Procedures for Requesting a Chemical Risk Evaluation under TSCA (Proposed Rule)

Forms and Documents

Document Name	Status
2781ss01.docx Supporting Statement A	2023-12-05

IC Document Collections

IC ID	Document Title	Status
263807	Manufacturer request for Chemical Risk Evaluation	New

ICR Details

OMB Control No:	ICR Reference No: 202312-2070-001
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2781.01
Title: Procedures for Requesting a Chemical Risk Evaluation under TSCA (Proposed Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/05/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3	0
Time Burden (Hours)	166	0
Cost Burden (Dollars)	100,000	0

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Abstract: This ICR is related to a requirement contained in a proposed rule to implement provisions outlined in the Frank R. Lautenberg Chemical Safety of the 21st Century Act which passed in June 2016 and amended the Toxic Substances Control Act (TSCA). The Environmental Protection Agency (EPA) is proposing to amend the process for conducting risk evaluations under the TSCA to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the known, intended, or reasonably foreseen conditions of use, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations. EPA has reconsidered the procedural framework rule for conducting such risk evaluations and determined that certain aspects of that framework should be revised to align with applicable court decisions and the statutory text, to reflect the Agency’s experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of scientific advances in the risk evaluation process without need to further amend the Agency’s procedural rule. Revisions to this rule also includes changes to the process by which a manufacture may request that EPA conduct a risk evaluation on a chemical for which they manufacture. This proposed rule outlines the criteria and information chemical manufacturers must provide for EPA to consider a chemical substance for risk evaluation. Also included is Agency’s process and timing to review the request to determine whether to grant or deny. The information collection activities covered by this ICR are those carried out by a chemical manufacturer in requesting a specific chemical risk evaluation under TSCA be conducted by EPA.

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Authorizing Statute(s): US Code: 15 USC §2605(b)(4) 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-AK90	Proposed rulemaking	88 FR 74292	10/30/2023

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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
Manufacturer request for Chemical Risk Evaluation

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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	3	0	0	3	0	0
Annual Time Burden (Hours)	166	0	0	166	0	0
Annual Cost Burden (Dollars)	100,000	0	0	100,000	0	0

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 collection.

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Annual Cost to Federal Government: $540,259

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: 12/05/2023

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