Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials (Renewal)

Forms and Documents

Document Name	Status
Form 7710-25 Form Completion, CBI Substantiation, Form Submission, Recordkeeping, and Rule Familiarization (Manufacturers & Processors) Form and Instruction	New
Form 9600-07 Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping Form and Instruction	Removed
Form 9600-07 Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping Form and Instruction	Removed
2517.04 Attachment D_Consultant Responses.pdf Supplementary Document	2024-09-30
2517.04 Attachment C_Consultation.pdf Supplementary Document	2024-09-30
2517ss04.docx Supporting Statement A	2024-09-30

IC Document Collections

IC ID	Document Title	Status
271290	Form Completion, CBI Substantiation, Form Submission, Recordkeeping, and Rule Familiarization (Manufacturers & Processors) Form and Instruction	New
242713	Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping Form and Instruction	Removed
215865	Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping Form and Instruction	Removed

ICR Details

OMB Control No: 2070-0194	ICR Reference No: 202409-2070-002
Status: Received in OIRA	Previous ICR Reference No: 202007-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2517.04
Title: Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2024
Responses	9	285
Time Burden (Hours)	959	40,090
Cost Burden (Dollars)	0	0

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Abstract: This information collection request (ICR) covers reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials. Under the Toxic Substances Control Act (TSCA) section 8(a), EPA requires reporting and recordkeeping for certain chemical substances as nanoscale materials. EPA requires that persons who manufacture or process these nanoscale materials notify EPA of certain information which includes production volume, methods of manufacture and processing, exposure and release information, and available health and safety information. The reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment. The information will also inform EPA’s assessments of new chemical nanoscale materials submitted to EPA under TSCA section 5.

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Authorizing Statute(s): US Code: 15 USC 2607(a) Name of Law: Toxic Substances Control Act (TSCA)
  

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:
	89 FR 6520	02/01/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 79583	09/30/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Form Completion, CBI Substantiation, Form Submission, Recordkeeping, and Rule Familiarization (Manufacturers & Processors)	9600-07, 7710-25	PMN Form ,   Nano Form
Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping	9600-07	TSCA §8(a) Reporting for Chemical Substances when Manufactured or Processed as Nanoscale Materials: Data Submission Form
Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping	9600-07	TSCA §8(a) Reporting for Chemical Substances when Manufactured or Processed as Nanoscale Materials: Data Submission Form

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ICR Summary of Burden

	Total Request	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	9	285	0	0	-276	0
Annual Time Burden (Hours)	959	40,090	0	0	-39,131	0
Annual Cost Burden (Dollars)	0	0	0	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 difference between the current cost and burden estimates and the previous ICR estimates are due to adjustments in EPAs estimation methodology of the costs and burden. Two key adjustments were made to the estimation methodology. In the previous ICR period, the burden estimates were based on expected submissions, not on actual submissions received by the agency, while the reporting covered in this period is based on actual submissions received by the agency. This significant change accounts for almost all the decrease in burden and cost estimates. In the previous ICR period, the burden was estimated separately for manufactures and processors, while the reporting covered in this period calculates a weighted burden for any given respondent without separating the manufacturers from the processors. This approach was deemed reasonable given that the agency received only 27 submissions related to TSCA 8(a) nanomaterials in the current three-year ICR period, which accounts for the decrease in number or responses.

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Annual Cost to Federal Government: $23,956

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: 09/30/2024

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