruction	Modified	Repair queued
Form 9600-5 Start-up & Initial Reporting for Processors (Phase 2 Reporting Only)	Form and Instruction	Modified	Repair queued
Form 9600-5 Start-up & Initial Reporting for Additional Manufacturers/Importers (Phase 2 Reporting Only)	Form and Instruction	Modified	Available
Form 9600-05 Start-Up & Initial Reporting for Manufacturers/Importers	Form and Instruction	Modified	Available
2565ss04.docx	Supporting Statement A	Uploaded 2019-11-08	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
238480	Form B - Future Submissions with Full CBI Substantiation	Form and Instruction	New
227887	Ongoing Reporting for Manufacturers and Processors	Form and Instruction	Modified
227886	CDX Registration and eSignature (Phase 1 & 2 Combined)		Unchanged
225209	Start-up & Initial Reporting for Processors (Phase 2 Reporting Only)	Form and Instruction	Modified
225208	Start-up & Initial Reporting for Additional Manufacturers/Importers (Phase 2 Reporting Only)	Form and Instruction	Modified
225207	Start-Up & Initial Reporting for Manufacturers/Importers	Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0201	ICR Reference No: 201911-2070-001
Status: Historical Inactive	Previous ICR Reference No: 201708-2070-004
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2565.04
Title: TSCA Section 8(b) Reporting Requirements for TSCA Inventory Notifications (Supplemental Proposed Rule)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 12/16/2019
	Date Received in OIRA: 11/08/2019
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	01/31/2021
Responses	1,874	0	1,874
Time Burden (Hours)	1,174,916	0	1,174,916
Cost Burden (Dollars)	94,937,104	0	94,937,104

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Abstract: The Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, required EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish that, EPA finalized a rule, the TSCA Inventory Notification (Active-Inactive) Requirements Rule (“Active-Inactive Rule”) requiring industry reporting of chemicals manufactured (including imported) or processed in the U.S. over the past 10 years, ending on June 21, 2016. 82 FR 37520 (8/11/17). Included in the Active-Inactive Rule were provisions for the submission of confidential business information (CBI). Submitters were required to substantiate all CBI claims made in that data collection, except for chemical substance identity. If the chemical was reported pursuant a retrospective reporting requirement, submitters had an option to voluntarily substantiate the CBI claim; if the chemical was reported pursuant a prospective reporting requirement, the submitters had to substantiate the CBI claim at the time of filing.

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Authorizing Statute(s): US Code: 15 USC 2607 Name of Law: Toxic Substances Control Act (TSCA)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK21	Proposed rulemaking	84 FR 60363	11/07/2019

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
CDX Registration and eSignature (Phase 1 & 2 Combined)
Ongoing Reporting for Manufacturers and Processors	9600-5, 9600-6	Form A ,   Form B
Start-Up & Initial Reporting for Manufacturers/Importers	9600-05, 9600-06	Form A ,   Form B
Start-up & Initial Reporting for Additional Manufacturers/Importers (Phase 2 Reporting Only)	9600-6, 9600-5	Form A ,   Form B
Start-up & Initial Reporting for Processors (Phase 2 Reporting Only)	9600-6, 9600-5	Form A ,   Form B
Form B - Future Submissions with Full CBI Substantiation	9600-06	Form B

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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: This is a new data collection activity resulting from the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires additional responsibilities of EPA in maintaining the TSCA Inventory, and imposes reporting requirements on regulated entities wishing to maintain claims of confidentiality for chemical substance identity. Specific to this SNRPM, EPA is addressing substantiation requirements pertaining to reverse engineering in response to a recent court ruling remanding the Active-Inactive Rule by adding two additional substantiation questions. As such, the change being implemented in this ICR period is the addition of new burden and cost for activities associated with the two new questions, as presented in Table 1. The total burden to industry for this ICR period is 0.4 hours occurring on an annual basis after the rule is enacted.

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Annual Cost to Federal Government: $1,352,866

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: 11/08/2019

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