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

Forms and Documents

Document	Type	Status	Availability
Form 9600-07 Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping	Form and Instruction	New	Repair queued
Form 9600-07 Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping	Form and Instruction	Modified	Missing upstream
2517ss03.docx	Supporting Statement A	Uploaded 2020-08-26	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
242713	Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping	Form and Instruction	New
215865	Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping	Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0194	ICR Reference No: 202007-2070-003
Status: Received in OIRA	Previous ICR Reference No: 201701-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2517.03
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: 08/27/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2021
Responses	285	1,043
Time Burden (Hours)	40,090	146,855
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:
	85 FR 4982	01/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 52995	08/27/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
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
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

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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	285	1,043	0	0	-758	0
Annual Time Burden (Hours)	40,090	146,855	0	0	-106,765	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 annual burden from the previously approved ICR was146,855 hours. The total annual burden requested for this ICR is 40,089 hours, or a decrease of 106,766 hours from the previous total burden. The difference between the current burden request and the previously approved requests are due to adjustments in EPA’s estimates of the burden. Several adjustments to the estimates were made, including: • In the previous ICR period, the rule required an initial one-time reporting on current nanomaterials, while the reporting covered in this period only requires the reporting of new nanomaterials. Therefore, a large portion of the adjustment in estimates stems from the decrease in the number of submissions expected after the initial one-time reporting on current nanomaterials. • Burden estimates include a one-time burden that firms incur to become familiar with the rule and its various requirements. In the first year of the rule, the manufacturers that submitted reports incurred the one-time rule familiarization burden. EPA assumes that the same manufacturers will submit reports on new nanomaterials during subsequent years and do not need to familiarize themselves with the rule. Therefore, part of the decrease in burden estimates, relative to the previous ICR period that included the first year of the rule, is due to the same manufacturers submitting reports without incurring the rule familiarization burden.

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Annual Cost to Federal Government: $480,600

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: 08/27/2020

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