View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0012
ICR Reference No:
201811-2070-005
Status:
Historical 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
Retrieve Notice of Action (NOA)
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
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).
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
15
IC Title
Form No.
Form Name
Bona Fide Intent Notifications (Bona Fides)
EPA Form 7710-25
Pre-manufacture notification
CDX Registration
Instant Photographic Film Articles Exemption
EPA Form 7710-25
Pre-manufacture notification
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)
EPA Form 7710-25
Pre-manufacture notification
Microbial Commercial Activity Notices (MCANs)
EPA Form 6300-07
EPA Biotech
Non-Testing Activities under Section 5(e)/5(f) Consent Orders
EPA Form 7710-25
Pre-manufacture notification
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
Pre-manufacture Notification
Polymer Exemption Post-Manufacture Annual Reports
Pre-Manufacture Notifications
EPA Form 7710-25
Pre-manufacture Notification
Research and Development Exemption
EPA Form 7710-25
Pre-manufacture notification
Rule Familiarization
TSCA Experimental Release Applications (TERAs)
EPA Form 6300-07
EPA Biotech Form
Test Data Submissions under Section 5(e)/5(f) Consent Orders
EPA Form 7710-25
Pre-manufacture notification
Test-Marketing Exemptions (TMEs)
EPA Form 7710-25
Pre-manufacture Notification
Tier I/Tier II Exemptions
EPA Form 6300-07
EPA Biotech Form
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.
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
Agency Contact:
Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov
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:
11/27/2018
Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.