Document ID: EPA-HQ-OPPT-2015-0688-0007
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: 2016-09-28T04:00Z

[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Notices]
[Pages 66657-66658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23384]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0688; FRL-9947-01-OEI]

Agency Information Collection Activities; Information Collection 
Request Submitted to OMB for Review and Approval; Comment Request; 
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: The Environmental Protection Agency (EPA) has submitted the 
following information collection request (ICR) to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act: ``Recordkeeping and Reporting Requirements 
for Allegations of Significant Adverse Reactions to Human Health or the 
Environment'' (EPA ICR No. 1031.11, OMB Control No. 2070-0017). This is 
a request to renew the approval of an existing ICR, which is currently 
approved through September 30, 2016. EPA did not receive any comments 
in response to the previously provided public review opportunity issued 
in the Federal Register of March 10, 2016 (81 FR 12730). With this 
submission, EPA is providing an additional 30 days for public review.

DATES: Comments must be received on or before October 28, 2016.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-HQ-
OPPT-2015-0688, to both EPA and OMB as follows:
    [ssquf] To EPA online using http://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, and
    [ssquf] To OMB via email to oira_submission@omb.eop.gov. Address 
comments to OMB Desk Officer for EPA.
    EPA's policy is that all comments received will be included in the 
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.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Environmental 
Assistance Division (7408M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington,

[[Page 66658]]

DC 20460; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:
    Docket: Supporting documents, including the ICR that explains in 
detail the information collection activities and the related burden and 
cost estimates that are summarized in this document, are available in 
the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William 
Jefferson Clinton Bldg., Rm. 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.
    ICR status: This ICR is currently scheduled to expire on September 
30, 2016. Under OMB regulations, the Agency may continue to conduct or 
sponsor the collection of information while this submission is pending 
at OMB.
    Under PRA, 44 U.S.C. 3501 et seq., 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 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.
    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.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by 
this ICR are companies that manufacture, process, import, or distribute 
in commerce chemical substances or mixtures.
    Respondent's obligation to respond: Mandatory; see 40 CFR part 717.
    Estimated number of respondents: 13,160 (total).
    Frequency of response: On occasion.
    Total estimated burden: 25,527 hours (per year). Burden is defined 
at 5 CFR 1320.03(b).
    Total estimated cost: $1,911,471 (per year), includes $0 annualized 
capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 1,405 hours in the 
total estimated respondent burden compared with the ICR currently 
approved by OMB. This decrease is due to EPA's estimate of fewer 
potential respondents affected by the reporting requirement.

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

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2016-23384 Filed 9-27-16; 8:45 am]
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