Document ID: EPA-HQ-OPPT-2015-0688-0008
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
Posted Date: 2021-03-29T04:00Z

[Federal Register Volume 86, Number 58 (Monday, March 29, 2021)]
[Notices]
[Pages 16347-16348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06417]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0688; FRL-10018-27]

Agency Information Collection Activities; Proposed Renewal of an 
Existing Collection and Request for Comment; Recordkeeping and 
Reporting Requirements for Allegations of Significant Adverse Reactions 
to Human Health or the Environment

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 an Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICR, entitled: ``Recordkeeping and Reporting Requirements for 
Allegations of Significant Adverse Reactions to Human Health or the 
Environment'' and identified by EPA ICR No. 1031.12 and OMB Control No. 
2070-0017, represents the renewal of an existing ICR that is scheduled 
to expire on October 31, 2021. Before submitting the ICR to OMB for 
review and approval, EPA is soliciting comments on specific aspects of 
the proposed information collection that is summarized in this 
document. The ICR and accompanying material are available in the docket 
for public review and comment.

DATES: Comments must be received on or before May 28, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2015-0688, by using the Federal eRulemaking 
Portal at http://www.regulations.gov. 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Thomas Forbes (7407M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-0810; email address: forbes.thomas@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.

[[Page 16348]]

    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 ICR does this action apply 
to?

    Title: Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment.
    ICR number: EPA ICR No. 1031.12.
    OMB control number: OMB Control No. 2070-0017.
    ICR status: This ICR is currently scheduled to expire on October 
31, 2021. 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 listed in 40 CFR 
part 9, 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.
    Abstract: TSCA section 8(c) requires companies that manufacture, 
process, or distribute chemicals to maintain records of significant 
adverse reactions to health or the environment alleged to have been 
caused by such chemicals. Since section 8(c) includes no automatic 
reporting provision, EPA can obtain and use the information contained 
in company files only by inspecting those files or requiring reporting 
of records that relate to specific substances of concern. Therefore, 
under certain conditions, and using the provisions found in 40 CFR part 
717, EPA may require companies to report such allegations to the 
Agency. EPA uses such information on a case specific basis to 
corroborate suspected adverse health or environmental effects of 
chemicals already under review by EPA. The information is also useful 
to identify trends of adverse effects across the industry that may not 
be apparent to any one chemical company. This ICR addresses the 
information reporting and recordkeeping requirements found in 40 CFR 
part 717.
    Responses to the collection of information are mandatory (see 40 
CFR part 717). Respondents may claim all or part of a notice as CBI. 
EPA will disclose information that is covered by a CBI claim only to 
the extent permitted by, and in accordance with, the procedures in 40 
CFR part 2.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 8 
hours per report. 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 are companies that manufacture, process, import, or distribute 
in commerce chemical substances or mixtures.
    Estimated total number of potential respondents: 13,160.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 
1.4.
    Estimated total annual burden hours: 25,527 hours.
    Estimated total annual costs: 1,987,487.00.

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

    There is an increase in the total cost associated with this ICR as 
a result in an increase in the wage rate from $1,911,477 to $1,987,487. 
This change is an adjustment.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal 
agencies and departments and is based on the submission instructions 
established by OMB in 1995, replacing the alternate format developed by 
EPA and OMB prior to 1995. EPA intends to update this Supporting 
Statement during the comment period to reflect the 18-question format, 
and has included the questions in an attachment to this Supporting 
Statement. In doing so, the Agency does not expect the change in format 
to result in substantive changes to the information collection 
activities or related estimated burden and costs.

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

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package 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 ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the technical person listed under 
FOR FURTHER INFORMATION CONTACT.

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

    Dated: March 18, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-06417 Filed 3-26-21; 8:45 am]
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