View Information Collection Request (ICR) Package

OMB Control No: 2070-0219	ICR Reference No: 202502-2070-001
Status: Received in OIRA	Previous ICR Reference No: 202007-2070-002
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2584.03
Title: TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 02/04/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	850	850
Time Burden (Hours)	950	950
Cost Burden (Dollars)	0	0

Abstract: The Environmental Protection Agency (EPA or the Agency) intends to initiate a new voluntary information collection for chemical industry research involving focus groups, one-on-one interviews, and other structured discussions to provide more comprehensive and accurate information to inform the risk evaluation and risk management of existing chemicals as required under section 6 of the Toxic Substances Control Act (TSCA). In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), which updated TSCA, was signed into law. Under TSCA, EPA must prioritize chemical substances for risk evaluation; conduct risk evaluations to determine whether chemical substances present unreasonable risk; and manage any unreasonable risks found to be presented, all under strict statutory deadlines. Many of these chemicals may have multiple conditions of use that fall under EPAs authority under TSCA. Under TSCA, for each chemical substance evaluated, EPA must evaluate hazards and exposures. The purpose of this ICR is to help fill data gaps for EPAs risk evaluations and risk management of existing chemicals under section 6 of TSCA. In accordance with TSCA section 26, EPA must make TSCA section 6 risk evaluation and risk management decisions consistent with the best available science and based on the weight of the scientific evidence. To carry out its statutory obligations, EPA needs sufficient information about chemicals undergoing risk evaluation and risk management, including information related to the chemicals conditions of use, hazards, exposures, potentially exposed or susceptible sub-populations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information. The collection of such information is subject to TSCAs strict statutory time frames (set forth in section 6). Therefore, EPA is seeking approval for a generic information collection request (ICR) to conduct interviews and focus groups of chemical users, processors, distributors, manufacturers (including importers), and recyclers, chemical waste handlers, consumers of chemical-containing products, employees who may be exposed to the chemical evaluated, state and local regulators, non-governmental organizations, industry experts, and knowledgeable members of the public (including potentially exposed or susceptible sub-populations) related to information collection for TSCA chemical risk evaluation and risk management. As appropriate, under this ICR EPA would collect data in several ways, such as interviews and focus groups. This research would consist of open-ended structured discussions or interviews with individuals or small groups of individuals, and therefore can provide in-depth information. These information collection efforts are intended to supplement other reasonably available information on chemicals in commerce and will provide support for the Agencys policy and regulatory activities regarding existing chemicals under TSCA section 6. Data collected under this generic clearance may be used in several ways during the risk evaluation and risk management processes, including establishing generic scenarios, developing models of various conditions of use of chemicals evaluated under TSCA or their alternatives, pretesting survey questions, and providing important context for publicly available information already available to EPA. By learning more about the conditions of use, hazards, exposures, potentially exposed or susceptible sub-populations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information for chemicals being evaluated or regulated, EPA would be able to more precisely and effectively carry out its risk evaluation and risk management obligations under TSCA.

Authorizing Statute(s): US Code: 15 USC 2601 et seq. Name of Law: Toxic Substances Control Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 42467	05/15/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 4741	01/16/2025
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 0

ICR Summary of Burden

	Total Request	Previously Approved
Annual Number of Responses	850	850
Annual Time Burden (Hours)	950	950
Annual Cost Burden (Dollars)	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:

Annual Cost to Federal Government: $93,264

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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

Agency Contact: Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov

View Generic ICR - Agency Submission