2024-10576. Agency Information Collection Activities; Proposed Renewal of Existing ICR Collections and Request for Comment; Toxic Substances Control Act (TSCA) Existing Chemical Risk Evaluation and Management; Generic ICRs for Interviews, Focus ...

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (PRA), this document announces the availability of and solicits public comment on the following two Information Collection Requests (ICRs) that EPA is planning to submit to the Office of Management and Budget (OMB): (A) “TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interview and Focus Groups” identified by EPA ICR No. 2584.02 and OMB Control No. 2070-0219, and (B) “TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Surveys” identified by EPA ICR No. 2585.02 and OMB Control No. 2070-0218. Both ICRs represent the renewal of ICRs that are currently approved through February 28, 2025. Before submitting the ICRs to OMB for review and approval under the PRA, EPA is soliciting comments on specific aspects of the information collection summarized in this document. The ICRs and accompanying material are available in the docket for public review and comment.

DATES:

Comments must be received on or before July 15, 2024.

ADDRESSES:

Submit your comments through https://www.regulations.gov using the docket identification (ID) number provided in Unit II. for the ICR that you are commenting on. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Katherine Sleasman, Mission Support Division (MC7602M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]-; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

II. What information collection activity or ICRs does this action apply to?

The following two ICRs are currently approved through February 28, 2025. Under the PRA, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., EPA must prioritize existing chemical substances for risk evaluation; conduct risk evaluations to determine whether chemical substances present unreasonable risk; and take appropriate regulatory action to manage the determined unreasonable risks. In accordance with TSCA section 26, EPA must make TSCA section 6 risk evaluation and 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 subpopulations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information. When available information is insufficient to inform the TSCA section 6 decisions, the collection of such information is necessary to ensure that necessary information is available in a timely manner for consideration by EPA, the Peer Reviewers, and the public. The purpose of these ICRs is to help EPA obtain information to inform the TSCA risk evaluations and risk management of existing chemicals under TSCA section 6. For more information about assessing and managing chemicals under TSCA go to https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca.

The ICRs in the docket provide a detailed explanation of the collection activities and estimates that are only summarized in this document.

A. Docket ID No. EPA-HQ-OPPT-2018-0611

Title: TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interview and Focus Groups.

EPA ICR No.: 2584.02.

OMB Control No.: 2070-0219.

Abstract: Under this generic ICR, EPA may 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 subpopulations) related to information collection for TSCA chemical risk evaluation and risk management. These information collection efforts are intended to supplement other reasonably available information on chemicals in commerce and will provide support for the Agency's 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 subpopulations, 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.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.5 hours per response for an interview and 2 hours per focus group. Burden is defined in 5 CFR 1320.3(b).

Respondents: Entities potentially affected by this ICR include chemical manufacturers (including importers), chemical users (including government agencies), processors, distributors, product manufacturers, recyclers, chemical waste handlers, consumers, employees, and others with important information about the chemical being evaluated or considered for risk management under TSCA.

Respondent obligation to respond: Voluntary.

Forms: None.

Frequency of response: On occasion.

Total estimated number of potential respondents: 850.

Total estimated average number of responses for each respondent: 1.

Total estimated annual burden hours: 950 hours.

Total estimated annual respondent costs: $ 27,743, which includes $ 0 for capital investment or maintenance and operational costs.

B. Docket ID No. EPA-HQ-OPPT-2018-0612

Title: TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Surveys.

EPA ICR No.: 2585.02.

OMB Control No.: 2070-0218.

Abstract: EPA will use this generic ICR to survey chemical users, processors, distributors, manufacturers (including importers), and recyclers, chemical waste handlers, consumers of chemical-containing products, employees exposed to the chemical evaluated (including unions), state and local regulators, non-governmental organizations, industry experts, and knowledgeable members of the public (including potentially exposed or susceptible subpopulations) who may have relevant information and are not covered by current information collection requests. The Agency will use the information collected to inform the development of any future regulatory efforts and to integrate consistent, meaningful, and transparent information into risk evaluation and risk management actions. This information is critical for adequately identifying conditions of use, conducting hazard and exposure assessments, characterizing risks, ascertaining benefits of and substitutes for each substance, estimating the economic consequences of regulation, and developing appropriate regulatory actions. Surveys are important information-gathering tools that will allow EPA to collect information that is necessary to inform the risk evaluation and management efforts and support unreasonable risk determinations from existing chemicals under TSCA.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 9.2 hours. Burden is defined in 5 CFR 1320.3(b).

Respondents: Include chemical manufacturers (including importers), chemical users (including government agencies), processors, distributors, product manufacturers, recyclers, chemical waste handlers, consumers, employees, and others with important information about the chemical being evaluated or considered for risk evaluation and management under TSCA.

Respondent obligation to respond: Voluntary.

Forms: None.

Frequency of response: On occasion.

Total estimated number of potential respondents: 2,400.

Total estimated average number of responses for each respondent: 1.

Total estimated annual burden hours: 7,360 hours.

Total estimated annual respondent costs: $ 653,362, which includes $ 0 for capital investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

There are no changes in burden or number of respondents when compared with that identified in the ICRs currently approved by OMB. However, there is an increase of $ 28 and $ 1,911 in the total estimated respondent costs due to undated wage rates. These changes qualify as adjustments.

IV. What is the next step in the process for this ICR?

EPA will consider the comments received and amend the ICRs as appropriate. The final ICR packages will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICRs to OMB and the opportunity to submit additional comments to OMB. If you have any questions about these ICRs or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

Authority:44 U.S.C. 3501 et seq.

Dated: May 8, 2024.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.