Document ID: EPA-HQ-OPPT-2010-1011-0014
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances, etc.
Posted Date: 2011-12-07T05:00Z

[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76403-76404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31405]

[[Page 76403]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2010-1011; FRL-9500-5]

Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request; Pre-Manufacture Review Reporting 
and Exemption Requirements for New Chemical Substances and Significant 
New Use Reporting Requirements for Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), 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: Pre-Manufacture Review 
Reporting and Exemption Requirements for New Chemical Substances and 
Significant New Use Reporting Requirements for Chemical Substances; EPA 
ICR No. 0574.15, OMB No. 2070-0012. 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 January 6, 
2012.

ADDRESSES: Submit your comments, referencing docket ID Number EPA-HQ-
OPPT-2010-1011 to (1) EPA online using http://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 August 3, 2011 (76 FR 46794), 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-2010-1011, 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 http://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 http://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 
copyrighted material, EPA will provide a reference to that material in 
the version of the comment that is placed in http://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 http://www.regulations.gov. For further information 
about the electronic docket, go to http://www.regulations.gov.
    Title: Pre-Manufacture Review Reporting and Exemption Requirements 
for New Chemical Substances and Significant New Use Reporting 
Requirements for Chemical Substances.
    ICR Status: This is a request to renew an existing approved 
collection. This ICR is scheduled to expire on December 31, 2011. Under 
OMB regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB.
    Abstract: Section 5 of the Toxic Substances Control Act (TSCA) 
requires manufacturers and importers of new chemical substances to 
submit to EPA notice of intent to manufacture or import a new chemical 
substance 90 days before manufacture or import begins. EPA reviews the 
information contained in the notice to evaluate the health and 
environmental effects of the new chemical substance. On the basis of 
the review, EPA may take further regulatory action under TSCA, if 
warranted. If EPA takes no action within 90 days, the submitter is free 
to manufacture or import the new chemical substance without 
restriction.
    TSCA section 5 also authorizes EPA to issue Significant New Use 
Rules (SNURs). EPA uses this authority to take follow-up action on new 
or existing chemicals that may present an unreasonable risk to human 
health or the environment if used in a manner that may result in 
different and/or higher exposures of a chemical to humans or the 
environment. Once a use is determined to be a significant new use, 
persons must submit a notice to EPA 90 days before beginning 
manufacture, processing or importation of a chemical substance for that 
use. Such a notice allows EPA to receive and review information on such 
a use and, if necessary, regulate the use before it occurs.
    Finally, TSCA section 5 also permits applications for exemption 
from section 5 review under certain circumstances. An applicant must 
provide information sufficient for EPA to make a determination that the 
circumstances in question qualify for an exemption. In granting an 
exemption, EPA may impose appropriate restrictions. This information 
collection addresses the reporting and recordkeeping requirements 
associated with TSCA section 5.
    Responses to the collection of information are mandatory (see 40 
CFR parts 700, 720, 721, 723 and 725). 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

[[Page 76404]]

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 
0.725 hours and 508 hours per response, depending upon the type of 
response. Burden is defined in 5 CFR 1320.3(b).
    Respondents/Affected Entities: Entities potentially affected by 
this action are manufacturers, processors or importers of chemical 
substances.
    Frequency of Collection: On occasion.
    Estimated Average Number of Responses for Each Respondent: 4.8.
    Estimated No. of Respondents: 443.
    Estimated Total Annual Burden on Respondents: 117,162 hours.
    Estimated Total Annual Costs: $34,417,821.
    Changes in Burden Estimates: This request reflects a decrease of 
350 hours (from 117,512 hours to 117,162 hours) in the total estimated 
respondent burden from that currently in the OMB inventory. This 
decrease represents a re-estimate in the number of annual submissions 
to reflect EPA's experiences since the most recent ICR. The decrease in 
the number of annual submissions is largely associated with the 
finalization of the e-PMN rule in 2010. The change is an adjustment.

    Dated: November 30, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-31405 Filed 12-6-11; 8:45 am]
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