2019-16616. Agency Information Collection Activities; Proposed New Collections; Comment Request; TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups (EPA ICR No. 2584.01) and Generic ICR for Surveys (...

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit two Information Collection Requests (ICRs) to the Office of Management and Budget (OMB). The first ICR is entitled: “TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interview and Focus Groups” and is identified by EPA ICR No. 2584.01 and OMB Control No. 2070-[NEW]. The second ICR is entitled: “TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Surveys” and is identified by EPA ICR No. 2585.01 and OMB Control No. 2070-[NEW]. Both ICRs are new requests. Before submitting these ICRs to OMB for review and approval, EPA is soliciting comments on specific aspects of the information collection activities that are summarized in this document. The ICRs and accompanying material are available for public review and comment in the relevant dockets identified in this document for the ICRs.

DATES:

Comments must be received on or before October 4, 2019.

ADDRESSES:

Submit your comments, identified by the docket identification (ID) number for the corresponding ICR as identified in this document, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line 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.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Albert Monroe, Economic and Policy Analysis Branch, Chemistry, Economics, and Sustainable Strategies Division, (MC7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave. Rochester, NY 14620; 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 activities does this action apply to?

EPA intends to initiate two new collection activities to provide more comprehensive and accurate information to inform the evaluation and risk management of existing chemicals as required under section 6 of the Toxic Substances Control Act (TSCA), which was amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, 15 U.S.C. 2601 et seq. EPA must prioritize, evaluate, and/or determine risks for at least 20 chemicals at a time, and manage any unreasonable risks, all under strict statutory deadlines. For each chemical evaluated, EPA must evaluate hazards and exposures for each condition of use and manage through regulations all risks that it has determined to be unreasonable. The Supporting Statement for each ICR, a copy of which is available in the corresponding docket, provides a more detailed explanation.

A. Docket ID Number EPA-HQ-OPPT-2018-0611

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

ICR number: EPA ICR No. 2584.01.

OMB control number: OMB Control No. 2070-[NEW].

ICR status: This ICR is for a new information collection activity. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to PRA approval unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the preamble of the final rule, are further displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instruments or form, if applicable.

Abstract: The purpose of this ICR is to help provide data for EPA's risk evaluations and risk management of existing chemicals under TSCA section 6 more efficiently and effectively. EPA must gather information with sufficient detail about chemicals, including hazards, conditions of use, exposures, potentially exposed and susceptible subpopulations, alternatives, and regulatory options in a timely fashion to meet TSCA's strict statutory timeframes as set forth in TSCA section 6. Therefore, EPA is proposing a generic ICR to conduct interviews and focus groups of chemical users, processors, distributors, manufacturers (including importers), recyclers, chemical waste handlers, consumers, employees, state regulators, non-governmental organizations, and industry experts related to information collection for TSCA chemical risk evaluation and management. This generic ICR is intended to supplement currently reasonably available information on chemicals in commerce and provide support for the Agency's evaluation and regulatory activities regarding existing chemicals.

As appropriate, EPA would collect data in several ways, such as interviews and focus groups. 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. 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. By learning more about the conditions of use, exposures, and alternatives to chemicals being evaluated or regulated, EPA would be able to more efficiently and effectively carry out its mandate under TSCA to protect human health and the environment from unreasonable risks.

EPA would not collect information of a sensitive or private nature. However, respondents may claim information provided in an interview or focus group as CBI under TSCA section 14. Please refer to TSCA section 14(b) to understand what information is not protected from disclosure. For example, TSCA section 14(a) does not prohibit the disclosure of information from health and safety studies that are submitted under TSCA. Information on the requirements for asserting CBI claims under TSCA can be found at https://www.epa.gov/​tsca-cbi/​making-cbi-claims-tsca-submissions. EPA would disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures of TSCA section 14, which provides advance notice and an opportunity to object prior to public disclosure.

Burden statement: The annual public reporting burden for this collection of information is estimated to average 0.99 hours per response. There are no recordkeeping burdens. Burden is defined in 5 CFR 1320.3(b). The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:

Respondents/Affected entities: Entities potentially affected by this ICR include chemical manufacturers (as long as the information requested does not duplicate information already in possession of the federal government), 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. As such, there are no typical respondent NAICS codes and the respondents will vary depending on the conditions of use of each chemical under consideration.

Estimated total number of potential respondents: 714.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: 1.

Estimated total annual burden hours: 237 hours.

Estimated total annual costs: $18,296. This includes an estimated burden cost of $18,296 and an estimated cost of $0 for capital investment or maintenance and operational costs.

B. Docket ID Number EPA-HQ-OPPT-2018-0612

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

ICR number: EPA ICR No. 2585.01.

OMB control number: OMB Control No. 2070-[NEW].

ICR status: This ICR is for a new information collection activity. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to PRA approval unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations in title 40 of the CFR, after appearing in the preamble of the final rule, are further displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instruments or form, if applicable.

Abstract: The purpose of this ICR is to help collect data for EPA's risk evaluations and risk management of existing chemicals under TSCA section 6. EPA must gather information with sufficient detail about chemicals' conditions of use, exposures, potentially exposed or susceptible subpopulations, alternatives, and regulatory options in a timely fashion in order to meet TSCA's strict statutory timeframes as set forth in TSCA section 6. Therefore, EPA is proposing a generic ICR to conduct surveys of chemical users, processors, distributors, manufacturers (including importers), recyclers, chemical waste handlers, consumers, employees, state regulators, non-governmental organizations, and industry experts related to information collection for TSCA chemical risk evaluation and management. Surveys are defined as the collection of information from a common group through interviews or the application of questionnaires to a representative sample of that group.

These information collection efforts are intended to supplement currently reasonably available information on chemicals in commerce and would provide support for the Agency's evaluation and regulatory activities regarding existing chemicals. By learning more about the conditions of use, exposures, potentially exposed and susceptible subpopulations, alternatives, and regulatory options for chemicals being evaluated or regulated, EPA would be able to more efficiently and effectively carry out its mandate under TSCA to protect human health and the environment from unreasonable risks.

EPA would not collect information of a sensitive or private nature. However, respondents may claim information provided in an interview or focus group as CBI under TSCA section 14. Please refer to TSCA section 14(b) to understand what information is not protected from disclosure. For example, TSCA section 14(a) does not prohibit the disclosure of information from health and safety studies that are submitted under TSCA. Information on the requirements for asserting CBI claims under TSCA can be found at https://www.epa.gov/​tsca-cbi/​making-cbi-claims-tsca-submissions. EPA would disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures of TSCA section 14, which provides advance notice and an opportunity to object prior to public disclosure.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2 hours per response. Burden is defined in 5 CFR 1320.3(b). The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:

Respondents/Affected entities: Potential respondents include chemical manufacturers, chemical users, processors, distributors, manufacturers (including importers), recyclers, chemical waste handlers, consumers, employees, state regulators, non-governmental organizations, and industry experts about the chemical being evaluated or considered for risk management under TSCA. As such, there are no typical respondent NAICS codes and the respondents will vary depending on the conditions of use of each chemical under consideration.

Estimated total number of potential respondents: 600.

Frequency of response: On occasion, as necessary to support risk evaluation and management of existing chemicals.

Estimated total average number of responses for each respondent: One.

Estimated total annual burden hours: 400 hours.

Estimated total annual costs: $31,008. This includes an estimated burden cost of $31,008 and an estimated cost of $0 for capital investment or maintenance and operational costs.

V. What is the next step in the process for these ICRs?

EPA will consider the comments received and amend the individual ICRs as appropriate. The final ICR packages will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.10. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of these ICRs to OMB and the opportunity for the public to submit additional comments for OMB consideration. If you have any questions about any of these ICRs or the approval process in general, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

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

Dated: July 18, 2019.

Alexandra Dapolito Dunn,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.