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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
1139.48_Appendices_.docx	Supplementary Document	Uploaded 2023-12-28	Repair queued
1139ss48.docx	Supporting Statement A	Uploaded 2023-12-27	Repair queued
1139.48 Attachment-5_Overview_TSCA_TestOrders.pdf	Supplementary Document	Uploaded 2023-12-27	Repair queued
1139.48 Attachment-4_CDX.pdf	Supplementary Document	Uploaded 2023-12-27	Repair queued
1139.48 Attachment-3_FAQs.pdf	Supplementary Document	Uploaded 2023-12-27	Repair queued
1139ss12_Attachment 1 Toxic Substances Control Act (TSCA) Section 4rev.pdf	Supplementary Document	Uploaded 2020-09-04	Repair queued
1139ss12_Attachment 2 Procedures Governing Testing Consent Agreements and Test Rules, 40 CFR 790.pdf	Supplementary Document	Uploaded 2020-08-24	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
270354	6:2 FTAc (CASRN 17527-29-6) -Test Order		New
266047	NMeFOSE Test Order (CASRN 24448-09-7)		New

ICR Details

OMB Control No: 2070-0033	ICR Reference No: 202312-2070-002
Status: Active	Previous ICR Reference No: 202203-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1139.48
Title: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement (Renewal)
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: 03/15/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/28/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2027	36 Months From Approved	03/31/2024
Responses	1,208	0	1,208
Time Burden (Hours)	112,095	0	97,314
Cost Burden (Dollars)	144,000,000	0	90,000,000

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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: 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:
	86 FR 60460	11/02/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 89686	12/28/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
6:2 FTAc (CASRN 17527-29-6) -Test Order
NMeFOSE Test Order (CASRN 24448-09-7)

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ICR Summary of Burden

table that charts list 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	1,208	1,208	0	0	0	0
Annual Time Burden (Hours)	112,095	97,314	0	0	14,781	0
Annual Cost Burden (Dollars)	144,000,000	90,000,000	0	0	54,000,000	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 annual estimated labor burden associated with testing costs increased by 4,927 hours. The standard battery of tests for Section 4 actions has now been updated to reflect actual data based on tests prescribed from previously issued Test Order and based on response to public comments. Additionally, the ICR now explicitly lists the testing burden and labor costs for activities associated with contacting laboratories and arranging testing as well as sample collection. The estimated non-labor testing costs increased due to inflation and in response to public comments on burden estimates related to these activities. With the increase in testing costs as well as increases in labor and overhead costs over time, the costs to the industry respondents increased by $54,000,000. The estimated agency burden increased by $45,982 due to increases in labor and overhead costs. There is an increase of 4,927 burden hours in the total annual estimated respondent burden as shown in Table 21, which reflects the addition of the burden being merged into this ICR that is associated with activities associated with contacting laboratories and arranging testing as well as reviewing guidance documents and pre-issuance outreach for Test Orders.

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Annual Cost to Federal Government: $551,043

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: 12/28/2023

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