Document ID: EPA-HQ-OPPT-2015-0688-0016
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Allegations of Significant Adverse Reactions to Human Health or the Environment (Renewal)
Posted Date: 2021-10-25T04:00Z

[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Notices]
[Pages 58905-58906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23122]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0688; FRL-9137-01-OMS]

Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; Allegations of Significant Adverse Reactions 
to Human Health or the Environment (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an 
information collection request (ICR), ``Allegations of Significant 
Adverse Reactions to Human Health or the Environment'' (EPA ICR Number 
1031.12 and OMB Control Number 2070-0017) to the Office of Management 
and Budget (OMB) for review and approval in accordance with the 
Paperwork Reduction Act. This is a proposed extension of the ICR which 
is currently approved through October 31, 2021. Public comments were 
previously requested via the Federal Register on March 29, 2021 during 
a 60-day comment period. This notice allows for an additional 30 days 
for public comments. A fuller description of the ICR is given below, 
including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before November 24, 
2021.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OPPT-2015-0688, online using www.regulations.gov (our preferred 
method), or by mail to: EPA Docket Center, Environmental Protection 
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 
20460. EPA's policy is that all comments received will be included in 
the public docket without change including any personal information 
provided, unless the comment includes profanity, threats, information 
claimed to be Confidential Business Information (CBI), or other 
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed 
information collection within 30 days of publication of this notice to 
www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Virginia Lee, Data Gathering and 
Analysis Division (7401M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460; telephone number: (202) 564-4142; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in 
detail the information that the EPA will be collecting, are available 
in the public docket for this ICR. The docket can be viewed online at 
www.regulations.gov or in person at the EPA Docket Center, WJC West, 
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For additional 
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Under section 8(c) of the Toxic Substances Control Act 
(TSCA), 15 U.S.C. 2607(c), companies that manufacture, process, or 
distribute chemicals are required to maintain records of significant 
adverse reactions to health or the environment alleged to have been 
caused by such chemicals. Since TSCA 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

[[Page 58906]]

recordkeeping requirements found in 40 CFR part 717. Respondents may 
claim all or part of a notice confidential.
    Form Numbers: None.
    Respondents/Affected Entities: Companies that manufacture, process, 
import, or distribute in commerce chemical substances or mixtures.
    Respondent's obligation to respond: Mandatory (40 CFR part 717).
    Estimated number of respondents: 13,160 (total).
    Frequency of response: 1.
    Total Estimated burden: 25,527 hours (per year). Burden is defined 
at 5 CFR 1320.03(b).
    Total Estimated cost: $4,701,622 (per year) includes $0 annualized 
capital or operation and maintenance costs.
    Changes in the Estimates: There is no change in the estimated 
annual burden compared with the ICR currently approved by OMB. There 
is, however, an increase in the estimated total burden cost from 
$1,987,487 to $4,701,622 that is related to an adjustment in the burden 
cost calculation associated with projected compliance determination 
activities. This change is an adjustment.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-23122 Filed 10-22-21; 8:45 am]
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