TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Renewal)

Forms and Documents

Document Name	Status
Form 7710-25 Existing Chemicals Activities Form and Instruction	Modified
Form 7710-56 Notice of Commencement Form and Instruction	Modified
Form 7710-25 Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing Form and Instruction	Modified
Form 7710-25 Bona Fide Intent Notifications (Bona Fides) Form and Instruction	Modified
Form 7710-25 Research and Development Exemption Form and Instruction	Modified
Form 7710-56 Polymer Exemption Post-Manufacture Annual Reports Form and Instruction	Modified
Form 6300-07 Tier II Exemptions Form and Instruction	Modified
Form 63007-07 Tier 1 Exemptions Form and Instruction	Modified
Form 6300-07 TSCA Experimental Release Applications (TERA) Form and Instruction	Modified
Form 7710-25 Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	Modified
Form 7710-25 Test Marketing Exemptions (TME) Form and Instruction	Modified
Form 6300-07 Microbial Commercial Activity Notices (MCAN) Form and Instruction	Modified
Form 7710-25 Significant New Use Notice (SNUN) Form and Instruction	Modified
Form 7710-25 Premanufacture Notice Form and Instruction	Modified
1188.16 Consultation_Responses.pdf Supplementary Document	2025-12-31
1188ss16.docx Supporting Statement A	2025-12-30

IC Document Collections

IC ID	Document Title	Status
273718	Existing Chemicals Activities Form and Instruction	Modified
254415	CDX Registration	Modified
254414	Notice of Commencement Form and Instruction	Modified
254413	Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing Form and Instruction	Modified
254412	Section 5(e) Orders with Triggered Testing	Modified
254409	Bona Fide Intent Notifications (Bona Fides) Form and Instruction	Modified
254408	Instant Photographic Film Articles	Modified
254407	Research and Development Exemption Form and Instruction	Modified
254406	Polymer Exemption Post-Manufacture Annual Reports Form and Instruction	Modified
254405	Tier II Exemptions Form and Instruction	Modified
254404	Tier 1 Exemptions Form and Instruction	Modified
254403	TSCA Experimental Release Applications (TERA) Form and Instruction	Modified
254402	Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	Modified
254399	Test Marketing Exemptions (TME) Form and Instruction	Modified
254398	Microbial Commercial Activity Notices (MCAN) Form and Instruction	Modified
254396	Significant New Use Notice (SNUN) Form and Instruction	Modified
254395	Premanufacture Notice Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0038	ICR Reference No: 202512-2070-004
Status: Received in OIRA	Previous ICR Reference No: 202501-2070-008
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1188.16
Title: TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/31/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	4,243	4,243
Time Burden (Hours)	129,367	129,367
Cost Burden (Dollars)	0	0

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Abstract: This information collection request addresses the reporting and recordkeeping requirements associated with both the new chemicals review and regulatory program and the existing chemicals program administered by EPA under section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) (15 U.S.C. 2604). EPA is requesting to renew and consolidating two existing approved Information Collection Requests (ICRs). This consolidated ICR will cover information collection activities associated with Significant New Use Rules (SNURs) for both new and existing chemicals under TSCA. The information for SNURs and required notifications includes chemical identity, use and exposure information, test information and descriptions of other information related to the effects on health and the environment of the manufacture, processing, use, distribution in commerce and disposal of the new or existing chemical substance. This ICR is required for the information to be collected under notices for Significant New Use Rules for new and existing chemicals.

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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:
	90 FR 19713	05/29/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 61147	12/30/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 17

IC Title	Form No.	Form Name
Bona Fide Intent Notifications (Bona Fides)	7710-25	PMN
CDX Registration
Existing Chemicals Activities	7710-25	PMN
Instant Photographic Film Articles
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	7710-25	PMN
Microbial Commercial Activity Notices (MCAN)	6300-07	BioTech
Notice of Commencement	7710-56	NOC
Polymer Exemption Post-Manufacture Annual Reports	7710-56	NOC
Premanufacture Notice	7710-25	PMN
Research and Development Exemption	7710-25	PMN
Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing	7710-25	PMN
Section 5(e) Orders with Triggered Testing
Significant New Use Notice (SNUN)	7710-25	PMN
TSCA Experimental Release Applications (TERA)	6300-07	Bio Tech
Test Marketing Exemptions (TME)	7710-25	PMN
Tier 1 Exemptions	63007-07	BioTech
Tier II Exemptions	6300-07	BioTech

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ICR Summary of Burden

	Total Request	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	4,243	4,243	0	0	0	0
Annual Time Burden (Hours)	129,367	129,367	0	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $26,697,996

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: 12/31/2025

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