Document ID: EPA-HQ-OPPT-2008-0221-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment; EPA ICR No. 1031.09, OMB Control No. 2070-0017
Posted Date: 2008-06-18T04:00Z

[Federal Register: June 18, 2008 (Volume 73, Number 118)]
[Notices]               
[Page 34733-34734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn08-59]                         

[[Page 34733]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2008-0221; FRL-8365-5]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Recordkeeping and Reporting Requirements for 
Allegations of Significant Adverse Reactions to Human Health or the 
Environment; EPA ICR No. 1031.09, OMB Control No. 2070-0017

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this document announces that EPA is planning to 
submit a request to renew an existing approved Information Collection 
Request (ICR) to the Office of Management and Budget (OMB). This ICR, 
entitled: ``Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment'' and 
identified by EPA ICR No. 1031.09 and OMB Control No. 2070-0017, is 
scheduled to expire on January 31, 2009. Before submitting the ICR to 
OMB for review and approval, EPA is soliciting comments on specific 
aspects of the proposed information collection.

DATES: Comments must be received on or before August 18, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0221, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-2008-0221. The DCO is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0221. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD-ROM you submit. If EPA cannot read 
your comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket materials are available electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT 
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at 
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. 
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding Federal holidays. The telephone 
number of the EPA/DC Public Reading Room is (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
are required to show photographic identification, pass through a metal 
detector, and sign the EPA visitor log. All visitor bags are processed 
through an X-ray machine and subject to search. Visitors will be 
provided an EPA/DC badge that must be visible at all times in the 
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Gerry Brown, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8086; fax 
number: (202) 564-4765; e-mail address: brown.gerry@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, 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.
    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.

[[Page 34734]]

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible and provide specific 
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified 
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

III. What Information Collection Activity or ICR Does this Action Apply 
to?

    Affected entities: Entities potentially affected by this action are 
companies that manufacture, process, import, or distribute in commerce 
chemical substances or mixtures.
    Title: Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment.
    ICR numbers: EPA ICR No. 1031.09, OMB Control No. 2070-0017.
    ICR status: This ICR is currently scheduled to expire on January 
31, 2009. 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 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 in certain EPA 
regulations is consolidated in 40 CFR part 9.
    Abstract: The Toxic Substances Control Act (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.
    Responses to the collection of information are mandatory (see 40 
CFR part 717). Respondents may claim all or part of a notice 
confidential. EPA will disclose information that is covered by a claim 
of confidentiality only to the extent permitted by, and in accordance 
with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range between 
1 minute and 8 hours per response, depending upon the nature of the 
response. Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements 
which have subsequently changed; train personnel to be able to respond 
to a collection of information; search data sources; complete and 
review the collection of information; and transmit or otherwise 
disclose the information.
    The ICR provides a detailed explanation of this estimate, which is 
only briefly summarized here:
    Estimated total number of potential respondents: 13,521.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 
0.43.
    Estimated total annual burden hours: 23,536 hours.
    Estimated total annual costs: $1,486,311. This includes an 
estimated burden cost of $1,486,311 and an estimated cost of $0 for 
capital investment or maintenance and operational costs.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a decrease of 1,012 hours (from 24,548 hours to 23,536 
hours) in the total estimated respondent burden compared with that 
identified in the ICR currently approved by OMB. This decrease 
primarily reflects EPA's current estimate of the number of employees in 
affected respondent companies. Because the allegation rate is based on 
the number of employees, the decrease in the estimated number of 
employees results in a decrease in total allegations, and thus a 
reduction in burden. This change is an adjustment.

V. 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 notice 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.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: June 11, 2008.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.

[FR Doc. E8-13841 Filed 6-17-08; 8:45 am]

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