Section 8 of the Toxic Substances Control Act (New)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 7710-51 Dioxin/Furan Report Form and Instructions	Form and Instruction	New	Available
Form 7710-35 Manufacturer's Report - Preliminary Assessment Info	Form and Instruction	New	Available
2703ss01.docx	Supporting Statement A	Uploaded 2022-08-30	Repair queued
2703.01 Attachhment 14_Wagerates.pdf	Supplementary Document	Uploaded 2022-08-03	Repair queued
2703.01 Attachment 13_Consultation.pdf	Supplementary Document	Uploaded 2022-08-03	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
255057	Chemical Specific Rules TSCA section 8(a)		New
255049	Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies TSCA section 8(d)	Instruction	New
255045	TSCA 8a Preliminary Assessment Information Rule (PAIR)	Form and Instruction	New	Dioxin/Furan Report Form and Instructions
255045	TSCA 8a Preliminary Assessment Information Rule (PAIR)	Form and Instruction	New	Manufacturer's Report - Preliminary Assessment Info
255045	TSCA 8a Preliminary Assessment Information Rule (PAIR)	Instruction	New
255041	Allegations of Significant Adverse Reactions to Human Health or the Environment TSCA section 8(c)		New

ICR Details

OMB Control No: 2070-0224	ICR Reference No: 202208-2070-001
Status: Historical 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.

table that charts list comparision

	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

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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.

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Authorizing Statute(s): US Code: 15 USC 2707 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
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

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

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

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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	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.

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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

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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: 08/30/2022

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