Final Rule; Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (Notice of Activity Form As) (Final Rule)

Forms and Documents

Document	Type	Status	Availability
Form NOA Form A Substantiation of TSCA CBI claims for Specific Chemical Identities	Form	Modified	Available
2594ss03.docx	Supporting Statement A	Uploaded 2020-03-06	Repair queued
2594.03_ICR_SS_Attachment-E (Sample Form B).docx	Supplementary Document	Uploaded 2020-02-28	Repair queued
2594.03_ICR_SS_Attachment-D (Active-Inactive ICR).docx	Supplementary Document	Uploaded 2020-02-28	Repair queued
2594.03_ICR_SS_Attachment-C (Sample Form A).docx	Supplementary Document	Uploaded 2020-02-28	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
235747	Substantiation of TSCA CBI claims for Specific Chemical Identities	Form	Modified

ICR Details

OMB Control No: 2070-0210	ICR Reference No: 202002-2070-002
Status: Active	Previous ICR Reference No: 201904-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2594.03
Title: Final Rule; Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (Notice of Activity Form As) (Final Rule)
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: 12/03/2020
	Date Received in OIRA: 03/06/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved
Responses	92	0	0
Time Burden (Hours)	1,736	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, required EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either “active” or “inactive” in U.S. commerce. To accomplish that, EPA finalized a rule, the TSCA Inventory Notification (Active-Inactive) Requirements Rule (“2017 Active-Inactive Rule”), requiring industry reporting of chemicals manufactured (including imported) or processed in the U.S. over the past 10 years, ending on June 21, 2016. This retrospective reporting was used to identify which chemical substances on the TSCA Inventory are active in U.S. commerce and will help inform the prioritization of chemicals for risk evaluation. The retrospective reporting period for manufacturers (includes importers) ended on February 7, 2018, and the retrospective reporting period for processors ended on October 5, 2018. 82 FR 37520 (8/11/17) https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0426-0070. Included in the 2017 Active-Inactive Rule were provisions for the submission of confidential business information (CBI) and requests to maintain existing CBI claims for the specific chemical identities of chemical substances. Submitters were required to substantiate all CBI claims made in that collection except for specific chemical identity CBI claims asserted during retrospective reporting—which they had an option to voluntarily substantiate at the time of filing their report. This regulatory action, the Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (RIN 2070-AK21), is a companion rule to the 2017 Active-Inactive Rule. TSCA section 8(b)(4)(C) requires that “[n]ot later than 1 year after the date on which the Administrator compiles the initial list of active substances [pursuant to the 2017 Active-Inactive Rule], the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the list” that were asserted during retrospective reporting under the 2017 Active-Inactive Rule. The statute at section 8(b)(4)(D) prescribes the requirements of the plan. TSCA section 8(b)(4)(E) provides the timeframe for the reviews of CBI claims for specific chemical identities, extension possibilities and process, and requirements for providing updates on the Agency’s progress. The data elements covered under the rule are chemical substance identities claimed as CBI in commercial activity notices, or Notices of Activity (NOAs), submitted as part of the 2017 Active-Inactive Rule collection. In many instances the CBI claims for specific chemical identities were voluntarily substantiated through the 2017 Active-Inactive Rule collection. This ICR covers the burden for those who submitted NOAs Form A (retrospective commercial activity notice) and requested to maintain an existing CBI claim for a specific chemical identity for the 2017 Active-Inactive Rule. Additional burden from this regulatory action that is related to NOAs Form B submissions (forward-looking commercial activity notices), which occur on an annual ongoing basis, are addressed in a separate ICR for the 2017 Active-Inactive Rule.

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

Citations for New Statutory Requirements: US Code: 15 USC 2607 Name of Law: TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK21	Final or interim final rulemaking	85 FR 13062	03/06/2020

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Substantiation of TSCA CBI claims for Specific Chemical Identities	NOA Form A	NOA Form A

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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	92	0	92	0	0	0
Annual Time Burden (Hours)	1,736	0	1,736	0	0	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: This is a new data collection activity resulting from the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires additional responsibilities of EPA in maintaining the TSCA Inventory and imposes reporting requirements on regulated entities wishing to maintain claims of confidentiality for chemical substance identity. As such, the change being implemented in this ICR period is the addition of new burden and cost for these activities.

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Annual Cost to Federal Government: $771,626

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: 03/06/2020

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