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

Forms and Documents

Document Name	Status
Form 7710-25 Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing Form and Instruction	New
Form 7710-25 Section 5(e) Orders with Triggered Testing Form and Instruction	New
Form 7710-25 Research and Development Exemption Form and Instruction	New
Form 7710-56 Polymer Exemption Post-Manufacture Annual Reports Form and Instruction	New
Form 6300-07 Tier II Exemptions Form and Instruction	New
Form 7710-25 Test Marketing Exemptions (TME) Form and Instruction	New
Form 7710-25 Premanufacture Notice Form and Instruction	New
1188ss13.docx Supporting Statement A	2022-06-30
1188.13_Attachment 11_PublicComment_ACC.pdf Supplementary Document	2022-06-28
1188.13_Attachment 10_Consultation.pdf Supplementary Document	2022-06-28
1188.13-Attachment 9_WageRates.pdf Supplementary Document	2022-06-28
1188.13_Attachment 8_NOC Form 7710-56.pdf Supplementary Document	2022-06-28
1188.13-Attachment7_BioTechForm 6300-07.pdf Supplementary Document	2022-06-28
1188.13-Attachment 6_PMNForm 7710-25.pdf Supplementary Document	2022-06-28

IC Document Collections

IC ID	Document Title	Status
254415	CDX Registration	New
254414	Notice of Commencement	New
254413	Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing Form and Instruction	New
254412	Section 5(e) Orders with Triggered Testing Form and Instruction	New
254409	Bona Fide Intent Notifications (Bona Fides)	New
254408	Instant Photographic Film Articles	New
254407	Research and Development Exemption Form and Instruction	New
254406	Polymer Exemption Post-Manufacture Annual Reports Form and Instruction	New
254405	Tier II Exemptions Form and Instruction	New
254404	Tier 1 Exemptions	New
254403	TSCA Experimental Release Applications (TERA)	New
254402	Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	New
254399	Test Marketing Exemptions (TME) Form and Instruction	New
254398	Microbial Commercial Activity Notices (MCAN)	New
254396	Significant New Use Notice (SNUN)	New
254395	Premanufacture Notice Form and Instruction	New
24882	Chemical Verification Instruction	Removed
204560	Rule Familiarization	Removed
192549	CDX Registration, electronic signature & Pay.gov setup Instruction	Removed
188156	Customer Notification Instruction	Removed
188155	Submitting SNUNs Instruction	Removed

ICR Details

OMB Control No: 2070-0038	ICR Reference No: 202206-2070-002
Status: Received in OIRA	Previous ICR Reference No: 201607-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 1188.13
Title: TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/30/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2022
Responses	4,286	14
Time Burden (Hours)	136,292	137
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 consolidate two currently 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, and the premanufacture review program for new chemicals. The consolidated ICR will cover ongoing activities necessary to fulfill statutory mandates in TSCA section 5 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:
	86 FR 73277	12/27/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 38745	06/29/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 16

IC Title	Form No.	Form Name
Bona Fide Intent Notifications (Bona Fides)
CDX Registration
CDX Registration, electronic signature & Pay.gov setup
Chemical Verification
Customer Notification
Instant Photographic Film Articles
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)
Microbial Commercial Activity Notices (MCAN)
Notice of Commencement
Polymer Exemption Post-Manufacture Annual Reports	7710-56	NOC Form
Premanufacture Notice	7710-25	PMN Form
Research and Development Exemption	7710-25	PMN Form
Rule Familiarization
Section 5(e) Orders with Pended Testing/ 5(f) Orders with No Testing	7710-25	PMN Form
Section 5(e) Orders with Triggered Testing	7710-25	PMN Form
Significant New Use Notice (SNUN)
Submitting SNUNs
TSCA Experimental Release Applications (TERA)
Test Marketing Exemptions (TME)	7710-25	PMN Form
Tier 1 Exemptions
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	4,286	14	0	-14	4,286	0
Annual Time Burden (Hours)	136,292	137	0	-137	136,292	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This information collection combines the burdens from two previously approved ICRs, EPA ICR No.1188.12 and EPA ICR No. 0574.18. The total combined burden from these two previously approved ICRs was [192,156 + 137 = 192,293 hours]. The total burden requested for this ICR is [136,292 hours], or a decrease of [56,001hours] from the previous total burden. The difference between the current burden request and the previously approved requests is primarily due to the declining number of section 5 submissions for new chemicals. Additionally, minor adjustments were made in EPA’s estimates of the number of respondents and of the burden. The total combined cost burden from these two currently approved ICRs is $54,542,968 [$26,752+$54,516,216], and the total cost burden requested for this ICR is [$37,354,814]. Once this ICR is approved, it will replace the existing ICRs, resulting in decrease in the estimated total cost burden of $17,188,154 [$54,542,968 - $37,354,814]. The difference between the current cost burden request and the previously approved requests are due to the consolidation of the individual ICRs when calculating the burden, as well as adjustments in EPA’s estimates of the number of respondents and of the burden. In addition to the adjustments listed above, the wage rates and material costs were revised to reflect 2020 dollars for this information collection request.

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Annual Cost to Federal Government: $26,959,416

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: 06/30/2022

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