Document ID: EPA-HQ-OPPT-2018-0611-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups (EPA ICR No. 2584.01)
Posted Date: 2019-08-05T04:00Z

[Federal Register Volume 84, Number 150 (Monday, August 5, 2019)]
[Notices]
[Pages 38029-38031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16616]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2018-0611 and EPA-HQ-OPPT-2018-0612; FRL-9988-54]

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 (EPA ICR No. 2585.01)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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: (202) 564-7116; email 
address: monroe.albert@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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

[[Page 38030]]

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

[[Page 38031]]

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.
[FR Doc. 2019-16616 Filed 8-2-19; 8:45 am]
 BILLING CODE 6560-50-P