Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (Supplementary Proposed Rule)

Forms and Documents

Document Name	Status
Form 9600-05 Form A Submissions Form and Instruction	Modified
2594ss02.docx Supporting Statement A	2019-11-08

IC Document Collections

IC ID	Document Title	Status
235747	Form A Submissions Form and Instruction	Modified

ICR Details

OMB Control No: 2070-0210	ICR Reference No: 201911-2070-003
Status: Historical Inactive	Previous ICR Reference No: 201904-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2594.02
Title: Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (Supplementary Proposed 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: Comment filed on proposed rule	Conclusion Date: 12/16/2019
	Date Received in OIRA: 11/08/2019
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	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 (“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. 82 FR 37520 (8/11/17). Included in the Active-Inactive Rule were provisions for the submission of confidential business information (CBI). Submitters were required to substantiate all CBI claims made in that data collection, except for chemical substance identity. If the chemical was reported pursuant a retrospective reporting requirement, submitters had an option to voluntarily substantiate the CBI claim; if the chemical was reported pursuant a prospective reporting requirement, the submitters had to substantiate the CBI claim at the time of filing. EPA is now supplementing and revising certain aspects of that proposal in response to a recent federal court decision remanding the Active-Inactive Rule, which implicates changes to requirements for Form A under the proposed Review Plan Rule and changes to requirements for Form B under the Active-Inactive Rule. EPA is addressing substantiation requirements pertaining to reverse engineering. The SNPRM proposes two additional questions that manufacturers and processors would be required to answer to substantiate CBI claims for specific chemical identifies asserted in an NOA Form A and an NOA Form B and proposes procedures for supplementing previously-submitted substantiations with responses to those questions.

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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: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK21	Proposed rulemaking	84 FR 60363	11/08/2019

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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
Form A Submissions	9600-05	Form A

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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. Specific to this SNRPM, EPA is addressing substantiation requirements pertaining to reverse engineering in response to a recent court ruling remanding the Active-Inactive Rule by adding two additional substantiation questions. As such, the change being implemented in this ICR period is the addition of new burden and cost for activities associated with the two new questions, as presented in Table 2. The total burden to industry for this ICR period is 1,123 hours, all occurring during a 90-day reporting period after the rule is enacted.

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Annual Cost to Federal Government: $0

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? Uncollected

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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: 11/08/2019

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