Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement (Revision)

Forms and Documents

Document Name	Status
1139ss12_Appendices_2020-12-09.docx Supplementary Document	2020-12-18
1139ss12_AsRevised_2020-12-18.clean.docx Supporting Statement A	2020-12-18
1139ss12_Attachment 9 Example of a Section 4 Test Order rev_Redacted.pdf Supplementary Document	2020-09-04
1139ss12_Attachment 1 Toxic Substances Control Act (TSCA) Section 4rev.pdf Supplementary Document	2020-09-04
1139ss12_Attachment 8 EPA's Response to Public Comments.docx Supplementary Document	2020-08-24
1139ss12_Attachment 7 American Chemistry Council (ACC) Comment.pdf Supplementary Document	2020-08-24
1139ss12_Attachment 6 Environmental Defense Fund (EDF) Comment.pdf Supplementary Document	2020-08-24
1139ss12_SS_Attachment 5 Center for Specialty Chemical Science, LLC (CSCS) Comment.pdf Supplementary Document	2020-08-24
1139ss12_Attachment 4 Consultations Message Sent by EPA to Potential Respondents.pdf Supplementary Document	2020-08-24
1139ss12_Attachment 3 TSCSA Section 4 ICR e-Reporting Screenshots.docx Supplementary Document	2020-08-24
1139ss12_Attachment 2 Procedures Governing Testing Consent Agreements and Test Rules, 40 CFR 790.pdf Supplementary Document	2020-08-24

IC Document Collections

IC ID	Document Title	Status
243498	Testing Costs (non-labor costs) for Test Rules	New
243497	Voluntary Data Submissions	New
243496	Voluntary Robust Summaries for Test Rules, Test Orders, and Enforceable Consent Agreements (ECAs)	New
243495	Test Results, ECAs	New
243494	Study Plan, Enforceable Consent Agreements (ECAs)	New
243493	Voluntary Initial Contact, Enforceable Consent Agreements (ECAs)	New
243492	Test Results, Test Rules	New
243491	Study Plan, Test Rules	New
243490	Initial Response, Test Rules	New
243489	CDX Registration for e-Reporting	New

ICR Details

OMB Control No: 2070-0033	ICR Reference No: 202008-2070-003
Status: Historical Active	Previous ICR Reference No: 201712-2070-004
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1139.12
Title: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement (Revision)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/18/2020
	Date Received in OIRA: 09/24/2020
Terms of Clearance: The agency is reminded to include the OMB control number and PRA burden statement for all generic ICs. In addition, the agency is required to provide OMB a report upon renewal that should cover the orders issued under this ICR and the associated fees and costs, in order to better estimate future burdens and associated costs of test data.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved	10/31/2021
Responses	788	0	36
Time Burden (Hours)	96,441	0	3,127
Cost Burden (Dollars)	15,681,705	0	9,010,065

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Abstract: Under TSCA section 4, EPA has the authority to promulgate rules, issue orders, and enter into consent agreements requiring manufacturers and processors to develop information on chemical substances and mixtures. The revisions to this ICR cover the information collection activities associated with the submission of information to EPA pursuant to TSCA section 4, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Under TSCA section 4, EPA has the authority to issue regulatory actions designed to gather or develop information related to human and environmental health, including hazard and exposure information, on chemical substances and mixtures. This information collection addresses the burden associated with industry activities involved in the reporting and recordkeeping pursuant to TSCA section 4.

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Authorizing Statute(s): US Code: 15 USC 2603 et seq. Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: US Code: 15 USC 2601 et seq. Name of Law: Toxic Substances Control Act

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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:
	85 FR 33151	06/01/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 60161	09/24/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Testing Costs (non-labor costs) for Test Rules
Study Plan, Enforceable Consent Agreements (ECAs)
Initial Response, Test Rules
Study Plan, Test Rules
Test Results, ECAs
CDX Registration for e-Reporting
Voluntary Robust Summaries for Test Rules, Test Orders, and Enforceable Consent Agreements (ECAs)
Test Results, Test Rules
Voluntary Initial Contact, Enforceable Consent Agreements (ECAs)
Voluntary 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	788	36	752	0	0	0
Annual Time Burden (Hours)	96,441	3,127	93,314	0	0	0
Annual Cost Burden (Dollars)	15,681,705	9,010,065	6,671,640	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: The modifications in this request would increase total respondent burden by 87,060 hours (29,020 hours annually) over the three-year period in which the generic ICR will be active. This increase reflects changes in the number of actions, CBI substantiation requirements, and methodological updates. However, there is a reduction in annual cost estimates due to a change in the assumed battery of tests that may be required for this three-year period under potential testing actions. The assumption is based on statutory changes under the Lautenberg Act, such as the mandated tiered testing approach. Further details about these changes are included in this ICR supporting statement.

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Annual Cost to Federal Government: $380,791

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? No

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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: 09/24/2020

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