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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 Generic ICR - OIRA Conclusion
OMB Control No:
2070-0033
ICR Reference No:
202008-2070-003
Status:
Historical Active
Previous ICR Reference No:
201712-2070-004
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
1139.12
Title:
Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirement (Revision)
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:
12/18/2020
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/24/2020
Terms of Clearance:
The agency is reminded to include the OMB control number and PRA burden statement for all generic ICs. In addition, the agency is required to provide OMB a report upon renewal that should cover the orders issued under this ICR and the associated fees and costs, in order to better estimate future burdens and associated costs of test data.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2023
36 Months From Approved
10/31/2021
Responses
788
0
36
Time Burden (Hours)
96,441
0
3,127
Cost Burden (Dollars)
15,681,705
0
9,010,065
Abstract:
Under TSCA section 4, EPA has the authority to promulgate rules, issue orders, and enter into consent agreements requiring manufacturers and processors to develop information on chemical substances and mixtures. The revisions to this ICR cover the information collection activities associated with the submission of information to EPA pursuant to TSCA section 4, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Under TSCA section 4, EPA has the authority to issue regulatory actions designed to gather or develop information related to human and environmental health, including hazard and exposure information, on chemical substances and mixtures. This information collection addresses the burden associated with industry activities involved in the reporting and recordkeeping pursuant to TSCA section 4.
Authorizing Statute(s):
US Code:
15 USC 2603 et seq.
Name of Law: Toxic Substances Control Act
Citations for New Statutory Requirements:
US Code: 15 USC 2601 et seq. Name of Law: Toxic Substances Control Act
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:
85 FR 33151
06/01/2020
30-day Notice:
Federal Register Citation:
Citation Date:
85 FR 60161
09/24/2020
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
10
IC Title
Form No.
Form Name
CDX Registration for e-Reporting
Initial Response, Test Rules
Study Plan, Enforceable Consent Agreements (ECAs)
Study Plan, Test Rules
Test Results, ECAs
Test Results, Test Rules
Testing Costs (non-labor costs) for Test Rules
Voluntary Data Submissions
Voluntary Initial Contact, Enforceable Consent Agreements (ECAs)
Voluntary Robust Summaries for Test Rules, Test Orders, and Enforceable Consent Agreements (ECAs)
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
788
36
752
0
0
0
Annual Time Burden (Hours)
96,441
3,127
93,314
0
0
0
Annual Cost Burden (Dollars)
15,681,705
9,010,065
6,671,640
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:
No
Burden Reduction Due to:
Short Statement:
The modifications in this request would increase total respondent burden by 87,060 hours (29,020 hours annually) over the three-year period in which the generic ICR will be active. This increase reflects changes in the number of actions, CBI substantiation requirements, and methodological updates. However, there is a reduction in annual cost estimates due to a change in the assumed battery of tests that may be required for this three-year period under potential testing actions. The assumption is based on statutory changes under the Lautenberg Act, such as the mandated tiered testing approach. Further details about these changes are included in this ICR supporting statement.
Annual Cost to Federal Government:
$380,791
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
Agency Contact:
Jonah Richmond 202 564-0210 richmond.jonah@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:
09/24/2020
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