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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form 7710-56 Notice of Commencement of Manufacture or Import	Form and Instruction	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Repair queued
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Modified	Available
Form EPA Form 6300-7 EPA Biotech Form	Form	Unchanged	Available
Form EPA Form 6300-7 EPA Biotech Form	Form	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
Form EPA Form Number 63 EPA Biotech Form	Form	Unchanged	Available
Form EPA Form 7710-25 Premanufacture Notice	Form and Instruction	Unchanged	Available
TDD 9 21 OPPT MTS Section 5 Notices and Supports Secondary Support User Guide v1.0.pdf	Supplementary Document	Uploaded 2015-07-16	Available
TDD 9.21 OPPT MTS Section 5 Notices and Supports Secondary Agent_Consultant User Guide v.1.0.pdf	Supplementary Document	Uploaded 2015-07-16	Available
TDD 9.21 OPPT MTS Section 5 Notices and Supports Secondary Authorized Official User Guide v1.0.pdf	Supplementary Document	Uploaded 2015-07-16	Available
TDD 9.21 OPPT MTS Section 5 Notices and Supports Primary Support User Guide v1.0.pdf	Supplementary Document	Uploaded 2015-07-16	Available
TDD 9.21 OPPT CIS Section 5 Notices and Supports Primary Agent_Consultant User Guide v1.0.pdf	Supplementary Document	Uploaded 2015-07-16	Available
TDD 9.21 OPPT CIS Section 5 Notices and Supports Primary Authorized Official User Guide v1_12152014.pdf	Supplementary Document	Uploaded 2015-07-16	Available
TDD 9 21 OPPT CIS CDX CSPP Registration User Guide v3 0p.pdf	Supplementary Document	Uploaded 2015-07-16	Available
0574ss16.docx	Supporting Statement A	Uploaded 2015-07-20	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 201507-2070-003
Status: Historical Active	Previous ICR Reference No: 201112-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 0574.16
Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Final Rule)
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: 11/03/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/20/2015
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved	12/31/2015
Responses	2,854	0	2,126
Time Burden (Hours)	117,176	0	117,163
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): US Code: 15 USC 2605 Name of Law: Toxic Substances Control Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AJ98	Final or interim final rulemaking	80 FR 42739	07/20/2015

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 42739	07/20/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 42739	07/20/2015
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

IC Title	Form No.	Form Name
Bona Fide Intent Notifications (Bona Fides)	EPA Form 7710-25	Premanufacture Notice
CDX Registration
Instant Photographic Film Articles Exemption	EPA Form 7710-25	Premanufacture Notice
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)	EPA Form 7710-25	Premanufacture Notice
Microbial Commercial Activity Notices (MCANs)	EPA Form Number 6300-07	EPA Biotech Form
Non-Testing Activities under Section 5(e) Consent Orders	EPA Form 7710-25	Premanufacture Notice
Notice of Commencement	EPA Form 7710-56	Notice of Commencement of Manufacture or Import
PMN-Related Significant New Use Notices (SNUNs)	EPA Form 7710-25	Premanufacture Notice
Polymer Exemption Post-Manufacture Annual Reports	EPA Form 7710-25	Premanufacture Notice
Pre-Manufacture Notifications	EPA Form 7710-25	Premanufacture Notice
Research and Development Exemption	EPA Form 7710-25	Premanufacture Notice
Rule Familiarization
TSCA Experimental Release Applications (TERAs)	EPA Form 6300-7	EPA Biotech Form
Test Data Submissions under Section 5(e) Consent Orders	EPA Form 7710-25	Premanufacture Notice
Test-Marketing Exemptions (TMEs)	EPA Form 7710-25	Premanufacture Notice
Tier I/Tier II Exemptions	EPA Form 6300-7	EPA Biotech Form

---

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	2,854	2,126	0	336	392	0
Annual Time Burden (Hours)	117,176	117,163	0	-246	259	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: Changing Regulations

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

Burden Reduction Due to: Using Information Technology

Short Statement: The burden changes analyzed in this ICR revision relate to both program changes and adjustments related to EPA's direct final rule. As explained in the supporting statement, a 258 hour burden adjustment increase is directly related to CDX registration activities that are already required under the e-PMN rule. The adjustment is related to the number of new and replacement employees of firms engaged in TSCA section 5 activities who need to register in CDX. In addition, EPA estimates a program change increase of 276 burden hours associated with respondents' familiarization with the requirements of the direct final rule, as well as a 522 burden hour program change reduction related to the electronic submission of bona fides as required by the direct final rule.

---

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

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

Common Form ICR:  No

---

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: 07/20/2015

---