Procedures for Requesting a Chemical Risk Evaluation under TSCA (Proposed Rule)
New collection (Request for a new OMB Control Number)
No
Regular
12/05/2023
Requested
Previously Approved
36 Months From Approved
3
0
166
0
100,000
0
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 Agencyâs 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 Agencyâs 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 Agencyâs 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.
2781ss01.docx
Manufacturer request for Chemical Risk Evaluation