View Information Collection Request (ICR) Package
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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 ICR - OIRA Conclusion
OMB Control No:
2070-0224
ICR Reference No:
202208-2070-001
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
2703.01
Title:
Section 8 of the Toxic Substances Control Act (New)
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/23/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/30/2022
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is approved for three years. The agency is reminded to include the OMB control number, expiration date, and PRA burden statement on all documents associated with this collection.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2025
36 Months From Approved
Responses
141,784
0
0
Time Burden (Hours)
59,855
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This consolidated ICR involves reporting and recordkeeping activities established under TSCA section 8 for chemical substances. Although imposed for a specific chemical substance, the activities are already established and only vary based on the specific authority under TSCA section 8 and the need for the information for that chemical. EPA is consolidating ICRs currently approved under control numbers 2070-0004, 2070-0017, and 2070-0054, and formerly approved under 2070-0067 to streamline the presentation of the paperwork burden estimates for these various activities, which will in turn facilitate and reduce the administrative burden for both the public reviewers and the Agency in terms of reviewing and updating the ICR every three (3) years as required by the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., as well as allow for a better assessment of the paperwork burden and costs associated with reporting and recordkeeping activities established under TSCA section 8 for specific chemical substances. This information collection request (ICR) covers reporting and recordkeeping requirements imposed under the authorities in section 8 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607, for persons who manufacture (the term manufacture includes import under TSCA) or process chemical substances, mixtures, or categories, or distribute them in commerce. The purpose of the information collection activities is to collect data that will help the Agency evaluate the potential for human health and environmental risks that may be caused by the manufacture, processing, and distribution in commerce of chemical substances, mixtures, or categories. This ICR addresses the following four (4) types of information collections (ICs) required by TSCA section 8 and identifies the persons required to keep records and report such information. The ICs are numbered to facilitate the presentation in the ICR and link to supporting information; and the numbering is not otherwise intended to convey any sequencing or prioritization.
Authorizing Statute(s):
US Code:
15 USC 2707
Name of Law: Toxic Substances Control Act
Citations for New Statutory Requirements:
None
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:
87 FR 12954
03/08/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 52967
08/30/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Allegations of Significant Adverse Reactions to Human Health or the Environment TSCA section 8(c)
Chemical Specific Rules TSCA section 8(a)
Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies TSCA section 8(d)
TSCA 8a Preliminary Assessment Information Rule (PAIR)
7710-35, 7710-51
Manufacturer's Report - Preliminary Assessment Info
,
Dioxin/Furan Report Form and Instructions
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
141,784
0
0
26,375
115,409
0
Annual Time Burden (Hours)
59,855
0
0
26,148
33,707
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 information collection combines the burdens from four previously approved ICRs. The total burden hours requested for this ICR is 59,855 and the total estimated cost is $5,462,257. There was an increase in the estimated number of responses for Section 8(d) Health and Safety Studies and Chemical Specific Section 8(a) because of the reinstatement of the 8(a) ICR, and increased number of potential Section 8(d) submissions. The increase for these two information collections is 50 responses, 7 for Section 8(d) Health and Safety Studies and 43 Chemical Specific Section 8(a) respectively, from the two previously approved ICRs. The total combined cost burden from the Section 8(d) Health and Safety Studies and the Chemical Specific Section 8(a) currently approved ICRs is $68,875 ($41,607 + $24,268). There were also errors in the previous calculations for the ICR covering Section 8(c) (OMB Control Number 2070-0067) which, when corrected, have resulted in increased costs and burden hours for this component of the new, consolidated ICR. Once this ICR is approved, it will replace the existing ICRs, resulting in an increase in the estimated total cost burden by $631,144 [$5,462,257 – $4,831,113]. The difference between the current cost burden request and the previously approved requests are due to adjustments in EPA’s estimates of the number of respondents and of the burden. In addition to the adjustments listed above, the wage rates and material costs were revised to reflect 2021 dollars for this information collection request.
Annual Cost to Federal Government:
$425,013
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:
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:
08/30/2022
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