Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Renewal)

Forms and Documents

Document Name	Status
Form EPA Form 7710-25 Pre-Manufacture Notifications Form and Instruction	Modified
Form EPA Form 7710-56 Notice of Commencement Form and Instruction	Modified
Form EPA Form 7710-25 Non-Testing Activities under Section 5(e)/5(f) Consent Orders Form and Instruction	Modified
Form EPA Form 6300-07 Tier I/Tier II Exemptions Form and Instruction	Modified
Form EPA Form 6300-07 TSCA Experimental Release Applications (TERAs) Form and Instruction	Modified
Form EPA Form 7710-25 Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	Modified
Form EPA Form 6300-07 Microbial Commercial Activity Notices (MCANs) Form and Instruction	Modified
Form EPA Form 7710-25 PMN-Related Significant New Use Notices (SNUNs) Form and Instruction	Modified
0574-18 Attachment P.docx Supplementary Document	2019-10-16
0574-18 Attachment O.pdf Supplementary Document	2019-10-16
0574.18_ss_AttachN_Consultation.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachM_CommentsResponse.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachL_Comment-ACC.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachK_Comment-Silvon.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachJ_PtC-Guide.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachH_instructionmanual.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachF_40CFR725.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachE_40CFR723.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachD_40CFR721.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachC_40CFR720.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachB_40CFR700.pdf Supplementary Document	2018-11-27
0574.18_ss_AttachA_15USC2604.pdf Supplementary Document	2018-11-27
0574-18_ss_2019-10-16.docx Supporting Statement A	2019-10-16

IC Document Collections

IC ID	Document Title	Status
24844	Pre-Manufacture Notifications Form and Instruction	Modified
217525	Rule Familiarization Instruction	Removed
217522	CDX Registration Instruction	Modified
183119	Notice of Commencement Form and Instruction	Modified
183118	Research and Development Exemption Instruction	Modified
183117	Instant Photographic Film Articles Exemption Instruction	Modified
183116	Polymer Exemption Post-Manufacture Annual Reports	Modified
183115	Non-Testing Activities under Section 5(e)/5(f) Consent Orders Form and Instruction	Modified
183114	Test Data Submissions under Section 5(e)/5(f) Consent Orders Instruction	Modified
183113	Bona Fide Intent Notifications (Bona Fides) Instruction	Modified
183112	Tier I/Tier II Exemptions Form and Instruction	Modified
183111	TSCA Experimental Release Applications (TERAs) Form and Instruction	Modified
183110	Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX) Form and Instruction	Modified
183109	Test-Marketing Exemptions (TMEs) Instruction	Modified
183108	Microbial Commercial Activity Notices (MCANs) Form and Instruction	Modified
183107	PMN-Related Significant New Use Notices (SNUNs) Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 201811-2070-005
Status: Active	Previous ICR Reference No: 201806-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.18
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Renewal)
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: 12/02/2019
	Date Received in OIRA: 11/27/2018
Terms of Clearance: Per 5 CFR 1320.5, the agency is reminded to display a valid OMB Control number. Per 5 CFR 1320.8, the agency is reminded to include a burden statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved	11/30/2019
Responses	4,541	0	2,854
Time Burden (Hours)	192,156	0	118,555
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR covers the information collection activities that implement the statutory mandates in section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016, 15 U.S.C. 2604, and the implementing regulations codified in 40 CFR parts 700, 720, 721, 723, and 725. Specifically, TSCA section 5 requires that any person who proposes to manufacture (which includes import) a new chemical substance (i.e., a chemical substance not listed on the TSCA section 8(b) Inventory) or a significant new use of a chemical substance (as identified by EPA rule) must provide a notice to EPA at least 90 days prior to commencing the manufacture of that chemical substance. EPA must review the notice, make an affirmative determination on the safety of the new chemical substance or significant new use, and, if appropriate, regulate the chemical substance to address any unreasonable risks identified before it can proceed to the marketplace. The submitter of a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN) is also required to inform EPA when non-exempt commercial manufacture of the substance in question actually begins by submitting a Notice of Commencement (NOC).

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Authorizing Statute(s): US Code: 15 USC 2601 et seq. Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: US Code: 15 USC 2604 Name of Law: Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016

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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:
	83 FR 35629	07/25/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 60845	11/27/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 15

IC Title	Form No.	Form Name
Pre-Manufacture Notifications	EPA Form 7710-25	Pre-manufacture Notification
PMN-Related Significant New Use Notices (SNUNs)	EPA Form 7710-25	Pre-manufacture Notification
Microbial Commercial Activity Notices (MCANs)	EPA Form 6300-07	EPA Biotech
Test-Marketing Exemptions (TMEs)	EPA Form 7710-25	Pre-manufacture Notification
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	EPA Form 7710-25	Pre-manufacture notification
TSCA Experimental Release Applications (TERAs)	EPA Form 6300-07	EPA Biotech Form
Tier I/Tier II Exemptions	EPA Form 6300-07	EPA Biotech Form
Bona Fide Intent Notifications (Bona Fides)	EPA Form 7710-25	Pre-manufacture notification
Test Data Submissions under Section 5(e)/5(f) Consent Orders	EPA Form 7710-25	Pre-manufacture notification
Non-Testing Activities under Section 5(e)/5(f) Consent Orders	EPA Form 7710-25	Pre-manufacture notification
Polymer Exemption Post-Manufacture Annual Reports
Instant Photographic Film Articles Exemption	EPA Form 7710-25	Pre-manufacture notification
Research and Development Exemption	EPA Form 7710-25	Pre-manufacture notification
Notice of Commencement	EPA Form 7710-56	Notice of Commencement of Manufacture or Import
CDX Registration
Rule Familiarization

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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	4,541	2,854	0	-336	2,023	0
Annual Time Burden (Hours)	192,156	118,555	27,388	-1,654	47,867	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This renewal reflects an increase in the total estimated respondent burden of 15,860 hours (from 118,555 hours to 134,415 hours) from that currently in the OMB inventory. This increase is driven by several changes. First, the mix of the estimated number of each type of notice changed, based on the most recent EPA data available. While the net effect of these changes was that the number of notices decreased by 440, increases in the types of notices with a high associated unit burden (such as Section 5(e)/5(f) Order Test and Non-Testing Section 5(e)/5(f) Order) led to a net increase in burden. Similarly, the estimated number of annual CDX registrants also increased (from 392 submissions to 2,855 submissions), reflecting the most recent EPA data available. This change results in increased burden of 1,626 hours. This ICR also integrates corrections to rounding errors and recordkeeping unit burden estimates for PMNs, SNUNs, LVEs, and LoREXs. This ICR removes 276 hours of rule familiarization attributed to the change request submitted for the 2015 amendment to the ePMN rule.

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Annual Cost to Federal Government: $28,287,555

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: 11/27/2018

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