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

Forms and Documents

Document Name	Status
ICR 0574.17_Emergency Request_EPA Determination_2018-06-07.pdf Supporting Statement A	2018-06-08
0574ss16.docx Supplementary Document	2018-06-08
TDD 9 21 OPPT MTS Section 5 Notices and Supports Secondary Support User Guide v1.0.pdf Supplementary Document	2015-07-16
TDD 9.21 OPPT MTS Section 5 Notices and Supports Secondary Agent_Consultant User Guide v.1.0.pdf Supplementary Document	2015-07-16
TDD 9.21 OPPT MTS Section 5 Notices and Supports Secondary Authorized Official User Guide v1.0.pdf Supplementary Document	2015-07-16
TDD 9.21 OPPT MTS Section 5 Notices and Supports Primary Support User Guide v1.0.pdf Supplementary Document	2015-07-16
TDD 9.21 OPPT CIS Section 5 Notices and Supports Primary Agent_Consultant User Guide v1.0.pdf Supplementary Document	2015-07-16
TDD 9.21 OPPT CIS Section 5 Notices and Supports Primary Authorized Official User Guide v1_12152014.pdf Supplementary Document	2015-07-16
TDD 9 21 OPPT CIS CDX CSPP Registration User Guide v3 0p.pdf Supplementary Document	2015-07-16

IC Document Collections

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

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 201806-2070-001
Status: Historical Active	Previous ICR Reference No: 201507-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.17
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Revision
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 06/11/2018
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/20/2018
	Date Received in OIRA: 06/08/2018
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	11/30/2018	6 Months From Approved	11/30/2018
Responses	2,854	0	2,854
Time Burden (Hours)	118,555	0	117,176
Cost Burden (Dollars)	0	0	0

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Abstract: Section 5 of the Toxic Substances Control Act (TSCA) requires manufacturers and importers of new chemical substances to submit to EPA a notice of intent to manufacture or import a new chemical substance 90 days before manufacture or import begins. (Formerly accomplished via paper documents, but now done electronically!) EPA reviews the information contained in the notice to evaluate the health and environmental effects of the new chemical substance. On the basis of the review, EPA may take further regulatory action under TSCA, if warranted. If EPA takes no action within 90 days, the submitter is free to manufacture or import the new chemical substance without restriction. TSCA section 5 also authorizes EPA to issue Significant New Use Rules (SNURs). EPA uses this authority to take follow-up action on new or existing chemicals that may present an unreasonable risk to human health or the environment if used in a manner that may result in different and/or higher exposures of a chemical to humans or the environment. Once a use is determined to be a significant new use, persons must submit a notice to EPA 90 days before beginning manufacture, processing or importation of a chemical substance for that use. Such a notice allows EPA to receive and review information on such a use and, if necessary, regulate the use before it occurs. Finally, TSCA section 5 also permits applications for exemption from section 5 review under certain circumstances. An applicant must provide information sufficient for EPA to make a determination that the circumstances in question qualify for an exemption. In granting an exemption, EPA may impose appropriate restrictions. This information collection addresses the reporting and recordkeeping requirements associated with TSCA section 5.

Emergency Justfication: EPA has determined that OMB's approval of this collection of information is needed prior to the expiration of the time periods established under the PRA. The issuance of this document and any associated collection of information is critical for the Agency to be able to make timely determinations on new chemical notifications as required under TSCA. The new requirements in TSCA related to new chemicals were effective immediately, and EPA continues to receive and review notices now. The regular process for ICRs under the PRA, which includes two comment periods with 60-day and 30-day timeframes, would disrupt the collection of information by preventing companies from accessing applicable and helpful EPA guidance with respect to PMNs and SNUNs submitted prior to OMB approval of the ICR and cause harm due to the ensuing delays in marketing new chemical substances because companies do not have access to the guidance. This would prolong the issues that submitters and EPA have experienced.

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Authorizing Statute(s): US Code: 15 USC 2605 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

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Pre-Manufacture Notifications	EPA Form 7710-25
PMN-Related Significant New Use Notices (SNUNs)	EPA Form 7710-25
Microbial Commercial Activity Notices (MCANs)	EPA Form Number 6300-07
Test-Marketing Exemptions (TMEs)	EPA Form 7710-25
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	EPA Form 7710-25
TSCA Experimental Release Applications (TERAs)	EPA Form 6300-7
Tier I/Tier II Exemptions	EPA Form 6300-7
Bona Fide Intent Notifications (Bona Fides)	EPA Form 7710-25
Test Data Submissions under Section 5(e) Consent Orders	EPA Form 7710-25
Non-Testing Activities under Section 5(e) Consent Orders	EPA Form 7710-25
Polymer Exemption Post-Manufacture Annual Reports	EPA Form 7710-25
Instant Photographic Film Articles Exemption	EPA Form 7710-25
Research and Development Exemption	EPA Form 7710-25
Notice of Commencement	EPA Form 7710-56
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	2,854	2,854	0	0	0	0
Annual Time Burden (Hours)	118,555	117,176	0	1,379	0	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: No

Burden Reduction Due to:

Short Statement: This increase in burden results from EPA's Agency issuance of a new information document entitled "Points to Consider When Preparing TSCA New Chemical Notifications"(PtC). The PtC document will assist submitters of new chemical notices, to speed Agency review, and to reduce time consuming interactions among stakeholders of submissions.

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Annual Cost to Federal Government: $6,394,457

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: 06/08/2018

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