Document ID: EPA-HQ-OPPT-2011-0699-0003
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Allegations of Significant Adverse Reactions to Human Health or Environment
Posted Date: 2012-07-18T04:00Z

[Federal Register Volume 77, Number 138 (Wednesday, July 18, 2012)]
[Notices]
[Pages 42306-42307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17485]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0699; FRL-9520-3]

Agency Information Collection Activities; Submission 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: In compliance with the Paperwork Reduction Act, this document 
announces that the following Information Collection Request (ICR) has 
been forwarded to the Office of Management and Budget (OMB) for review 
and approval: Recordkeeping and Reporting Requirements for Allegations 
of Significant Adverse Reactions to Human Health or the Environment; 
EPA ICR No. 1031.10, OMB No. 2070-0017. The ICR, which is abstracted 
below, describes the nature of the information collection activity and 
its expected burden and costs.

DATES: Additional comments may be submitted on or before August 17, 
2012.

ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2011-0699 to (1) EPA online using www.regulations.gov (our 
preferred method), by email to oppt.ncic@epa.gov or by mail to: 
Document Control Office (DCO), Office of Pollution Prevention and 
Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB at: Office of 
Information and Regulatory Affairs, Office of Management and Budget 
(OMB), Attention: Desk Officer for EPA, 725 17th Street NW., 
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Pamela Myrick, Acting Director, 
Environmental Assistance Division, Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, Mail code: 7408-M, 1200 
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-554-
1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB 
for review and approval according to the procedures prescribed in 5 CFR 
1320.12. On October 25, 2011 (76 FR 66061), EPA sought comments on this 
renewal pursuant to 5 CFR 1320.8(d). EPA received no comments during 
the comment period. Any comments related to this ICR should be 
submitted to EPA and OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID 
No. EPA EPA-HQ-OPPT-2011-0699, which is available for online viewing at 
http://www.regulations.gov, or in person inspection at the OPPT Docket 
in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 
Constitution Ave. NW., Washington, DC. The EPA Docket Center Public 
Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Reading Room is 
202-566-1744, and the telephone number for the Pollution Prevention and 
Toxics Docket is 202-566-0280. Use www.regulations.gov to submit or 
view public comments, access the index listing of the contents of the 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the docket ID number identified above.
    EPA's policy is that public comments, whether submitted 
electronically or in paper, will be made available for public viewing 
in www.regulations.gov as EPA receives them and without change, unless 
the comment contains copyrighted material, confidential business 
information (CBI), or other information whose public disclosure is 
restricted by statute. When EPA identifies a comment containing

[[Page 42307]]

copyrighted material, EPA will provide a reference to that material in 
the version of the comment that is placed in www.regulations.gov. The 
entire printed comment, including the copyrighted material, will be 
available in the public docket. Although identified as an item in the 
official docket, information claimed as CBI, or whose disclosure is 
otherwise restricted by statute, is not included in the official public 
docket, and will not be available for public viewing in 
www.regulations.gov. For further information about the electronic 
docket, go to www.regulations.gov.
    Title: Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment.
    ICR Status: This is a request to renew an existing approved 
collection. This ICR is scheduled to expire on August 31, 2012. Under 
OMB regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB.
    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.
    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 CFR, after appearing in the Federal 
Register, are listed in 40 CFR part 9 and included on the related 
collection instrument or form, if applicable.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range between 
approximately 1 minute and 8 hours per response, depending upon the 
type(s) of activity that a respondent must complete. Burden is defined 
in 5 CFR 1320.3(b).
    Respondents/Affected Entities: Entities potentially affected by 
this action are companies that manufacture, process, import, or 
distribute in commerce chemical substances or mixtures.
    Frequency of Collection: On occasion.
    Estimated No. of Respondents: 13,951.
    Estimated Total Annual Burden on Respondents: 26,978 hours.
    Estimated Total Annual Costs: $1,797,800.
    Changes in Burden Estimates: This request reflects an increase of 
3,442 hours (from 23,536 hours to 26,978 hours) in the total estimated 
respondent burden from that currently in the OMB inventory. This 
increase reflects EPA's estimate of a greater number of potential 
respondents affected by the reporting requirement. The Supporting 
Statement provides details about the change in burden estimate. The 
change is an adjustment.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-17485 Filed 7-17-12; 8:45 am]
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