In accordance with 5 CFR 1320, OMB is filing comment and withholding approval at this time.
The agency shall examine public comment in response to the proposed rulemaking and include
in the supporting statement of the next ICR--to be submitted to OMB at the final rule stage--a
description of how the agency has responded to any public comments on the ICR, including
comments on maximizing the practical utility of the collection and minimizing the burden.
Inventory as of this Action
Requested
Previously Approved
06/30/2027
36 Months From Approved
06/30/2027
3
0
3
166
0
166
0
0
0
This ICR is related to regulatory requirements that 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 amending 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 other non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations. EPA is reconsidering provisions of a 2024 amendment to the procedural framework rule for conducting such risk evaluations to determine whether they are consistent with the best reading of TSCA and whether they may impede the timely completion of risk evaluations and unnecessarily impair the effective and efficient protection of human health and the environment. Proposed revisions to the framework rule also include changes to the process by which a manufacture may request that EPA conduct a risk evaluation on a chemical for which they manufacture. This proposal would revise the criteria and information chemical manufacturers must provide for EPA to consider a chemical substance for risk evaluation, as well as the 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.
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:
(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;
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.
2781.03 risk_evaluation_rule_user_guide_-_primary_authorized_official_v2.0.pdf
2781ss03.docx
Submission Package